Waiver
and Alteration of Informed Consent and Authorization for
Research
This
Policy provides the following information:
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Overview
of Common Rule and HIPAA Privacy Rule standard regarding
waiver/alteration of informed consent and authorization.
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The
process for submitting a request for a waiver of informed
consent and authorization.
Description of the new individual rights that the
Privacy Rule requires for any research conducted pursuant
to a waiver of authorization.
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The
process for obtaining oral consent and authorization.
Overview:
The Common Rule allows the IRB to approve a waiver or
an alteration of the requirement for informed consent
to the research if the proposed protocol meets the
following specific criteria found at 45 CFR § 46.116(d).
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The research involves no more than minimal risk to
the subjects;
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The
waiver or alteration will not adversely affect the
rights and welfare of the subjects;
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The
research could not practicably be carried out without
the waiver or alteration; and
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Whenever
appropriate (generally, when there is a health justification),
the subjects will be provided with additional pertinent
information after participation.
The
HIPAA Privacy Rule, which has a compliance date
of April 14, 2003, will change this standard of practice.
The Privacy Rule has its own list of criteria that must
be met in order to waive a subject's written authorization
to use and disclose individually identifiable health
information for research. The following criteria
found at 45 CFR § 164.512(i)(2)(ii) are similar,
but not identical, to the criteria in the Common Rule.
1.
The research involves no more than minimal risk to the
privacy of the subjects. The protocol must include,
at a minimum, the following elements:
a)
An adequate plan to protect identifiers from improper
use and disclosure.
b) An adequate plan to destroy the identifiers at
the earliest opportunity. Identifiers can be maintained
if there is a health or research justification or
if retention is required by law. The investigator
must document such justification.
c) Adequate written assurances that the identifiable
information will not be reused or disclosed except:
· As required by law
· For authorized oversight of the research
project
· For other research for which the use or disclosure
would be permitted
2.
The research could not practicably be carried out without
the waiver or alteration.
3.
The research could not practicably be conducted without
access to and use of this identifiable information.
Process
for submitting a request for waiver of informed consent
and authorization:
As of April 14, 2003, the IRB will consider both sets
of criteria before determining whether informed consent
and authorization for the research can be waived.
In
order for the IRB to make these determinations, the
investigator is required to complete any of the forms
listed below that are appropriate for his/her study.
Each of these meets the requirements for seeking a waiver
of informed consent and authorization; an investigator
need only complete the generalized Request for Waiver
of Informed Consent and Authorization for Research if
none of the other forms apply.
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Research
Limited to the Use of Medical Records
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Request
for Waiver of Informed Consent and Authorization for
Research
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Please
note: existing forms will be updated to include
the waiver criteria and will be listed here, including
Research Related Use of Discarded Human Material and
Secondary Uses of Samples/Data, among others.
Description
of new individual rights that the Privacy Rule requires
for any research conducted pursuant to a waiver of authorization:
1. Disclosures must be tracked: Investigators should note
that disclosures of subjects' individually identifiable
health information outside the Partners system that are
made as part of research conducted with a waiver of authorization
must be tracked in accordance with the accounting requirements
of the Privacy Rule. Specifically, the Privacy Rule gives
subjects the right to request a list of disclosures of
their individually identifiable health information outside
Partners (indicating how, when, why, what information,
and to whom this information has been disclosed) over
the previous six years.
For more detailed information concerning the Privacy Rule's
accounting requirements, see "Individual
Rights in the Research Context" and the Partners
policy, "Accounting
of Disclosures".
2.
The minimum necessary standard must be met: Investigators
conducting research under a waiver may use or disclose
only the minimum necessary identifiable information needed
for the research. (Please see Minimum Necessary Standard:
Research Activities)
The
process for obtaining oral consent and authorization:
The
Common Rule allows an IRB to approve research in which
consent is obtained orally from subjects under limited
circumstances. Typically, scripts are required (especially
if non-medically trained staff is getting oral consent)
and these must be submitted for IRB review and approval.
Ideally, some written study information is provided to
the subject during his/her participation in the research.
The
Privacy Rule allows a waiver or alteration of the written
authorization requirement. Researchers obtaining oral
consent may obtain oral authorization as well if the waiver
of authorization criteria listed above are met.
Oral
consent and/or authorization should be documented by the
investigator. If obtaining oral consent/authorization,
researchers should ask subjects if they wish to receive
a copy of the Privacy Notice and provide the Notice if
requested. The minimum necessary standard and the requirement
to track disclosures do not apply.
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