Human subjects research (IRB)

This policy describes the procedures the Institutional Review Board (IRB) at Lynn University will follow when reviewing research with human subjects in compliance with federal requirements for the protection of research subjects. For information on the federal regulations, please refer to the United States Department of Health and Human Services Regulations, Protection of Human Subjects: Title 45, Code of Federal Regulations, part 46 (45 CFR 46), revised June 18, 1991, December 28, 2000, August 14, 2002, and 21 CFR parts 50 and 56 [Food and Drug Administration Regulation on Protection of Human Subjects]. Also see the Health Insurance Portability and Accountability Act (HIPAA) of 1996; the Privacy Rule (also known as Standards for Privacy of Individually Identifiable Health Information) is in Title 45 of the Code of Federal Regulations, Part 160 and Subparts A and E of Part 164.

Lynn University is committed to a policy of safeguarding the rights and welfare of all human subjects in research. As standards for the ethical treatment of human subjects, the university accepts the principles set forth by the national Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly known as the Belmont Report) and Title 45, section 46 of the U.S. Code.

Principal investigator means a person who has ultimate administrative and fiscal authority in conducting and coordinating a research project.

Co-investigator means a person who conducts research for a given project but does not have ultimate administrative or fiscal responsibility.

Institution means any public or private entity or agency (including federal, state, and other agencies), and in particular Lynn University.

Legally authorized representative means an individual, judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

A minor generally means a person who is under the age of 18 who is not an emancipated minor except for certain purposes as specified by law.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities under this policy.

Research subject to regulation, and similar terms, is intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration).

Research includes questionnaires, interviews, tests, observations, surveys, and other experiments under the auspices of the university.

The following activities do not meet the definition of research and do not require IRB review:

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship) that focus directly on the specific individuals about whom the information is collected;
2. Public health surveillance activities authorized by a public health authority to assess onsets of disease outbreaks or conditions of public health importance;
3. Certain criminal justice and intelligence activities; and
4. Authorized operational activities in support of intelligence, homeland security, defense or national security missions.

Refer to 45 CFR 46.102(l) of the revised Common Rule for the full description of the categories of activities excluded from the definition of Research.

Human subject means a living person about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

Begin behavioral interventions are interactions that are brief, harmless, painless, not physically invasive, not likely to have significant adverse lasting impact, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

Interaction includes communication or interpersonal contact between an investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to obtain the information to constitute research involving human subjects.

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Identifiable biospecimen is a biospecimen for which the identity of the subject is or may be ascertained by the investigator or associated with the biospecimen.

IRB means an institutional review board established in accord with and for the purposes expressed in this policy.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

Legally authorized representative is an individual/judicial/body authorized under applicable law to consent on behalf of a prospective research subject.

Limited review is a review carried out by the IRB Chair or by one or more experienced reviewers designated by the chair from among members of the IRB, and is confined to approving the storage and maintenance plan for the privacy and confidentiality of identifiable data under exempt category two (2) and three (3).

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Protected health information (PHI) means health information transmitted or maintained in any form or medium that: (a) identifies or could be used to identify an individual; and (b) is created or received by a healthcare provider, health plan, employer or healthcare clearinghouse; and (c) relates to the past, present or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of healthcare to an individual.

Vulnerable subject is a research subject vulnerable to coercion or undue influence.

I. Purpose of the IRB

The Lynn University Institutional Review Board (IRB) is an independent ethical review committee mandated by the U.S. Department of Health and Human Services (DHHS). The IRB’s purpose is to review research proposals for compliance with federal regulations and ethical principles to insure that human research subjects are adequately protected from harm, and that they give voluntary, informed consent to their participation.

The IRB and Lynn University research activities are subject to review by a variety of agencies, chief among them is the Office for Human Research Protections (OHRP). The Office of Academic Affairs, under the direction of the Vice President for Academic Affairs, is the administrative office responsible for the University’s system of protections for human research participants.

II. Role and authority of the IRB

The Lynn University IRB is established under authority delegated by the Board of Trustees to the President of Lynn University and under the governing federal regulations outlined above.

Vested with the ethical imperative to safeguard the rights and welfare of human subjects in research studies at Lynn University, the IRB has jurisdiction over any research project that involves or has the potential to involve human beings as the subjects of research and that is proposed to be carried out by a member of the Lynn University community (including faculty, students, staff, and administrators), or proposed to be carried out on Lynn University property, or that involves members of the Lynn University community as subjects of the research.

Specifically, the IRB has the authority to approve, require modifications, or disapprove proposals for research on human subjects conducted at Lynn University, or conducted by members of the Lynn University community (including faculty, students, staff, and administrators) so as to assure protection of human subjects in three major areas:

• The procedures do not place the subject at risk, include no unnecessary risks and minimize potential risks to subjects;
• The subject is informed about the purpose and intent of the research along with the necessary and sufficient details, including description of the risks or discomforts and the anticipated benefits, to assure voluntary and informed consent; and
• Privacy of the subjects and confidentiality of subject data are adequately protected.

Where the participants are members of a vulnerable population, the IRB determines whether appropriate additional safeguards are in place to protect the rights and welfare of these research participants.

In addition, the benefits of the research must outweigh the risks to the subjects. The IRB measures the importance and significance of the scientific knowledge potentially gained against risks to study subjects. The researcher is required to provide the supporting documentation. For Lynn University, the IRB is the only authorized university committee to make this determination. The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination or approval includes a statement of the reasons for the IRB’s action and is reported promptly to the investigator, appropriate institutional officials, and pertinent external bodies.

The IRB is responsible for review of Applications and Research Protocols required for all new research. The IRB determines intervals of periodic review (continuation/renewal), and, where appropriate, determines that adequate provisions are in place for monitoring the data collected to ensure the safety of subjects. The IRB is responsible for review of procedural revisions, advertisements to recruit subjects, and reports of adverse events and project termination. In addition, for research activities involving Protective Health Information (PHI), the IRB acts as the institution’s Privacy Board (required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA)) to review and approve the proposed access, use, and disclosure of the PHI. Where applicable, The IRB will determine whether research subjects are required to sign an authorization for the use and disclosure of their PHI, or if one of the exceptions to the authorization requirements applies. Examples of these exceptions include waivers of authorization and the use of de-identified data or limited data sets.

