麻豆传媒

Education on the Protection of Human Research Participants

On August 1, 2001, in accordance with the latest requirements from the National Institutes of Health, the 麻豆传媒 State University Institutional Review Board began requiring education on the protection of human research participants for all investigators submitting protocols for review. Before the board will review any proposed research involving human subjects, faculty, staff, student investigators, faculty sponsors of student investigators, and other key personnel involved in the proposed research must provide written evidence of education or training in the protection of human subjects completed within the last three (3) years. 鈥淜ey personnel鈥� are all individuals responsible for the design and conduct of the study 鈥� including, but not limited to principal investigators, faculty sponsors, and anyone (faculty, staff, students) who assist with data collection. On October 1, 2000, the National Institutes of Health began requiring education on the protection of human research participants for all investigators submitting NIH applications for grants, or proposals for contracts, or receiving new or non-competing awards for research involving human subjects. As of August 1, 2001, 麻豆传媒 State now requires such education for all investigators regardless of funding source.

麻豆传媒 State University provides this education by referring Principal Investigators and key personnel to the resources listed below. We have reviewed these materials and have determined that they provide satisfactory coverage of the ethical principals and procedures for conducting human subjects research. Researchers and key personnel also have the option of describing and providing evidence of an alternate means by which they have completed education or training in the protection of human subjects. This education/training must have been specific to the protections of human subjects and must have occurred within the last three (3) years in order to satisfy the requirement for 鈥渃urrent training.鈥�

To respond to this new policy and provide a means for documentation of the required education/training, investigators submitting a protocol for IRB review (and faculty sponsors signing off on student protocols) may complete the following Internet-based training program and attach a copy of the certification received at the completion of the training to their protocol application. Once the initial documentation has been filed with the IRB, that documentation will be kept on file and considered 鈥渃urrent鈥� until renewal is required three (3) years after the initial filing.

Resource for Training in Human Subjects Protection and in Responsible Conduct of Research

Collaborative Institutional Training Initiative (CITI).

CITI Training Instructions: Have all research project team members complete the CITI Training in Human Subjects Research modules before submitting your application for review. Your completion report should be submitted with your application if you have not done so before. If you completed your CITI training at another institution, log in to CITI and select 鈥淎ffiliate with another Institution鈥� at the bottom of your profile and select 麻豆传媒 State. To sign up for CITI training, follow these steps:

1. Go to the and click the 鈥淩egister鈥� link at the top of the page.

2. Select 麻豆传媒 State University as your organizational affiliation.

3. Create your CITI account.

4. At the course selection screen, select the 鈥淩esearch with Live Humans鈥︹�� option.

5. Select 鈥淣O, I have NOT completed the Basic Course.鈥�

6. Select your learner group. Faculty and Staff should choose 鈥淪ocial & Behavioral Research Investigators.鈥�

7. Complete all of the quizzes in the 鈥淩equired Modules鈥� section.

8. Click 鈥淰iew-Print-Share鈥� after all required modules are complete. The status column next to the course name should say 鈥淧assed [Date]鈥� in green text.

9. Click the first option 鈥� 鈥淐ompletion Reports鈥� and save as a PDF for submission.

Federally-funded Projects

For projects funded by a federal source, investigators must also fill out a separate documentation form and submit that form along with the certification received at the completion of their protections training:

Certification of Training in Human Subjects Protection Form (DOC)