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Revised 3/17/2015

Federal/State Agency Regulation Title Source
OFFICE OF SCIENCE AND TECHNOLOGY POLICY Federal Policy on Research
Misconduct; Preamble for Research Misconduct Policy

Federal Register: December 6, 2000 (Volume 65, Number 235)]
[Notices]
[Page 76260-76264]

http://www.gpo.gov/fdsys/pkg/FR-2000-12-06/pdf/00-30852.pdf

DEPARTMENT OF HEALTH AND
HUMAN SERVICES (DHHS)
Public Health Service Policies on
Research Misconduct
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations
http://ori.hhs.gov/sites/default/files/42_cfr_parts_50_and_93_2005.pdf
DHHS Update on the Requirement for Instruction in the Responsible Conduct of Research NOT-OD-10-019, November 24, 2009
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html
NATIONAL SCIENCE FOUNDATION (NSF) Research Misconduct https://www.nsf.gov/oig/resmisreg.pdf
NSF Responsible Conduct of Research http://www.gpo.gov/fdsys/pkg/FR-2009-08-20/html/E9-19930.htm
Other Federal Agencies, Departments, Centers that provide extramural funding such as NASA, EPA, USDA, DOT, Energy, Education, DOL, DHS, DOD, VA, NEH, HUD. SBA Research Misconduct/ Responsible Conduct of Research http://ori.hhs.gov/federal-policies
HEALTH AND HUMAN SERVICES (HHS)/NATIONAL INSTITUTES OF HEALTH (NIH) Human Studies 45 CFR 46 (the HHS Human Research Regulations) FAQs (PDF - 38KB)
HHS/NIH Human Studies AIDS Research, Guidance for IRBs (1984)
HHS/NIH Human Studies Approval of Research with Conditions: OHRP Guidance (2010) (PDF -63KB)
HHS/NIH Human Studies Assurance Process FAQs (PDF -68KB)
HHS/NIH Human Studies Belmont Report
HHS/NIH Human Studies Certificates of Confidentiality - Privacy Protection for Research Subjects: OHRP Guidance (2003) (PDF -18.9KB)
HHS/NIH Human Studies Children: Information on Special Protections for Children as Research Subjects
HHS/NIH Human Studies Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process (2005)(PDF -113KB)
HHS/NIH Human Studies Children: Research with Children FAQs(PDF -69KB)
HHS/NIH Human Studies Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005) (PDF - 33.5KB)
HHS/NIH Human Studies Coded Private Information or Biological Specimens: Issues to Consider in the Research Use of Stored Data or Tissues, Operation of Biological Repositories: OPRR Memoranda (1996, 1997)
HHS/NIH Human Studies Coded Private Information or Biological Specimens: OHRP Guidance on Research (2008) (PDF - 37.5KB)
HHS/NIH Human Studies Coded Private Information or Biological Specimens, Research Use (Video)
HHS/NIH Human Studies Compliance Oversight Procedures Used by OHRP (2009)  (PDF - 47KB)
HHS/NIH Human Studies Continuing Review: OHRP Guidance (2010) (PDF - 52KB)
HHS/NIH Human Studies Correspondence
HHS/NIH Human Studies Emergency Medical Care and Research: OPRR Letter (1991)
HHS/NIH Human Studies Emergency Research Informed Consent Requirements (OPRR Letter, 1996)
HHS/NIH Human Studies Engagement of Institutions in Human Subjects Research: OHRP Guidance (2008) (PDF - 66 KB)
HHS/NIH Human Studies Engagement of Institutions in Human Subjects Research: Correspondence Regarding "Non-engagement" Scenarios (2011) (PDF - 28KB)
HHS/NIH Human Studies Engagement: When are Survey Firms Engaged in Research?; Clarification Regarding the Relationship between Institutional Engagement and the Federalwide Assurance (FWA) (January 13, 2009, OHRP Letter)
HHS/NIH Human Studies Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996)
HHS/NIH Human Studies Exempt Research and Research That May Undergo Expedited Review
