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IV.02 |
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Determination of Research Exempt from Full Committee
Review |
Objective
This Procedure describes the processing of a request for determination that the research is exempt from full Committee review.
Policy/Procedure
The PI will submit via the iRIS system studies that may qualify for exempt status.
I. The Director or Manager of the Office of Research Support Committees shall be designated by the Executive Committee Chairman to review studies submitted to the CPHS requesting Exempt status to determine whether ethical and regulatory criteria for the designation are met. The reviewer should not have any conflicting interest as defined by HRP PP II.05 and should be familiar with applicable federal regulations and local policies and procedures to be utilized in making the determination that a protocol is exempt from further review. Investigators do not have the authority to make an independent determination that research involving human participants is exempt and must contact the CPHS if there are any changes to the research. The CPHS may not create new categories of exempt research.
II. The principal investigator (PI) shall submit the request for determination of “Exempt” via the iRIS system, providing any applicable documentation as described in P & P Information Required to Conduct Initial Review. Requests for exemption shall be reviewed in a timely period (within 21 days).
III. Research activities in which the only involvement of human participants will be in one or more of the following categories are exempt. Note: These categories do not apply to research involving prisoners and A-E do not apply to FDA regulated research.
A. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
1. Research on regular and special education instructional strategies, or
2. Research on the effectiveness of or comparisons of instructional techniques, curricula, or classroom management methods
B. Research involving the use of educational tests (cognitive, diagnostic, aptitude. achievement), survey procedures, interview procedures or observation of public behavior, unless:
1. Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and
2. Any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation; and
C. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (B)(1) of this procedure, if:
1. The human participants are elected or appointed public officials or candidates for public office; or
2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
D. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
1. To qualify for this exemption, data, documents, records, or specimens must have been collected before the research project begins.
2. Under this exemption, an investigator (with proper HIPAA Waiver or Alteration authorization) may inspect private, identifiable records, but may only record information in a non-identifiable manner. The data must be permanently and completely de-linked at the time of extraction. A code may be used to organize data as it is collected. However the code may not be a means of re-linking the data set to the original data source.
E. Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
1. Public benefit or service programs;
2. Procedures for obtaining benefits or services under those programs;
3. Possible changes in or alternatives to those programs or procedures; or
4. Possible changes in methods or levels of payment for benefits or services under those programs.
5. The following criteria must be satisfied to invoke the exemption for research and demonstration projects examining “public benefit or service programs as specified in Department of Health and Human Services regulations:
a) The program under study must deliver a public benefit or service.
b) The research or demonstration project must be conducted pursuant to specific federal statutory authority.
c) There must be no statutory requirement that an IRB review the project.
d) The project must not involve significant physical invasions or intrusions upon the privacy of participants.
e) This exemption is for projects conducted by or subject to approval of Federal agencies, and is most appropriately invoked with authorization or concurrence by the funding agency.
IV. If the proposed research plan does not adequately protect the human subjects according to ethical and regulatory standards, the study will not be processed as exempt, but will be promoted to a higher level of review.
V. Determinations shall be documented in the iRIS system, with notation of the category under which the exemption is granted.
VI. The determination of the request for exemption shall be communicated to the PI in the iRIS system in the form of a letter.
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Applicable Regulations and Guidelines 21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html
) 21CFR 56( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html
) 38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html
) 45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html
) ICH E6 (http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB
) OPRR letter dated May 5,
1995 - Subject: Exempt Research and
Research That May Undergo Expedited Review (http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc95-02.htm
) OHRP
Guidance on the Involvement of Prisoners in Research dated May 23, 2003 (http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.pdf |
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