in this issue:

915 15th Street, NW Suite 400 Washington, DC 20005 Phone: (202) 783-1112 Fax: (202) 783-1113 www.aahrpp.org accredit@aahrpp.org

• PhRMA Supports Accreditation, 3

• HRPP Innovations, 4

• AAHRPP Accreditation Conference, 7

Accreditation’s Role in the Behavioral and Social Sciences by Todd P. Bentsen

Winter 2004-5, Vol. I, No. 2

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From its inception, AAHRPP designed an accreditation program that is meaningful and relevant to the behavioral and social

sciences. Throughout the accreditation process,

AAHRPP recognizes the important differences between biomedical research review and review in the behavioral and social sciences. That said, the ethical principles that govern the conduct and review of research are the same for all types. Respect for persons, benefi cence, and justice all apply. In a psychological experiment involving students, in interviews conducted with adults, or in a secondary analysis of identifi able data, investigators have the obligation to respect individuals as human beings and to protect their rights and welfare.

But many behavioral and social science researchers believe that IRBs are overzealous in the review process, overly interpreting the federal regulations for these studies. And this is where AAHRPP accreditation can be of help.

For example, when examining a broad research portfolio at a university, an AAHRPP site visit team—which will include a behavioral or social scientist—interprets the accreditation standards according to the different types of research being conducted. The team will examine pertinent IRB issues to behavioral and social scientists, such as how the IRB reviews the informed consent process, handles consent documentation requirements for behavioral and social science research, and uses the expedited review process for research involving no more than minimal risk.

However, in behavioral and social science research, there is both over- and under-

interpretation of the regulatory requirements. While the site visit team will be looking for instances of over-interpretation, it will also be looking at areas where regulations might not be applied fully, such as privacy protections or maintenance of confi dentiality of data. In reviewing an organization that conducts behavioral and social science research, the site visit team will look to ensure that the organization appropriately interprets the federal regulations to protect participants.

Centralized or decentralized oversight?

Organizations with broad, comprehensive research portfolios utilize both centralized and decentralized systems for oversight of human research. Both models can be effective, and for the purposes of accreditation, either is acceptable. Regardless of the model used, IRBs often fi nd themselves challenged to address concerns of frustrated behavioral and social scientists.

A decentralized oversight system—that is, physically

distinct facilities and separate sets of policies and procedures—is employed by Washington University in St. Louis, which received Full AAHRPP Accreditation in July. The university also has a separate education program, confl ict of interest committee, and compliance program for its behavioral and social science arm. The research program comprises the medical campus—the medical school, affi liated hospitals, and practices—and the Hilltop campus, which includes all other university schools and covers primarily behavioral and social science research. About 10 percent of the university’s research is

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Executive Director&

A 360-Degree Look

From the

““

Whereas the self-assessment often

began with an examination of

the IRB as a fi rst step, by the end of the process,

institutional buy-in, commitment,

and support were necessary for

accreditation to proceed—and

succeed.

News notes&News notes&

Marjorie A. Speers, Ph.D.

A AHRPP operates on the premise that accreditation is an organization-wide process: the responsibility to protect research participants is shared among the

IRB, investigators, and the organization. IRBs have a critically important job in determining

that research is ethically justifi able. Equally important is the obligation of investigators to protect research participants by informing them about the research, obtaining their consent to participant, administering the research procedures according to the protocol, and monitoring their safety.

IRBs and investigators can best meet their ethical obligations when they have adequate institutional support. Thus, the AAHRPP standards and elements were designed to address the responsibilities of the triad: organization, investigators, and the IRB.

A broader system of protection also takes into account the roles sponsors and participants play. To that end, the AAHRPP standards address the interactions between organizations and sponsors, and organizations and participants. The accreditation standards, therefore, are grouped into fi ve domains—Organization, Research Review Unit (including IRBs), Investigator, Sponsored Research, and Participant Outreach—which comprises an organization’s human research protection program.

In its accreditation program, AAHRPP takes a 360-degree look at the sum total of activities that constitute the research protection program. Do research activities have adequate resources? Suffi cient staffi ng? Support from “the top”? Are investigators aware of, and following, their ethical obligations to participants? Are confl icts of interest being managed by the organization? Do participants have channels to voice concerns? These are but a few of the questions that get asked, and answered, during the accreditation process.

