The following pointers in preparing your Institutional Review Board application typify some of the common problems encountered by applicants over the last few years.
1) Fill-in forms required for IRB applications can be found here. The completed IRB form should be submitted as a pdf file and all other materials as one attachment. Once completed, all forms should be emailed to email@example.com. No paper copies are necessary.
2) Researchers should plan on at least two (2) weeks for the IRB to review and initially comment on a new submission, with additional time for revisions and further reviews. See the IRB website for a schedule of committee meetings and deadlines.
3) Anticipate writing an expedited application, as presented in the IRB procedures section on the IRB website. Few requests meet the guidelines for an exempt status, since most proposed projects do not meet those criteria. In cases that involve particularly invasive research practices and/or significant risks to participants, a full review is usually in order. If you suspect that it will be necessary to write a full review, please consult with IRB for confirmation prior to writing the submission.
4) Writing an IRB request is different from writing a grant application. Too much jargon or information slows down the review process. Petitioners should address each question on the application form bearing in mind that they are writing to a group of generalists who are not necessarily conversant with the conventions of other academic fields beyond their own. Petitioners should, therefore, provide sufficient background information to assist IRB in understanding the need for whatever research practices are being proposed.
5) IRB monitors neither the scientific merit nor the research methodology presented in applications.
6) Consent is needed in all cases. To bypass the use of a consent form will require a specific rationale that the applicant must articulate. Keep the informed consent form separate from the data gathered.
7) A. Researchers should be very clear in distinguishing between and maintaining confidentiality and anonymity concerning the identity of human subjects throughout the data collection, analysis, and dissemination stages. These two standards are not the same.
- Confidentiality means knowledge of the person, directly or indirectly, and the researcher is required to neither identify the subject nor to attribute private or restricted information to a participant. Thus, the researcher is able to correlate data with a specific participant; however, this correlation is never revealed. Most research is of a confidential nature.
- Anonymity means that the researchers cannot ever identify participants. Thus, the researcher, atevery point in the research, is unable to correlate the data with any specific participant.
B. Once this decision has been made, particular attention should next be paid to explaining the procedures in the application that will be used to protect participants’ identities.
8) Students may not act as principal investigators (PIs). Even if a student is to conduct the vast majority of the work involved in project, a sponsoring faculty member must act as the PI and submit the application. In cases involving students as co-investigators, the sponsoring faculty member must play an active role in writing the petition and must maintain on-going, significant supervision of the project throughout all of its phases. The faculty member is ultimately responsible for protecting the human subjects.
9) The chair of IRB is willing to field questions as faculty members develop their petitions. Please feel free to contact the chair at firstname.lastname@example.org if you are unsure about procedures.