Records accumulated in the development and implementation of standards and procedures
for protection from risks, hazards and dangers stemming from biomedical research or
clinical care, where NIH has broad responsibilities extending beyond NIH itself.
Records of the Office for Protection from Research Risks.
7000-A-1 Special assurance
files and Single Project Assuance files for individual DHHS-supported
projects, grants and contracts with supporting papers, including
grant or contract application, revisions or amendments to the assurance,
and related correspondence.
a. Office file.
Disposition: Place in inactive file on final payment of contract, close-out of
grants, or settlement of claims of litigation. Transfer each fiscal year file to Federal
Records Center after 1 year in inactive file. Destroy 6 years after file is closed.
b. Other copies.
Disposition: Destroy no later than 2 years after final payment, close-out, or
settlement of claims or litigation of related grant or contract.
7000-A-2 General Assurance files, Multiple Project Assurance files,
Cooperative Project Assurance, Animal Welfare Assurance files, and all other OPRR Assuance
files covering DHHS-supported projects, grants or contracts of an organization.
Included are records related to preliminary negotiations, signed assurances with revisions
or amendments, related correspondence, and other supporting documents.
a. Official file.
Disposition: Place in inactive files on final payment or close-out of all
projects, contracts or grants, or settlement of claims of litigation. Transfer each
in fiscal year file to Federal Records Center after 1 year in inactive file. Destroy 6
years after close-out.
b. Other copies.
Disposition: Destroy no later than 2 years after final payment, close-out, or
settlement of claims or litigation of all contracts or grants covered by the assurance.
7000-A-3 Case files of negotiations for assurance of compliance
which are withdrawn, deactivated, or not completed for other reasons.
a. Official file.
Disposition: Place in inactive file when the assurance or the related project,
contract or grant is withdrawn, disapproved or otherwise inactivated. Transfer each fiscal
year file to Federal Records Center after 1 year in inactive file. Destroy 6 years after
file is closed.
b. Other copies.
Disposition: Destroy no later than 2 years after assurance or the related
contract or grant is withdrawn, disapproved or otherwise inactivated.
7000-A-4 Cumulative List of
Institutions in Compliance with policy for protection from research
risks, with supporting documents.
a. Official file.
Disposition: DISPOSAL NOT AUTHORIZED. Review for disposal with NIH Records
Management Officer before 1989.
b. Other copies.
Disposition: Destroy when no longer needed for administrative reference.
7000-A-5 Inquiries and complaints
of violations on research supported by DHHS involving human
subjects and animal subjects.
a. Official file.
Disposition: Place in inactive file on final
payment of contract, close-out of project or grant, or settlement of claims or litigation,
or OPRR determination that corrective action has been implemented or is unwarranted.
Transfer each fiscal year file to Federal Records Center after 1 year in inactive file.
Destroy 6 years after file is closed.
b. Other copies.
Disposition: Destroy no later than 2 years after final payment close-out, or
settlement of claims or litigation of related grant or contract.
7000-A-6 Reports of compliance
oversight investigations and special site visits made for purposes
of assuring that grantee and contractor institutions are following
NIH policy for protection of research subjects and to respond to
questions about the policy.
a. Official file.
Disposition: Place in inactive file on final payment of contract, close-out of
project or grant, or settlement of claims or litigation, or OPRR determination that
corrective action has been implemented or is unwarranted. Transfer each fiscal year file
to Federal Records Center after 1 year in inactive file. Destroy 6 years after file is
closed.
b. Other copies.
Disposition: Destroy no later than 2 years after final payment close-out or
settlement of claims or litigation of related grant or contract.
7000-A-7 Biohazards - Protection of Research Subjects
Electronic copies created on electronic mail and word processing systems.
Disposition: Delete when file copy is generated or when referencing or
updating is completed.
7000-B-1 Memoranda of understanding
and agreement for use of controlled agents in research: Forms
documenting the observance by NIH investigators and outside institutions
of agreed upon standards governing the use of hazardous microbiological
agents in either intramural or extramural research. Files include
related papers.
a. Memoranda of understanding which, in the opinion of the Assistant Director for
Environmental Health and Safety or equivalent program official, may be important for
future environmental or biomedical research.
Disposition: DISPOSAL NOT AUTHORIZED. Review with NIH Records Management Officer
in 1988 for possible destruction.
b. All other memoranda files.
Disposition: Destroy 5 years after completion of experiment or project.
c. Electronic copies created on electronic mail and word processing systems.
Disposition: Delete when file copy is generated or when referencing or
updating is completed.
7000-C-1 NIH Environmental
review document and environmental statement, made in accordance
with the HHS General Administration Manual, Part 30.
Disposition: DISPOSAL NOT AUTHORIZED.
7000-C-2 NIH Chemical Waste
management documents, including manifest, annual report, permits,
etc., made in conformance with the Resource Recovery and Reclamation
Act of 1976 and related laws and regulations.
Disposition: DISPOSAL NOT AUTHORIZED.
7000-C-3 Environmental Impact
Electronic copies created on electronic mail and word processing systems.
Disposition: Delete when file copy is generated or when referencing or
updating is completed.
