Filing a Request for IRB Review
According to action taken by the Minot State University Institutional Review Board for the Protection of Human Research Subjects (IRB), all members of the Minot State University faculty, staff, and student body (whether full or part-time), who are conducting research or related activities with human beings as subjects, must conform with certain procedures prescribed by the U.S. Department of Health and Human Services. Filing a "Request for Exempt Status" or "Request for Review" constitutes the first step of this procedure. Before initiating any such research the principal investigator of the project should review The Approval Process. The forms should be submitted to the IRB Chair, Dr. Bryan Schmidt, in the Division of Science or electronically at email@example.com.
REVIEW PROCEDURE: A "Request for Exempt Status" or a "Request for Review" is examined by the chairperson of the IRB, who determines which category of review is appropriate (EXEMPT from review, EXPEDITED REVIEW, or FULL IRB REVIEW) and informs the principal investigator concerning any further action to be taken. In reviewing projects, the IRB decides whether the human subjects are at risk, and if so, whether the following criteria for approval have been satisfied:
- Risks to subjects have been minimized, by using procedures which are consistent with sound research design and which do not unnecessarily expose subject to risk.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and to the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
- Informed consent will be appropriately documented.
- Where appropriate, the research plan makes adequate provision for monitoring the data to ensure the safety of subjects.
- Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data.
- Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included in the research plan.
CONTINUING REVIEW: For projects running for more than one year, continuing review is required on each anniversary date of the project's original approval. A brief form entitled "Request for Continuing Review" must be filed each year for ongoing projects. Whenever an ongoing project acquires a new principal investigator, or whenever there are substantial changes in the protocol or the subject population, an initial "Request for IRB Review" must be filed.
These criteria, and the other rules and regulations under which the IRB operates, are set forth in the CODE OF FEDERAL REGULATIONS: 45 CFR 46, Revised March 8, 1983 ("PROTECTION OF HUMAN SUBJECTS").
DOCUMENTATION OF REQUEST FOR REVIEW: Each request for review must be accompanied by the appropriate documents for the project, such as:
- A copy of the research proposal, plan, or protocol. This should set forth the objective of the research and describe the procedures designed to reach that objective. (A proposal or plan for a student's thesis or dissertation should either be signed by the degree candidate's committee, or the committee chairperson should provide the IRB with a signed letter endorsing the plan.)
- Copies of all questionnaires, interview schedules, tests, etc. used in the project.
- A copy of the forms which the subjects will sign to document their informed consent. For subjects who are unable to sign for themselves (infants, school children below the fifth grade, and the mentally incompetent), written informed consent must be obtained from the subjects' legally authorized representative. Investigators using minor subjects at risk must obtain not only their own consent (if they are in grade 5 or higher), but also the consent of their legally authorized representative (usually a parent). Informed consent forms must adhere to the guidelines provided in the document "Requirements For Informed Consent".
IRB decisions will be communicated to investigators in writing. Occasionally, an investigator may be asked to appear before the IRB to provide additional information and/or clarification.