Federal regulations require all research projects involving human subjects to be reviewed and approved by a qualified Institutional Review Board (IRB). The IRB provides oversight of all scholarly research activities involving human subjects to ensure that ethical standards are followed and that the rights, welfare and well-being of participants are protected. This is outlined in the Code of Federal Regulations (45 CFR Part 46, subparts A-D) for the protection of human subjects in biomedical and social-behavioral research, and in accordance with institutional policy and procedures. This includes any research involving human subjects, conducted under the auspices of AACC, in which the principal investigator intends to present or publish findings outside of AACC to contribute to a larger body of generalizable knowledge.
IRB review may not be required for research conducted for internal assessment purposes and/or to fulfill state or federal requirements unless the intent includes publishing findings to a broader audience beyond AACC.
All research involving AACC faculty, students or staff requiring IRB review must receive IRB approval prior to the initiation of the proposed research study. This includes research proposed by third parties such as individuals and/or institutional review boards outside of AACC.
Investigators must submit the following documentation (as applicable):
- Fully completed IRB application, which includes a detailed description of the research protocol (e.g., the rationale for the study, research questions, hypotheses, research methods, selection of subjects including sampling methods, potential benefits/risks, managing confidentiality, compensation of subjects, etc.)
- Copies of questionnaires/survey instruments, interview/focus group guides or other materials that will be used with research participants over the course of the proposed study
- Evidence of completion of the CITI (Cooperative Institutional Training Initiative) Human Subjects Research-Social-Behavioral-Educational (SBE) Comprehensive training. Contact the IRB administrator at firstname.lastname@example.org for CITI program training information.
- Informed consent forms and related materials, including any advertisements/recruitment documents
- Copy of any external IRB approvals
- Approval forms from applicable government agencies
Investigators should submit one of the following applications for IRB approval:
- Request for Exempt Status
Research in which the only involvement of human subjects will be in one or more of the categories eligible for exemption under 45 CFR 46 or 21 CFR 56.104. Exempt research requires IRB initial approval but is then exempt from further review. If there are any substantive changes made to exempt research, the new proposed study must be submitted to and approved by the IRB.
- Proposal for Expedited Review
Research that (1) presents no more than minimal risk to human subjects, and (2) involves only procedures listed in one or more of the categories eligible for expedited review under 45 CFR 46.110 and 21 CFR 56.110.
- Proposal for Full Board Review
All research that does not qualify for exempt status or expedited review requires full board review.
- Proposal for Continuing Review or Protocol Modification
Previously approved research studies that require IRB reapproval.
Email email@example.com to request the application that best suits your needs. Send your completed application form and supporting materials as an attachment back to firstname.lastname@example.org for submission.
You will receive an acknowledgment within 48 hours from our IRB Coordinator and your project will receive a unique number for tracking purposes.
Project Status and Notification
Once logged, members of the IRB will review your project and make a decision. Allow up to 25 business days. Should the IRB require further editing or additional documents, you will be asked to provide this information.
Once a decision has been reached, the IRB coordinator will communicate the decision to you in writing.