Protecting Human Research Subjects

Research involving human subjects can pose complex ethical issues that require careful thought and consideration on the part of both researchers and participants. Research teams must seek ethics certifications for human subjects approval to apply for and obtain IRB approval and to protect the rights and welfare of study participants in a research project. This page will discuss the when, how, and who of ethics certifications for human research subjects.

Read First

• DIME's Research Ethics Standards
• To protect the rights and welfare of study participants, IRBs require ethics certifications; depending on IRB requirements, these may be obtained via NIH, CITI, or elsewhere.
• For more information on how to protect human research subjects, see, for example, IRB Approval, Informed Consent, De-identification, and Encryption

Overview

As a prerequisite for IRB approval, all members of the research team who manage personally identifiable information (PII) must obtain ethics certifications to conduct research with human subjects. This may include principal investigators, research assistants, field coordinators, and/or survey firm staff. Two commonly accepted sources of certification are:

• The National Institute for Health (NIH), which offers a free course on Protecting Human Research Participants, and
• The Collaborative Institutional Training Initiative (CITI), which offers a course on Human Subjects Research

These courses cover the historical development of human subject protections, discuss the ethical issues involved in this human subjects research, and present the principles and regulations governing it. They are divided in modules that provide reading materials and entail quizzes for which a minimum score is required to pass each module. Learners may complete the modules at their own pace.

Certificates usually have expirations and must be renewed. The CITI certificate must be renewed every 3 years, whereas the expiration of the NIH depends. Note that the IRBs can also define a date past which the certificates are considered invalid.

United States Standards

(The Common Rule)

European Standards

(GDPR)

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This article is part of the topic Research Ethics

Additional Resources

• Berk Özler (World Bank), Research with adolescents: Issues surrounding consent
• Berk Özler (World Bank), Taking Ethics Seriously: Response #1
• Committee on the Use of Humans as Experimental Subjects (MIT), Forms and templates for IRB applications, informed consent, and authorization forms
• DIME Analytics (World Bank), Research Ethics & Data Security
• Martin Ravallion (World Bank), Taking Ethical Validity Seriously
• US Department of Health and Human Services (HHS), The 'Common Rule' for Protection of Human Subjects