Policy Governing Plymouth State College's Institutional Review Board (IRB)

Why do we have and Institutional Review Board (IRB)?

In 1991, the Department of Health and Human Services issued a set of revised regulations for protecting the rights and welfare of human-research participants. These regulations--subscribed to by sixteen other federal departments and agencies, --constitute the core regulatory structure for research involving human particpants that is funded by the federal government. These regulations are Part 46 (Protection of Human Subjects) of Title 45 (Public Welfare) of the Code of Federal Regulations [hereafter CFR 46]. What follows is consistent with those regulations.

CFR 46 encourages universities to extend Human Participants protection to all research as they are required to provide an "assurance" to the government that "at a minimum" includes: A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. Legally, this is why all research conducted at Plymouth State University is under the purview of the Institutional Review Board.

For an IRB to approve a research project, it must ensure that the "risks to subjects are minimized," that the "risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and [to] the importance of the knowledge that may be reasonably expected to result," that the "selection of subjects is equitable," and that "informed consent [has been] sought from each prospective subject or the subject's legally authorized representative." CFR 46.111

Definitions

According to the federal legislation governing institutional research boards, research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." CFR 46.102(d)

The definition of "human subject" is described as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." CFR 46.102(f).

What are the criteria that the IRB uses to determine whether or not it approves a research proposal?

1. Risks to participants 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.

2. Risks to participants 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).

3. Selection of particpants 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, and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women mentally disabled persons, or economically or educationally disadvantaged persons.

4. Informed consent will be sought from each prospective particpant or the subject's legally authorized representative, in accordance with, and to the extent required by CFR46.116.

5. Informed consent will be appropriately documented, in accordance with, and to the extent required by CFR46.117.

6. When appropriate, the research plan makes adequate provision for monitoring the data collected, to ensure the safety of participants.

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

8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, 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 participants.

Exemptions

CFR 46 is clear about the categories of research--six in all--that are explicitly exempt from the policy:

(1) research in education settings on instructional techniques, curricula, or classroom-management methods;

(2) research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, unless the subject can be identified and disclosure of the subject's responses could put the individual at risk of criminal or civil liability or could damage the subject's financial standing, employability, or reputation;

(3) research involving elected or appointed officials or candidates for public office;

(4) studies using existing data, documents, or records, as long as these resources are publicly available or the human subject cannot be identified;

(5) studies of public benefit or service programs; and

(6) research focusing on consumer consumption of food and the taste and quality of food.

These kinds of research typically pose little or no risk of physically or mentally harming human participants. However, whether in a particular instance, the risk is more than minimal is for the IRB to decide. Researchers need to submit documentation to verify that the project is indeed exempt from review. The Chair or his/her designee will make the determination of exemption using guidelines from CFR46.102. Specifically, the chair or his/her designee will consider "Minimal risk ": 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."

Expedited Review

Approval of research can also be granted through an expedited review. The procedure is as follows: Either the chair of the IRB or another member designated by the chair reviews the research. The review is expedited not because of a different procedure--but because fewer people are doing it. The IRB members who are responsible for conducting an expedited review can approve the research, but only the full IRB can disapprove the research (CFR 46.110)

For research to be eligible for expedited review, it must pose no more than a minimal risk to the human participant(s) and fit into one of nine research categories. Of the nine categories, two are relevant to the types of research likely to be undertaken at PSU.

1) Collection of data from voice, video, digital, or image recordings made for research purposes.

2) 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.

Efforts will be made to respond to researchers under the expedited review process within 5 working days. It is anticipated that most student research will be either exempt or reviewable under the expedited review process.

Full Review

All research not exempt or eligible for expedited review will be reviewed by the full committee. A response will be made in a timely manner.