Drug Information Association (DIA) Conference

The DIA is holding its 48th annual conference in Philadelphia June 24-28 at the Pennsylvania Convention Center.

The theme is “Collaborate to Innovate.” The DIA is working with the Bill and Melinda Gates Foundation, the Tufts Center for the Study of Drug Development, and other groups to provide content that “speaks to key trends affecting global development.” With more than 270 sessions, the conference will emphasize partnerships and innovation worldwide, including “breakthroughs that are improving health and wellness around the world.”

There are discounted registration fees for nonprofit and educational organizations. For more information please click on the attached link: http://www.diahome.org/DIA2012

Disapproval of Research

In 2011, AAHRPP added a new metric, the percent of research protocols reviewed and disapproved by the IRB. Nearly 63 percent of organizations reported that they did not disapprove any protocols in the past year. Twenty-four percent disapproved one percent or less of protocols and 13.2 percent disapproved two or more percent. The percent of research protocols disapproved at a majority of organizations is zero. The perception that IRBs disapprove a significant portion of research protocols submitted is not true.

OHRP Hosts Research Community Forum in Pittsburgh

The Office for Human Research Protections (OHRP) Research Community Forum (RCF) will take place at the Sheraton Station Square Hotel in Pittsburgh, Pennsylvania on June 22, 2012. The forum, “BUILDING BRIDGES: Research Around the World,” is co-sponsored by the University of Pittsburgh, Carnegie Mellon University, and the VA Pittsburgh Healthcare System.  

More than 450 biomedical and psychosocial researchers, students, coordinators, IRB staff, and institutional administrators are expected to attend the event. The goal is to raise awareness of diverse global interests and to strengthen collaborations between U.S. investigators and those abroad.

For more information: http://www.irb.pitt.edu/2012conf.aspx

The Evolution of AAHRPP’s Accreditation Standards

The research enterprise has seen significant changes in the decade since we introduced AAHRPP’s first accreditation standards, yet today the standards are more relevant than ever.

One reason is that the original standards were on the mark. They were rooted in ethical principles and sound research practices. Equally important, the original standards recognized the activities and controls that are at the heart of quality research protections.

Like our accredited organizations, AAHRPP is committed to continuous quality improvement. By 2009, we had identified opportunities to update the AAHRPP Accreditation Standards to keep pace with the more global research landscape. We also had listened to accredited organizations and responded to their concerns about the need for more flexibility and less burdensome processes.

After a fairly lengthy public comment period, we launched a new and streamlined set of standards that strengthened human research protection programs (HRPPs) by accomplishing the following:

• Addressing new, pressing issues such as conflicts of interest, community-based participatory research, data monitoring, and transnational research.
• Organizing the AAHRPP Accreditation Standards in a more logical framework in three domains instead of the earlier five.
• Better defining the roles and responsibilities of the entities within an HRPP.
• Consolidating the numbers of standards and elements.
• Giving organizations more flexibility to develop their own approach to complying with the AAHRPP Accreditation Standards.

We understand the challenges that organizations face when pursuing AAHRPP accreditation, so we are determined not to make it a moving target. At the same time, our overriding commitment is to strong research protections.

Today’s AAHRPP Accreditation Standards reflect both of these positions, and the resulting benefits extend to all of us: accredited organizations, research participants, and the research enterprise as a whole.

Promoting Community-Based Participatory Research

When the AAHRPP Accreditation Standards were revised in 2009, Element I.4.C. was added, that requires organizations to promote the involvement of community members, when appropriate, in the design and implementation of research and the dissemination of results. An organization can conduct community-based participatory research to meet the new Element. This methodology involves community members in the research process, but it presents unique ethical challenges to IRBs.

Educate your IRB about the ethical issues related to community-based participatory research:

• Consider the risks to the community, as well as the individual participants.
• Evaluate the working relationships between the researchers and community members, including the possibility for undue influence on the community members when they are prospective participants.
• Obtain consent from community members who are both research participants and representatives of the research team (e.g., conducting surveys).
• Approve the use of interview tools that evolve and change from one interview to the next.
• Provide research results to the community.