HHS/NIH Human Studies Exempt Research Determination FAQs(PDF -26KB)
HHS/NIH Human Studies Exempt Research: Exemptions for Public Benefit and Service Programs (OPRR Guidance)
HHS/NIH Human Studies Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)
HHS/NIH Human Studies Expedited Review Procedures: OHRP Guidance (2003) (PDF - 207KB)
HHS/NIH Human Studies Expedited Review: Clarification of "Noninvasive" in Expedited Review Category 3
HHS/NIH Human Studies Extension of an Institutional FWA via an Individual Investigator Agreement: OHRP Guidance (2005) (PDF - 43.9KB)
HHS/NIH Human Studies Fetal Tissue Transplantation: OHRP Guidance (2003) (PDF - 14.7KB)
HHS/NIH Human Studies Fetal Tissue Transplantation Research, Public Law 103-43, Section 498A (1993)
HHS/NIH Human Studies Financial Conflict of Interest: HHS Guidance (2004) (PDF - 85 KB)
HHS/NIH Human Studies Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009) (PDF- 38 KB)
HHS/NIH Human Studies HIV Serostatus, Informing Those Tested, PHS Policy (1988)
HHS/NIH Human Studies HIV Serostatus, Sex-Partner Notification, PHS Policy (1990)
HHS/NIH Human Studies Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance (2002)
HHS/NIH Human Studies Human Subject Regulations Decision Charts (2004)
HHS/NIH Human Studies Informed Consent Checklist (1998)
HHS/NIH Human Studies Informed Consent FAQs (PDF - 135KB)
HHS/NIH Human Studies Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
HHS/NIH Human Studies Informed Consent: Obtaining and Documenting Informed Consent of Non-English Speakers (OPRR Memo, 1995)
HHS/NIH Human Studies Informed Consent Requirements (Video)
HHS/NIH Human Studies Informed Consent Requirements for In Vitro Medical Device Clinical Investigations Conducted Under FDA’s Interim Final Rule at 21 CFR 50.23(e) (OHRP Guidance, 2006) (PDF - 46KB)
HHS/NIH Human Studies Informed Consent Tips (1993)
HHS/NIH Human Studies Investigator Responsibility FAQs (PDF-44KB)
HHS/NIH Human Studies IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000) (PDF - 54KB)
HHS/NIH Human Studies IRB Membership (Video)
HHS/NIH Human Studies IRB Records, Part One (Video)
HHS/NIH Human Studies IRB Records, Part Two (Video)
HHS/NIH Human Studies IRB Registration Process FAQs (PDF - 34KB)
HHS/NIH Human Studies  IRB Review of Applications for HHS Support: OPRR Memorandum (2000)
HHS/NIH Human Studies IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to the National Cancer Institute, 2008)
HHS/NIH Human Studies Prisoner Research Certification
HHS/NIH Human Studies Prisoner Research: OHRP Guidance (2003) (PDF - 22KB)
HHS/NIH Human Studies Prisoner Research FAQs (PDF - 64KB)
HHS/NIH Human Studies Quality Improvement Activities FAQs(PDF - 37 KB)
HHS/NIH Human Studies Quality Improvement Activities: OHRP Correspondence Regarding Indwelling Catheter Procedures (2008)
HHS/NIH Human Studies Reporting Incidents to OHRP: Guidance on When and How to File Incident Reports (2011) (PDF -51.6KB)
HHS/NIH Human Studies Research Involving Vulnerable Populations (Video)
HHS/NIH Human Studies Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007) (PDF -180KB) 
HHS/NIH Human Studies Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (Video)
HHS/NIH Human Studies Secretarial Waiver
HHS/NIH Human Studies Use of a Central Institutional Review Board (OHRP Letter, 2010)
HHS/NIH Human Studies Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (OHRP Letter, 2010)
HHS/NIH Human Studies Viewpoint on Conflicting Interests of Pediatric Central IRB (PedCIRB) Members (2005)