III. Statement of research principles

The following are the principles governing Lynn University in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research.

• Research must be justifiable for its scientific or other meaningful purpose or value.
• Even if an inquiry has scientific or other value, it must not be pursued if the benefit is outweighed by risk to the subject.
• The research must be conducted by sufficiently competent and knowledgeable people.
• The research must be conducted under a sound design, suited to the nature of the study.
• Informed consent is a process ensuring ethical conduct of research. No person should serve as the subject of research unless he or she, or an authorized or legal representative, has given voluntary consent after being fully informed of the nature, risks, and benefits of the study and their rights as participants. Additional safeguards must be included in the study to protect the rights and welfare of subjects.
• Participation as a subject in a research study should be voluntary, and care should be exercised to ensure that subtle pressures are not used to obtain participation.
• Care must be taken throughout the duration of the research study (and sometimes beyond) to ensure against the risk of harm to subjects, either physical or emotional.
• Research must be terminated if there arises a serious risk of harm to subjects, either physical or emotional.
• The subject should be entitled to withdraw from participation in a research study at any time.

IV. IRB membership & meetings

A. IRB membership

IRB members are selected for their experience, expertise, diversity and breadth in backgrounds and represent individuals with primary concerns in both scientific and non-scientific areas.

The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Every nondiscriminatory effort will be made to ensure that the IRB does not consist entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. Additionally, the IRB shall not consist entirely of members of one profession.

In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If the IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. It must also include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

The Vice President for Academic Affairs shall appoint members to the Lynn University IRB to ensure compliance with federal and state requirements and institutional policies.

The IRB shall include at least five (5) members. The Chair is selected annually from among the sitting members of the IRB and is appointed by the Vice President for Academic Affairs. The Chair serves a one (1) year term and can be re-elected for a second one (1) year term among the sitting members of the IRB. Service as the Chair will rotate amongst members of the committee. If the position of Chair becomes vacant, a new Chair shall be elected at the next scheduled meeting.

At the option of the IRB, a Vice Chair may be elected from among the IRB members to assist the Chair in performance of duties.

Members may include:

• Deans of the colleges in the university (or their designated representatives);
• Coordinators of the Ph.D. programs (or their designated representatives);
• The General Counsel; from a non-scientific area (or a designated representative);
• One non-affiliated university member from the community at-large: A non- affiliated member means an IRB member who is not affiliated with or employed by the university, nor part of the immediate family of a person who is affiliated or employed by the university;
• Members of the full-time teaching faculty from each of the Lynn University discipline areas;
• Representatives are elected by members of the discipline areas for a 3-year term** and must be approved by the Vice President for Academic Affairs.

Responsibilities of the Chair

The Chair shall preside over meetings of the IRB.

Each application, request or report pertaining to a research proposal shall be identified by an IRB Number that begins with the year of initial submission, followed by three digits. For example, the first application submitted in the year 2016, has the seven digit assigned IRB number of: 2006001 and the second application has the IRB number of 2016002. A record is maintained on each IRB project, appropriately labeled with an IRB number.

Assign review to IRB members for applications and research proposals and other requests or reports that do not require a convened full-board review.

The Chair shall forward all applications and IRB report forms to the Office for Academic Affairs for records maintenance at the end of the calendar year (June 30). (See Records Maintenance)

All formal correspondence, decisions and recommendations in the name of the IRB shall include the IRB number and bear the signature of the Chair. The Chair shall forward all communications to the Office for Academic Affairs for records maintenance at the end of the Calendar year (June 30).

The Chair shall maintain a list of IRB members for each academic year and include the following: (a) a list of IRB members identified by name; (b) earned degrees; (c) representative capacity; (d) indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and (e) any employment or other relationship between each member and the institution. (See 45 CFR §46.103).

In instances where a project is funded or sponsored by the Federal Government changes in IRB membership must be reported to the Department or Agency head, unless in accord with §46.103(a), the existence of a DHHS-approved assurance is accepted. In this case, change in IRB membership must be reported to the Office for Protection from Research Risks, National Institutes of Health, DHHS.

The IRB will conduct at least two scheduled IRB Meetings annually. However, proposals for review will be reviewed on a continuous basis and proposals may be submitted when they are ready for review.

The Chair will forward all proposals to each IRB member no later than one week prior to convened meetings. Communications to investigators shall be made in writing, within 5 working days of the IRB meeting.

The IRB will notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (45 CFR § 46.109)

The IRB Chair will keep all IRB members advised of actions which use the expedited review procedure and applications through regular reporting at convened meetings for approved expedited reviews, exemptions, continuation, procedural revisions, and advertisements to recruit subjects, and reports of adverse events and project termination.

B. Meetings

The IRB shall meet and conduct business at least twice a year, or more often at the call of the chairperson. Electronic submission of applications will be accepted on a rolling basis.

Except for where expedited review is appropriate under HHS regulations at 45 CFR 46.110(b)(1), initial and continuing reviews of research will be conducted by the IRB at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

Procedures for IRB meetings

Principal Investigators and Co-Principal Investigators may attend the IRB meeting upon the invitation of the Chair to provide information to the members, but they may not be present during the final discussions and vote.

IRB members may not participate in the initial review or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. Examples of such conflicts of interest could include: a member of the IRB who serves as an investigator on research under consideration by the IRB; or a member who holds a significant financial interest in a sponsor or product under study.

At its discretion, the IRB may invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available to the IRB. Individuals invited to assist in review at the discretion of the IRB shall not vote.

