OFFICE FOR PROTECTION FROM RESEARCH RISKS
OFFICE FOR PROTECTION FROM RESEARCH
RISKS
Issues to Consider in the Research Use of Stored Data or Tissues
November 7, 1997
Human Tissue Repositories collect, store, and distribute human tissue materials for research purposes. Repository activities involve three components: (i) the collectors of tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators.
If supported by the Department of Health and Human Services (HHS), each component must satisfy certain regulatory requirements.
| Tissue Collector |  |
Repository
Storage |
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| Tissue Collector | |
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| Tissue Collector | |
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IRB Review |
IRB Review |
Recipient Agreement |
| For Additional Information: | Dr. Tom Puglisi Director, Division of Human Subject Protections Office for Protection from Research Risks 6100 Executive Blvd Suite 3B01 - NIH MSC 7505 Rockville, MD 20892-7507 301-402-5189 / FAX 301-402-2071 / E-MAIL tp10y@nih.gov |
| August 19, 1996 | |
| TO: | Professional Staff Division of Human Subject Protections |
| FROM: | Melody H. Lin, Ph.D. Acting Director Division of Human Subject Protections |
| SUBJECT: | Operation of Human Cell Repositories Under HHS Regulations at 45 CFR 46 |
| OPRR offers the following
guidance concerning operation of human cell repositories
under Department of Health and Human Services (HHS)
regulations for the protection of human subjects (45 CFR 46). The guidance assumes that repository
activities include nonexempt humansubjects research as
defined under HHS regulations.. |
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| (1) | The operation of any
HHS-supported human cell repository and its data
management center should be subject to oversight by an
Institutional Review Board (IRB) convened under an
applicable OPRR-approved Assurance of Compliance. This
IRB should set the conditions under which data and
specimens may be accepted and shared. OPRR strongly
recommends that one such condition stipulate that
recipient-investigators not be provided access to the
identities of donor-subjects or to information through
which the identities of donor-subjects may readily be
ascertained. |
| (2) | Collection of data and
specimens should be subject to oversight by local IRBs
convened under applicable OPRR-approved Assurances |
| (3) | Written informed consent
should be obtained from each donor-subject in accordance
with HHS regulations at 45 CFR 46.116. Included among the basic elements of informed
consent should be a clear description of (i) the
operation of the cell repository; (ii) the specific types
of research to be conducted; (iii) the conditions under
which data and specimens will be released to
recipient-investigators; and (iv) procedures for
protecting the privacy of subjects and maintaining the
confidentiality of data. |
| (4) | Informed consent
information describing the nature and purposes of the
research should be as specific as possible. |
| (5) | Where human genetic
research is anticipated, informed consent information
should include information about the consequences of DNA
typing (e.g., regarding possible paternity
determinations). |
| (6) | Informed consent
documents may not include any exculpatory language
through which subjects are made to waive or appear to
waive any legal rights. |
| (7) | OPRR recommends that the
cell repository develop a sample collection protocol and
informed consent document for distribution to
collector-investigators and their local IRBs. |
| (8) | A written submittal
agreement for collector-investigators should require
written informed consent of the donor-subjects utilizing
an informed consent document approved by the local IRB.
It should also contain an acknowledgment that
collector-investigators are prohibited from providing
recipient-investigators with access to the identities of
donor-subjects or to information through which the
identities of donor-subjects may readily be ascertained. |
| (9) | A written usage agreement
for recipient-investigators should include the following: |
| "Recipient
acknowledges that the conditions for use of this research
material are governed by the cell repository
Institutional Review Board (IRB) in accordance with
Department of Health and Human Services regulations at 45 CFR 46. Recipient agrees to comply fully with all such
conditions and to report promptly to the cell repository
any proposed changes in the research project and any
unanticipated problems involving risks to subjects or
others. Recipient remains subject to applicable State or
local laws or regulations and institutional policies
which provide additional protections for human subjects. |
|
| This research material
may only be utilized in accordance with the conditions
stipulated by the cell repository IRB. Any additional use
of this material requires prior review and approval by
the cell repository IRB and, where appropriate, by an IRB
at the recipient site, which must be convened under an
applicable OPRR-approved Assurance." |
|
| (10) | OPRR recommends that a Certificate of Confidentiality be obtained to protect confidentiality of human cell repository specimens and data. |
OFFICE FOR PROTECTION FROM RESEARCH RISKS
Guidance on Protections for
Human Subjects in the
National Institute of General Medical Sciences
Human Genetic Mutant Cell Repository
May 21, 1997
| The Office
for Protection from Research Risks (OPRR) provides the
following guidance in response to requests from
Institutional Review Boards, the National Institute of
General Medical Sciences (NIGMS), and the research
community. |
|
| (1) | Local IRB Review.
Collection of data and specimens for inclusion in the
NIGMS Human Genetic Mutant Cell Repository should be
subject to oversight by local Institutional Review Boards
(IRBs) convened by the collecting institutions under
OPRR-approved Assurances.1 The local IRB is
familiar with the particular circumstances of its
research setting and is in the best position to weigh
critical considerations like local professional and
community standards, institutional policies and
resources, and the needs of differing patient or subject
populations. |
| (2) | Informed Consent.