Experts in your organization might serve as consultants, IRB members, or teachers. Literature reviews show that community-based participatory research is increasing in the scientific community and is being sponsored by both public and private funders. Organizations should encourage researchers to conduct this type of research and train IRBs to review it. Working together can benefit all—researchers, the organization, the IRB, and the community—while still protecting participants in the research.

Representative publications on community-based participatory research and IRBs:

Brugge, D. Institutional review boards need to increase their understanding of community-based participatory research: commentary on a case study in the ethics of mental health research. J Nerv Ment Dis. 2012 Mar;200(3):242.

Brown P, Morello-Frosch R, Brody JG, Altman RG, Rudel RA, Senier L, Pérez C, Simpson R. Institutional review board challenges related to community-based participatory research on human exposure to environmental toxins: A case study. Environ Health. 2010 Jul 16;9:39.

Hyatt RR, Gute DM, Pirie A, Page H, Vasquez I, Dalembert F. Transferring knowledge about human subjects protections and the role of institutional review boards in a community-based participatory research project. Am J Public Health. 2009 Nov;99 Suppl 3:S526-31.

Flicker S, Travers R, Guta A, McDonald S, Meagher A. Ethical dilemmas in community-based participatory research: recommendations for institutional review boards. J Urban Health. 2007 Jul;84(4):478-93.

http://depts.washington.edu/ccph/commbas.html Accessed 4/23/2012.

Article of Note

Improving Ethical Review of Research Involving Incentives for Health Promotion
London, A.J., Borasky Jr, D.A., Bhan, A.
PLoS Medicine (2012) 9(3):e1001193

This article comes from the Ethics Working Group of the HIV Prevention Trials Network. The authors discuss the current ethical frameworks for reviewing material or financial incentives provided to research participants either as compensation for their time and expenses, or as an inducement to participate in research. This article is of interest to IRBs because it offers guidance for improving the evaluation of research in which incentives are used as an intervention intended to promote healthy behavior.

Link to abstract: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001193
accessed 4/4/2012

Trends in Technology Use in IRBs

New and improved electronic systems for information and communication technology have been exploding in our society, and this phenomenon is also reaching into the IRB world with profound impact. AAHRPP began collecting metrics from organizations in 2009, and while this represents only three years of data, the trends for technology use reveal one of the most striking changes in practice.

Reliance on electronic databases to track IRB protocols has been pervasive. In 2009, 94.1 percent of organizations with an IRB used such systems, and 94.2 percent reported using them in 2011. But in 2009, fewer than half of organizations (47 percent) used electronic distribution of materials (as compared to paper), while in 2011 this number increased to over 66 percent. A similar increase occurred for online IRB applications, with 34 percent reporting using them in 2009, 41 percent in 2010, and 54 percent in 2011. Likewise the use of online systems for IRB review functions has grown from 30 percent to 42 percent to 51 percent, respectively.

Technology is enabling IRBs to be more efficient, to commit fewer errors, and to collect metrics more easily. Online applications with required fields give IRBs all the information they need to make determinations. Minute taking and other forms of compliance with regulations and policies are enhanced. The downside of these systems is that they can be expensive to purchase or modify and that they produce less personal IRB and researcher relations. Also, computers and electronic systems cannot replace good ethical discussions and determinations. These systems are tools to assist and enhance IRB functions, not replace them. There is little doubt that the trend toward more technology will continue for IRBs. Proper use of the technology can improve IRB function and regulatory compliance. Along with old-fashioned brainpower and ethical thinking, technology can facilitate research and help protect research participants. 

The Role of the Vice Chair of the IRB

IRB chairs have defined responsibilities and a central and prominent role in IRB activities. The roles and responsibilities of vice chairs are much less defined and usually in the background. Recently, when AAHRPP asked organizations about vice chairs, 93 percent of those responding reported having vice chairs. Seventy-four percent have one vice chair per IRB, while 18 percent have two, 3 percent have three, and 5 percent have four or more vice chairs per IRB. Fixed terms for the vice chair range from a one-year term for 8 percent of organizations and a two-year term for 14 percent to a three-year term for 22 percent, but in 56 percent of organizations there is no fixed limit and the term of the vice chair is indefinite. Fifty-seven percent of organizations compensate their vice chairs, most commonly including a yearly stipend or release time from other responsibilities. The vice chair is usually appointed by the organizational official in consultation with senior HRPP administrators and the IRB chair.

