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. . . . . . . . 22.1.1 Policy
22.1.2 LBNL Support Organizations
22.1.3 Implementation
22.1.3.1 Human Subjects Committees
22.1.3.2 Human Subject Involvement
22.1.3.3 Review and Approval Procedures
22.1.3.4 Authority to Suspend or Terminate Approval of Research
22.1.4 Standards22.2 Research with Radioactive Drugs
22.1.5 References
22.2.1 Policy
22.2.2 LBNL Support Organizations
22.2.3 Implementation
22.2.4 Radioactive Drug Research Committee
22.2.5 Review and Approval
22.2.6 Standards
22.2.7 References
22.3.1 Policy
22.3.2 LBNL Support Organizations
22.3.3 Implementation
22.3.3.1 Responsibilities
22.3.3.2 Animal Welfare and Research Committee
22.3.3.3 Protocol Requirements
22.3.3.4 Special Use Protocols
22.3.3.5 Approval Procedures
22.3.3.6 Authority to Suspend or Terminate Approval of Research
22.3.4 Standards22.4 Glossary
22.3.5 References
22.4.1 Research With Human Subjects
22.4.2 Research With Radioactive Drugs
22.4.3 Research With Animals
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It is the policy of the Laboratory to implement the principles and regulations formulated by the Department of Health and Human Services (DHHS) for research projects involving human subjects.
It is the responsibility of the Laboratory to maintain an agreement by which Laboratory projects may be reviewed and certified in accordance with DHHS principles and regulations. Investigators are responsible for safeguarding the welfare, privacy, and rights of human subjects who take part in their research experiments and for observing both the letter and the spirit of the DHHS regulations.
The Laboratory has a long-standing agreement with the UC Berkeley Committee for Protection of Human Subjects (CPHS) to review and certify Laboratory projects. CPHS is an Institutional Review Board with DHHS Multiple Project Assurance #M-1349.
The Berkeley Lab Human Subjects Committee (HSC) is responsible for pre-reviewing and approving all Laboratory projects. Requests for approval go to the Berkeley Lab HSC and not to the CPHS on campus.
All proposed research projects that involve human subjects must be reviewed to determine risk. Human subject involvement includes:
personally identifiable
human-derived data or cultures of human cells.
If the human subject involvement in a research project satisfies certain criteria, it may be declared exempt from further review. This does not mean that review of the project is not required. Human subject involvement must be documented for every project and grant application. It must be reviewed even if the proposed involvement appears to be similar to a previously approved project. Research involving vulnerable subjects always requires a full review.
All research projects involving human subjects require prior review and formal approval by an Institutional Review Board. The purpose of this review is to determine whether subjects are at risk, whether the potential benefits of the research outweigh the risk, and whether adequate provision has been made to obtain informed consent. Risk is defined as exposure to the possibility of harm, whether physical, psychological, sociological, or other, to a participant in a research activity. Research is defined as a systematic investigation designed to contribute to scientific knowledge. This definition extends to pilot studies. Except in extraordinary cases, the researcher must obtain the informed consent of a subject to participate in research. Research involving vulnerable subjects requires special care in design and review.
Projects that involve human subjects must not be initiated until the appropriate CPHS approval has been received.
Both the HSC and the CPHS meet monthly. The HSC meetings are scheduled for timely submission to the CPHS for its agenda deadline.
Human subject protocols should be submitted to the HSC two weeks prior to its meeting date. Final CPHS review generally takes about seven weeks from the time of submission.
Many funding agencies require that certification of human subjects approval be submitted with the grant proposal. The National Institutes of Health (NIH) allows a grace period of 60 days following the proposal submission date. Human subjects review should be requested when a research proposal is being prepared, since delays sometimes occur before final approval can be granted. Annual reviews are required for continuing projects.
Under the DHHS Assurance of Compliance for Protection of Human Subjects, the Laboratory, upon recommendation by the Committees, has the authority and the responsibility to suspend or terminate research that is not being conducted in accordance with CPHS decisions, conditions, and requirements or that has been associated with unexpected serious harm to subjects.
In the case of suspension of research, research must not resume until the Committees have assurance that the appropriate corrective actions have been implemented.
The reporting requirements for issues and concerns that might involve suspension or termination of research are as follows: The CPHS must report information concerning noncompliance by Berkeley Lab research investigators, injuries to subjects, and unanticipated problems involving risk to the DHHS Office for Protection from Research Risks (OPRR). If the CPHS suspends or terminates approval of research, the Committee must include a statement of the reason for the action and must report the action promptly to the research investigator, the Berkeley Lab Director, and the OPRR. The Laboratory has an institutional responsibility to inform the DOE Human Subjects Program Manager and the Field Office. If the research is funded by DOE, the Laboratory must inform the appropriate Program Secretarial Office; if funded by a non-DOE agency or source, the Berkeley Lab Sponsored Projects Office must be informed.
Call the LBNL Human and Animal Regulatory Committees Office at (510) 486-5507 for information on human subjects research.
It is the policy of the Laboratory to implement the regulations and policies of the Food and Drug Administration for the use of radioactive drugs in human subjects.
It is the responsibility of the Laboratory to review and approve protocols for the use of radioactive drugs in human subjects in accordance with Food and Drug Administration regulations and policies. Investigators are responsible for obtaining the appropriate approval to use a radioactive drug in a human subject prior to requesting protocol approval from the HSC. (See Section 22.1, Research with Human Subjects, for information on the HSC.)
The Laboratory maintains a Radioactive Drug Research Committee (RDRC) in compliance with Food and Drug Administration regulations (21 CFR 363.1.) The LBNL RDRC is identified as RDRC #38. The RDRC meets quarterly, or more often as required. In addition to its FDA-mandated responsibilities, the RDRC is required by the Laboratory to review the doses of all radiopharmaceuticals administered to human subjects at the Laboratory.