Meetings

(45 CFR §46.115 IRB records) Attendance shall be recorded. Agenda Items include:

• Approval of minutes
• Approval of agenda
• Old business
• New business: reports or IRB committee review and action (include assigned IRB number, title, and author). Provide records of actions, discussion and resolution of controverted issues:
  • Application and protocol for review of research involving human subjects for a new project (IRB form 1)
  • Application to continue (renew) a previously approved IRB project (form 2)
  • Application for procedural revisions of or changes in research protocol and/or informed consent for IRB form 1 of a previously approved project (IRB form 3)
  • Report on unexpected adverse event, serious injury, or death (IRB form 4)
  • Applications and protocol for requests for exemptions (IRB form 5)
  • Applications and protocol for expedited reviews (IRB form 6)
  • Request for approval of advertisements to recruit subjects (IRB form 7)
  • Report of termination of IRB projects (IRB form 8)
• Other business
• Adjournment and announcement of next meeting date

Rules of order

Parliamentary procedures follow Robert's rules of order.

Quorum

A quorum of the IRB shall consist of at least 1/2 of the current membership. Furthermore, it shall consist of at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Should the quorum fail during a meeting, the IRB may not take further actions or votes unless quorum can be restored.

Voting

Voting on matters shall be by viva voce (by the voice), or "show of hands," general (unanimous) consent unless someone objects, or by request for a secret (written) ballot by any single member of the committee.

Proxy voting. A proxy is a power of attorney given by one member of the committee to another to vote in his/her behalf.

All actions shall require affirmation of a majority of a quorum of the current membership except in the following instances where two-thirds of the majority is required.

Motions requiring a two-thirds of the majority include but are not limited to the following:

• Amend any rules of order, previously adopted;
• Suspending the rules.

In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

The IRB may consult outside experts, target populations, and others to assist in decision-making during the review process when deemed necessary.

V. Criteria for IRB approval of research

In order to approve research covered by this policy, the IRB will determine that all of the following requirements are satisfied:

A. Risks to subjects are minimized

Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. Minimal risk implies that the likelihood and degree of harm or discomfort expected as a result of the research are not greater than the risks encountered during the course of daily activity or during the course of routine physical or psychological examinations. Such risk considerations should not be limited to physical risk alone, but should also consider emotional and psychological risk, personal risk, and possible insurability risk.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

B. Selection of subject is equitable

In making this assessment, the IRB will take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as minors, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Investigators should detail any extra precautions taken to safeguard the rights and welfare of subject populations.

C. Informed consent and assent

Informed consent has been obtained and appropriately documented from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required set forth in the general requirements for informed consent section of this policy.

D. Subject safety

Where applicable, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. The IRB will review who has been identified as having the primary responsibility for analyzing individual events to determine whether the study should be modified to minimize risk to current or future research subjects.

E. Privacy of subject

When appropriate, the research plan makes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

F. Vulnerable subjects

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as minors, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. A full description of safeguards to ensure the fair and equitable treatment of these subjects and protect their rights and welfare can be found in the Department of Health and Human Services Office for Human Research Protections Code of Federal Regulations.

G. Required IRB training

Lynn University offers an IRB training course through www.citiprogram.org. This training is up-to-date and meets the federal requirements for training in human subjects protections. Completion of this training is required for individuals participating in the IRB process, including investigators.

VI. IRB application instructions

The Lynn University IRB will review and have authority to approve, require modifications in, or disapprove all research activities covered by this document. All proposals for human subjects’ research must be submitted to the IRB for review and approval in accordance with the application instructions below. No involvement of human subjects may take place prior to formal, written notification from the IRB.

A submission for review by the IRB must be prepared for each research study using human subjects or human materials. All of the appropriate forms must be neatly typed and accurately completed. The IRB review cannot be accomplished unless all of the sections are completed. Any application that is not completed properly will be returned, possibly resulting in a delay in the review process.

Application materials (IRB Forms) are available on the myLynn portal.

Submissions to the IRB are accepted in electronic format. Please follow the instructions for completing the forms that are in PDF format.

All new research projects require the submission of IRB Form 1 (IRB Application and Research Protocol for Review of a New Project). In addition, either Form 2 (Request for Exemption) or Form 3 (Expedited Review) is to be completed and submitted along with Form 1 if the investigator believes the proposal qualifies for:

• An exemption from federal regulations as noted in 45 CFR §46.101(b), exempt from full board or expedited review; or
• An expedited review as noted in CFR 45 §46.110, for certain kinds of research involving no more than minimal risk.

Note: Institutional research surveys are not subject to IRB review.

VII. Levels of IRB review

There are five types of IRB reviews: (1) a full board review; (2) an expedited review; (3) a limited review and (4) a continuing review. In addition, some research with human subjects is (5) exempt from review.

A. Convened full board review of new research projects

A full-board review occurs when the application and research protocols (form 1) involve more than minimal risk to research participants or vulnerable populations of research participants (other than minors when the protocol qualifies for expedited review) and are reviewed by the IRB at a convened meeting. Full board review is required for studies that involve greater than minimal risk or vulnerable populations that require special protection by the IRB. These populations include, but are not limited to: pregnant women, human fetuses and neonates, prisoners, and minors.

Examples of greater than minimal risk are:

• A clinical interventional study that randomly assigns human subjects to alternative experimental or placebo groups; and
• Studies involving sensitive information connected to personal identifiers.

Researchers intending to conduct research which will require full IRB review/discussion should submit their research protocols to the IRB Chair at least two weeks prior to the board’s next scheduled meeting. All submissions to the IRB are done electronically and are immediately distributed to the committee for review. Therefore, IRB notifications are rolling. Only those proposals that do not obtain consensus votes or have an IRB member indicate that they wish a formal discussion would be held for the full board meeting. Notification from the IRB will also occur in an electronic format.

To submit a full-board research protocol to the IRB, the following materials must be submitted electronically to the IRB Chair:

• Electronically signed IRB application and research protocol (IRB form 1) - all pages must be completed;
• Consent form and other requested materials and attachments; and
• Advertisement for subject recruitment, if applicable (IRB form 7).

In determining whether an IRB application and research is subject to full IRB review, the IRB will utilize the Office for Human Research Protections decision charts.

