Required Education in Protecting Human Research Participants
Agencies that fund research, including federal agencies, require investigators to demonstrate that they understand the principles and regulations related to protecting human subjects. For example, since 2000, the National Institutes of Health have required education in the protection of human research participants for all investigators and key personnel submitting applications for grants or proposals for contracts, or receiving new or non-competing awards.
Such requirement are often extended to all research involving human participants at colleges and universities, whether funded or not, by institutional policies governing such research.
There are several reasons for such requirements.
Researchers will be better able to plan and conduct research that upholds the values of respect, beneficence and justice and to prepare applications that meet the criteria for approval if they have a basic understanding of relevant fundamental principles and current applicable applications that meet the criteria for approval if they have a basic understanding of relevant fundamental principles and current applicable regulations.
The IRB will be more confident in approving a research application if it has evidence that the researcher possesses that basic understanding of fundamental principles and current regulations.
At St. Norbert College, the required human participants research ethics tutorial is one developed by the National Institutes of Health (NIH) Office of Extramural Research, and is titled, Protecting Human Research Participants.
The tutorial includes five educational modules:
- Codes and Regulations
- Respect for Persons
Case studies (applied scenarios) and brief quizzes accompany each module. A certificate is issued once all modules are completed successfully.
Users may complete one module on one occasion and return at a later time to complete another module. Users may work through a module, quiz and scenario as often as need to successfully complete the module.
Once all the modules have been successfully completed, a certificate of completion will be provided. One copy of this certificate should be sent via email to the IRB; a copy of the certificate of completion should also be kept on file by the applicant.
Researchers and those who supervise student researchers will renew their certificate every five years.
Student researchers will renew their certificate ever two years.
To access and complete the required NIH Protecting Human Research Participants tutorial, please visit the Protecting Human Research Participants website.