Ch. 3 - Required Assurances, Certifications and Research-Related Regulations
3.1 Protection of Human Subjects
3.2 Research Involving Vertebrate Animals
3.3 Compliance with Export Laws and Regulations
3.4 Education of Student and Postdoctoral Researchers in the Responsible Conduct of Research
3.5 Biosafety (rDNA, Infectious Agents, Human or Primate Materials)
3.6 Controlled Substances and Chemical Precursors
3.7 Radiation Safety and Laser Protection
The protection of human research subjects became an issue during the Nuremberg Trials at the end of World War II when it was disclosed that prisoners had been subjected to medical experiments without consent. The Nuremberg Code, issued in 1949, recommended all medical experiments abide by ten principles that would satisfy moral, legal and ethical principles for the involvement of human subjects in research. In 1964, the World Medical Association (WMA) developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human materials and data. In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report, which identified basic ethical principles for the conduct of biomedical and behavioral research involving human subjects and provided guidelines to assure that such research is conducted in accordance with those principles.
The Federal Policy for the Protection of Human Subjects covers research conducted, supported or otherwise subject to regulation by any federal department or agency, including research done outside of the U.S.
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Caltech investigators may not conduct research involving human subjects without the prior approval of the Caltech Committee for Protection of Human Subjects. This requirement reflects Caltech's implementation of federal-wide regulations for the protection of human subjects and applies to all research involving human subjects, regardless of the source of support for that research.
The Committee for Protection of Human Subjects operates under federal regulations requiring the review and approval of research involving human subjects. Caltech has been given a Federalwide Assurance (FWA00003897) from the federal Office for Human Research Protections signifying it will perform the initial and annual reviews of all Caltech human subjects research as required by federal regulations.
Federal regulations and accreditation standards require all proposed use of animals to undergo review by an Institutional Animal Care and Use Committee (IACUC). The IACUC is responsible for review of all animal use protocols, ensuring compliance with federal regulations, inspecting animal facilities and laboratories, and overseeing training and educational programs. The primary role of the IACUC is to ensure the ethical and humane care and use of animals in research, testing and teaching. Animal care and use programs are regulated by both the U.S. Department of Agriculture and the U.S. Public Health Service.
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All research or teaching activities involving Caltech personnel or resources which use vertebrate animals or tissues directly obtained from vertebrate animals must be reviewed and approved initially and on a continuing basis by the Institutional Animal Care and Use Committee (IACUC).
Caltech has received a Federalwide Assurance (A3426-01) from the federal Office of Laboratory Animal Welfare signifying it will perform the initial and annual reviews of all Caltech research and teaching activities involving vertebrate animals as required by federal regulations.
Caltech's laboratory animal program is fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care, an independent, international organization that inspects and evaluates animal research programs and facilities. This accreditation has been active since February 10, 2003.
Questions may be directed to the Committee chair or committee coordinator identified at http://researchadministration.caltech.edu/osr/committees
U.S. laws and regulations issued by several federal agencies over the years control export and import transactions on the basis of national security or economic competitiveness. Export control regulations govern the exchange of sensitive information, technology and goods to individuals, entities or countries "of concern." Import regulations implement laws applicable to goods entering the United States, including the assessment of duty. Export control regulations may affect faculty who travel abroad, engage in collaborations with foreign investigators, students or businesses, or ship export controlled items out of the United States. Since 2011, the Department of Homeland Security has required Caltech to determine whether an export license or exemption is required before a Foreign Person can be employed by Caltech. Federal regulations apply to all export controlled Institute activities, not just to sponsored research projects funded by a grant or contract.
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Caltech is committed to complying fully with federal export control laws and regulations. With a growing number of our faculty and staff engaged in research projects or collaborations in the U.S. or abroad involving foreign individuals or foreign entities, it is important to emphasize Caltech's expectations for faculty and staff to comply with the export control requirements. Noncompliance may result in violations subjecting the individual and the institution to civil and criminal charges and penalties.
The Caltech Export Compliance Office was established to assist faculty and staff in understanding the complex export control policies and obtaining any required licenses for the transfer of information, technology or commodities.
The National Institutes of Health (NIH) is the first federal agency requiring institutional training grant applications to describe formal and informal activities related to instruction for trainees in matters of scientific integrity and/or the responsible conduct of research. While the NIH requirement for Responsible Conduct of Research (RCR) education has no specific curriculum, programs are encouraged to consider instruction in: conflicts of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. NIH also endorses a discussion of the topics from a trainee and an institutional perspective. Applications without RCR plans are considered incomplete.
