Federal/Maryland – IRB Regulations and Policies

Federal Human Research Use Guidelines and Regulations

34 CFR Part 99, Family Educational Rights and Privacy Act of 1974 (FERPA) – U.S. Department of Education

34 CFR Part 97, Protection of Human Subjects – U.S. Department of Education

34 CFR 98 – Protection of Pupil Rights Amendment (PPRA)

45 CFR 46 – Protection of Human Subjects – Department of Health and Human Services (2018 requirements)

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.

Current members serving on the UMBC IRB

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

Most of the listings include a hyperlink that allows the user to directly access the law, regulation, or guideline of interest. The Compilation (last updated March 2022) can be accessed on the OHRP website.

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 

 

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