A creative partnership to improve human subjects protection. (Case Study).

Introduction

SUNY and The Research Foundation

This complex institutional structure is composed of two distinct entities-the State University of New York (SUNY) and The Research Foundation of the State University of New York (RE). SUNY is a highly diverse educational system that includes 64 campuses, with 30 conducting sponsored research through RF. All types of research are conducted at SUNY with a strong emphasis on both biomedical and social/behavioral sciences. Certain campuses within the system specialize; for example, the University at Buffalo has a fairly equal distribution of biomedical and behavioral research projects/humans protocols whereas Upstate and Downstate Medical Centers focus on biomedical research, and the university colleges concentrate on social/behavioral science research.

The Research Foundation of SUNY (RF) is a private, nonprofit educational corporation that administers externally funded contracts and grants for and on behalf of SUNY. Since 1951, it facilitates research, education, and public service at research campuses. RF carries out its responsibilities through an agreement originally implemented in 1977. The RF provides independence and administrative flexibility to meet the special demands of sponsored research in a manner that facilities the scientific and technical aspects of academic research.

To put the SUNY system in perspective, during FY 2002 approximately $565 million was awarded in federal and non-federal sponsored research, and 5000 active human research protocols were approved through 30 Institutional Review Boards (IRB).

History of the Partnership

The Human Subjects Forum (the Forum), established in July 2000, responded to the National Institutes of Health (NIH) policy notice requiring education for the protection of human research subjects for all investigators submitting NIH applications for grants or proposals for contracts for research involving human participants. Prior to establishment of the Forum, there was no organized method for communication among the diverse people (e.g., compliance officers, IRB administrators) responsible for human research protections at the SUNY campuses. The Forum provides structure and communication linkage.

Structure. The purpose of the Forum is to provide for collaborative discussion, dialogue, and pragmatic decision-making to ensure protections for human research participants and compliance with federal and state requirements. The Forum's slogan is "Doing the Right Thing for the SUNY System." It convenes primarily via facilitated conference calls (agendas are followed, issues/action items identified, and decisions made). Currently, there are 38 members, 35 represent the SUNY campuses and 3 represent the RF central office. Membership includes IRB chairs (7) and administrators, general faculty, principal investigators, vice provosts for research, associate/assistant vice presidents for research, directors of research compliance, and compliance officers/administrators. Approximately twice a year, SUNY campuses host the Forum for roundtable meetings where members benefit from sharing experiences with colleagues.

SUNY Proactive Response. The RF took a proactive position on behalf of the SUNY campuses and arranged for the Office for Protection from Research Risks (OPRR) Director of Education, Dr. Jeffrey Cohen, to conduct three educational workshops during the spring of 2000, prior to the announcement of the NIH policy notice issued in June and prior to establishment of the Forum. The workshops' formats were well-received by faculty and a second round was held in the spring of 2001.

Initial Forum Activities. During the period of July-October 2000, the Forum took immediate action to respond to the NIH policy by implementing short-term education programs at the SUNY campuses. Given the complex SUNY structure and the diverse sponsored research and human research protocols at the university centers and colleges, the Forum opted to use the NIH Tutorial and comprehensive lecture formats. Immediately following implementation of the short-term education program, the Forum began discussion on a long-term education program focusing on education as a continuing process.

At an early 2001 Forum meeting, members began the discussion and decision-making for the best web-based education program for the SUNY community. Several existing products were reviewed and the Forum decided to add the University of Miami's Collaborative IRE Training Initiative (CITI) to the education program by early 2002. Working closely with CITI, Forum members opting to use their program tailored the standard web pages to best fit the needs of each participating campus and type of research performed. CITI is an enhancement and an option to the educational programs. Some of the colleges with minimal research activity find it more effective for their faculty and students to participate in a lecture versus the online learning method.

