Section 4: Training in the Protection of Human Participants

4.0 Background (NIH Policy on Required Training in Research Ethics)
4.1 The University of Texas at Austin's Policy for Required Training in Human Participants Ethics
4.2 Alternative Sources of Information on Human Subjects Ethics
4.3 Online Training Verification
4.4 Additional Ethical Training Resources
4.5 Training for IRB Members
4.6 Training for DRC Members
4.7 Training for ORS Staff Members

4.0 Background (NIH Policy on Required Training in Research Ethics)

To increase the Federal commitment to the protection of human research participants, several new initiatives to strengthen government oversight of research with human subjects were announced by HHS Secretary Shalala on May 30, 2000.  On October 1, 2000, the NIH required 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.  Before funds can be awarded for competing applications or contract proposals involving human subjects, investigators must provide a description of education completed in the protection of human subjects for each individual identified as “key personnel”¹¹ in the proposed research.

For further information on the NIH policy, also see Required Education in the Protection of Human Research Participants at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html and Frequently Asked Questions for the Requirement for Education on the Protection of Human Subjects at http://grants.nih.gov/grants/policy/hs_educ_faq.htm

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4.1 The University of Texas at Austin's Policy for Required Training in Human Participants Ethics

Although the mandate from the DHHS applies only to NIH grants and contracts, the UT policy extends this mandate to include all human subjects research conducted by UT faculty, researchers, and students, including researchers from other institutions who wish to conduct research at UT. All key personnel, originally listed or later added to a project through an amendment, must upload documentation of compliance into IRBaccess.  In order to comply with the policy, researchers are required to complete the four-part Human Participant Training: History of Human Subjects Protections, Ethics and Federal Regulations, University of Texas at Austin Training, http://www.utexas.edu/research/rsc/humansubjects/training/index.html (Appendix P) and review the Belmont Report.  Effective June 1, 2005, completion of this training is mandatory for all researchers and key personnel and must be completed every three years.

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4.2 Alternative Sources of Information on Human Subjects Ethics

For more information about the violations of human subject protections, the foundations for the mandate of consent, and ethical treatment of human subjects: The Nuremberg Code, The Helsinki Declaration, The Belmont Report, The National Cancer Institute Training and NIH Printable Certificate, 45 CFR 46, 21 CFR 50 and 56, and this Policies and Procedures Manual.

If you have any questions about the educational training requirements and procedures, please contact orsc@uts.cc.utexas.edu.

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4.3 Online Training Verification

All human subject research requires compliance with the educational mandate for human subjects protections. Satisfactory methods of complying with this requirement are described above.  Prior to submission, all applications require PIs to have uploaded their training verification into IRBaccess.  IRBaccess is intentionally designed to only allow submission by PIs with human subjects training on file. To upload documentation of the educational training requirement visit: https://utdirect.utexas.edu/vr/
trngVerify.WBX.  All researchers without high-assurance UTEIDs are required to upload a memo listing their training, date, and contact information.

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4.4 Additional Ethical Training Resources

Codes of research ethics have been developed, in part to address the historical disregard for human safety and dignity. The Nuremberg Code of 1947 was the first international code of research ethics.  Another early code was the Helsinki Declaration, adopted by the World Medical Assembly at its meeting in Helsinki, Finland in 1964.  The first ethical code covering social and behavioral research was a set of 10 ethical principles adopted by the American Psychological Association in 1972. The American Psychological Association’s principles were the first to recognize the principle of confidentiality. Most professional organizations have ethical codes, and most require authors of manuscripts submitted to the journals of these organizations to state that they have followed these ethical principles in their research.  The University of Texas at Austin IRB encourages investigators to abide by their respective professional codes of conduct.

