INSTITUTIONAL REVIEW BOARD
Institutional Review Board
Policy Recommendation on Educational Training for Students and Faculty
This policy recommendation is intended for both faculty teaching graduate and undergraduate research, as well as graduate and undergraduate students taking a research course. Under this policy, the following recommendations apply:
1. Graduate schools should integrate educational training on human subjects’ protections with students’ research courses.
2. Undergraduate students, as part of their research course, should take the smallest educational training component (i.e., NIH CBT, see below for more information).
3. Faculty teaching research courses should be expected to complete educational training on human subjects’ protections ideally before teaching a research course and conducting any research activities.
Because OHRP recommends research investigators to complete appropriate institutional educational training before conducting human subjects’ research, all students and faculty planning to conduct research will need to complete appropriate educational training and obtain approval from the IRB. Compliance with this standard supports good teaching and the knowledge development of prospective research investigators.
Compliance with the IRB’s training standard may be met through the completion of any ONE of the following:
1. Completion of the CITI basic course in Social/Humanistic/Behavioral Research (14-15 modules (plus HIPAA module for those who are part of the nursing and/or health sciences teams, respectively); OR
2. Completion of the NIH CBT; OR
3. Provision of a certificate from another institution that provides a similar certification.
It is important to note that completion of only one of the three abovementioned training options is needed to comply with the IRB training standard. It is at the discretion of each individual to select only one training option from the three that are listed above. It is not necessary to complete more than one of the three training options.
Following are details on each of the three abovementioned training options. For students or faculty who have not received any IRB training or have training that is outdated, certification can be obtained by completing either Training Option # 1 (CITI Basic Course in SBR) or Training option #2 (NIH CBT).
To help students and faculty understand the differences between the CITI Basic Course in SBR and the NIH CBT, acomparative chart is available on the IRB SharePoint site. The biggest difference is in time. That is, the NIH CBT takes significantly less time to complete than the CITI SBR, only 1 hour compared to nearly 6 hours.
Regardless of the training option chosen, the IRB requires documentation of completed training. To this end, research investigators should make sure that the IRB has their training certification on file. Upon completion of the CITI IRB training or the NIH CBT, learners should be able to print/save a certificate documenting completion of the training. Learners should retain a copy of the certificate for personal record-keeping and send a copy to the IRB, care of Domarina Oshana at .
Training Option #1: CITI Basic Course in Social/Humanistic/Behavioral Research (SBR)
Accessible from: https://www.citiprogram.org/default.asp
A detailed instruction set providing step-by-step directions on how to register for and complete the course is available on the IRB SharePoint site.
Stringent adherence to the directions in the instruction set is strongly recommended. If a person does not follow the instructions, and therefore, ends up taking a course other than the basic course in SBR, which as noted above has 14-15 modules, then it is that person’s responsibility to take the correct course.
Certification in a “Refresher” course or a “Responsible Conduct in Research” course, or any course other than the basic course in Social/Humanistic/ Behavioral research will not be accepted. When in doubt, the OIE staff should be contacted for further direction in taking the basic SBR course.
Training Option #2: NIH Computer-Based Training (CBT)
Accessible from: http://phrp.nihtraining.com/users/login.php
The very first page of the NIH CBT Website includes clear and brief instructions for registering and completing the training. The training is straightforward and brief in comparison to the CITI training.
Training Option #3:
A certificate from another institution providing similar certification as Training Option #1 or Training Option #2 will also be accepted. However, one limitation applies. We will not accept training documentation that is outdated (i.e., more than 7 years old). Stated differently, 7 years is how far back the IRB will accept documentation of IRB training.
Note: Before the IRB can review an investigator’s protocol, documentation of educational training in the protection of human subjects must be on record. No exceptions will be made.
KHE IRB : Associate Chair
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