OHRP Ambassador Visit. In October 2001, Dr. Gregory Koski, Director OHRP, made an ambassador visit to SUNY, speaking at the SUNY President's Meeting and addressing the IRE chairs. The essence of Dr. Koski's message was that "the bottom line is to do it right together, the emphasis is on together-it's required by law and it's the right thing to do." He stressed that universities needed to get out of a compliance/oversight mindset and move toward focusing on the performance of the programs and the prevention of harms. He strongly emphasized that the IRE cannot do it alone--their job is to focus and assure the protection of human research subjects--the institutions need to adopt a program-based approach to assure protection and compliance with the army of overarching federal requirements. Dr. Jeffrey Cohen, also engaged in a Town Hall Meeting with the IRB chairs. This was an opportunity for the audience to interact and the exchange was a stimulating dialogue. Common topics included IRB flexibilities, ethical pri nciples vs. compliance, enhancement to the required education program, conflict of interest, audit, and oversight. The take-away points for a more effective IRB program/process were to:

1. Identify the unnecessary, institutional, and bureaucratic burdens IRB's self-imposed and apply the flexibility provided in the current regulations without mitigating the quality of their human research protections.

2. Remove unnecessary duplication in the paperwork IRB's require/maintain.

3. Improve communications (verbal, written) with principal investigators, clearly informing them what they have to do and why they have to do it.

With implementations under development, in spring 2002 the Forum began serious discussions on how to audit/evaluate the entire human subject protection program. Self-audit was a viable option to consider based on the expertise among the Forum members. The objective was to develop a mechanism for each institution to assess its own program and to make the necessary improvements. Several options to develop a self-audit program were explored but none were acceptable to a majority of Forum members.

Implementing a Partnership SUNYIRF and OHRP

In May 2002 the Forum received an invitation from OHRP to participate in a partnership to develop and implement a quality assessment/quality improvement program (QA/QI) for human research protection at SUNY. The vision was that a team of volunteers from the Forum with knowledge of the regulations would be trained by OHRP and, upon the invitation of SUNY institutions, conduct QA/QI assessments. The training would involve a one-day session with the QA/QI team members (and other interested members of the Forum), followed by consultation at two institutions -- SUNY Albany (primarily social/behavioral research) and SUNY Stony Brook (primarily biomedical research).

The one-day training with two OHRP staff was held at RF central office in June 2002. The training included a review of the appropriate characteristics and qualifications of QA/QI team members, an overview of IRB policies and procedures each institution should have in place, an introduction to the newly developed draft OHRP Quality Assurance Self-Assessment Tool and a possible site visit schedule for consultation. The outcomes of this training were two recommendations; first, voluntary consultation should be conducted in a collegial and non-threatening way, with an informal but professional approach and second, barring any potentially dangerous situations, all information gathered should be confidential since this is an assessment, not an audit.

Consultations took place shortly after the training at SUNY Albany and SUNY Stony Brook. Prior to these visits, team members received each institution's policies and procedures manual, copies of IRB minutes, institutional organizational charts, and materials needed to understand the nature of the human subjects protection program of the institutions. Both consultation sessions included meetings with the human subject protections' staff to discuss office operations/procedures and to review the physical facilities such as database and office support. The QA/QI team consisted of three OHRP staff members and three or four Forum members; they reviewed protocol files, compared them to the minutes, and checked for compliance issues. The team met with institutional officials to determine the culture of the institution with respect to concern for human research subjects and federal compliance. They also met with the IRB chair, and separately, with members of the IRB committee to assess their commitment and understandi ng of the issues and regulations. Finally the team met with faculty members who perform human subject research and interact with the IRB, to discuss their opinions on how well the institution addresses human subjects protection. Each consultation visit ended with an exit interview with the appropriate institutional officials and other interested parties to discuss the team's findings.

Both voluntary institutions had well grounded programs and committed people so suggestions for improvement focused on how the program staff could simplify their work in the long run. Ideas included (a) more faculty education to improve protocols, (b) more expansive use of electronic tools, and (c) greater use of the flexibility built into the federal regulations.

