Human Research Protection Program: Policy

Education and Training of HRPP Personnel

Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School

Adoption Date: December 8, 2005

Revised By: Human Research Protection Program Advisory Committee

Revised: October 18, 2006

Revised: December 6, 2007

Revised: January 11, 2008

Revised: April 10, 2008

Revised: May 6, 2010

Revised: March 1, 2012

Purpose:  This document describes how UW-Madison ensures that its research investigators, IRB members and staff, and other personnel, when appropriate, maintain continuing knowledge of, and comply with, their legal and ethical obligations to protect human subjects when conducting research.

Policy

I.      At the UW-Madison, the responsibility for the protection of human research participants is shared by the Institutional Official (IO), the Research Policy Office (RPO), the Institutional Review Boards (IRBs), and the investigators.  Each has a crucial, yet distinct, role to play.

II.     Ethical Obligations. 

A.   In all research involving human participants, UW-Madison is guided by the ethical principles as set forth in the “Belmont Report” by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [Ethical Principles and Guidelines for the Protection of Human Subjects of Research], regardless of whether the research is federally-funded or non-federally funded research. 

III.    Federalwide Assurance

A.   Through its Federalwide Assurance (FWA) with the Department of Health and Human Services (DHHS), UW-Madison guarantees that all UW-Madison investigators working on all federally-funded human subjects projects will comply with the terms of assurance for protection of human subjects for institutions within the United States.  The FWA places shared responsibility for protecting the rights of human research participants on research investigators and on the UW-Madison as an institution. 

IV.   Federal Common Rule

A.   With respect to all federally-supported human subject research, UW-Madison complies with the Federal Policy for the Protection of Human Subjects, known as the Common Rule, 45 CFR Part 46, as well as any additional human subject regulations and policies of the sponsoring Department or Agency. 

V.    Other Applicable Rules and Guidelines

A.   Where applicable, UW-Madison also complies with the Food and Drug Administration’s (FDA’s) regulations and guidance on protection of human research participants in research studies involving drugs, medical devices and biologics, 21 CFR Parts 50 and 56; the Veteran’s Administration (VA) regulations pertaining to the protection of human research participants, 38 CFR Part 16; and the privacy requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) implemented by 45 CFR Parts 160 and 164 (Privacy Rule).

Procedure

VI.   Communication of ethical standards and legal obligations

A.   The UW-Madison’s Human Research Protection Program (HRPP), the HRPP Advisory Committee, and the four UW-Madison IRBs are responsible for ensuring constructive communication among the research administrators, department heads, research investigators, clinical care staff, research participants, and institutional officials as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of research participants.

VII.   Training in ethical standards and legal obligations

A.   IRB Members and Staff

 

1.   New UW-Madison IRB members and IRB staff participate in orientation and training programs provided by the University covering research review and human research protection. 

 

See, ED IRB & SBS IRB Member Training SOP

        HS IRB & MR IRB Member Training and Orientation SOP.

 

2.   UW-Madison IRB members and IRB staff receive training manuals, IRB Member Handbooks, and have access to reference books and copies of the Belmont Report. 

 

3.   IRB members and IRB staff also participate in ongoing education and training through continuing education provided by the IRB chairs and staff, as well as during discussion of protocols at IRB meetings, CITI IRB member training, and attendance at meetings and workshops relating to human research protection ethics, including the UW-Madison Graduate School Seminar Series and Public Responsibility in Medicine and Research (PRIM&R) sessions.

 

a.   Education Research and Social & Behavioral Science IRBs (ED/SBS IRBs) Staff are also provided copies of all of the same materials that are provided to IRB members and access to all UW-Madison policies and guidance through the web based document storage and management system.  IRB staff are required to take CITI training and to attend/participate in any ongoing programs offered by the ED/SBS IRBs Office and the Graduate School Seminar Series and may attend professional conferences.

 

b.   In addition to what is described above, HS IRBs staff involved in the triage and review of submissions are required to complete and pass campus human subjects protection training and HIPAA Privacy Rule training for researchers.  New staff reviewers undergo a two-month training period by an experienced staff member and work under the mentorship and oversight of an experienced staff member for at least six months.  Ongoing education occurs at the weekly meetings held for all staff, which include review of existing and new policies and discussion of review and operational issues.

B.   Investigators and Research Staff

 

1.   Training and educational requirements.

 

a.   UW-Madison’s HRPP website and the websites of the four campus IRBs provide educational and instructional material, including online tutorials, for investigators and research staff. 

 

b.   UW-Madison requires that all personnel engaged in human subjects research, as defined in Sec. VII.B.5 of this policy, to complete human subjects training.  The required UW-Madison training consists of certain CITI human subjects protection training modules [https://my.gradsch.wisc.edu/citi/index.php] designated by the UW-Madison. CITI training is provided by the Collaborative Institutional Training Initiative.

 

c.   Personnel engaged in human subjects research who have dual appointments with the William S. Middleton Veteran’s Affairs Hospital and the UW-Madison (“dual appointees”) and are required to take the VA human subjects training are not required to take the UW-Madison CITI human subjects protection training.  Completing the VA human subjects training will satisfy the UW-Madison human subjects training requirements stated in Section VII.B.2.

 

d.   University of Wisconsin Hospital and Clinics Authority (UWHCA) employees are required to take UW-Madison CITI human subjects training, even if they have no UW-Madison appointment and are not UW-Madison students.