In many non-IRB committee structures, the vice chair is a chair-in-training. For IRB vice chairs, this is true in only 36 percent of organizations. Sixty-four percent of organizations do not consider vice chairs as part of succession planning. The majority of comments indicated that the vice chair might be considered to become the chair or may step in on an interim basis but in general is not considered the heir apparent of the chair.

So then, what is the role of the vice chair? In 97 percent of organizations, the vice chair directs an IRB meeting when the chair cannot attend or must leave a meeting because of a conflict of interest. Most organizations report that except for filling in for the chair, the vice chair acts as any other member would during IRB meetings (when the chair is present). In a few instances the vice chair performs duties such as presenting continuing review applications. Between IRB meetings some vice chairs are given additional responsibilities, the most common being review of protocols by the expedited procedure. In some organizations the vice chair is designated to review adverse events and incidents of non-compliance or to serve on the Conflict of Interest Committee. One organization reported, “We have a chair or vice chair in the office every day of the week. They rotate reviewing responsibilities, provide clarification to IRB staff members, consult with researchers, and are involved with policymaking.” But by far the comment that is most common and most emphasized is that the vice chair is at the ready to step in when the chair is not available, for chairing the IRB meeting, helping staff or researchers, or signing letters.

Sarah Kiskaddon Joins AAHRPP

Sarah Kiskaddon has recently joined AAHRPP as the Director of Business Development, Communications, and Public Relations. “It’s an amazing opportunity to get involved encouraging research sites worldwide to strengthen their human research protection programs and get accredited,” said Kiskaddon. “The growth in interest from international sites is really under way.”

Kiskaddon, an attorney, comes to AAHRPP with more than 15 years of experience leading human subject protection programs. “Since I have spent most of my career at an academic medical center, ‘in the trenches,’ I understand what motivates HRPP directors to go through the accreditation process,” she said. “What I found was that the enhancements I wanted to make to our program met with less institutional resistance when I could demonstrate that they would help us meet AAHRPP’s standards.”

Kiskaddon has also been a site visitor for AAHRPP for several years, so she has seen the process from both sides. She considers “improving the experience for research participants and promoting the public trust in the research enterprise” as goals for all. “The evaluation and accreditation process is one important tool for doing that,” she said. “I’m looking forward to making my contribution to that effort.”

Click here to read Sarah Kiskaddon’s biosketch.

Celebrating Our Successes Together

Our 2012 AAHRPP Conference was a reminder of how far we’ve come together since AAHRPP introduced its accreditation standards in 2002. Three years later, we hosted our first conference and drew a respectable crowd of nearly 300 participants. This year, approximately 450 individuals attended. That says a great deal about both the educational value of the conference and the support for accreditation and research protections.

AAHRPP’s early conferences focused almost exclusively on building human research protection programs (HRPPs) and on the accreditation process. This year, as in the past, we offered pre-conference sessions to help organizations that are new to accreditation or in the midst of the accreditation process. For the main conference, we took a different approach and concentrated on protecting vulnerable participants. This issue is central to human research protections but often is misunderstood. It also relates directly to our accreditation standards.

Why the shift? Primarily because AAHRPP and the research enterprise have matured considerably in the past decade, and our conference and other education efforts reflect this changing landscape. Once a rarity, HRPPs are now firmly entrenched in research organizations around the world. Furthermore, more than 240 organizations have demonstrated their commitment to research protections by achieving accreditation.

If your organization is among them, we commend you for your continued commitment to high-quality, ethical research. If you have yet to apply for accreditation, we invite you to learn more about AAHRPP and the accreditation process—and to join us and our accredited organizations as we pursue our goal of one standard worldwide.