The IRB will attempt to review any full-IRB research proposal and respond with a decision within thirty (30) days of receipt of the proposal. When a proposal is submitted, it is checked for completeness. If not complete, it is returned to the principal investigator. If complete, it will be circulated to the members of the IRB for review at a convened meeting. At the meeting of the IRB, the proposal will be evaluated for the extent to which it provides for the protection of human subjects, demonstrates scientific merit and meets the criteria set forth in the Criteria for IRB Approval of Research section above. A majority of the members of the IRB must be present at a convened meeting, including at least one member whose primary concerns are in nonscientific areas. In order for the application to be approved, it must receive the approval of a majority of those members present at the meeting. The IRB chair will notify the investigator of the outcome of the full review.

B. Expedited review of new research projects

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the full IRB. Federal regulations make provisions for certain categories of research to be reviewed through an expedited procedure if the research involves no more than minimal risk. Expedited review is intended to enable the university to conserve administrative resources, provide timely reviews and focus the convened meetings of the IRB on those research activities involving greater risks or ethical complexities. In addition, the IRB may also use the expedite review procedure to review minor changes in previously approved research during the period covered by the original approval.

The following categories of research may be reviewed by the IRB through an expedited review procedure.

Research categories that meet criteria for expedited review

1. Clinical studies of drugs and medical devices only when certain conditions are met;
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts;
3. Prospective collection of biological specimens for research purposes by noninvasive means;
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x‐rays or microwaves.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects (45 CFR 46.104). This listing refers only to research that is non-exempt);
6. Collection of data from voice, video, digital, or image recordings made for research purposes; and
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

(NOTE: Categories 1, 2, 3 and 4 are specific to clinical studies and/or medical procedures, which are generally not applicable at Lynn University. Also, some research in the exempt category may be exempt from the HHS regulations for the protection of human subjects (45 CFR 46.104). This listing refers only to research that is non-exempt.)

Applicability for expedited review

Research protocols that qualify for expedited review must meet two conditions:

1. The research must be determined to be minimal risk; and
2. All proposed research activities must be included in the list of eligible categories of expedited research as established by the DHHS for this purpose (see above, as well as hhs.gov).

Expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. In addition, expedited review procedures may not be used for classified research involving human subjects.

Standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or Full Board--utilized by the IRB.

See also the Office for Human Research Protections expedited review decision chart.

Procedures for expedited review

Under expedited review procedures, reviews may be carried out by the IRB Chair, or at the discretion of the Chair, by one or more experienced reviewers designated by the Chair from among members of the IRB. The expedited reviewer possess all the same authorities as the full IRB to approve, modify, or conditionally approve the proposed research activities, except the authority to disapprove a research activity. A research activity may be disapproved only after review in accordance with the ordinary, non-expedited procedure set forth in 45 CFR 46.108(b).

To submit an expedited research protocol to the IRB, the following materials must be submitted electronically to the IRB Chair:

• Electronically signed IRB application and research protocol (IRB form 1) - all pages must be completed;
• Consent form and other requested materials and attachments;
• Completed request for expedited review (form 3); and
• Advertisement for subject recruitment, if applicable (form 7)

Under normal circumstances, the Chair or other assigned reviewer(s) is able to review protocols in this category within ten (10) business days after receipt of a substantively complete protocol.

C. Limited review

Limited IRB review is a new concept added by the Revised Common Rule and is utilized for the review of research that will record, store, maintain or, make secondary use identifiable private information (see the Research Categories that Meet Criteria for Limited Review clause below). It is an alternative to the IRB approval criteria otherwise used for review of research. In a limited IRB review, an IRB must conduct a review and make certain determinations as a condition of exemption.

Limited IRB review is designed to:

1. Ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens;
2. Reduce the chances that the disclosure of identifiable private information will occur and lead to harm; and
3. Respond to commenters who believe that IRB oversight should be retained for the secondary research use of identifiable private information and identifiable biospecimens.

Research categories that meet criteria for limited review

1. Research exempt under category #2(iii)6 [45 CFR 46.104 (2), iii]: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7)7 .
2. Research exempt under category #3(i)(C) [45 CFR 46.104 (3), i, C]: Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7).
3. Research exempt under category # 7 [45 CFR 46.104 (7)] - Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §__.111(a)(8)8 .
4. Research exempt under category # 8 [45 CFR 46.104 (8)] -
   1. Secondary research for which broad consent is required: research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
      1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with the required elements of informed consent;
      2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with the requirements for documentation of consent;
      3. An IRB conducts a limited IRB review and makes the determination required by §__.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent; and
      4. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Procedures for limited review

For purposes of conducting the limited IRB review, the IRB need not apply the IRB approval criteria otherwise used for review of research, and shall make the following determinations:

1. Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the required elements of broad consent;
2. Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with the requirements for documentation of consent; and
3. If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Continuing review of research is not required for research reviewed in accordance with the limited IRB review.

As an alternative to limited IRB review, the IRB may use the expedited review procedure to review research for which limited IRB review is a condition of exemption. Additional guidance on Limited Review is available at https://www.hhs.gov.

D. Continuing review

The IRB is required by the revised common rule (Section II.109(e)) to conduct continuing review of research requiring review by the full IRB (i.e., full review) at intervals appropriate to the degree of risk, not less than once per year. Each year, the IRB will send PIs an Annual Progress Report to complete. Continuing reviews are required until the research involves only data analysis, or “accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care” – unless the IRB reviewer provides a justification that continuing review beyond this point would enhance protection of research subjects.

Under the revised common rule, continuing review is not required for:

1. Research that is eligible for expedited review;
2. Exempt research conditioned on limited IRB review; and
3. Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable.

The IRB may override this default and still choose to require continuing review, as long as the IRB documents the decision and the rationale for this decision. Refer to 45 CFR 46.109(f), 46.110, and 46.115(a)(8) of the revised Common Rule.

Investigators still have the obligation to report various developments (such as unanticipated problems, adverse events or proposed changes to the study) to the IRB.

Pre-2019 research

Any study approved prior to January 21, 2019 will be subject to the university’s prior human subject research policy.