HHS/NIH Human Studies Withdrawal of Subjects from Research: Data Retention and Other Related Issues: OHRP Guidance (2010) (PDF-45KB)
HHS/NIH Human Studies Written Institutional Review Board (IRB) Procedures: OHRP Guidance (2011)(PDF -58KB)
DHHS Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care Federal Register / Vol. 79, No. 206 / Friday, October 24, 2014 / Notices
DHHS Meeting on the Secretary’s Advisory Committee on Human Research Protections Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices
DHHS Meeting of the Secretary’s Advisory Committee on Human Research Protections Federal Register / Vol. 79, No. 128 / Thursday, July 3, 2014 / Notices
DHHS Meeting of the Secretary’s Advisory Committee on Human Research Protections Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices
DHHS/NIH Announcement of a Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices
DHHS Title 45—Public Welfare DHHS, Part 46—Protection of Human Subjects; Common Rule – Subpart A, Vulnerable Pop – Subparts B-D 45 CFR 46
DHHS Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request Federal Register / Vol. 79, No. 98 / Wednesday, May 21, 2014 / Notices
DHHS Agency Information Collection Activities; Proposed Collection; Public Comment Request Federal Register / Vol. 79, No. 44 / Thursday, March 6, 2014 / Notices
HHS/NIH/OFFICE OF LABORATORY ANIMAL WELFARE (OLAW) PHS Policy on Humane Care and Use of Laboratory Animals, 2002  http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf
- 282 KB
HHS/NIH/OLAW Guide for the Care and Use of Laboratory Animals, 8th Edition http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf
1.2 MB
HHS/NIH/OLAW AVMA Guidelines for the Euthanasia of Animals: 2013 Edition https://www.avma.org/KB/Policies/Documents/euthanasia.pdf
1.4 MB
HHS/NIH/OLAW U.S. Government Principles http://grants.nih.gov/grants/olaw/references/phspol.htm#USGovPrinciples
HHS/NIH/OLAW Public Law 99-158, Animals in Research http://grants.nih.gov/grants/olaw/references/hrea1985.htm
HHS/NIH/OLAW Public Law 103-43, Plan for Use of Animals in Research, 1993 http://grants.nih.gov/grants/olaw/pl103-43.pdf
22 KB
HHS/NIH/OLAW International Guiding Principles for Biomedical Research Involving Animals,  http://grants.nih.gov/grants/olaw/Guiding_Principles_2012.pdf
123 KB
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)  Enforcement Guidance for Personal Protective Equipment (PPE) in General Industry 29 C.F.R. § 1910.132
OSHA Bloodborne Pathogens Standard 29 C.F.R. § 1910.1030
OSHA Requires employers to train employees on hazards in the workplace, to provide information to employees, to report occupational injuries and illnesses to the federal government, and to keep records of same, and to provide controls and protective equipment as well.

29 U.S.C. § 651-678
29 C.F.R. §§ 1900-2400

OSHA Hazard Communication Standard 29 C.F.R. § 1910.1200
ENVIRONMENTAL PROTECTION AGENCY (EPA) Resource Conservation and Recovery Act 42 U.S.C. §§ 6901-6992k

40 C.F.R. § 98.250
40 C.F.R. § 260

EPA The Public Health Security and Bioterrorism Preparedness and Response Act  18 U.S.C. § 175b
NSF Institutional plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project. America COMPETES Act § 7009
42 U.S.C. § 1862o-1
74 Fed. Reg. 42126
UNITED STATES DEPT OF AGRICULTURE (USDA) Treatment of animals used for research: dogs, cats, monkeys, guinea pigs, hamsters, and other warm-blooded animals Animal Welfare Act 
7 U.S.C. §§ 2131-2159
9 C.F.R. §§ 1-4
HAWAII DEPT OF AGRICULTURE (HDOA) Subtitle 3—Division of Animal Industry  
