Beginning July 1, 2002, ALL IUB researchers have to document that they have been trained to involve humans in research by passing the IU test for using humans in research, before their study will be reviewed. The tutorial and test can be found at www.indiana.edu/~rcr/.
Proof of having passed the test should accompany the application at the time of submission. Failure to provide proof with the application will delay the review until documentation is obtained. This applies to all submissions (new, continuation and/or amendment) regardless of funding or rank of the PI, sponsor and co-investigators.
The office staff can access the database to see who has passed the test, but sometimes names are not spelled the same in the database as in the application to us. Because of this we suggest you follow the procedures in the next paragraph, so we are notified as soon as the test is passed.
When you are at the log-on page for the test, you should enter your own e-mail address in the appropriate box. Be sure you check the box to receive a notice of your own score. Also enter our e-mail address <iub_hsc@indiana.edu> in the appropriate box, so we will receive a notice as soon as you have passed the test.
Those individuals specifically listed in the application
as PI, sponsor, and/or co-investigators must have passed the test.
NIH Requirements
Protection of Human Subjects in Research Web-Based Tutorial
Human Subjects Protection Test
Request a new copy of your results via e-mail
Documentation of Education on the Protection of Human Subjects Form for the NIH
Certification Sample Letter for the NIH
Beginning October 1, 2000, the NIH will require education on the protection of human resarch 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.
A) Certification by October 1st, 2000 is ONLY required by that date if you are currently NIH funded and will be getting funds after that date for renewals or non-competing renewals. For example, if you are currently NIH funded and your renewal is for November 2000-November 2001, Sponsored Research Services will have to notify the NIH that you have completed successful training prior to receipt of funds.
B) If you are submitting an NIH grant for October 1st deadline, you are not required to have completed training by October 1st due to the "just in time" requirements. Certification will be required along with the other support pages etc. after the initial review. However, it is suggested that you include acknowledgement of this requirement in your human subjects section. For example, you may wish to write "Indiana University currently offers several educational courses and certification of training in research involving human subjects. The PI and all appropriate key personnel will have successfully completed that training prior to award receipt."
The mechanisms by which you can train/certify are:
1) Go through the Indiana University Web based tutorial "Protection of Human Subjects in Research".
2) View the videotape of the live session in September that will be available in approximately October and take the test on line.
3) If you have already completed training in human subjects, you can just take the test. However, very few "training" programs will prepare you well for the test so it is recommended that you also complete the tutorial.
To be "certified" that you have completed training, you will need to pass the test, and also provide a list of training courses completed. Complete the Documentation of Education on the Protection of Human Subjects Form.