The U. S. Department of Health, Education, and Welfare issued ethical guidelines in 1971 that were codified into Federal Regulations in 1974. However, the primary impetus for current government ethical regulation began with the establishment of a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research under the aegis of the Department of Health, Education, and Welfare in 1974. The Commission was charged with identifying the basic ethical principles that should underlie research with human subjects. The report of the Commission, called The Belmont Report because it was based on deliberations held at the Smithsonian Institution’s Belmont Conference Center, was published in 1978. The Belmont Report identified three basic ethical principles. They are:

1. Respect for Persons (autonomy): This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from all potential research subjects (or their legally authorized representatives)¹² (see Definitions, Appendix A).
2. Beneficence: This principle requires that researchers maximize benefits and minimize harms or risks associated with research. Research-related risks must be reasonable in light of expected benefits.
3. Justice: This principle requires the equitable selection and recruitment and fair treatment of research subjects.

These three principles were the underpinnings of both an early (1980) version of a Common Federal Policy for the Protection of Human Research Subjects and the current version of that policy. Sixteen federal departments and agencies, including the Department of Health and Human Services, the National Science Foundation, the Department of Education, and the Central Intelligence Agency adopted the regulations. The Food and Drug Administration (FDA) has concurred with the Federal Policy and has made changes in its IRB and informed consent regulations so that they correspond to the Federal Policy. This Federal Policy, sometimes called the Common Rule, is codified as the Common Federal Policy for the Protection of Human Subjects and was published in the Federal Register in 1991. It is referred to as 45 CFR 46 and its regulations underlie the decisions of IRBs. The regulations further require that each institution at which federally funded research is conducted adhere to the principles of The Belmont Report and set forth in writing its ethical principles, policies, and procedures. University of Texas at Austin’s agreement to abide by the Belmont Report, and 45 CFR 46 (called a Federal Wide Assurance or FWA¹³) is approved by the federal agency that oversees ethical issues in human research. Because UT has an FWA, UT has determined that all research projects involving human subjects, regardless of funding status, abide by the same ethical and regulatory standards.

For additional online training resources visit: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

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4.5 Training for IRB Members

        IRB members and their alternates are provided with required training that provides information and copies of the following information:

1.  Policies and Procedures Manual for the IRB
2. Website for the ORS
3. The Belmont Report
4. 45 CFR 46
5. 21 CFR 50 and 56
6. University of Texas at Austin ‘s 3-Part Tutorial on Human Subject’s Protection
7. CD Rom of the PRIM&R 101 Tutorial
8. A copy of the book:  Institutional Review Board: Member Handbook, by Robert Amdur, 2003.
9. Use of outside consultants
10.  The difference between the determination of explicit conditions and tabled.

In addition, IRB members must document that they have completed the online NIH training for IRB members, UT-Austin’s 3-Part Tutorial, and read The Belmont Report.  Continuing educational material(s) are distributed at each IRB meeting in the form of relevant periodicals, or articles.

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4.6 Training for DRC Members

The following is a list of educational resources that all DRC’s at The University of Texas at Austin are encouraged to complete:

1. Policies and Procedures Manual for the IRB
2. Website for the ORS
3. 45 CFR 46
4. 21 CFR 50 and 56
5. University of Texas at Austin ‘s 3-Part Tutorial on Human Subject’s Protection

DRC members must document that they have completed the online NIH training for IRB members, UT-Austin’s 3-Part Tutorial, and read The Belmont Report.  DRC’s are invited to attend IRB meetings as necessary.   Additionally, DRC’s may look to the ORS website for links to new information on policies and conference links.

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4.7 Training for ORS Staff Members

The following is a list of educational resources that all staff in the Office of Research Support are required to complete within the first 3 months of employment:

1. Policies and Procedures Manual for the IRB
2. Website for the ORS
3. 45 CFR 46
4. 21 CFR 50 and 56
5. University of Texas at Austin’s 3-Part Tutorial on Human Subject’s Protection
6. Use of Outside Consultants

ORS members must document that they have completed the online NIH training for IRB members, UT-Austin’s 3-Part Tutorial, and read The Belmont Report.  Quarterly, each staff member is asked to attend a full-board meeting of the IRB.  Typically, two ORS staff members attend each IRB meeting monthly.  Attendance at regional and national meetings, such as PRIM&R/ARENA are encouraged and supported for staff members.

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