Future Plans

Participating members of the QA/QI team from the Forum remain enthusiastic about the team approach and acquired ideas and resources to implement improvements at their own institutions. SUNY now has the foundation to develop a program that fulfills the initial Forum idea expressed in early 2001, a program that allows for a non-threatening, continuous review and improvement of an institutional human subject protection program.

The Forum has several additional activities planned for this academic year.

1. Hosting an OHRP videoconference on social/behavioral aspects of human subject protections to be broadcast on SUNY campuses in October 2002.

2. Formalizing the QA/QI team, developing and implementing the QA portion of the program in partnership with OHRP.

3. Arranging for additional volunteer QA/QI consultation visits to other SUNY campuses.

4. Implementing local changes to human research protection policies and procedures from lessons learned during the campus QA/QI consultations.

A Win-Win Experience

The QA/QI partnership enabled each of the partners to achieve their mission. The SUNY/RF Forum members found the training and consultations to be a cost-effective mechanism to improve the quality of human subject protections on diverse SUNY campuses because the team members have a unique understanding of the resources, federal and state regulations, and the SUNY-wide issues that Forum members share despite differences in structure, staffing, research emphasis, and size. The visits enable the partners to make suggestions and recommendations for improvements based upon existing resources. Forum members have an opportunity for their own professional development. The QA team will generally be more welcome at SUNY campuses because the Forum volunteers are there to assist their peers to improve the process.

Additionally the Forum, especially the QA/QI Partnership, is an effective process to assist the SUNY campuses to gain increased positive recognition from their campus administrators and from SUNY senior staff as to the importance of promoting a culture that focuses on protecting research subjects on each campus.

The SUNY system as a whole benefits because the Forum's activities assist the SUNY chancellor to achieve his goals for the system by having SUNY campuses work together as a system and recognizing SUNY for being the first educational institution in the country to partner with OHRP to establish a QA/QI program for human subject protections.

The OHRP was able to pilot a train-the-trainer program and a team approach to QA/QI consultation in fulfillment of their new, proactive focus on performance and prevention of harms.

References

Policy Notice OD-00-039, 5 June 2000.

Author's Note: The Forum members gratefully acknowledge the support of staff from the Division of Assurances and Quality Improvement and the Division of Education at OHRP, and the Research Foundation of SUNY Central Office who helped to make this partnership possible.

This paper was originally developed as a contributed paper for the SRA Annual Meeting 2002, Orlando. Contact the corresponding author, Colleen T. Donaldson, CRA, Grants Development Director, IRB Administrator at SUNY College at Brockport, 350 New Campus Drive, Brockport, N.Y. 14420, Phone: [phone]; Email: [e-mail].

Colleen Donaldson, MA, CRA, Grants Development Director, Office of Academic Affairs, State University of New York College at Brockport has over 15 years of research administration experience in higher education. She is currently a grants consultant to a variety of governmental and nonprofit organizations. Ms. Donaldson has taught a one-credit grants writing workshop for 10 years. She has a MA in urban studies from the SUNY College at Brockport. She previously wrote for the journal and served on the ERB. Lorrie B. Anthony, MS, Director, Office of Grants and Contracts, Empire State College of SUNY, has 15 years of experience in research administration and technology transfer in the college environment. She held numerous positions in academia and in private enterprise. Her graduate degree is in instructional design, development, and evaluation from Syracuse University. Carol H. Berdar, Compliance Manager for Sponsored Programs, The Research Foundation of State University of New York, serves SUNY campuses by prov iding guidance, support, and interpretation on legislation and regulation impacting sponsored research, developing policy, and serving as liaison and advocate with federal and state government agencies in the regulatory/rulemaking arena. Ms. Berdar has a Bachelor of Science in Public Administration, with a major in public policy, from SUNY Empire State College. She has been active in NCURA at the regional and national levels.