NIST
OU Director or Deputy Director
What
are the OU Director or Deputy Director's Responsibilities?
14.01.05b. OU Directors are hereby
delegated responsibility and authority for determining whether
research projects involve human subjects that fall into a
class of subjects covered by 45
CFR Part 46, Subpart B, C,
or D
and for determining in writing whether research projects involving
human subjects fall within one of the exemptions to the Common
Rule as stated in 15
CFR 27.101(b). OU Directors may seek the advice of the
NIST IRB Chairperson in making these determinations. In the
case of research projects involving contracts, grants, or
cooperative agreements, OU Directors shall coordinate with
the NIST Deputy Chief Counsel and the Office of the General
Counsel's Office of Finance and Litigation in making exemption
determinations. The determinations shall be made with the
written approval of the NIST Deputy Chief Counsel and shall
be submitted to the NIST IRB Chairperson with copies to other
interested parties. No exemptions are available for research
involving human subjects that is conducted under 45
CFR Part 46, Subpart B, C,
or D
(A sample exemption memorandum is included as Appendix A to
this subchapter.)
How
Does the OU Know Whether My Project Requires IRB Review? 14.01.05b.
The National Institute of Standards and
Technology requires that all research protocols involving
human subjects be submitted through line management to the
OU Director for determination whether the research involves
Protected Classes of Human Subjects, is exempt from the requirement
of IRB review, or requires IRB review.
What
Does the OU Need to Look for When a Potential Project Comes
to the Laboratory? Review
the procedures section of the NIST Administrative Manual Section
14.01.06 to help determine what type of review is required
for your protocol.
What
is an Exemption? Some
projects may not require a full IRB review. Review the list
of what is exempt under 15
CFR 27.101(b). If you think your protocol
falls within one of the exemption categories, submit required
documentation for your OU Director to make an exemption determination.
Sample
Exemption Memorandum (NIST
Administrative Manual 14.01 Appendix A)
in a text format.
When
is a Project Exempt? The only time
a project is exempted is when the criteria for exemption is
met under the policy 15
CFR 27.101(b).
When
is a Full IRB Review Required? If
the research project is expected to involve human subjects,
the work will be performed at NIST, the protocol does not
involve a
Protected Class, and is determined not to be exempt.
What
is an Expedited Review and When is it done? When
research involves no more than minimal risk and involves only
procedures listed in one or more of the categories
listed by DHHS, the NIST IRB Chairperson may review the protocol
under the expedited review procedures authorized by 15 CFR
27.110.
What
If the Protocol Requires IRB Review, What Must the OU Submit
to the NIST IRB? A
sample submission package is located in the NIST Administrative
Manual 14.01 Appendix B
text format.
What
is an Informed Consent Form and What are the Requirements?
Review the general requirements
for an informed consent form under 15
CFR 27.116.
What
Documentation is Required for an Informed Consent Form? Review
the documentation requirements under 15
CFR 27.117.
Requirements/Sample
of an Informed Consent Form (NIST
Administrative Manual 14.01 Appendix C) in
text format.
How
Do I Know the Human Subject Package is Complete and Ready
to Proceed? For an Exemption
checklist. For an Expedited
or Full Review Checklist.
What
is a "
Protected Class"? NIST
IRB is not authorized to review research involving the Protected
Classes. For additional information concerning
the "Protected Classes" review the NIST
Administrative Manual 14.01.04 and 45
CFR Part 46 Subpart B (Protections for Pregnant
Women, Human Fetuses and Neonates Involved in Research); 45
CFR Part 46 Subpart C (DHHS Protections Pertaining
to Biomedical and Behavioral Research Involving Prisoners
as Subjects; and 45
CFR Part 46 Subpart D (DHHS Protections for Children
Involved as Subjects in Research)
What
if NIST Funds a Project Involving Human Subjects Under a Grant,
Contract or a Cooperative Agreement? The NIST Administrative
Manual 14.01.06b states that "NIST-funded or
supported projects involving external research using human
subjects, and research conducted at NIST under proprietary
and non-proprietary facilities use agreements -
If a research project is expected to involve human subjects,
and the work involving human subjects will be performed outside
NIST through either a grant, a contract, or a cooperative
agreement used as the funding mechanism, or if a project involving
human subjects will be performed at NIST by an outside organization
under a facilities use agreement (either proprietary or non-proprietary),
the NIST principal investigator must develop a package to
be submitted through line management to the OU Director whose
OU will fund the project, or in which the facility is located,
for determination as to whether the human subjects involved
fall into a class of subjects covered by 45 CFR Part 46, Subpart
B, C, or D, and, if not, whether the project fits within an
exemption to the Common Rule."
When
is a Renewal Required? All projects approved by
the NIST IRB require an annual renewal. The IRB Office will
sent notification to the Researcher or Principle Investigator
three (3) months prior to the renewal date. Exemptions do
not require a renewal.
What
Should I Do if Changes Occur During the Year? Any
change to the protocol requires approval by the IRB Chairman
in writing. Any work related to the said change(s)
can not proceed until the IRB Chairman approves the change(s).
Human
Subjects Computer Base Training (CBT) for NIST Staff
Protection
of Human Subjects and Vertebrate Animals Used in Research
- This is a Power Point
Presentation that Dr. Alan H. Cookson, NIST IRB Chairman and
Mrs. Melissa Lieberman, Office of NIST Counsel gave on June
12, 2001.
Protection
of Human Subjects in Research at NIST -
This is a Power Point Presentation that Dr. Alan H. Cookson,
NIST IRB Chairman and Mrs. Melissa Lieberman, Office of NIST
Counsel put together for the NIST scientists who are involved
with or planning or approve human subjects research. This
will also be used to meet the annual education requirements.
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