For approval purposes, a radiopharmaceutical falls into one of three classifications: experimental, under investigational new drug permit, or commercially available. Basic research involving human use of experimental radiocompounds must be approved by the Laboratory RDRC. Investigators are responsible for filing an Investigational New Drug (IND) application with the Food and Drug Administration for qualifying radiopharmaceuticals; such applications are not reviewed by the RDRC. Human subjects protocols involving the use of IND-covered or commercially available radiopharmaceuticals are not reviewed by the RDRC but are reviewed for human subjects approval, as described in Section 22.1, Research with Human Subjects.
Protocols calling for the use of an experimental radioactive drug in humans must be submitted at least 90 days in advance of the required approval date. The RDRC reviews the protocol to ensure that pharmacological and radiation doses lie within federal guidelines, that the radiation exposure is justified by the benefits of the research, and that the study meets certain other requirements in investigator expertise and radiation safety.
Protocols approved by the RDRC are automatically forwarded for human subjects approval, as described in Section 22.1, Research with Human Subjects.
Investigators using experimental radioactive drugs must additionally file form FDA 2914 quarterly with the RDRC.
Call the LBNL Human and Animal Regulatory Committees Office at (510) 486-5507 for information on radioactive drug research.
It is the policy of the Laboratory that all research involving animals performed at or funded through the Laboratory shall be conducted in accordance with the Public Health Service’s Policy on Humane Care and Use of Laboratory Animals.
The Laboratory is responsible for:
Investigators are responsible for:
The Animal Welfare and Research Committee (AWRC) was formed at the Laboratory in 1975 in accordance with federal statutes and regulations. The AWRC is an Institutional Animal Care and Use Committee with OPRR Multiple Project Assurance #A3054-01. The AWRC meets monthly, or more often, as required.
The AWRC is responsible for:
All research projects involving live vertebrate animals or vertebrate animal tissues or products require prior review and formal approval by the AWRC.
Researchers are responsible for submitting a complete animal use protocol to AWRC for experiments using live vertebrate animals.
The AWRC is responsible for determining whether the activity is in compliance with the following requirements:
There are four special use protocols that may be obtained to allow limited animal use:
Exempt protocols allow the acquisition and analysis of tissues from public sources such as abattoirs.
Collaborative protocols enable an investigator to acquire and analyze the tissues or products of experimental animals held by another investigator either at the Laboratory or at another institution.
Shipping protocols allow a Laboratory investigator to send animals to another facility.
Facility use protocols allow an investigator from another institution to use the specialized equipment available at the Laboratory.
Collaborative, shipping, and facility use protocols must be reviewed to ensure that the investigator from an outside institution is operating under a protocol approved by an institutional animal care and use committee with a current Assurance. In general, if an outside institution does not have a current Assurance, a full animal use protocol must be filed with the AWRC.
Requests for approval of projects involving animals must be submitted to the AWRC four weeks before the proposed use of the animals.
Many funding agencies require that certification of AWRC approval be submitted with the proposal. NIH allows a grace period of 60 days following the proposal submission date. To avoid delays in a grant proposal review and funding, certification of animal use protocol approval should be obtained by the time a proposal is submitted to the sponsoring agency.
Projects that involve animals must not be initiated until the appropriate animal use protocol has received AWRC approval.
Annual reviews by the AWRC are required for continuing projects. The researcher holding the protocol is responsible for submitting renewals in a timely fashion, and for ceasing animal use under protocols which have expired.
All requisite forms and implementing procedures can be found in the Berkeley Lab Guidelines for Vertebrate Animal Use and are available through the AWRC office.
Under the Assurance to the National Institutes of Health (NIH), the Laboratory, upon recommendation by the Committee, has the authority and responsibility to suspend or terminate research that is not being conducted in accordance with AWRC decisions, conditions, and requirements. In addition, United States Department of Agriculture regulations stipulate that research activities may be suspended if the standards for animal welfare, care and housing, or mitigation of pain and distress are not being met.
In case of suspension of research, research must not resume until the Committee has assurance that the appropriate corrective actions have been implemented.
The reporting requirements for issues and concerns that might involve suspension or termination of research are as follows. The AWRC must report information concerning noncompliance by research investigators to the NIH OPRR. If the AWRC suspends or terminates approval of research, the Committee must include a statement of the reason for the action and must report the action promptly to the research investigator, the researcher’s Division Director, to Berkeley Lab Sponsored Projects Office, and to the OPRR.
Call the LBNL Human and Animal Regulatory Committees Office at (510) 486-5507 for information on animal use approval.
A human subject is a living person about whom a researcher obtains (1) data through intervention or interaction or (2) identifiable private information.
Informed consent is consent to participate in research based on a full and complete understanding of the research and any attendant risk.
An Institutional Review Board is a board or committee duly authorized by a federal assurance to review human subjects use.
Vulnerable subjects are subjects especially susceptible to coercion or undue influence (including, but not limited to, the mentally or physically infirm, children, the illiterate, prisoners and parolees, addicts, and the poor).
An experimental radioactive drug is a radioactive drug used to obtain basic information regarding the metabolism of the drug or regarding human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic, diagnostic, or similar purposes.
An investigational new drug is a drug product for human use covered by an investigational new drug permit from the Food and Drug Administration.
A radioactive drug is any radioactive compound or isotope which is intended for use in humans.
A Radioactive Drug Research Committee is a committee duly authorized by the Food and Drug Administration to review the use of experimental radioactive drugs.
Animal use is the use of a live vertebrate animal or the product of a live vertebrate animal for research purposes.
An Institutional Animal Care and Use Committee is a committee duly authorized under federal regulations to review and approve animal use.
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