The IRB reviews all human research proposals to insure protection of both the project participants (e.g., confidentiality, informed consent, measures of care) and Clarke University (e.g., liability). To this end, each proposed project is reviewed to consider such things as the possible physical, mental, personal, and emotional risks to participant; invasiveness; clarity of informed consent; and research design. To read more on IRBs in general, visit the Department of Health and Human Services Office for Human Research Protections and the National Institute of Health. The IRB Protocol Review Standards from the NIH offers some insight into the kinds of questions the IRB is considering when reviewing applications.
Applications will be accepted on a rolling basis. Submit all materials as detailed below to email@example.com. Exempt and expedited applications will be reviewed by a committee member. You should receive a response within four weeks of submission. Be sure to include in your timeline the possibility that you may need to make corrections and have your application reprocessed before receiving final approval. The committee meets during regular school sessions and not during winter or summer break.
1. In order to apply for IRB approval for your research project, you must first determine whether you are conducting human research. If you are, then continue with the application process.
2. Decide if your project meets exempt requirements, expedited requirements, or requires a full review.
3. Complete all forms required for your application. You must include the
- IRB application form
- Proposal abstract
- Research tool: questionnaire, survey, or interview questions (if used)
- Informed consent forms (if required)
- Signed statement from faculty advisor (when PI is a student)
- Exempt, expedited or full cover forms if applicable
- Permission statement from research location if research is to be conducted outside of Clarke University
- Documentation of CITI Certification
4. Submit completed application and all other necessary documents in a single PDF to firstname.lastname@example.org. The file should be labeled as follows: Lastname_Firstinitial_Keyword_IRB_version#.pdf (eg: Mai_J_Balance_IRB_v2.pdf).
Incomplete applications will be returned to the Principal Investigator (PI) without review (i.e., an application is incomplete if the questions are unanswered, information is left blank or pertinent forms are missing).
Application deadlines for the 2020-2021 academic year are as follows:
Fall: Friday, November 6, 2020 (full reviews); Monday, November 16, 2020 (exempt and expedited reviews)
Spring: Wednesday, April 7, 2021 (full reviews); Monday, April 19, 2021 (exempt and expedited reviews)
Clarke University Research Ally
A Clarke University Research Ally is any faculty or staff member interested in receiving information about Clarke Internal Review Board (IRB) approved studies for the purpose of promoting faculty and student research. Research allies receive emails from the IRB about researchers in need of participants for their study. As an ally, you are not obligated to take further action, but are encouraged to share the information with parties you think would be interested (e.g., your class). Research allies can also support the research process by educating themselves and others about the Internal Review Board purpose, process and policies. If you are interested in being a Research Ally or are a researcher recruiting from the Clarke community, email email@example.com.