NIH Researchers

IMPORTANT NOTICE - Revised 8/3/00

To:	All Researchers Who Receive Support From NIH

From:	Mark L. Brenner, Associate Vice President for Research - IU
	Vice Chancellor for Research and Graduate Education - IUPUI

Subject:	NIH Education Requirement on the Protection of Human Research Subjects

Recently, NIH announced a new requirement that researchers using human subjects demonstrate the completion of education in the protection of human research participants http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. Because this announcement from the NIH was rather sudden, imposes new levels of compliance, and bears significant penalties for both non-compliant institutions and individuals, it is imperative that Indiana University introduce new procedures. This notice explains the new requirement and the steps the University is taking to assist researchers, and the institution, to meet that requirement. If you have any questions regarding the information in this notice, please contact Mark L. Brenner at (317) 274-1020 or mbrenner@iupui.edu.

Who must comply?

ALL personnel involved in the design or conduct of research involving human subjects supported by NIH contracts and grants that will receive funding on or after October 1, 2000. It applies to individuals, whether or not they receive compensation from the award, who work on projects supported by NIH.

Applies to all applications (from RFAs, PA, and investigator initiated grant applications).
Applies to non-competing continuation awards.
Applies to NRSA research fellowships for individual fellowship applications and trainees in institutional training grants who are conducting human subject research.
Applies to third party (subcontract) key personnel that are involved in the design or conduct of research involving human subjects.
Applies to foreign awards and foreign subcontracts when the personnel are involved in the design or conduct of research involving human subjects.
Applies to consultants if they are identified as key personnel and are involved in the design or conduct of research involving human subjects.

Timeline for this requirement:

Applies to all proposals submitted to NIH on or after October 1, 2000.
Applies to all existing projects that will receive NIH funding on or after October 1, 2000.

How may this education requirement be fulfilled?

Although NIH has not prescribed specific courses or reading material, they have identified a number of available resources and institutions and individuals may select those resources that best meet their needs. The University supports this approach. Accordingly, individuals may select their own educational program to meet the requirement.

Document readings or attendance of specific course(s) on protection of human research subjects. NIH has posted a number of resources that individuals may wish to read -- http://www.nih.gov/sigs/bioethics/.
Certification from an applicable course on research involving human subjects.
Take one of the courses offered by Indiana University. Further information regarding these courses will be posted on the IU Research Gateway web page: http://www.research.indiana.edu/ .
- Faculty Clinical Research Training Seminar organized by Dr. Sharon Moe - to be offered on September 25, 2000. The first 90 minutes of this seminar will cover human subjects research generally. Researchers at IUB may participate through videoconference arrangements.
Research Coordinator's Education Program (RCEP) - to be offered September 12-14,2000
Take the web-based tutorial program developed by Indiana University (this should be available by mid to late August 2000. A specific link will be posted on the IU Research Gateway web page: http://www.research.indiana.edu/.

Documenting how the education requirement has been completed:

With respect to the type of documentation, the NIH requires:

a letter that includes each name of any key personnel who are responsible for the design and conduct of the study;
the title of the education program completed by each named personnel
a one sentence description of the program
the letter must be signed by the principal investigator and co-signed by a University official.

The timing of submission of documentation is in keeping with just-in-time procedures. Thus, the NIH will request this letter documenting education before an award is issued.

The Research Office will provide a template form so that each researcher can report what they completed to meet the education requirement. http://www.research.indiana.edu/.

All individuals must pass a short Indiana University test to reflect that they understand the basic principles and procedures related to protection of human research subjects:

In order for the university to be able to verify to NIH that researchers have completed the education requirement, IU, along with a number of other institutions and consistent with the recommendations of the Association of American Universities Task Force on Research Accountability, is requiring that each individual involved with the design or conduct of human subjects research demonstrate that they understand the basic principles and procedures related to protecting human research subjects. To accomplish this, we are developing a web-based instrument to test this knowledge that will be available by mid to late August. The test will cover the rules discussed in the IU web-based tutorial. This initial version of the tutorial and test will cover basic rules that apply to all types of human subjects research. However, we recognize that there are many different types of human subjects research that occur at IU, many of which involve specialized populations (such as children or cognitively impaired persons) or therapies (such as gene therapy). We expect to continue to develop and refine the IU tutorial and test to take account of the differences among researchers, and to ensure that researchers are provided materials that are relevant to their particular work. Specific instructions regarding the test will be posted on the IU Research Gateway web page: http://www.research.indiana.edu/.

Researchers with prior education and experience in human subjects research may proceed directly to take the test, if they wish. Those who pass the test would then describe on the Research Office form how they learned about the principles and policies related to research on human subjects (e.g., prior educational programs, readings, experience with human subjects based research and interactions with an IRB). If the researcher does not successfully complete the test on the first try, he or she should pursue any of the educational options described above before trying again.

Researchers are encouraged to contact staff and members of their IRB or Human Subjects Committee at any time to discuss any questions they may have regarding the human subjects rules and their application. Once the web-based test is passed, the university will sign and transmit the documentation to NIH. Please note that researchers who complete the 90-minute human subjects portion of the Faculty Clinical Research Seminar on September 25 (discussed above), have the option of taking the test at the completion of the 90-minute session.

Future educational developments related to research involving human subjects:

The Office of Research Integrity recently proposed that all researchers receiving Public Health Service (including NIH) funds participate in a more comprehensive program on the responsible conduct of research, including human and animal subjects rules, conflicts of interest, publication practices, mentor/trainee relationships, and other areas. It is likely that such a program will have to be in place by July 1, 2001 and completed by all researchers by July 1, 2002. We will continue to provide information on these requirements and the university's efforts in these areas.

For further information see the NIH Frequently Asked Questions web site: http://grants.nih.gov/grants/policy/hs_educ_faq.htm.