New York University Langone Medical Center/School of Medicine
Institutional Review Board
Continuing Education
Genetic Information Nondiscrimination Act (GINA) 2008
May 2009
Background on GINA:
GINA is a Federal law that prohibits discrimination in health coverage and employment based on genetic information.
GINA, together with already existing nondiscrimination provisions of the Health Insurance Portability and Accountability
Act, generally prohibits health insurers or health plan administrators from requesting or requiring genetic information of an
individual or an individual's family members, or using such information for decisions regarding coverage, rates, or
preexisting conditions. GINA also prohibits employers from using genetic information for hiring, firing, or promotion
decisions, and for any decisions regarding terms of employment.
How does this new law affect the IRB and research involving human subjects?
GINA has implications regarding the actual or perceived risks of genetic research and an individual's willingness to
participate in such research. IRBs should be aware of the protections provided by GINA as well as the limitations in the
law's scope and effect. For genetic research undergoing initial or continuing review investigators and IRBs should
consider whether consent processes and documents should include language regarding the protections provided by
GINA, and if so, ensure that such language accurately describes the impact of GINA on the risks and confidentiality
protections for such research.
Protections under GINA and the Criteria for IRB Approval of Research
 The discrimination protections provided by GINA address health coverage and employment only.
 GINA's provisions prohibiting discrimination in health coverage based on genetic information do not extend to life
insurance, disability insurance, or long-term care insurance. Therefore, GINA provides no protection from the
potential risks associated with the research and the loss of this type of insurability.
 GINA generally does not apply to employers with fewer than 15 employees. Therefore, subjects who are or will be
employed by such employers receive none of the GINA protections that prohibit discrimination in employment on
the basis of genetic information.
When IRBs consider whether research satisfies the findings for the approval human subjects research, there are three
findings in particular that are affected by GINA. These are:
o
o
o
Are risks to subjects are minimized;
Are risks to subjects reasonable in relation to anticipated benefits; and
When appropriate, are there adequate provisions to protect the privacy of subjects and maintain
confidentiality of data
GINA will decrease the potential risk for loss of insurability and employability by protecting research participants from
discrimination as a result of findings made through genetic testing. The Informed Consent document and process should
outline these protections. IRBs should keep in mind the following:
(1) The new law protects against discriminations in health coverage and employment ONLY.
(2) Subjects should be informed regarding the extent of protection under GINA and that a potential risk still exists
for certain insurances as outlined above.
(3) The protection may not extend to subjects who are or will be employed by an employer with fewer than
15 employees.
(4) For projects after May 2009 (initial or continuing reviews), IRBs need to be aware that GINA has implications
for how risks are described for genetic research conducted prior to the effective dates the IRB must consider if
the consent process and document will need to include language regarding the protections provided by GINA.
If language is included, it must accurately describe the impact of GINA on the risks and confidentiality
protections for such research.
Effective Date
The new law becomes effective sometime within a year of May 21, 2009, and the law related to employment does not
take effect until November 21, 2009.
IRB Standard Language
The IRB Office will be developing standard language to meet the changes outlined under GINA. This will be routinely
added to consent forms before the projects come to the full board for review.
References: OHRP Guidance on the GINA Act: Implications for Investigators and Institutional Review Boards (March 24, 2009)
Page 1 of 1