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

• The DIME Research Ethics Standards discuss the provisions for protecting human subjects in development research.
• 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.
• Besides protecting human research subjects, the research team must also keep in mind best practices for IRB approvals, 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

In the United States of America, the Federal Policy for the Protection of Human Subjects, or the Common Rule outlines the basic provisions for Institutional Review Boards (IRBs), informed consent, and other aspects related to protecting the rights of human research subjects. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research involving human research subjects..

European Standards

For countries that are part of the European Union, the General Data Protection Regulation (GDPR) lays down rules relating to the protection of human research subjects in terms of processing (or analysis) and free movement of personal information. In doing so, the GDPR protects fundamental rights and freedoms of human subjects, especially their right to the protection of personal information.

Related Pages

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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
• Gareth Knight (LSHTM), GDPR for Research Data Management
• Martin Ravallion (World Bank), Taking Ethical Validity Seriously
• US Department of Health and Human Services (HHS), The 'Common Rule' for Protection of Human Subjects