Annual reporting

The discontinuing of continuing review for most research means that the IRB will no longer send annual progress reports to pIs. However, Investigators should report to the IRB, on at least an annual basis, the withdrawal of subjects after informed consent for reasons related to the research study, or complaints from subjects or their legally authorized representatives (for example, parents or guardians). If there are not such events, investigators do not need to provide an annual report to the IRB. See also the sections on changes in IRB-approved research, and on unanticipated problems and adverse events, below.

E. Research exempted from review

Federal guidelines and university IRB policy permit certain types of research to proceed without IRB oversight. Exempt research activities involve no more than minimal risk and may include classroom studies, surveys, observation of public behavior, the non-invasive collection of physiological data, and the analysis of existing data that involves human subjects. Research that includes both exempt and non-exempt categories is not exempt. Irrespective of whether a study is exempt from full review, it must meet accepted standards of protection of privacy and a subject’s right to refuse participation without penalty. The determination as to whether any particular research project qualifies as "exempt" must be made by at least one IRB member in accordance with the exemption review procedures set forth below. Investigators do not have the discretion to make this determination.

Research activities exempt from IRB full review

The following research activities shall normally be exempt from full IRB review:

Exemption #1 [45 CFR 46.104 (1)]: Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special educational strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Exemption #2 [45 CFR 46.104 (2) i, ii, iii]: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation; or
3. (The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review (see Section C above) to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Exemption #3 [45 CFR 46.104 (3) i, ii, iii]:

1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation, or
   3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review see Section C above) to make the determination that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
2. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
3. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Exemption #4 [45 CFR 46.104 (4) i, ii]: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

1. The identifiable private information or identifiable biospecimens are publicly available;
2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.

[Criteria (iii) and (iv) involve the use of identifiable health information which usually would not apply to research at Lynn University and therefore is not listed in this policy.]

Exemption #5 [45 CFR 46.104 (5) i, ii] Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

1. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
2. [Reserved]

Exemption #6 [45 CFR 46.104 (6)] Taste and food quality evaluation and consumer acceptance studies:

1. If wholesome foods without additives are consumed, or
2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Exemption #7 [45 CFR 46.104 (7)] Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § 46.111(a)(8).

Exemption #8 [45 CFR 46.104 (8)] Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with § 46.116(a)(1) through (4), (a)(6), and (d);
2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with § 46.117;
3. An IRB conducts a limited IRB review and makes the determination required by § 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

More detailed information regarding exempt research activities may be found at 45 CFR §46.101(d)(1-8).

Exempt review procedures

IRB exemption reviews may be carried out by the IRB Chair, or at the discretion of the Chair, by one or more experienced reviewers designated by the Chair from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in CFR 45 § 46.108(d)(1-8).

To submit an expedited research protocol to the IRB, the following materials must be submitted electronically to the IRB Chair:

• Electronically signed IRB application and research protocol (IRB form 1) - all pages must be completed;
• Consent form and other requested materials and attachments;
• Completed request for exemption (form 2) - an exemption from federal regulations as noted in 45 CFR §46.101(b), exempt from full board or expedited review; and
• Advertisement for subject recruitment, if applicable (form 7)

Under normal circumstances, the Chair or another member, and generally not exceeding 3 IRB members, is able to review protocols in this category within ten (10) business days after receipt of a substantively complete protocol. In determining whether an IRB application and research is exempt from full IRB review, the IRB Chair or other IRB member will utilize the Office for Human Research Protections decision charts. If the activity does not qualify for exemption, the IRB Chair or a designee notifies the investigator in writing or via email. If the IRB Chair, or designee, determines that an application does not qualify for exemption, the application will be processed either through expedited review or by full IRB review.

The IRB reserves the right to request the investigator to provide additional information concerning applications or reports.

E. Research reviewed elsewhere

In certain instances, an investigator from Lynn University may be involved in a collaborative research project involving human subjects which is to be conducted at another institution. If this project has already been approved by the IRB at the collaborating institution, Lynn University's IRB Chair may waive review requirements by the Lynn University IRB if the collaborating institution's IRB is willing to enter into an Institutional Review Board Authorization Agreement, which would allow Lynn University's investigator to rely on the IRB oversight and OHRP Federal Wide Assurance (FWA ) at the collaborating institution. Likewise, Lynn University may provide IRB oversight to a collaborating institution by entering into an IAA as the institution providing IRB review.

F. Other IRB reviews

Training or center grants

When training grants are submitted and some projects are expected to involve human subjects, the training grant will be reviewed by the IRB Chair, or at the discretion of the Chair, by the full board or by one or more experienced reviewers designated by the chairperson from among members of the IRB. A certification of IRB review and approval will be sent to the funding agency. (Note: training and Center grants will be reviewed even though specific research projects for trainees or sub-projects are not fully described in the application. When IRB approval is provided for such applications, it will be contingent upon each project director submitting a complete or updated Application and Research Proposal (from 1) to the IRB prior to the initiation of their particular project.)

The investigator is responsible for ensuring that all subprojects supported by the training grant are also submitted for full IRB review prior to initiation. The annual continuing review of the training grant requires submission of a list of subprojects that involve human subjects and documentation that they have been reviewed by the IRB.

To submit a research protocol involving training or center grants to the IRB, the following materials must be submitted electronically to the IRB Chair:

• A copy of the complete proposal/grant as it was submitted to the funding agency;
• Electronically signed IRB application and research protocol (IRB form 1), form 2 (request for exemption) or form 3 (expedited review) if applicable – all pages must be completed;
• Consent form and other requested materials and attachments; and
• Advertisement for subject recruitment, if applicable (form 7).

Preliminary/Indefinite plans

The IRB will preliminary review research proposals under the following circumstances: (a) where there is no immediate involvement of human participants, such as grant proposals planned for submission; or (b) where the research application and research protocol (form 1) is not complete and a preliminary review is desired. Generally, the review is conducted by the IRB Chair, or at the discretion of the Chair, by the full board or by one or more experienced reviewers designated by the Chair from among members of the IRB.

Upon completion of the review, a letter advising to proceed with the funding request, request for further information or further development of the proposal will be sent to the investigator. In cases of a funded project, upon funding, a detailed protocol describing the research (including the informed consent process and research instruments) must be reviewed and approved by the IRB (as a full, expedited or exempt study), pending the nature of the investigation.

