IRB Review Process

What is an Institutional Review Board (IRB)?

An IRB is a board, committee, or other group formally designated by an institution to review research involving humans as subjects. IRBs have authority to approve, require modification to, or disapprove all research activities covered by the HHS and FDA Protection of Human Subjects Regulations. Following initial approval, IRBs must conduct periodic reviews of such research. Every institution engaged in human subjects research conducted or supported by a Federal department or agency that has adopted the Common Rule (Federal Policy for the Protection of Human Subjects) is required to designate one or more IRBs under an assurance of compliance.

Additionally, when FDA-regulated products are investigated in human subjects, the protocol is subject to review and approval by an IRB. Hospitals, academic medical centers, government units, and others engaged in federally conducted or supported health research activities involving human subjects and entities conducting FDA regulated clinical investigations, among others, have designated IRBs. Human subjects research that is conducted or supported by a Federal department or agency that has adopted the Common Rule (found for HHS at 45 CFR part 46, subpart A) and that does not meet the criteria for exemption or is regulated by the FDA is subject to review and approval by an IRB. In most instances, in order to approve research, an IRB must determine that specified criteria have been satisfied. Among these criteria, an IRB must determine that, when appropriate, the research protocol includes “adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data” (see 45 CFR 46.111(a)(7) and 21 CFR 56.111(a)(7)).

 

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

 

  1. Informed Consent
    The informed consent requirements found in HHS 45 CFR 46 Regulation for the Protection of Human Subjects in Research provide bedrock protections for individuals participating in research studies. While the regulatory default for non-exempt research is to obtain and document the informed consent of all participants, the regulations anticipated scenarios where this default requirement would be inappropriate given the proposed research methods, the context in which the research would be conducted or the subject population. The regulations included provisions allowing IRBs to waive some or all elements of informed consent when specific conditions have been met.
  2. Principal Investigator (Faculty/Staff/Student) Designs and Submits
    Investigators must indicate if the application requires exempt, expedited, or full board review. The final determination of the review category is made by the IRB.
  3. Dean/Departmental head Sign-off:
    Once the application is submitted the Dean/departmental head must review and sign off on the application. In some cases, a departmental representative must also sign the application. This sign-off represents consideration of scientific merit, availability of resources, or other issues at the department level. 
  4. IRB Committee:
    After Dean/department head approval is obtained, an initial review of the application is conducted by the IRB Committee or IRB designee. At Lincoln University, the IRB committee conducts a thorough pre-review of the application to verify the correct level of review, and to evaluate the protocol and supporting documents (e.g., consent form, recruitment materials). If a study is approved as exempt or determined to be “not human subjects research,” no further IRB action is required. Any significant changes to the approved study must be submitted and reviewed by the IRB prior to the implementation of changes.  For studies designated as expedited or full board, IRB review is required from a designated reviewer or the full board, respectively.
  5. Study Approved and PI Notified:
    The researcher will be notified through a letter when the study has been approved.