The National Science Foundation is the second federal agency to implement a requirement for instruction in RCR. The NSF requirement applies to all students and postdocs who are supported by NSF awards, where the award resulted from a proposal submitted January 2010 or later; as older awards expire, the requirement will eventually apply to all NSF-supported students and postdocs. Caltech’s plan for managing the NSF requirement can be found here.
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In order to meet the NIH requirement, Caltech requires that all trainees supported by NIH funds take Biology course 252 “Responsible Conduct of Research”. The BIO 252 course includes the following topics:
· Guidelines and Regulations
· Ethical and Moral Issues
· Research Misconduct
· Data Management and Analysis
· Research with Animal and Human Subjects
· Conflicts of Interest
· Professional Advancement
In order to meet the NSF requirement, Caltech requires that all students and postdocs supported from NSF funds as described above take the Collaborative Institutional Training Initiative (CITI) Program. If a student or postdoc can document having passed a similar, qualifying program at Caltech or another institution, Caltech will accept that in place of completing Caltech's program:
· Research Misconduct
· Data Acquisition and Management
· Responsible Authorship and Publication
· Responsible Mentoring
· Conflicts of Interest and Commitment
· Collaborative Science
NIH trainees and NSF-supported students and postdocs will be informed of the need to participate in the relevant instructional program.
The CITI Program can be accessed by logging into Access.Caltech and following the link “CITI Federal Compliance Testing”, and then selecting the “NSF Required Students and Postdocs, Basic Course”.
The Biosafety program is managed by Caltech Environmental Health and Safety to minimize the health risk to employees, students, and the public from potential exposure to biohazardous materials that are used in research laboratories. Biohazardous materials include:
- All infectious organisms (bacteria, fungi, parasites, prions, rickettsias, viruses, etc.) that can cause disease in humans or cause significant environmental or agricultural impact.
- Recombinant DNA (rDNA) derived from organisms that are Risk Group 2 and above.
- Work with human or primate tissues, fluids, cells or cell cultures.
Federal guidelines require an Institutional Biosafety Committee (IBC) to be constituted to review and approve all rDNA research not in the exempt category. A Biological Safety Officer must be appointed when large-scale research or production activities involve viable organisms containing rDNA.
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All research projects and activities involving Caltech personnel or resources that require the use of biohazardous materials must be reviewed and approved initially and on a continuing basis by the Institute Biosafety Committee (IBC).
The IBC assures the Institute's compliance with federal regulations of activities through the review of research proposals involving the use of non-exempt biohazardous agents and recombinant DNA molecules.
Controlled substances and chemical precursors are highly regulated materials used in research. Controlled substances are Schedules II - V drugs and other substances included in the Controlled Substances Act, 21 U.S.C. sec. 801 et seq. Chemical precursors are any substance listed under California Health and Safety Code sec. 11100 et seq.
The U.S. Drug Enforcement Administration issues licenses to institutions and laboratories requiring controlled substances for research and teaching.
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Caltech fully complies with applicable federal and state laws and regulations concerning the registration, procurement, inventory, storage, record keeping, use and disposal of controlled substances and chemical precursors.
Principal Investigators, staff, and students who will use controlled substances and/or chemical precursors for research and/or teaching must understand the requirements of this policy and follow all applicable procedures before they will be authorized to handle controlled substances or chemical precursors.
Failure to comply with this policy may result in disciplinary action up to and including separation from the Institute. Penalties for violations of applicable federal and state regulations include the imposition of heavy fines, imprisonment of those responsible, and the rescission of Caltech's registrations.
The California Department of Health Services issues licenses allowing organizations to possess and use radioactive material and radiation-producing machines.
Lasers are found in many laboratories as research tools. Lasers and laser systems are classified as potential hazards based on several factors including wavelength, power output, accessible emission level, and emission duration.
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Caltech fully complies with applicable state and federal regulations concerning the use of radioactive materials, radiation-producing devices, and lasers by researchers and staff.
The Radiation Safety Committee (RSC) is responsible for authorizing individuals to work with radioactive materials and approving the use of radiation-producing devices. Faculty members who wish to acquire and use radioactive materials must submit an Application for Possession and Use of Radioactive Materials form to the RSC via the Division Radiation Safety Officer (DRSO).
Principal Investigators have primary responsibility for ensuring their research staff is trained in the proper use of lasers, including the use of personal protective equipment when necessary. The Caltech Safety Office oversees the use of lasers on the campus, provides training to laser operators, provides appropriate signage, determines proper protective equipment, and reviews operating and safety procedures.