Difference between revisions of "Protecting Human Research Subjects"

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== Read First ==
 
== Read First ==
*[https://github.com/worldbank/dime-standards/tree/master/dime-research-standards/pillar-1-research-ethics DIME's Research Ethics Standards]
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* The [https://github.com/worldbank/dime-standards/tree/master/dime-research-standards/pillar-1-research-ethics DIME Research Ethics Standards] discuss the provisions for '''protecting human subjects''' in development research.
*To protect the rights and welfare of study participants, [[IRB Approval | IRBs]] require ethics certifications; depending on IRB requirements, these may be obtained via NIH, CITI, or elsewhere.
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* To protect the rights and welfare of study participants, [[IRB Approval | 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]]
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* Besides '''protecting human research subjects''', the [[Impact Evaluation Team|research team]] must also keep in mind '''best practices''' for [[IRB Approval|IRB approvals]], [[Informed Consent|informed consent]], [[De-identification|de-identification]], and [[Encryption|encryption]].
  
 
== Overview ==
 
== Overview ==

Revision as of 18:17, 7 October 2020

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

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:

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)

Related Pages

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Additional Resources