Institutional Review Board (IRB)
“The IRB is a committee whose primary responsibility is to protect the rights and welfare of research subjects and to function as a type of ethics committee…” (Amdur & Bankert, 2011, p. 5). Until 1950, the federal government had little involvement regulating research. Now the federal government regulates all aspects of research. The policies and procedures apply to biomedical and social science research. The changes in federal regulations were results of many historical milestones such as the 1948 Nuremberg Code, the 1955 Wichita Jury Study, the 1962 Thalidomide Experience, and the Belmont Report to name a few (Amdur & Bankert, 2011).
According to Bankert, Gordon, Hurley, & Shriver (2022), “An IRB is charged with safeguarding the rights and welfare of people who participate in human subject research, including the procedures and methods to be employed. The regulations that govern human subjects research specify certain characteristics that are needed in the composition of an IRB to ensure the review of the research is thorough” (p.91).
Additional resources can be found on the following sites:
- Office for Human Research Protections (HHS):
https://www.hhs.gov/ohrp/education-and-outreach/faq-and-other-guidance/index.html
- The Protecting Human Research Participants (PHRP):
On this site you can find information and documents most often needed by researchers to submit IRB applications at SHU. The current documents are located in the Application Forms section (click at top of page). Please read the notes below:
IMPORTANT NOTES:
1. All applicants must show proof of successful Protecting Human Research Participant Training. To access a free course (that will provide you with a certificate) follow these directions:
a. Go to the aalaslearninglibrary.org website
b. Create a FREE account
c. On the left hand side menu you will click ‘Free Courses’ > ‘Human Research Protections’ > ‘Protecting Human
Research Participants (Biomedical)’
d. Carefully review the 8 sections of the course, you should be prepared to take notes.
e. Take the 20 question Final Exam
f. The site will no longer allow you to Download the certificate as a free account user, you will need to take a screenshot of your final score stating that you passed. You will need to include this as proof of successful completion of this course in the appendix in your IRB application.
IF YOU HAVE A CERTIFICATE FROM A DIFFERENT TRAINING (PHRP, CITI, NIH, etc..) YOU MAY UTILIZE IT IF IT IS RECENT
2. Only use your SHU email for correspondence with the IRB (otherwise your application material may not be received).
3. Applications are processed at a first-come, first served basis. Review of research proposals by the IRB will typically occur as needed, from the 1st day of classes in the Fall semester to the last day of classes in the Winter semester, reviews will be suspended for University recognized holidays and breaks.
- Preliminary review may take 2-4 weeks.
- Most applications will require revisions. The entire process length will vary and is greatly affected by the length of time it takes for revisions to be completed and submitted.
- Applications and supporting documents with the following problems will be returned immediately for revisions:
- Grammar, spelling, or punctuation errors
- Lack of professionalism
- Lack of consistency or clarity
- Incomplete applications
- Plagiarism
**Failure to minimize these errors will cause delays in your processing time**
References
Amdur & Bankert (2011). Institutional review board: Member handbook (3rd ed.)
Jones and Barlett Publishers.
Bankert, E.A., Gordon, B.G., Hurley, E. A., & Shriver, S. P. (2022). Institutional
review board: Management and function (3rd ed). Jones and Barlett Learning.