To submit a preliminary research plan to the IRB, the following materials must be submitted electronically to the IRB Chair:

• A cover letter requesting a preliminary review and purpose;
• An electronically signed IRB application and research protocol (form 1), form 2 (request for exemption) or Form 3 (Expedited Review) if applicable, all pages must be completed; and
• Advertisement for Subject Recruitment, if applicable (Form 7).

Application to Continue or Renew a Previously Approved Project

The IRB will conduct continuing review of research covered by this Policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research CFR 45 §46.109)(e).

The Lynn University IRB determines that adequate provisions are in place for monitoring the data collected to ensure the safety of subjects. Following initial approval, the researcher must seek review for projects at the intervals mandated by the IRB, not to exceed one year. The researcher is expected to forward Form 4 in a timely manner, allowing the IRB to review the project well before it expires, thus avoiding an interruption in research. Failure to seek continuing review may jeopardize present and future projects.

For projects that require a Convened Full-Board Review, the researcher forwards Form 4 and an updated consent form to the IRB no later than two months prior to the due date for renewal.

If a research proposal was authorized by expedited review, or the researcher believes the renewal qualifies for expedited review, the researcher forwards Form 4 and an updated consent no later than one month prior to the due date for renewal.

If a research proposal was authorized for exempt status, the researcher forwards IRB Form 4 and an updated consent no later than one month prior to the due date of the anniversary of initial approval.

VIII. IRB action & length of approval

The investigator will be notified in writing (print or electronic) of the IRB’s action on his/her research proposal. These actions include:

Full approval: The IRB approves the proposed purpose and design as described in the application for a period of one (1) year to conduct the approved research informing the IRB in writing of any change or modification made to the study after approval is secured and/or continuing progress reports may be required.

Contingent approval: An application receiving contingent approval requires addition information or minor revision. When the requested changes have been made, the IRB Chair has the authority to provide full approval.

Deferred: Applications that are deferred require significant revision and must be resubmitted for IRB review.

Disapproval: This is a rare action and is taken only when, in the judgment of IRB members, the risks of the research outweigh the benefits to study participants, or other, significant problems exist specific to the proposed study.

Suspension or termination: The IRB has the authority to suspend or terminate any research project, including projects with full approval, that is not being conducted in accordance with the IRB’s decisions, conditions, and requirements, or when unexpected serious harm to human subjects has been discovered. The investigator will receive a written explanation of the decision for suspension or termination. Any suspension or termination of approval will be determined by the committee as a whole, shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator and appropriate university officials.

IX. Unanticipated or unexpected adverse event

An “unanticipated or unexpected adverse event” refers to an adverse event or other problem arising during the research the specificity or severity of which is not consistent with information already provided to the Lynn University IRB. Adverse events are categorized as follows.

Adverse events - undesirable and unintended, though not necessarily unanticipated, injuries or physical or emotional consequences for the subject.

Serious adverse events - adverse events which are fatal or life-threatening; that result in significant or persistent disability; that require hospitalization, or represent a significant hazard or potentially serious harm to research subjects or the researchers and their staff.

Unanticipated problems - specific events experienced by subjects or developments that occur during implementation of research protocols that suggest the potential for increased risk to research subjects or the researchers and their staff.

In the event of an unanticipated or unexpected result, the investigator is required to submit a written report to the IRB via IRB form 6. The time frame for the submission of the report is determined by the type of unanticipated or unexpected event that has occurred.

• When an adverse event is serious and unanticipated, the principal investigator must submit IRB form 6 within 24 hours or by the end of the next working day.
• When an adverse event is serious but not unanticipated, the principal investigator must submit IRB form 6 within five (5) working days.
• When an adverse event occurs which is not serious but is unanticipated, the principal investigator must submit IRB form 6 within 10 working days.
• When an unanticipated problem occurs which does not meet the definition of an adverse event, the principal investigator must submit IRB form 6 within 10 working days.

X. Proposed changes to research protocol

The principal investigator is responsible for obtaining prior approval for proposed changes to an approved research protocol.

The Revised Common Rule allows the IRB to use expedited review procedures for minor changes in previously approved research during the period for which approval is authorized.

Changes that must be submitted to the IRB for review include:

1. Significant changes in subject recruitment or selection/exclusion procedures, or in your research protocol (including in questionnaires, interviews or other data collection procedures, or in research sites/locations);
2. Changes in the informed consent procedures or the informed consent form(s) that alter the information given to participants with respect to procedures, risks and/or benefits, or that might affect their willingness to participate;
3. Changes in data monitoring procedures to protect the safety of participants, such as monitoring for suicidal ideation, or other risks of harm to self or others;
4. Changes in procedures that were designed to reduce any risks to participants, such as procedures to protect confidentiality;
5. Other changes that may affect the risks to subjects, or the balance of risks and benefits;
6. Changes in the PI or other key personnel.

The IRB office must have copies of the most up-to-date protocols and consent documents, even if they did not require an IRB amendment.

Under an expedited review procedure, the review may be carried out by the IRB Chair or by one or more experienced reviewers designated by the Chair from among members of the IRB. In reviewing the research, the reviewer(s) may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in CFR 45 §46.108(b). If the procedural change is judged to involve more than minimal risk, intentional deception, or questions pertaining to a protected population and does not meet the categories for exempt or expedited review it must be presented to a convened full review board for discussion and consideration of approval or non-approval. The IRB reserves the right to request the investigator to provide additional information concerning the application for a procedural change. After review, the IRB will send the applicant formal notification of IRB actions.

Examples of minor changes that do not require IRB review include, but are not limited to:

1. Minor changes to wording of the recruitment materials that do not alter the risks or benefits to study participants (e.g., addition of a sentence to provide more information about timing or scheduling);
2. Minor procedural changes that do not alter the risks or benefits to study participants or that would reduce risk to participants (e.g., changes in the order of task administration;
3. Minor adjustment of the number of trials used; discontinuing the use of an approved self-report measure; omitting a portion of an approved experimental task);
4. Editorial changes that clarify but do not alter the existing meaning of an approved document (including the consent form) or instrument;
5. Correction of typographical errors on the consent form; and
6. Inclusion of new student research assistants with appropriate human subjects training and under the supervision of a faculty mentor.