A great deal of this examination occurs during the self-assessment phase, when organizations perform an intensive internal examination of their protection programs’ strengths

and weaknesses—which many have never done before. AAHRPP adopted a self-assessment model because the organization is in the best position to do the “fi rst look” at its program. More important, sustainable change, which is often needed to meet the accreditation standards, must come from within.

Using AAHRPP’s evaluation instrument, organizations guide themselves through the self-assessment. The AAHRPP standards are designed to be interpreted and applied in a fl exible manner. This fl exibility ensures that the standards are relevant to the full range of research settings, including contract research organizations, hospitals, independent review boards, and universities, and encourages organizations to be innovative in meeting the standards.

AAHRPP does not use a numeric scoring system to tell organizations what they do right and what they do wrong. Instead, it relies upon an educational approach to guide organizations through a process where they are lauded in areas where they excel, recognized for their strengths, and provided clear instruction about what improvements are necessary. At every stage of the accreditation process the organization is in control of its destiny, with AAHRPP serving as a guide through the standards.

Organizations that have completed accreditation describe the experience—many to their surprise—as a truly evolving, positive process. Whereas the self-assessment often began with an examination of the IRB as a fi rst step, by the end of the process, institutional buy-in, commitment, and support were necessary for accreditation to proceed—and succeed.

Institutional leadership is won over to the perspective that organizations seeking accreditation share a commitment to change and an interest in going beyond the status quo. Organizations that achieve accreditation demonstrate excellence that goes beyond compliance with federal regulations. §

Clinical Research Safety and Accreditation of Human Research Protection Programs—A View from PhRMABy Theodore J. Roumel, Ph.D., M.P.H., Senior Advisor

Today, more than ever, there is a need to provide assurances to the general public and elected offi cials that the administration of clinical research in the

United States is safe and conducted in an ethical and patient-oriented manner. This is a concern to all parties in the process, including the pharmaceutical industry, that support and conduct this type of research.

The Pharmaceutical Research and Manufacturers of America (PhRMA) is a trade organization comprising the

largest research-based pharmaceutical and biotechnology companies. Its mission is to advocate

public policies that encourage the discovery by research companies of life saving and life-enhancing new medicines for patients.

A critical part of that discovery process is clinical research. In sponsoring and conducting clinical research, PhRMA members place great importance on respecting and protecting the safety of research participants. In conducting research, there are many different entities and individuals that contribute to the safe and appropriate conduct of clinical research, including sponsoring companies, regulatory agencies, scientifi c investigative staff and medical professionals, hospitals and institutions where research is conducted, and institutional review boards (IRBs) and ethics committees.

Recently, the PhRMA Science and Regulatory Executive Committee reviewed the matter of accreditation of human research protection programs. As a result of that review, the Committee adopted the position that it supports the movement toward the voluntary accreditation of such programs. PhRMA also supports working with its partners in academia, government, and patient organizations in improving the public’s understanding of the role and conduct of clinical trials in the drug development process.

In addition to their continuing commitment to sponsoring and conducting clinical research that fully complies with all legal and regulatory requirements, PhRMA members have also adopted an updated “Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.” These principles reinforce PhRMA

members’ commitment to the safety of research participants, and they provide guidance to address issues that bear on this commitment in the context of clinical trials that are designed, conducted, and sponsored by member companies. You are encouraged to access this document and learn more about the pharmaceutical industry by visiting the PhRMA Web site at www.phrma.org. §

Information: Theodore J. Roumel, troumel@phrma.org

AAHRPP welcomes newly elected members to the Board of Directors:

• Norman B. Anderson, Ph.D.American Psychological Association

• Thomas F. Boat, M.D.Cincinnati Children’s Hospital Medical Center Cincinnati Children’s Hospital Research Foundation

• Richard Browdie, M.B.A., Benjamin Rose

• John T. Casteen III, Ph.D., University of Virginia

• Theodore J. Cicero, Ph.D.Washington University in St. Louis

• Carol Ann Saunders, R.N.New England Institutional Review BoardCenter for Clinical Research Practice

