HSIRB Procedures

Procedures used by the Human Subjects Institutional Review Board:

Human Subjects

The Davidson College Institutional Review Board (IRB) safeguards the welfare and rights of human subjects in human subject research conducted by faculty, staff and students. The IRB has authority to review and approve, require appropriate modifications to, or disapprove human subject research in accordance with 45 Code of Federal Regulations, Part 46 and Davidson College policy.

The college subscribes to the ethical principles of respect for persons, beneficence and justice outlined in The Belmont Report and therefore elects to apply federal regulations to all of its human subjects research regardless of source of support. Davidson maintains a Federal-wide Assurance (FWA) for the protection of human subjects with the Office for Human Research Protection.

Federal regulations define "research" as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." "Human subject" is defined as "a living individual about whom an investigator (whether professional or student) conducting the research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information."

Every research project review shall begin with the submission by the investigator of a completed Protocol Application Form (Application for Request for Exemption or Standard Application for Non-Exempt Research) and all required attachments.

Expedited Review

Under certain circumstances, the IRB will provide expedited review for proposed research that presents no more than minimal risk to human subjects. Details on expedited review.

General Review

In every review (other than an expedited review), one or more experienced primary reviewers, designated by the chairperson, shall conduct an in-depth examination of the Application and Protocol Form, all required and other attachments submitted by the investigator, and any additional documents submitted by the investigator at the request of the primary reviewer(s). These materials shall fully disclose any risks to subjects or others and any risks of noncompliance.

Reviewer Recommendation

The primary reviewer(s) shall then write memos to the IRB summarizing the proposed research and appraising the risks involved. The memos shall contain a recommendation that the IRB approve the research, disapprove the research, or approve the research provided that certain modifications are made in the protocol or in the proposed informed consent process.

The reviewer memos, the Application and Protocol Form, the proposed informed consent document, and any other documents specified by the primary reviewer, shall then be submitted to all IRB members at least five business days prior to a regular monthly or specially scheduled IRB meeting.

IRB Meeting

At such an IRB meeting, at which a majority of the IRB members are present, including at least one member whose primary concerns are in nonscientific areas (an IRB quorum), the IRB shall fully consider the proposed research and the recommendation of the primary reviewers. Proposed research shall be approved by a majority vote of the IRB quorum. Should the quorum fail during the meeting (e.g., loss of a majority through recusal of members with conflicting interests or early departures, or absence of a nonscientist member) the IRB shall not take further action or votes unless the quorum is restored.

The deliberation, action and vote on each proposed research by the IRB quorum shall be recorded in the meeting minutes. The recorded vote shall include the number of members voting for, against, and abstaining, for example: Total = 10; Vote: For - 9, Opposed - 0, Abstained - 1.

Continuing Review

A continuing review shall be performed once a year by the Institutional Review Board (IRB) for every ongoing human subject research project. The continuing review for a project shall be done in the same fashion as the initial review. For example, if the initial project had an expedited review, the continuing review shall also be an expedited review.

The IRB shall determine if a human subject research project continuing for more than one year requires a continuing review more than once a year. If so, the project shall be scheduled for more frequent reviews in accordance with a schedule determined by the IRB.

In the course of each continuing review, the IRB shall consider whether the project requires verification from sources other than the researcher that no material changes have occurred since prior IRB review.

Projects approved as "exempt from further review" do not need to be reviewed on an annual basis unless changes have been made to the original protocol.

Project Changes

Each revision to a research protocol shall be incorporated into the written protocol to assure that there is only one complete protocol, with the revision dates noted on each revised page and on the first page of the protocol itself.

IRB project approvals shall advise investigators that any proposed material changes in research activity must be promptly reported to the IRB and that such changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to subjects.

IRB project approvals shall also advise investigators that they should report promptly to the IRB any unanticipated or undisclosed problems involving risks to subjects or others, or any serious or continuing noncompliance with the protocol or with the requirements or determinations of the IRB.

Conflict of Interest

No IRB member shall participate in the IRB's initial or continuing review of a project in which the member has a conflicting interest. Except when requested by the IRB to be present to provide information, IRB members with conflicting interests must absent themselves from the meeting room when the IRB reviews research in which they have conflicting interests. Their absence shall be reported in IRB meeting minutes.

Reporting

The IRB chairperson shall ensure prompt reporting, within 30 days, to the IRB, appropriate college officials, the Office for Human Research Protections of the U.S. Department of Health and Human Services and any other appropriate entities of any unanticipated problems involving risk to subjects or others, or any serious or continuing noncompliance with 45 CFR, Part 46, or the requirements or determinations of the IRB, or any suspension or termination of IRB approval.

Composition of the IRB

The IRB shall consist of at least five members with the varying backgrounds and professional competence necessary to promote complete and adequate review of research activities commonly conducted under the auspices of the college. The chairperson and board members shall be appointed annually by the vice president for academic affairs. The chairperson may designate another committee member to conduct necessary business in his/her absence.

The IRB shall not consist entirely of men or women; at least one member shall be primarily concerned in a scientific area and one member shall be primarily concerned in a non-scientific area; and at least one member shall be unaffiliated in any way with the college. The IRB may invite other qualified persons (non-voting) with competence in special areas to assist it in the review of complex research, especially that which involves vulnerable populations.

When necessary, or when in the best interest of the IRB, other individuals may be invited by the chairperson to attend and participate in meetings as an invitee. Invitees shall not be eligible to vote. The director of the Grants and Contracts Office serves ex-officio, non-voting.

Timetable

The IRB meets monthly during the academic year (September through May) and as needed during the summer months of June, July and August. Other meetings may be called at the discretion of the chair.

The review of a protocol application typically takes a week to ten days. If revisions are required, the process may require more time. On rare occasions, the entire membership of the IRB may need to discuss a protocol at its monthly meeting before making a final decision.

Research can begin after the IRB approves the project or exempts it from further review. To avoid delay in the commencement of research and attendant problems, students in particular should plan to submit their protocol as early in the semester as possible. 

Because the IRB may not be available over the summer and during holidays, protocols should be submitted well in advance for projects to be carried out during these times or during the first few weeks of the semester.

Training

The Office for Human Research Protections (OHRP) requires that all members of the college's Human Subjects Institutional Review Board and any individual conducting and/or supervising federally-funded research involving human subjects complete a program of instruction on the responsible treatment of human subjects. 

As a public service, the NIH Office of Extramural Research offers "Protecting Human Research Participants," a free tutorial institutions may elect to use to meet the human subjects protections education requirement.

Additional IRB reviewer resources are available to IRB members and the larger research community are also available.

Retention of Records of the IRB

IRB records shall be retained for at least three years and records relating to conducted research shall be retained for at least three years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the Department of Health and Human Services at reasonable times and in a reasonable manner.

(Approved by the Davidson College Institutional Review Board on 11/12/2003)