Libraries Administration:
Library Human Subjects Departmental Review Committee

Procedures for Researchers

1. All research projects involving human subjects must be approved before they may begin.
2. All investigators must sign and date the request form; no electronic submission.
3. The committee needs five working days to review an application.
4. The DRC Chair (or the designated committee member) will notify the applicant of the decision/recommendation of the Committee.
5. Research projects with external funding require final approval by the Office of Research, Compliance Section.
6. Research in a school system, another university, or external institution must have written permission from that organization's designated official attached to the application.
7. Form A (exempted from IRB review) is reviewed and approved by the department review committee (DRC) when a project meets one of the six categories for exemption (see Form A Guidelines).
   Normally, research involving a paper survey (not email survey) or interview procedures (without audio/video recording) can submit Form A, if anonymity is guaranteed. Signed consent is not a requirement for these situations, but an information sheet must be used in lieu of a consent form.
   See IRM Instruction Guide, sections 4, 5 and 11)
8. Form B (expedited review) is reviewed first by the DRC and then the Compliance Section staff if a project meets one of the 10 categories for expedited review (See Form B Guidelines), but does not meet the requirements for Form A. Usually, research involving children (those under 18 years of age) or audio/video recording of data must be submitted as Form B (expedited review). In these cases, a written consent form must be used.
   See IRM Instruction Guide, sections 4, 6, 9 and 11)
9. Form B is reviewed by the DRC, the Compliance Section, and the UT Institutional Review Board if the research falls outside the exempt or expedited categories (See Form B Guidelines)
   See IRM Instruction Guide, sections 4, 7, 8, 9 and 11)
10. Form D is used to report completion of a project or to request minor changes in a previously IRB-approved research project which was prepared under a Form B, such as changes of project title, informed consent, co-PIs, advisor, additional sites, etc.

Procedures for Library DRC

1. The primary responsibility of the DRC is to review all research projects involving human participants initiated by faculty and staff in the Libraries for scientific merit and for compliance with legal, regulatory, and ethical provisions for the protection of research participants' rights. (DRC Guide, p. 1). Specific review criteria regarding participant protection are as follows:
   
   A. Risks to Subjects
   B. Risks vs. Benefits
   C. Subject Selection (How subjects will be selected?)
   D. Informed Consent
   E. Confidentiality and Privacy
   F. Other Considerations (methods and procedures used in the project)
   
   
2. All committee members must have a copy of applications.
3. The chair will be responsible for communicating to the applicant(s) in a timely manner.
4. The reviewers should get back to the chair with in four working days.
5. If a reviewer has a schedule conflict,the chair should be notified immediately and a substitute reviewer will be assigned as needed.
6. When the chair is out of office for more than a week, a committee member will be asked to act as interim chair
7. When revisions are needed, the chair will notify the applicant(s) in five working days with a memo/email.
8. Upon approval, the Chair will sign the application on behalf of the committee and seek the approval and signature of the Dean.
9. The applicant will be notified of DRC approval.

• for Form A, the project may start at this point.
• for Form B the DRC will submit an approved Form B to the Compliance Section, Office of Research
  (404 Andy Holt Tower) for final approval. The project may not start until the Compliance Section and/or the IRB approves it.

The DRC chair has the additional responsibilities set forth by the Compliance Section:

• A copy of each Form A that is approved must be submitted to the Compliance Section within a week.
• The departmental committee must retain the original copy of each Form A
• Any correspondence between the DRC and the investigator(s) must be kept for three years after the project is officially complete.