XI. IRB documents and records

An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:

• Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects;
• Actions taken by the IRB and separate deliberations for each action;
• Minutes of all convened IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. The recusal of any IRB members because of a conflicting interest shall also be documented when recording votes on IRB actions;
• Records of continuing review activities;
• Copies of all correspondence between the IRB and the investigators;
• A list of IRB members in the same detail as described in §46.103(b) (3);
• Written procedures for the IRB in the same detail as described in §46.103(b) (4) and §46.103(b) (5);
• Statements of significant new findings provided to subjects, as required by §46.116(b) (5). CFR 45§46.116(b) (5) (Informed Consent). This is: A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject;
• Required determinations and protocol-specific findings justifying those determinations for:
  • Waiver or alteration of the consent process. [45 CFR 46.116(c) and (d)];
  • Justification for the waiver of the requirement for written documentation of consent [45 CFR 46.117];
  • Research involving pregnant women, fetuses, and neonates. [45 CFR 46.204];
  • Research involving prisoners. [45 CFR 46.306];
  • Research involving children. [46 CFR 46.404-407];
  • The rationale for determining that risk associated with using a medical device in a study significant or non-significant (referred to as significant risk/non-significant risk device determinations); and
  • When the expedited procedure for review is used, documentation of discussions, decisions, and findings will be included in the protocol file.

The records required by this policy shall be retained for at least 3 years, and records relating to research, which is conducted, shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the federal department or agency at reasonable times and in a reasonable manner when applicable.

XII. Informed consent

Except as provided elsewhere in this Policy, no investigator may involve a human being as a subject in research covered by this document unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative and at an appropriate reading level. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights or releases or appears to release the investigator, the sponsor, the University or its agents from liability for negligence.

Basic elements of informed consent

In seeking informed consent, the following information must be provided to each subject:

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
• A description of any reasonably foreseeable risks or discomforts to the subject;
• A description of any benefits to the subject or to others which may reasonably be expected from the research;
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
• For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
• One of the following statements is required about any research that involves the collection of identifiable private information or identifiable biospecimens:
  • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
  • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional Elements of Informed Consent

When appropriate, one or more of the following elements of information shall also be provided to each subject:

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
• Any additional costs to the subject that may result from participation in the research;
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
• A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject; and
• The approximate number of subjects involved in the study.
• A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws, which require additional information to be disclosed in order for informed consent to be legally effective.

Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.

Documentation of informed consent

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.

The Revised Common Rule (45 CFR 46.116(a)(5)(i)) requires that informed consent form begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

Moreover, the consent form must indicate either that information or biospecimens collected for the research might be stripped of identifiers and used in other research in the future, or that this will not happen. Note that this is only about future research use of information and biospecimens that will be stripped of identifiers. Consent for the future use of identifiable private information and identifiable biospecimens for future unspecified research is covered under the section for “broad consent,” or could also occur under conditions where an IRB determines that a waiver of informed consent is appropriate.

Waiver of written informed consent

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

• That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
• That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Oral consent, however, is still required and the investigator must provide all of the above information.

Parental consent/child assent

For individuals with “diminished autonomy” (for example, children), informed consent procedures typically involve obtaining consent from an individual who has the legal authority to make decisions about the individual’s participation in research. In the case of children, The Ethical Standards for Research with Children of the Society for Research in Child Development suggest that informed consent should be obtained from parents, legal guardians or those who act in loco parentis (e.g., teachers, school superintendents). Where feasible, children should also be given the opportunity to assent to participate, even if they do not fully comprehend the full significance of such assent, as well as the opportunity to refuse to participate.

Waiver or alteration of informed consent

Informed consent may be waived or altered under the following conditions:

Waiver

The IRB may waive the requirement to obtain informed consent provided the IRB finds and documents that:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver or alteration;
3. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Alteration

If a total waiver is not approved, an IRB may approve a consent procedure that omits or alters some of the elements of informed consent. However, there are complicated restrictions on alterations, and the Revised Common Rule does not allow the IRB to approve alterations of the general requirements, including requirements that:

1. Informed consent is obtained prior to beginning the research;
2. Without coercion and under circumstances that allow opportunity to discuss and consider whether or not to participate;
3. With information presented in language that is understandable to the participant or legally authorized representative;
4. The participant is provided with the information a “reasonable person” would want to have;
5. The informed consent begins with a concise and focused presentation of the key information; and
6. Does not include any exculpatory language that waives or appears to waive “any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”

Alterations must also meet the same conditions as those for a waiver of informed consent.

If a broad consent procedure is used, the IRB may not omit or alter any of the elements required for broad consent.

Requirements for waiver and alteration:

In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver or alteration;
3. If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects.

Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Broad consent

The Final Common Rule allows the use of “broad consent” (i.e., seeking prospective consent to unspecified future research) from a research participant for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.

Broad consent is an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, requesting an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.

Required elements of broad consent

1. The following information:
   1. A description of any reasonably foreseeable risks or discomforts to the subject;
   2. A description of any benefits to the subject or to others that may reasonably be expected from the research;
   3. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
   4. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
   5. When appropriate:
      1. A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
      2. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
2. A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
3. A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
4. A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
5. Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject’s identifiable private;
6. Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
7. An explanation of whom to contact for answers to questions about the subject’s rights and about storage and use of the subject’s identifiable private information or identifiable biospecimens, and whom to contact in the event of a research‐related harm.

Note: If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens and refused to consent, the IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.

XIII. Institutional endorsement

If a funding entity requires certification by an authorized official of Lynn University that the research involving human subjects for which application for support has been approved by an IRB, the IRB Administrator shall provide the requested information on behalf of Lynn University.

XV. Payment to research participants

It is not uncommon for subjects to be paid for their participation in research, especially in early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies must not be considered a benefit. Financial incentives are often used when health benefits to a subject are remote or non-existent. The amount and schedule of payment must be presented to the IRB at the time of the initial review. The IRB will review both the amount of the payment and the proposed method and timing of disbursement to assure that neither are coercive nor present undue influence.

