Federal Human Research Use Guidelines and Regulations
34 CFR Part 97, Protection of Human Subjects – U.S. Department of Education
34 CFR 98 – Protection of Pupil Rights Amendment (PPRA)
OHRP FAQs for the 2018 Requirements
OHRP Guidance on COVID-19: April 8, 2020
The Department of Justice (DOJ) is not a signatory of the Revised Common Rule; pre-2018 DOJ regulations regarding human subjects protection (28 CFR Part 46) remain in effect for DOJ research awards
See: National Institute of Justice, Office of Justice Programs
NIH extramural research guidance involving human subjects
University System of Maryland/UMBC
USM Policy on Human Subjects of Research (USM IV-2.10)
Description of individuals whom are adults and of legal age (released from parental authority), (attains the age of 18 years) https://statelaws.findlaw.com/maryland-law/maryland-legal-ages-laws.html
Requirements of conducting human subject research and Institutional Review Boards http://mlis.state.md.us/2002rs/billfile/hb0917.htm
The University of Maryland, Baltimore County has a Federalwide Assurance (IRB registration number: IORG0000202 / FWA number: 00000069 approved through 06/16/2026) from the Office for Human Research Protections.
International Research
The Office for Human Research Protections (OHRP) has developed an International Compilation of Human Subject Research Protections. The Compilation provides listings of over 1,000 laws, regulations, and guidelines on human subject protections in 130 countries, as well as standards issued by a number of international and regional organizations.
The listings are organized into nine categories:
1. General Research
2. Drugs and Devices
3. Clinical Trial Registries
4. Research Injury
5. Social-Behavioral Research
6. Privacy/Data Protection
7. Human Biological Materials
8. Genetic Research
9. Embryos, Stem Cells, and Cloning
The Compilation (last updated March 2022) can be accessed on the OHRP website. Country specific requirements are presented in a table and includes a hyperlink to directly access the law, regulation, or guideline of interest.
Compilation of European GDPR Guidance
The Office for Human Research Protections has created a resource that lists the data protection authorities of all European countries that fall under the new E.U. General Data Protection Directive (GDPR). For each country, the compilation also provides the links to any general GDPR guidance, as well as specific guidance on the topics of Research, Legal Basis, Consent, and International Data Transfer.
The new Compilation is available at https://www.hhs.gov/ohrp/international/index.html