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Chapter X - General Procedures for IRB Submissions Involving Exempt Research

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Investigators must submit a request for an Exemption Determination using a templated form which includes specific content to allow the IRB to determine eligibility under the specific exempt category permitted by federal regulation. This request form should be used to obtain a written opinion that a proposed project is exempt from the requirement for IRB review or does not require IRB review because the project does not involve research or does not involve human participants.

Investigators are required to answer questions about the proposed project which allows the IRB to evaluate the protection of human participants participating in the exempt project, including information about risk to participants, participant selection, and provisions for protecting the privacy interests of participants and the confidentiality of participant data.

To request a Determination, the investigator needs to submit the completed (templated)
application together with the following:

  • A copy of the protocol or a detailed description of the project;
  • Copies of all data collection tools including case report forms and surveys; AND
  • Copies of any interview or focus group questions that will be used.

CRITERIA FOR EXEMPTION
The IRB Chair or IRB reviewer determines if the proposed research is exempt from federal policies governing human participant protections. This determination is made in accordance with:
The OHRP Decision Chart # 2- "Is the Research Involving Human Participants Eligible for Exemption under 45 CFR 46.101 (b)?";
The criteria for exemption as specified under 45 CFR 46.101 (b)(1), (b)(2) and (b)(4) and 21 CFR 56.104(c) and (d);
If participants are under the age of 18 years, the exemption criteria described in 45 CFR 46.101(b)(2), are not applicable except for research limited to (a) the use of educational tests or (b) to observations of public behavior when the investigator does not participate in the activities being observed.

DOCUMENTATION OF DETERMINATION
After reviewing the protocol submission, the IRB reviewer documents his/her determination in writing and the principal investigator of the research activity is notified.

DETERMINATION NOTIFICATION: RESEARCH QUALIFIES AS EXEMPT
The principal investigator of the research activity is notified of IRB concurrence that the Research is exempt, under Exemption Category X. This notification letter specifies the regulatory basis for granting exempt status (i.e., 45 CFR 46.101 (b) (1-6) and/or 21 CFR 56.104(d)) and

  • A notice that if there is a change in the project that may reflect its determination status, the investigator will contact the Genetic Alliance IRB to re-evaluate the project; AND
  • If a change of Principal Investigator is required for any reason, a new exempt request has to be submitted.

Note: The IRB may grant a waiver of HIPAA Authorization for an exempt project if the recording of medical information, without identifiers, will be conducted by or under the oversight of an investigator who would normally have access to this information by his/her patient care responsibilities.

FREQUENCY OF REVIEW
Protocols designated for exempt are not required to be submitted for annual renewal.

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