Additional Human Research Protections Resources
- AAHRPP Accreditation Standards
- Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons.”
- FDA 21 CFR 50.24: Exception from Informed Consent (EFIC) Requirements for Emergency research
- FDA Amendments Act of 2007 (FDAAA)
- FDA Draft Guidance on INDs – Determining Whether Human research Studies Can Be Conducted Without an IND
- FDA FAQs - Clinical Studies Involving Electronic Cigarettes and INDs
- FDA FAQs for Form 1572.
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs: AE Reporting to IRBs- Improving Research Participants Protections (January 2009)
- FDA Guidance for Industry Using a Centralized IRB Review Process in Multi-center Clinical Trials
- FDA Guidance for informed consent.
- FDA Guidance for Investigator Responsibilities
- FDA Guidance on Exception from Informed Consent Requirements for Emergency research
- FDA Guidance on IRB Continuing Review after Clinical Investigation Approval
- FDA Guidance on Marijuana research with Human Subjects
- FDA Guidance on SR and NSR Medical Device Studies
- FDA ICH Guidance Documents
- FDA Investigator Responsibilities for Investigator-Initiated IND Applications
- FDA Investigator’s Responsibilities for INDs
- FDA Recruiting Study Subjects- Information Sheet
- FDA regulations (21 CFR 50, 56, 312, 812) for clinical trials and device studies
- FDA Website: Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency research
- FDA's Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies
- FDAAA 801 Requirements
- Federal Privacy Act
- Health Information Privacy: Research
- HHS 42 CFR Part 50, Sub-part F – Promoting Objectivity in research
- HHS 42 CFR Part 50; HHS 42 CFR Part 94 - Responsibility of Applicants for Promoting Objectivity in research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
- HHS 45 CFR 2 –Confidentiality of Alcohol and Drug Abuse Patient Records
- HHS 45 CFR 46 (Revised January 15, 2009, Effective July 14, 2009)
- HHS 45 CFR 46 (Revised January 19, 2017, Effective January 19, 2018)
- HHS Health Information Privacy Website
- HHS Office for Civil Rights (OCR) Health Insurance Portability and Accountability Act of 1996 (HIPAA) or 45 CFR Parts 160, 162, and 164
- Improving Access to Services for Persons with Limited English Proficiency. Executive Order 13166 of August 11, 2000.
- Federal Registrar Vol. 65, No 159, August 16, 2000. Title 3.
- Medicare Clinical Trial Policies
- National Cancer Institute Central IRB
- New York Codes, Rules and Regulations, Title 14, Department of Mental Hygiene, Part 527, Rights of Patients
- New York Mental Hygiene Law, Article 81
- New York State Public Health Law, Article 24A –Protection of Human Research Participants New York’s Family Health Care Decisions Act (FHCDA) (Public Health Law §29-CC)
- New York State's Public Health Law 18: Access to Patient Records
- New York’s Family Health Care Decisions Act (FHCDA) (Public Health Law §29-CC)
- NIH Guidance: Protecting PHI in research: Understanding the HIPAA Privacy Rule
- NY State Department of Health HIPPA Preemption Charts
- NYS 10 NYCRR Part 63 (HIV/AIDS Testing, Reporting and Confidentiality of HIV-Related Information
- NYS 1-2.13 NY Estates Powers and Trusts Law
- NYS Civil Rights Law Section 79-L (Confidentiality of genetic tests)
- NYS DOH HIPAA Preemption Charts
- OCR Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009
- OHRP Guidance: Obtaining and Documenting Informed Consent of Research Participants Who Do Not Speak English”
- OHRP Guidance: Approval of research with Conditions
- OHRP Guidance: FAQs
- OHRP Guidance: Informed Consent Requirements in Emergency research, for research not subject to FDA regulations
- OHRP Guidance: IRB Review of Clinical Trial Websites
- OHRP Guidance: Use of a Central IRB
- OHRP International Program website
- U.S. Department of Commerce, Bureau of Industry and Security, Export Administration Regulations (EAR) 15 C.F.R. §§730-774
- U.S. Department of Education, Family Educational Rights and Privacy Act (FERPA), (20 U.S.C. § 1232g; 34 CFR Part 99)
- U.S. Department of Education, Protection of Pupil Rights Amendment (PPRA) (20 U.S.C. § 1232h; 34 CFR Part 98)
- U.S. Department of Education, Title 34 Part 350: Disability and Rehabilitation Projects and Centers Program
- U.S. Department of Education, Title 34 Part 356: Disability and Rehabilitation research
- U.S. Department of Health and Human Services (HHS) Regulations for Protection of Research Participants under 45 CFR 46 (including Sub-parts A, B, C, D, and E)
- U.S. Department of State, Directorate for Defense Trade Commission, International Traffic in Arms Regulations (ITAR) 22 C.F.R. §§120-130.
- U.S. Food and Drug Administration (FDA) regulations under 21 CFR 11, 50, 56, 312, 812, and 814
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