Summary of Institutional Review Board (IRB) Procedures - Fall 2011
All research involving humans as subjects or sources of data must be approved by Heidelberg’s IRB before it is begun. The only exceptions are research that involves normal classroom practices (such as polling students), research that involves observing public behavior where individuals can’t be identified, and research conducted on existing data that is publicly available or is from individuals who can’t be identified.
- The Co-Chair of IRB will organize one workshop each semester for students, and faculty/staff research advisors, and researchers. It will cover the history behind IRBs, current Federal standards, and proposal submission.
- All proposals must be submitted through a faculty/staff member (researcher or research advisor) who must approve the submission before it is forwarded to the IRB co-chair.
- The Co-Chair is responsible for evaluating proposals as they come in to determine if they are eligible for expedited review and to conduct those reviews when warranted. The full IRB Committee will meet in person to conduct full reviews. The Spring 2013 proposal deadlines are noon on January 16, January 30, February 20, March 20, and April 10. Proposals must be received by the Co-chair at least 48 hours before a meeting to be considered at that meeting.
- Evaluation of proposals will focus on the following elements:
- risk to the subjects has been minimized and justified,
- risk to the subjects is offset by the potential benefits of the research to society,
- all participation is voluntary (nothing can be required by coaches or teachers),
- all subjects are aware of the research goals, methods, and personal risks before they agree to participate and that proof of this informed consent is obtained and retained by Heidelberg,
- there is a mechanism to monitor the health and safety of subjects during (and immediately after) the research,
- personal information about the subjects is collected only when relevant to the research and justified ,
- there is a clear mechanism for keeping confidential all personal information given by the subjects,
- research that includes deception of subjects includes a debriefing mechanism and gives subjects the option of having their data removed from the study,
- that consent forms used meet Federal standards (see below).
- Consent forms used by researchers must describe a) the research being conducted, b) the risks to the subject, c) the offsetting benefits to the subject or others, d) how confidentiality will be maintained, e) what medical treatment is available if an injury occurs, f) contact information if questions arise, and g) a statement that participation is voluntary. A signature is required, even in cases where verbal consent is given (see Federal standards). A copy of the consent form must be provided to every human subject and the original must be retained by Heidelberg for 3 years. Student researchers must forward original consent forms to the IRB co-chair.
- IRB approval, when granted, is good for 365 days and is only for research conducted exactly as proposed. Changes to research or failure to complete it within the 365 days require a new review.
- The IRB committee can monitor research for which they have ethical and/or health and safety concerns.
- New IRB forms are being placed on Server Six and on the Heidelberg website. All other forms and submission packets should be discarded. The new submission packet contains directions, the submission form, and a sample consent form.
- Questions about IRB for the 2012-2013 academic year should be directed to the IRB Co-Chairs, Mr. Jerry Bean, firstname.lastname@example.org or x2519 or Dr. Ellen Nagy, email@example.com or x2063.