Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards
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| Audience/Grade: | Graduate-Professional Development |
| Discipline(s): |
Bioengineering and Biomedical Engineering Engineering Ethics |
| Special Topic(s): | |
| Learning Resource Type: |
Reference - Article/Document |
| Media Type: |
Unknown |
| Author(s): |
Organization:US Department of Health and Human Services |
| Description: | "This guidance represents OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777. his document applies to non-exempt human subjects research conducted or supported by HHS. It provides background information regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and institutional review boards (IRBs) that review, non-exempt human subjects research involving genetic testing or the collection of genetic information (hereinafter referred to as "genetic research"), particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent. The information presented in the background section of this document is intended for general information purposes only. While the background section does not cover all of the specifics of GINA, it does provide an explanation of the statute to assist those involved in the conduct or oversight of research to understand the law and its prohibitions related to discrimination based on genetic information in (a) coverage provided either by health insurers or by employment-based group health plans (hereinafter referred to as "health coverage"), and (b) employment. This information should not be considered legal advice. In addition, some of the provisions of GINA discussed involve issues for which the rules have not been finalized, and this information is subject to revision based on publication of regulations. " |
| Rating: |
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| Related Resources | |
| Keywords: | human subjects genetic information patient privacy |
| Usage Tip | |
| Related ABET Criteria: |
(b) Design and conduct experiments, analyze and interpret data |
| Use of Resource: |
Target Audience: Investigators who conduct, and IRBs that review, genetic research involving human subjects that is conducted or supported by HHS. |
| Difficulty: |
Difficult |
| Interactivity Level: |
Very low |
| Version Info | |
| Publication Date: | April 2009 |
| Platform/Format: |
WWW |
| Cost: |
Free |
| Download URL: | http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html |
| Metadata: |
IEEE LOM Record |
| Collection: |
NEEDS
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