HHS Regulations on Human Research Protections Lisa Buchanan

HHS Regulations on Human Research Protections Lisa Buchanan, MAOM Division of Compliance Oversight Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS)

OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP) - WHO ARE WE? Mission Provides leadership in the protection of the rights, welfare and wellbeing of subjects involved in research conducted or supported by the U. S. Department of Health and Human Services (HHS) as required by the regulations at 45 CFR 46 for the Protection of Human Subjects 2

OHRP Structure Office of the Director Division of Education & Development Division of Policy & Assurance Division of Compliance & Oversight 3

REGULATIONS ON HUMAN RESEARCH PROTECTIONS 4

Tuskegee Syphilis Study (1933 -72) q Subjects were not told that they were participating in a research study q Subjects were not offered penicillin when this became established as the standard of treatment q Subjects were even prevented access to it § 1974: National Research Act 1979: Belmont Report 1981: Protection of Human Subjects laws § § 5

The Belmont Report Three Basic Principles 1. Respect for Persons ü 2. Beneficence ü 3. Promoting autonomy Maximize benefits; minimize harms Justice ü Equitable distribution of burden & benefits 6

HHS Regulations on Human Research Protections 45 CFR Part 46 p Subpart A – Rule” n “The Common IRB & Informed Consent p Subpart B – Pregnant women and fetus p Subpart C - Prisoners p Subpart D – Children p Subpart E – IRB Registration

“The Common Rule” 45 CFR Part 46 Subpart A Adopted by 18 federal departments & agencies 8

“The Common Rule” Providing the ABCs in Human Protections q Institutional Assurance of Compliance (Federalwide assurance - FWA) q Institution Review Boards (IRB) q Informed Consent 9

When do HHS Regulations Apply? q Research involving human subjects conducted or supported by HHS that is not otherwise exempt q Non-exempt human subject research covered by the Assurance of Compliance n ‘Checking the box’ 10

Federalwide Assurance (FWA) p Required when institutions are engaged in nonexempt human subject research conducted or supported by a federal department/agency p Documentation of institution’s commitment p n to protecting the rights and welfare of human research subjects; n comply with applicable regulations Designate the IRB(s) to be used to review applicable human subjects research 11

Contact OHRP p Visit OHRP website p OHRP email box ohrp@hhs. gov p Phone inquiries 240 -453 -6900 p Join OHRP List. Serv at http: //www. hhs. gov/ohrp/newsroom/index. html 12