HDOA 16 Cattle, Sheep, and Goats AR-16.PDF
HDOA 17 Swine AR-17.PDF
HDOA 19 Poultry and Birds – REPEALED (see chapter 28)  
HDOA 19 Subchapter 6 – West Nile Virus – Import Requirements for Birds and Poultry – REPEALED (see chapter 28)  
HDOA 20 Non-domestic Animals AR-20.PDF
HDOA 21 Vaccines, Microorganisms, and Parasites  AR-21.PDF
HDOA 22 Reporting of Animal Diseases List of Diseases, AR-22.PDF
HDOA 23 Horses AR-23.PDF
HDOA 24 Meat Grading AR-24.PDF
HDOA 27 Brands AR-27.PDF
HDOA 28 Poultry and Birds AR-28.PDF
HDOA 29 Dogs, Cats, and Other Carnivores Hospital Form.PDF
Notice of AT Insp.PDF
AR-29.PDF
HDOA Subtitle 6—Division of Plant Industry  
HDOA 66 Pesticides AR-66.PDF
HDOA 67 Seed Rules AR-67.PDF
HDOA 68 Noxious Weed Rules AR-68.PDF
HDOA 69A Pests for Control or Eradication AR-69A.PDF
HDOA 70 Plant and Non-Domestic Animal Quarantine,
Plant Import Rules, Amendment,
Amendment on Bromeliad Import
AR-70.PDFAR-70-Bromeliads.PDF
HDOA 71 Plant and Non-Domestic Animal Quarantine,
Non-Domestic Animal Import Rules
AR-71.PDF
HDOA – List of Conditional Approved Animals AR-71C.PDF
HDOA – List of Restricted Animals – For Research and Exhibition AR-71RA.PDF
HDOA – List of Restricted Animals – For Private and Commercial Use AR-71RB.PDF
HDOA – List of Prohibited Animals AR-71P.PDF
HDOA 71A Plant and Non-Domestic Animal Quarantine, Microorganism Import Rules AR-71A.PDF
HDOA – List of Restricted Microorganisms Part A AR-71A-RA.PDF
HDOA – List of Restricted Microorganisms Part B AR-71A-RB.PDF
HDOA – List of Selected Human Pathogens AR-71A-SP.PDF
HDOA – List of Nonrestricted Microorganisms   AR-71A-N.PDF
HDOA 72 Plant and Non-Domestic Animal Quarantine,
Plant Intrastate Rules – Amended
AR-72A.PDF
HDOA 73 Plant and Non-Domestic Animal Quarantine,
Quarantine Plant Export Rules 
AR-73.PDF
DEPT OF HEALTH 11-104.1  Management and Disposal of Infectious Wastes http://co.doh.hawaii.gov/sites/har/admrules/Rules/1/11-104.1.pdf
DEPT OF LABOR 12-08-221. Boiler & Pressure Vessel -  Existing and New Boiler and Pressure Vessel (Autoclave Certification) Title 12, Subtitle 8, Part 10
DEPT OF LAND AND NATURAL RESOURCES
Division of  Aquatic Resources
Aquatic Resources
Special Activity Permit:  Scientific, educational or propagation purposes
HRS 187A-6
  Activities involving native wildlife, introduced wild birds and game animals (Wildlife Permit Guidelines) Permit Guidelines
Contact: Jason Omick (jason.d.omick@hawaii.gov)
  Activities involving native invertebrates Permit Guidelines
Contact: Cynthia King
(cynthia.b.king@hawaii.gov)
  Activities involving rare, threatened or endangered plants
(Plant Permit Guidelines)
Permit Guidelines
Contact: Charmian Dang
(charmian.c.dang@hawaii.gov)
  Collection or exportation of injurious wildlife
(Wildlife Permit Guidelines)
Permit Guidelines
Contact: DOFAW Main Office at (808) 587-0166
  Activities within a Natural Area Reserve
(NARS Permit Guidelines)
Permit Guidelines
Contact Charmian Dang
(charmian.c.dang@hawaii.gov)
FEDERAL OSHA Personal Protective Equipment (Respirator, Eye Wear, foot, Hand) Part 1910, Subpart I, 1910.132-1910.138
  Bloodborne pathogens
(Bloodborne Pathogens and Needle Stick Prevention Program)
Part 1910, Subpart Z, 1910.1030
  Hazard Communication
(Letter of Interpretation of Established Human Cell Lines)
Part 1910, Subpart Z, 1910-1200
FEDERAL CENTER FOR DISEASE CONTROL (CDC) Biosafety in Microbiological  and Biomedical Laboratories 5th Ed. Dec 2003 http://www.cdc.gov/biosafety/publications/bmbl5/
