APPENDIX: Regulations, Regulatory Agencies, and Policies

HUMAN SUBJECTS RESEARCH

Principles of Human Subject Protection

• Declaration of Helsinki
• Nuremberg Code
• Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

Federal Regulations

• Office of Human Research Protections (OHRP)
• 45 CFR Part 46: Federal Regulation for Protection of Human Subjects: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

State of California Statutes

• Health and Safety Code: Sections 24170-24179.5 (State of California Protection of Human Subjects in Medical Experimentation Act): http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=24001-25000&file=24170-24179.5
• Health and Safety Code: Sections 111515-111545 (Includes Consent for Minors Provision):
  http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=111001-112000&file=111515-111545
• State Health and Safety Code: Section 102231 (Use of Death Data Records):
  http://www.leginfo.ca.gov/cgi-bin/waisgate?WAISdocID=5519342859+1+0+0&WAISaction=retrieve

UC Systemwide Policies

• UC Policy on Protection of Human Subjects in Research: http://www.ucop.edu/raohome/cgmanual/chap18.html#18-200

UCB Campus Policies and Procedures

• Policies and Procedures of the UC Berkeley Human Research Protection Program (HRPP): http://cphs.berkeley.edu/content/policiesandprocedures.pdf

ANIMAL SUBJECTS RESEARCH

Federal Law, Regulations, and Policies

• Animal Welfare Act and Animal Welfare Regulations (USDA APHIS, AC): http://www.nal.usda.gov/awic/legislat/usdaleg1.htm
• PHS Policy on Humane Use of Laboratory Animals (OLAW): http://grants.nih.gov/grants/olaw/references/phspol.htm

Guidelines and Accreditation Standards

• The Guide for the Care and Use of Laboratory Animals: http://www.nap.edu/readingroom/books/labrats/
• AVMA Guidelines on Euthanasia (June 2007): http://www.avma.org/resources/euthanasia.pdf
• AAALAC, Intl. Accreditation Standards: http://www.aaalac.org/

UC System-wide Policy

• Use of Animals in Research and Teaching: http://www.ucop.edu/raohome/cgmanual/chap18.html#18-400

UCB Campus Policies, Procedures, and Guidelines

• Animal Care & Use Committee: http://www.acuc.berkeley.edu/
• Office of Laboratory Animal Care: http://www.olac.berkeley.edu/
• The Faculty Guide to Campus Life: http://facultyguide.berkeley.edu/work/faq_9.html
• Research Regulations at UCB: http://research.chance.berkeley.edu/main.cfm?id=9

LABORATORY SAFETY

Boating Guidelines, Information, and Courses

• California Department of Boating and Waterways: http://www.dbw.ca.gov
• U.S. Coast Guard Auxiliary: http://www.cgaux.org/
• U.S. Power Squadrons: http://www.usps.org

RESEARCH MISCONDUCT

Federal Regulations:

• Office of Research Integrity: http://ori.dhhs.gov/
• 42 CFR Part 50 Subpart A: Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science: http://ori.dhhs.gov/misconduct/reg_subpart_a.shtml

UC Research Policies:

• UC Policy on Integrity in Research: http://www.ucop.edu/raohome/cgmemos/90-01S1.html
• APM-020: Regulation 4, Special Services to Individuals and Organizations: http://www.ucop.edu/acadadv/acadpers/apm/apm-020.pdf

UC Berkeley Policies

• Updated Summary Statement of University Policy Related to Conduct of Research: http://research.chance.berkeley.edu/page.cfm?id=105
• Research Misconduct: Policies, Definitions and Procedures

SECURITY AND RELATED ISSUES POST 9/11

Federal Policies and Regulations

• National Security Decision Directive (NSDD) 189, National Policy on the Transfer of Scientific, Technical and Engineering Information, September 21, 1985: http://www.fas.org/irp/offdocs/nsdd/nsdd-189.htm
• Export Administration Regulations (EAR), Title 15, sections 730-774 of the Code of Federal Regulations (CFR) are promulgated and implemented by the Department of Commerce. The EAR regulate the export of goods and services identified on the Commodity Control List (CCL), Title 15 CFR section 774, Supp. 1. The EAR and CCL are available online at http://www.access.gpo.gov/bis/index.html.
• International Traffic in Arms Regulations (ITAR), 22 CFR sections 120-130, are promulgated and implemented by the Department of State and regulate defense articles and services and related technical data that are identified on the Munitions Control List (MCL), 22 CFR § 121.1. The ITAR and MCL are available online at http://www.pmddtc.state.gov/reference.htm.

University of California Policies

• Guidelines on University-Industry Relations, May 17, 1989: Guideline 1: Open Academic Environment, Guideline 2: Freedom to Publish: http://www.ucop.edu/raohome/cgmemos/89-20.html (University Contract and Grant Manual)
• 1-400 Publication Policy and Guidelines on Rights to Results of Extramural Projects or Programs: http://www.ucop.edu/raohome/cgmanual/chap01.html#1-400

UC Berkeley Policies

• Policy Guidelines Governing Openness of the Research Environment and Freedom to Publish, 1991: http://www.spo.berkeley.edu/Policy/ucmemos/publish.html