Education on the Protection of Human Research Participants


Frequently asked questions

For most questions, the quickest way to receive an answer is to look for it on this page. If your question isn't answered here, see Contact Information.

Questions about The Test | Contact Information | Documentation and Proof | Collaborators and Subcontractors


The Test

Contact Information

Documentation and Proof

Collaborators and Subcontractors


The Test

What information does IU receive when I take the test?

IU research offices (e.g., Research and Sponsored Programs at IUPUI and Sponsored Research Services at IUB) have access to a database of tests with a score of 70% or higher and adequate contact information. The database includes the contact information supplied by the test taker (first name, last name, IU campus, and e-mail address), along with the test version, the test ID, and the date the test was taken. Tests that score below 70% are not listed in this database.

If I don't pass the test, may I take it again?

Yes. The test may be taken as many times as needed.

Is there a limit to how many times I can take the test?

No. The test may be taken as many times as needed.

Can only Indiana University investigators take the tutorial and test?

No. The tutorial and test may be taken by anyone, regardless of their affiliation. Test results will be sent to all individuals who complete the test and provide an e-mail address. However, Indiana University will only verify certification to funding agencies for Indiana University faculty, staff, and students. Indiana University reserves the right to determine the nature and scope of all grant related affiliations involving outside collaborators.

Do I have to take the test and document human subjects education if NIH funding is not involved?

Yes. All Indiana University researchers are required to read and understand the appropiate tutorial ("Protection of Human Subjects in Research" or "Protection of Human Subjects in Non-Biomedical Research") and pass the test. This requirement is intended for everyone having direct contact with research subjects at IUPUI and IUB campuses or their affiliates. This requirement may include, but is not limited to, principal and co-investigators, coordinators, faculty sponsors, and students. Please note that the research offices will not be able to process paperwork until this requirement has been fulfilled by all investigators listed on the summary safeguard statement.

The Protection of Human Subjects in Research tutorials and test can be found at http://www.indiana.edu/~rcr/.

I made a mistake when I provided on my e-mail address. Can you fix it for me?

No. Altering the database is not a trivial undertaking. If you made a mistake in entering any of your contact information, you should take the test over.

My e-mail address has changed since I took the test. Can you fix it for me?

No. Altering the database is not a trivial undertaking. If your contact information has changed (whether your e-mail address or your name), you should take the test over.


Contact Information

Who should I contact if I have technical difficulties with the test?

Send technical questions to rcr@indiana.edu.

Who should I contact if I have other questions?

For questions regarding certification, including sample certification letters and the documentation form, see http://www.iupui.edu/~resgrad/Human%20Subjects/human-menu.htm or contact:

IUPUI:
Research and Sponsored Programs
Union Building 618
Indianapolis IN 46202
(317) 274-8289
resrisk@iupui.edu
IUB:
Office of Research Compliance
Carmichael Center, Suite L03
530 East Kirkwood Avenue
Bloomington IN 47408-4003
(812) 855-3067
iub_hsc@indiana.edu

Documentation and Proof

What documentation that I passed the test is needed when I submit a grant proposal?

When you take the test, there is a box to check to request that the results be sent to you by e-mail (see http://www.indiana.edu/~rcr). The e-mail is the only documentation that you will receive. It is not necessary to include the e-mail with your grant proposal. The following section explains what forms must be sent with a proposal.

What is the process for documenting that I have passed the test?

Non-competing proposals: When a non-competing proposal is submitted to NIH, the Principal Investigator and Indiana University are required to certify that all key personnel involved in the design or conduct of a study involving human subjects have completed the required human subjects education. The IU "Human Subjects Certification" Web site (see http://www.iupui.edu/~resgrad/Human%20Subjects/human-menu.htm) contains two forms - a documentation form and a certification letter. Each individual identified as Key Personnel in the proposal should complete a documentation form. The Principal Investigator prepares the certification letter, attaches the documentation forms to the letter, and forwards the documents to her or his campus research office with the proposal. The research office checks a database to verify that each individual has passed the test, then signs and submits the certification letter along with the proposal.

New or competing proposals: For new or competing proposals, no documentation should be submitted until requested by NIH. Further questions on this process should be directed to:

IUPUI:
Research and Sponsored Programs
Union Building 618
Indianapolis IN 46202
(317) 274-8289
resrisk@iupui.edu
IUB:
Office of Research Compliance
Carmichael Center, Suite L03
530 East Kirkwood Avenue
Bloomington IN 47408-4003
(812) 855-3067
iub_hsc@indiana.edu

Do I send the documentation forms directly to NIH?

No. If you are submitting a non-competing application, the certification letter with the documentation forms attached should be sent to your research office with your proposal. If you are submitting a new or competing application, you may wait to submit the forms until requested by NIH.

Do I need to include the documentation with my IRB submission?

No.

Can I get a report of the test results for all the faculty and/or students in my department?

No. The test results are confidential so they cannot be provided to anyone other than the individual who took the test. Also, the database where the test results are tracked does not capture the department nor does it have the capability to generate reports. People who take the test are given the option of having the results of the test sent to them via e-mail, which they are then free to forward. They also have the option of having the test results sent directly to anyone with an e-mail address.

My research administrator (or someone else) wants proof that I passed the test. How can I provide it?

If you know this before you take the test, provide that person's e-mail address and a notification will be automatically sent if you pass. You can also forward the e-mail message you received confirming your test score.

I can't find my e-mail confirmation that I passed the test. How can I get another copy?

Follow this link to http://www.indiana.edu/~rcr/ereqform.php. Fill out the form and you will receive a new e-mail message that you can then forward as you please.


Collaborators and Subcontractors

I am not affiliated with Indiana University in any way; may I take the tutorial or test?

Yes. Test results will be sent to all individuals who complete the test and provide an e-mail address. However, Indiana University will only verify certification to funding agencies for Indiana University faculty, staff, and students. Indiana University reserves the right to determine the nature and scope of all grant related affiliations involving outside collaborators.

Do researchers on my grant from other institutions have to take the IU Web-based tutorial and test?

Indiana University has decided that if a subcontractor is a member of the Council on Governmental Relations (COGR), certification signed by an appropriate institutional official will be sufficient documentation that the subcontractor's personnel have obtained the required education and are in compliance with the NIH regulations. For a list of current COGR members, see http://www.cogr.edu/docs/List.PR.pdf. Consultants, foreign subcontractors, or subcontractors who are not members of COGR must take and pass the Indiana University web-based test which can be found at http://www.indiana.edu/~rcr/.

How can researchers who are not in the United States take the tutorial and the test?

If they have a good Internet connection, they should be able to take the tutorial and test via the World Wide Web. If they are unable to read the tutorial or take the test because of technical difficulties, a co-investigator at Indiana University can print and mail a copy of the tutorial to an overseas colleague(s). The person at Indiana University with primary responsibility for the grant should feel free to suggest appropriate mechanisms for assuring that co-researchers abroad have adequate understanding of the regulations to protect human subjects.

Some of my co-researchers cannot read English. Will the tutorial and test be translated?

No. We do not have the resources to translate the tutorial or the test. In this case, the person at Indiana University with primary responsibility for the grant should feel free to suggest appropriate mechanisms for assuring that co-researchers abroad have adequate understanding of the regulations to protect human subjects. For example, researchers who do not read English might be able to get help from a translator.


Last updated: 23 April 2008
URL: http://www.indiana.edu/~rcr/
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