  CDC import permit applications Applications
  Interstate Shipment of Etiologic Agents 42 CFR Part 72
  Etiologic Agent Import Permit Program 42 CFR Part 71
  CDC Morbidity and Mortality Weekly Report (MMWR) recommendations for safe laboratory practices Supplement / Vol. 60 / April 15, 2011, MMWR Guidelines for Biosafety Laboratory Competency, MMWR Supplements: Past Volume (2011) Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories)
  2014 ISAC Biosafety Standards Cytomatry Cell Sorter Biosafety Standards Cytometry Part A85A:  434-453, 2014
NIH (Program on Biosecurity and Biosafety policy) NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules November 2013 NIH Guidelines (PDF)
FISH AND WILDLIFE SERVICE Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) Endangered Species Act (ESA)
USDA BRS  Plant Pest Biotechnology 7CFR 340
  Permits – for introduction of GE organisms  
  Notifications – to submit a notification  
  Report an accidental release of genetically modified organism  
  Plant Pest Program Information  
  Agricultural Select Agent Program  
  Biotechnology Title IV Plant Protection Act Introduction of Organism altered or produced through Genetic Engineering which are Plant Pests or which there is reason  to believe are Plant Pests 7 CFR 340
  Agricultural Bioterrorism Protection Act of 2002; Possession, Use and Transfer of Biological Agents and Toxins 7 CFR 331
9 CFR 121 USDA Final Rule
  Import and Shipment permits for animal and plant pathogens as well as biotechnology (plant and agricultural microorganism) permits Import Export
  USDA Veterinary Services National Center for Import and Export Import Export
EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)  List A: EPA’s Registered Antimicrobial Products as Sterilizers (PDF)
  Anti-Microbial Pesticide Products & Registration, products used to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms on inanimate objects and surfaces List B: EPA Registered Tuberculocide Products Effective
Against  Mycobacterium tuberculosis  (PDF)
    List C: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1
Virus (PDF)
    List D: EPA’s Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus (PDF)
    List E: EPA’s Registered Antimicrobial Products Effective
Against  Mycobacterium tuberculosis  Human HIV-1 and Hepatitis B Virus
(PDF)
    List F: EPA’s Registered Antimicrobial Products Effective Against Hepatitis C Virus (PDF)
    List G: EPA’s Registered Antimicrobial Products Effective
Against  Norovirus  (PDF)
    List H: EPA’s Registered Antimicrobial Products Effective Against Methicillin
Resistant  Staphylococcus aureus (MRSA)  and Vancomycin
Resistant  Enterococcus faecalis  or  faecium  (VRE) (PDF)
    List J: EPA’s Registered Antimicrobial Products for Medical Waste Treatment
(PDF)
    List K: EPA’s Registered Antimicrobial Products Effective Against Clostridium difficile Spores (PDF)
    List L: EPA's Registered Antimicrobial Products that Meet the CDC Criteria for
Use Against the Ebola Virus
AMERICAN SOCIETY OF MICROBIOLOGY Guidelines for Biosafety in Teaching Laboratories http://www.asm.org/images/asm_biosafety_guidelines-FINAL.pdf
  Appendix to the Guidelines for Biosafety in Teaching Laboratories http://www.asm.org/images/Education/FINAL_Biosafety_Guidelines_Appendix_Only.pdf
THE AMERICAN COMMITTEE OF MEDICAL ENTOMOLOGY OF THE AMERICAN SOCIETY OF TROPICAL MEDICINE AND HYGIENE Arthropod Containment Guidelines (Version 3.1) http://www.astmh.org/AM/Template.cfm?Section=ACME&Template=/CM/ContentDisplay.cfm&ContentID=1444