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. Classroom research projects that meet exempt or expedited review criteria require the completion of the course level application form instead of the IRB application outlined in step 3 below. Classroom research projects are defined as activities for learning the process of research as opposed to engaging in research intended for publication or dissemination to an audience outside of the class.
3. For all projects not considered course level research, your application must include the following documents:
- Appropriate cover sheet (exempt, expedited, or full cover sheet)
- IRB application form with faculty signature if Primary Investigator (PI) is a student
- Proposal abstract
- Appropriate CITI Training Certificate. See the right-hand column for information on registration and required courses.
- Appropriate informed consent form (in-person, verbal, or electronic) (if required)
- Research tool(s) (e.g., questionnaire, survey, interview questions, test questions)
- Documentation of permission to use the identified research tools (e.g., a references section).
- Recruitment materials (including but not limited to copies of script for face-to-face recruitment, a copy of recruitment e-mail, social media post, recruitment flyers/posters)
- Permission statement from research location if research is to be conducted outside of Clarke University (if applicable)
4. Submit the completed application and all other necessary documents as a single PDF to firstname.lastname@example.org. The file should be labeled as follows: Lastname_Firstinitial_Keyword_IRB_version#_.pdf.
5. 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).
6. Once a research procedure has been approved, it should not be altered without consultation with the IRB. For the protection of study participants, prior to making any changes, PIs are asked to complete the Request for Modification Form and submit it to the IRB at email@example.com for review and approval.
7. Any activity associated with, or oversight of, research involving human participants that fail to comply with the research plan approved by Clarke University IRB or federal research regulations constitutes noncompliance and is subject to disciplinary action. For more information, consult the Noncompliance Policy.
2023-2024 ACADEMIC YEAR REVIEW SESSIONS:
APPLICATIONS WILL BE ACCEPTED FOR REVIEW DURING THE FOLLOWING TIMEFRAMES
Fall: Monday, August 22, 2023 through Tuesday, November 21, 2023
Spring: Monday, January 8, 2024, through Tuesday, April 18, 2024
Applications that are submitted outside of this timeframe will still be accepted, but will not be processed until the next review session begins.
- Downloadable application
- Cover sheets (full, expedited, exempt, renewal of approved study)
- Consent forms (in-person, verbal, electronic)
- Request for modification form Any change to the original IRB approved study protocol requires submission of an amendment to the IRB. Planned changes to approved protocols require submission of a request for modification form and must be reviewed by the IRB prior to the change being implemented.
- Report of deviation form Unintentional or unplanned events that diverge from the original IRB approved study are considered deviations and require submission of the report of deviation form. If the deviation caused participants to experience adverse effects or compromised the integrity of the data, this must also be documented on the report of deviation form.
- Transcriptionist confidentiality statement form If your research will involve the use of a transcriptionist who is not listed on the application form as an investigator, a transcriptionist confidentiality statement form should be submitted along with your application.
- Closure of IRB Approved Project form Following the completion of your IRB approved project, you are required to submit a closure of approved research project form.
- Renewal of an Approved Study form This form is to be used in place of the standard application form by investigators who are continuing or repeating a project that has already been approved by the IRB. This form may be used no more than twice. The fourth continuation or repetition event must be accompanied by a complete IRB application
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 firstname.lastname@example.org.