INDIANA UNIVERSITY HEALTH
BLOOMINGTON
TITLE: Genetic Information
Nondiscrimination Action (GINA)
APPROVED: Wanda Katinszky
ORIGINATION: 06/20/2013
IRB – INSTITUTIONAL REVIEW BOARD
POLICY NUMBER: SC 504
PAGE 1 OF 3
REVIEW WITH REVISION: 08/05/2013
REVIEW ONLY:
1. POLICY
Genetic Information Nondiscrimination Action
The Genetic Information Nondiscrimination Act (GINA) is a federal law that,
together with already existing nondiscrimination provisions of the Health
Insurance Portability and Accountability Act (HIPAA), prohibits
discrimination in health coverage and employment based on genetic
information.
1.1
GINA Protections
1.1.1
In general, GINA 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.
1.1.2
1.2
GINA also prohibits employers from using genetic information for
hiring, firing, or promotion decisions, and for any decisions
regarding terms of employment.
IRB Responsibilities Under GINA
1.2.1
When reviewing proposed or ongoing genetic research, the IRB
will consider the protections provided by GINA when determining
whether the research satisfies the following criteria required for
IRB approval of research.
1.2.1.1 Risks to subjects are minimized: i) by using
procedures which are consistent with sound
research design and which do not unnecessarily
expose subjects to risk; and ii) whenever
appropriate, by using procedures which are already
being performed on the subjects for diagnostic or
treatment purposes (45 CFR 46.111(a)(a));
1.2.1.1.1 GINA’s protections do not apply to life insurance,
disability insurance or long-term care insurance.
GINA does not mitigate potential risks to subjects in
terms of their ability to obtain such insurance or
purchase such financial products. The IRB will
consider whether protections against disclosures of
genetic data are adequate.
1.2.1.2
Risks to subjects are reasonable to anticipated
benefits, if any, to subjects, and the importance of
the knowledge that may reasonable by expected to
result (45 CFR 46.111(a)(2));
TITLE: Genetic Information
Nondiscrimination Action (GINA)
REVIEW WITH REVISION: 08/05/2013
1.2.1.3
1.2.1.4
1.2.1.5
1.3
POLICY NUMBER: SC 504
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When appropriate, there are adequate provisions to
protect the privacy of subjects and maintain the
confidentiality of data (45 CFR 46.111(a)(7));
A description of any reasonable foreseeable risks or
discomforts is to the subjects (45 CFR 46.111(a)(2);
and
The informed consent document includes a statement describing
the extent, if any, to which confidentiality of records identifying
the subject will be maintained (45 CFR 46.111(a)(5).
Informed Consent
1.3.1
The protections provided by GINA should be disclosed to subjects
during the informed consent process. Such protections include:
1.3.1.1 Health Insurance companies and group health plans
may not request an individual’s genetic information
obtained from research;
1.3.2
1.31.2
Health Insurance companies and group health plans
may not use an individual’s genetic information
when making decisions regarding the individual’s
eligibility or premiums; and
1.3.1.3
Employers with fifteen or more employees may not
use an individual’s genetic information obtained
from research when making a decision to hire,
promote, or file the individual, or when setting the
terms of his/her employment.
The protections provided by GINA should not be overstated
during the informed consent process. Specifically, subjects
should be informed that:
1.3.2.1 The discrimination protections provided by GINA
address health coverage and employment only.
1.3.2.2
GINA’s provisions prohibiting discrimination in health
coverage based on genetic information do not
extend to life insurance, disability insurance or longterm care insurance.
1.3.2.3
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
TITLE: Genetic Information
Nondiscrimination Action (GINA)
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: SC 504
PAGE 3 OF 3
discrimination in employment on the basis of
genetic information.
2. SCOPE
These policies and procedures apply to all research submitted to the IRB.
3. RESPONSIBILITY
IRB Administrator is responsible for maintaining up-to-date review tools for review of
research pertaining to these categories based on new and evolving applicable regulations
and guidelines.
IRB Chairperson (or designee) is responsible for ensuring the IRB members are well versed in
new and evolving regulations and guidelines pertaining to these categories, for selecting
primary reviewers with appropriate expertise to conduct the reviews of such research, and for
securing appropriate consulting expertise as needed for selected reviews.
IRB Reviewer is responsible for conducting appropriate review of research planned for these
categories in consultation with any appropriate experts and resources.
4. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.111
5. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.
6. ATTACHMENTS - None
7. PROCESS OVERVIEW
Present requirements concerning review of specific types of research that may require
additional considerations by the IRB.
8. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY
Who
Task
IRB Chair and
Administrator
Ensure that IRB members are kept up to date on
new and evolving regulations and guidelines
pertaining to GINA.
Tool