Preparing an IRB protocol for review
Troy University has assured the federal government that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of research participants, 45 CFR 46. Troy University has agreed that research activities involving human participants, regardless of sponsorship, will be reviewed by the IRB when one or more of the following apply:
- the research is sponsored by this institution, or
- the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
- the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
- the research involves the use of this institution's non-public information to identify or contact human research participants or prospective participants.
Steps to Take to Prepare for Review
- Complete the online training program. Have your results emailed to the IRB Office at email@example.com.
- Read the FAQ page. If you have any additional questions, contact your College or Site representative (see Committee Members page) or the IRB Office.
- Complete the "Application for Institutional Review Board Review" form. All Applications must be typed.
- Create and include in the form or append any and all necessary additional documents.
- Informed Consent Documents Informed consent documents are required for every proposal.
- Grant Proposals Whenever funding for a protocol is being sought from any source, whether on or off campus, one copy of the grant proposal must be attached.
- Thesis, dissertation and DNP project research When research is being conducted for a student's thesis, dissertation, or DNP project, one copy of the complete Methods Section should be attached.
- Research instruments Attach one copy of any survey, questionnaire, and/or interview questions that are not published. Published materials can be incorporated by providing a full citation to the materials. Graphical and verbal stimuli, if not completely described on the IRB application form, should be attached or a complete citation provided.
- Debriefing Whenever deception is involved as part of the research or information is withheld from a participant prior to or during the research, this information must be disclosed to the participant at the close of the research either verbally or in writing. A copy of this statement must be attached.
- Advertisements If participants will be obtained through advertisements, attach a copy of the ad.
- Certificates of confidentiality When data are being collected about sensitive issues (such as illegal behavior, or alcohol or drug use), Principal Investigators may consider applying for a certificate of confidentiality. Under Federal law, researchers can obtain an advance grant of confidentiality that will provide protections against a subpoena for research data [Public Health Service Act 30l(d)]. Protection will be granted sparingly and only when the research is of a sensitive nature and where the protection is judged necessary to achieve the research objectives. See the Information about Certificates of Confidentiality page for more information. For information on how to obtain a Certificate, see the Certificates of Confidentiality Contacts page.
- Have your supervisor (supervising faculty member if you are a student) review and sign the form.
- Email your application with ALL attachments, in one document if possible, to firstname.lastname@example.org.