Written informed consent should be obtained from each
donor-subject in accordance with Department of Health and
Human Services (HHS) regulations at 45 CFR 46.116. |
| Included among the basic
elements of informed consent should be a clear
description of (i) the operation of the cell repository;
(ii) the specific types of research to be conducted;
(iii) conditions under which data and specimens will be
released to recipient-investigators; and (iv) procedures
for protecting the privacy of subjects and maintaining
the confidentiality of data. Informed consent information
describing the nature and purposes of the research should
be as specific as possible. Where human genetic research
is anticipated, informed consent information should
include information about the consequences of DNA typing
(e.g., regarding possible paternity determinations).
Informed consent documents may not include any
exculpatory language through which subjects are made to
waive or appear to waive any legal rights. |
|
| The Cell Repository
should provide tissue collectors with an NIGMS-approved
sample informed consent document containing these
elements and with a sample protocol for tissue
collection. IRBs may request copies of these sample
documents to assist in their review of local informed
consent documents and protocols. |
|
| (3) | Oversight of
Repository Activities. Operation of the
NIGMS Human Genetic Mutant Cell Repository and its data
management center should be subject to oversight by an
Institutional Review Board (IRB) convened by the Coriell
Institute of Medical Research under an OPRR-approved
Assurance of Compliance. The IRB should review and
approve a protocol specifying the conditions under which
data and specimens may be accepted and shared, and
ensuring adequate provisions to protect the privacy of
subjects and maintain the confidentiality of data. The
IRB should also review and approve a sample collection
protocol and informed consent document for distribution
to tissue collectors and their local IRBs. A Certificate
of Confidentiality should be obtained to protect
confidentiality of repository specimens and data. |
| (4) | Submittal Agreement.
A written submittal agreement for tissue collectors
should require written informed consent of the
donor-subjects utilizing an informed consent document
approved by the local IRB. It should also contain an
acknowledgment that collectors are prohibited from
providing recipient-investigators with access to the
identities of donor-subjects or to information through
which the identities of donor-subjects may readily be
ascertained. |
| (5) | Usage
Agreement. A written usage agreement for
recipient-investigators should include the following:
"Recipient acknowledges that the conditions for use
of this research material are governed by the cell
repository Institutional Review Board (IRB) in accordance
with Department of Health and Human Services regulations
at 45 CFR 46. Recipient agrees to comply fully with all such
conditions and to report promptly to the cell repository
any proposed changes in the research project and any
unanticipated problems involving risks to subjects or
others. Recipient remains subject to applicable State or
local laws or regulations and institutional policies
which provide additional protections for human subjects.
This research material may only be utilized in accordance
with the conditions stipulated by the cell repository
IRB. Any additional use of this material requires prior
review and approval by the cell repository IRB and, where
appropriate, by an IRB at the recipient site, which must
be convened under an applicable OPRR-approved
Assurance." |
| 1 | Under certain
circumstances, collecting institutions may elect to rely
upon the Cell Repository IRB at Coriell Institute. This
requires a written Cooperative Amendment, signed by the
collecting institution and the Coriell Institute, and
approved by OPRR. Contact OPRR fordetails. |
| For Additional Information: | Dr. Tom Puglisi Director, Division of Human Subject Protections 301-402-5189 / FAX 301-402-2071 / E-MAIL tp10y@nih.gov |
OFFICE FOR PROTECTION FROM RESEARCH RISKS
Protections for Human Subjects
in the
NIGMS Human Genetic Mutant Cell Repository
Submission of Non-Identifiable
Materials to the Repository
May 22, 1997
In response to requests from the National Institute of General Medical Sciences (NIGMS), the Office for Protection from Research Risks (OPRR) provides the following clarification regarding submission of "non-identifiable" materials to the Human Genetic Mutant Cell Repository.
As Chart 1 (attached) illustrates, human subjects are involved in research when the research involves (i) an intervention or interaction with a living individual that would not occur (or would occur in some other fashion) but for the research; or (ii) the use of identifiable private data or information in a form associable with a living individual [also see 45 CFR 46.102(f)].
| Human
subjects would not be involved when material
submitted to the Repository satisfies both
of the following conditions: |
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| (1) | The material, in its
entirety, was collected for purposes other than
submission to the Repository (e.g., the material was
collected solely for clinical purposes, or for legitimate
but unrelated research purposes, with no
"extra" material collected for submission to
the Repository). |
| and |
|
| (2) | The material is submitted
to the Repository without any identifiable private data
or information (i.e., no codes or linkers of any sort may
be maintained, either by the Submitter or by the
Repository, that would permit access to identifiable
private data or information about the living individual
from whom the material was obtained). |
While OPRR requires neither an Assurance of Compliance nor a Certification of Institutional Review Board (IRB) review [45CFR46.103(a),(f)] for activities that do not involve human subjects, local institutional requirements regarding review of such activities are, nevertheless, binding. Some institutions may require IRB or administrative review of all research activities involving human materials, even where "human subjects" are not involved.
For Additional Information: Dr. Tom Puglisi
Director, Division of Human Subject Protections
301-402-5189 / FAX 301-402-2071 / E-MAIL tp10y@nih.gov
