Human Subjects Policy

IRB approval (or a formal indication that research is exempt) must be obtained before research activities may begin. To obtain approval or exemption, an application with the IRB must be filed. The IRB conducts different levels of review, depending on the type of research activities and subjects that are involved. Expedited reviews may be conducted for certain types of minimal risk research, as permitted by federal guidelines (45 CFR Part 46). Other reviews must be conducted by the convened IRB at a regular meeting. The IRB will determine what type of review is applicable to each submitted protocol.

Approval for some projects must be renewed annually; others do not require annual review. Your approval letter will indicate whether annual continuing reviews are required.

Where annual review is required, continuing review forms are due in the IRB office (humansubjects@clarku.edu) at least 45 days prior to protocol expiration (typically one year after the approval date).  These are submitted via the Mentor IRB website.

If a continuing review form to extend approval for ongoing research is not received by the deadline, the approval will expire and research must cease.

Procedures to obtain a reliance agreement with IRBs of other institutions is located here: Reliance Agreements with IRBs of Other Institutions Policy and Procedures

IRB approval is an institutional permission to conduct research. It is not an agreement for the university to provide data on Clark students, staff, or faculty (including contact information) for recruiting human subjects. Please also note that the university will not assist in disseminating surveys or interview requests using university email addresses. Recruitment of subjects must be conducted by the principal investigator through other means.

The names of current members of Clark’s IRB may be obtained from the Office of Sponsored Programs and Research. Questions concerning protocols for the protection of human subjects should be addressed to the Office of Sponsored Programs and Research.

Safeguarding the rights and welfare of human subjects involved in research and training at Clark University, or off campus with funds administered by Clark University, is the responsibility of the institution. The Public Health Service policy states that no grant, award, or contract for the support of research involving human participants shall be made unless the research is given initial and continuing review (where required) and approval by an appropriate committee of the applicant institution.

Clark University’s IRB operates under an assurance agreement with the United States Department of Health and Human Services. Under this agreement, the IRB reviews all human subjects research to ensure that the rights and safety of subjects are protected. Following 45 CFR Part 46, in order to approve research subject to IRB oversight, the IRB shall determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized:
   • By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
   • Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. 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 (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116.
5. Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Proposal application guidelines, deadlines and forms are found on the Mentor IRB website. Upon receipt and review of a completed proposal, the IRB may take various actions, including (1) approval, (2) granting an exemption from further IRB review (3) request for major or minor revisions, or (4) rejection. Investigators must retain consent forms (or other documentation of consent, as relevant) and other research records for a minimum of three years following the date of protocol approval.

Investigators who wish to change a previously approved protocol must submit a formal request for amendment (or modification) to the IRB. Amendment requests should be submitted using the Mentor IRB website, select the “Amendments” tab at the bottom of the protocol page. Investigators may only implement changes to approved research prior to IRB review and approval, if the changes are necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.108(a)(3)(iii) under the 2018 Requirements and 45 CFR 46.103(b)(4)(iii) under the pre-2018 Requirements).

Investigators on approved IRB proposals must notify the IRB chair immediately of:

1. Any unanticipated problems that occur during the research and affect subject welfare (adverse events), and
2. Any deviations from the approved protocol (whether intentional or unintentional).

These reports are also submitted via the Mentor IRB website by choosing the “Adverse Events” or “Protocol Deviations” tab at the bottom of the protocol page.

The IRB is only responsible for reviewing human subjects research to ensure the rights and welfare of subjects, as described under 45 CFR 46.  Other questions regarding research conduct and ethics should be directed to the Office for Sponsored Programs and Research.

• United States Department of Health and Human Services
• National Institutes of Health – Office of Human Subjects Research
• National Institutes of Health – IRB Protocol
• National Science Foundation: Federal Policy for the Protection of Human Subjects
• Public Responsibility in Medicine and Research
• The Nuremberg Code
• Tutorial and Certification Program for Research Involving Human Subjects