 

e.   All personnel engaged in human subjects research, as defined in Sec. VII.B.5 of this policy, must retake the required UW-Madison human subjects training every three years.

 

·         Outside collaborators from institutions that do not have an FWA must also satisfy UW-Madison’s three year retraining requirement. 

 

·         Dual appointees, as defined in Sec. VII.B.3 of this policy, who take the VA human subjects training to satisfy the UW-Madison human subjects training requirements are subject to the VA’s annual retraining requirements.

 

f.    All personnel engaged in human subjects research, as defined in Sec. VII.B.5 of this policy, must achieve an 85% pass rate averaged across all modules each time they take the UW-Madison CITI human subjects protection training course.  

 

g.   Personnel engaged in human subjects research, for purposes of this policy, means, individuals who:

 

·         design research,

·         direct research or serve as the principal investigator,

·         enroll research subjects (including obtaining subjects’ informed consent or screening potential subjects) or make decisions related to eligibility to participate in research,

·         conduct study procedures,

·         analyze or report research data,

·         analyze or report adverse events, or

·         author manuscripts concerning the research for publication.

 

      Students, subcontractors, and consultants who act in any of the roles listed above are personnel engaged in research, as defined in Sec. VII.B.5 of this policy, and required to take human subjects training. Any new research personnel, including investigators or other research staff, added during the course of a project must also complete human subjects training.

 

h.   For personnel at other institutions collaborating with UW-Madison researchers, UW-Madison IRBs may accept certification of the completion of a comparable human research training program as a substitute for completion of UW-Madison’s required training. UW-Madison IRBs accept the following substitutes:

 

·         the Veterans Affairs Good Clinical Practice & Human Subjects Protection training,

·         training taken at another institution that uses the CITI Course in The Protection of Human Research Subjects,

·         the National Institutes of Health training, and

·         training from other institutions holding a Federalwide Assurance.

 

      Investigators can also apply to the IRB Offices for approval to substitute other training programs for personnel engaged in human subjects research, as defined in Sec. VII.B.5 of this policy, who are not otherwise affiliated with the UW-Madison, if circumstances warrant. For example, a different substitute training program might be approved, if other personnel would have difficulty accessing one of the training programs listed above because they are not located in the U.S.

 

i.    When relevant, UW-Madison investigators and research personnel must also take HIPAA research training before being permitted to conduct research involving humans. 

 

j.    Individuals having an interest in translational and clinical research may also participate in the UW-Madison Medical School’s Clinical Investigator Preparatory Program (CIPP), a training program funded by the National Institutes of Health.  The program provides two years of coursework linked to research and mentoring. 

 

k.   Investigators and research staff are required to review the principles of the Belmont Report when completing the UW-Madison CITI training modules.

 

2.   Monitoring and Verifying Training Completion

 

a. ED/SBS IRBs

·         Verification of training for researchers and other personnel listed on an Initial Review, Continuing Review and Change of Protocol application is ensured by an automated process built into the ED/SBS IRBs’ electronic protocol submission system.  Unless all personnel listed on an electronic application have a current human subjects training date in the training date field, the system will not allow the Principal Investigator to electronically submit the application to the IRB office.  Instead, when the PI attempts to submit the application, an automated response identifies who on the research team has not completed human subjects training.

 

b. HS IRBs

·         During IRB administrative review of an initial application IRB staff verify that all members of the study team have completed required human subjects protection training and, if applicable, HIPAA Privacy Rule training for researchers via the campus training database.  Additionally, the HS IRB and MR IRB confirm human subjects protection training requirements via the campus training database when personnel changes are submitted for review.

C.   Institutional Official and IRB Chairs

 

1.   UW-Madison’s designated Institutional Official and IRB chairs complete the online Assurance Training offered by the OHRP. [See, http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp] 

VIII.  Written Policies and Procedures

A.   UW-Madison HRPP has and follows written policies and procedures to assure human research is conducted in compliance with applicable ethical and legal obligations, including policies and procedures for (i) conducting initial and continuing review of research, (ii) handling amendments to protocols, (iii) ensuring IRB approval before research and changes in approved research are initiated, and (iv) reporting and processing unanticipated problems involving risks to participants or others, instances of serious or continuing non-compliance, and the suspension and termination of research approval.  These policies and procedures are made available to all individuals involved in the research review process, including investigators and research staff, IRB members and staff, and institutional officials.  The UW-Madison IRBs also provide investigators and research staff with written guidance documents and forms and instructions relating to the research review and reporting processes.

IX.   Sponsors

A.   Before any sponsored research study may begin, the study must be reviewed and approved by a UW-Madison IRB to assure compliance with applicable federal regulations, state laws and ethical requirements for human research. 

B.   UW-Madison’s FWA requires all human research, including industry-sponsored research, to be conducted in accordance with the Belmont Rule. 

C.   The standard research agreement used as a model for agreements between UW-Madison and sponsors specifically identifies the UW-Madison’s responsibility to comply with rules and regulations for human research including adherence to applicable ethical principles, state, local and federal laws, federal guidance and all requirements of the approved research protocol.  See, UW-Madison Standard Clinical Trials Agreement

D.   Sponsor protocols contain terms and conditions requiring studies to be conducted in compliance with federal regulations governing protection of human subjects and the UW-Madison’s ethical obligations.  See, UW-Madison Policy on Sponsored Research Agreements; Standard Clinical Trials Agreement