Difficult questions must be addressed by the IRB when considering payment to research subjects. For example, how much money should research subjects receive, and for what should subjects receive payment, their time, the inconvenience, discomfort or some other consideration? The IRB must consider whether any aspect of the proposed remuneration will be an undue influence, thus interfering with the potential subject’s ability to give voluntary informed consent. In no case should remuneration be viewed as a way of offsetting risks; that is it should not be considered a benefit to be weighed against study risks. The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration. The same principle would apply to remuneration offered to parents whose children are prospective subjects.

XVI. Lynn University students as research subjects

The university recognizes that in some research situations, use of one's own students is integral to conducting research. This is particularly true of research into teaching methods, curricula and other areas related to the scholarship of teaching and learning. The following are two models of research design that may be permissible to the IRB:

• Collection of data by third party: In situations where the activities to be undertaken by the students are not part of required class activities, and thus students may or may not choose to participate, the instructor/researcher should arrange to have the data collected by an independent third party, so that the instructor does not know who participated, and does not have access to the identifiable data or identity of participants for any purpose until grades have been assigned and entered; and
• Collection of data by instructor/researcher: In situations where the collection of data by a third party is not feasible, the IRB may approve the research if the student provides written consent to use his or her own data, e.g., test results, papers written, homework, etc., after grades are entered.

Note: the giving of course credit or extra credit to students who participate in research as part of a course requirement will be approved by the IRB only when alternative means of obtaining credit is made available to students who do not wish to volunteer as research subjects. The IRB will carefully review these alternatives to make sure that students are not being coerced into becoming subjects. The informed consent statement must make clear the consequences of withdrawing from a project prior to completion.

XVII. Investigator responsibilities

(Adapted from OHRP] Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include, in summary:

1. Obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB;
2. Obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects;
3. Ensuring that amendments, requests for continuing review and approval, and notification of completion of the research study are submitted to the IRB in accordance with IRB policy and procedures.
4. Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others;
5. Providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB; and
6. Keeping certain records, including informed consent forms, as required by the HHS regulations for at least three years after completion of the study. (footnote 1)

XVIII. Research completion

The principal investigator must inform the IRB in writing when the research project has been completed through the completion of IRB form 8, accompanied by study completion documents and archival records.

Research studies can be deemed completed for a number of reasons, each requiring a different degree of IRB involvement. Most often, the investigator will close the study and the IRB’s role is passive, receiving study completion documents and archiving the records for the study. In some cases, the IRB must perform in a supervisory or disciplinary fashion and require that a study be ended.

XVIII. Non-compliance

The IRB is responsible for determining the validity of all allegations of noncompliance with respect to human subjects research activities conducted under the auspices of Lynn University and, if found to be non-compliant, determining whether it constitutes non-compliance that is serious or continuing in nature. If it is determined that a research protocol is not in compliance with regulations, regardless of whether it received prior review and approval by the IRB, it may direct corrective action to be taken.

There are two levels of noncompliance:

Serious: non-compliance that may affect the rights and welfare of participants including: (i) conducting non-exempt human research without submitting an IRB protocol; (ii) actions that compromise confidentiality of the participants or the integrity or validity of the research; (iii) actions that harm the participants either physically, psychologically or emotionally; (iv) the use of subjects from federally identified protected groups, which were not identified on the IRB protocol; (v) failure to report serious events, unanticipated problems, or substantive changes to the proposed protocol to IRB; and

Continuing: a pattern or multiple instances of non-compliance that: (I) indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others; (ii) compromises the scientific integrity of a study such that important conclusions can no longer be reached; (iii) suggests a likelihood that noncompliance will continue without intervention; or (iv) involves frequent instances of noncompliance or a failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance.

All cases of non-compliance are to be reported to the IRB Chair on an immediate basis. Reports can be made by research subjects, members of the research team or anyone else familiar with the research project.

• Whether action needs to be taken, and if so what form it will take. This can include requiring changes be made to the protocol, assigning a person to monitor the remainder of the research, requiring the researcher to undergo training, or suspension/termination of the research; and
• A recommendation on whether any sponsoring federal agencies need to be informed.

For cases of serious or continuing noncompliance, the IRB Chair will report to the Vice President for Academic Affairs the non-compliance and the IRB’s decisions on remedial action. In cases of continuing non-compliance, the Vice President for Academic Affairs may revoke the research privileges of the individual at the University or institute other disciplinary actions. Although the IRB can suspend or terminate the research project only the Vice President for Academic Affairs may suspend the researcher’s ability to conduct research.

The IRB Chair will inform the principle investigator (and sponsoring agency if applicable) that a non-compliance report has been made. The IRB Chair will also determine whether the report is serious enough to merit suspension of the research.

The IRB Chair will investigate and determine whether the non-compliance is serious or continuing. In the case of serious or continuing non-compliance, the IRB Chair will call a meeting of the full IRB. The researcher will be given the opportunity to attend the meeting to present information, but may not be present while the IRB makes its decisions. At this meeting the following will be determined:

• Whether action needs to be taken, and if so what form it will take. This can include requiring changes be made to the protocol, assigning a person to monitor the remainder of the research, requiring the researcher to undergo training, or suspension/termination of the research; and
• A recommendation on whether any sponsoring federal agencies need to be informed.

For cases of serious or continuing noncompliance, the IRB Chair will report to the Vice President for Academic Affairs the non-compliance and the IRB’s decisions on remedial action. In cases of continuing non-compliance, the Vice President for Academic Affairs may revoke the research privileges of the individual at the university or institute other disciplinary actions. Although the IRB can suspend or terminate the research project only the Vice President for Academic Affairs may suspend the researcher’s ability to conduct research.

(Footnote 1) If all research-related interventions or interactions with human subjects have been completed, and all data collection and analysis of identifiable private information described in the IRB-approved research plan have been finished, then the human subjects research study has been completed.

For more information about this policy, please contact Academic Affairs.