• Douglas L. Strong, M.B.A.University of Michigan Health System

• Marianne Vanderwel, M.Eng., M.Sc., Pfi zer Canada

The Offi ce for Human Research Protections has updated the Human Subject Regulations Decision Charts, at www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm. New graphic aids help in determining if an activity is research involving human subjects that must be reviewed by an IRB under Health and Human Services regulations. The charts address decisions on the following: 1) whether an activity is research that must be reviewed by an IRB; 2) whether the review may be performed by expedited procedures; and 3) whether informed consent or its documentation may be waived.

New Tip Sheets have been posted to the AAHRPP Web site, which help organizations write policies and procedures and other human research protection documents: Review of Research by the Convened IRB and Review of Research by the Expedited Procedure (www.aahrpp.org/tips.htm).

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Winter 2004

HRPPHRPP Risk-Benefi t Analysis Tool at Chesapeake Research Review Chesapeake Research Review

Culturally Appropriate Outreach at Cedars-Sinai Medical Center

AnswersAAHRPPAnswersAAHRPPAnswersApplicant Resources

As part of its educational mission, AAHRPP will periodically disseminate information on innovations encountered in accredited organizations.

InnovationsInnovationsHRPP

InnovationsHRPPHRPP

InnovationsHRPPChesapeake

Although federal regulations require IRBs to make judgments that research risks are reasonable in relation to potential benefi ts, they provide no guidance for making them.

For analyzing the relationship between risks and potential benefi ts for research protocols under review, Chesapeake Research Review in Columbia, Md., employs a scoring tool that effectively frames the reviewers’ concerns for presentation and discussion to the convened IRB.

Protocols at Chesapeake are assigned to one or more primary reviewers, who use the Protocol Presentation and Evaluation Form to frame the risk/benefi t analysis. Questions about safety parameters and efforts to minimize risk are included, and the form documents information on known risks or known potential benefi ts. The responses take the form of a score from 1 to 5; 1 representing no known risk or potential benefi t and 5 the maximum risk or benefi t.

The outlined risks are detailed: social, including confi dentiality issues; psychological risk; risk of death, risk of physical harm, or risk of worsening of disease; and economic or legal risk. Potential benefi ts are outlined in the same categories, and all responses in either risk or potential benefi t receive a numerical score.

Protocols often have more than one primary reviewer at Chesapeake, so the use of a scoring system also helps inform the concerns among reviewers. “The scoring analysis provides a consistency in framework for deliberations by primary reviewers and consistency in presentations to the IRB,” said David Smithwick, Chesapeake’s chief operating offi cer. “It’s a tool that aims for consistent reasoning in the review process and has served us well.”

Information: Jeff Trunzo, R.P.H., M.B.A., C.I.P., Vice President, jtrunzo@irbinfo.com, (443) 283-1509

Cedars-Sinai

Visitors to any of Cedars-Sinai Medical Center’s 90 patient waiting rooms see something in common: a poster and brochures that provide information about the organization’s research and clinical trials activities. And, if English is not their native language, they are likely to see the information

in a language they will understand, as the brochures are also printed in Spanish, Farsi, and Russian.

This participant outreach tool was designed to respond specifi cally to Cedars-Sinai’s patient population. The information on the top languages used at Cedars-Sinai was pulled from an analysis of data on past and current patients’ language selections. The text is written at a seventh-grade reading level to ensure wide comprehension.

The poster states that research is ongoing at Cedars-Sinai and that patients may be asked to participate; their voluntary participation and their rights as research participants are also broadly outlined. The brochures delve more deeply, providing detailed answers to these frequently asked questions about research participation:

• What is research?

• What are some types of research or clinical trials?

• How do I take part in a research study?

• What is informed consent?

• Will it cost me anything to take part in a research study?

• What are my rights as a research participant?

• Who protects research subjects?

• Who do I contact about research concerns or complaints?

For information or brochures: Eifaang Li, D.V.M., M.P.H., Director of Research and Compliance, eifaanf.li@cshs.org, (310) 423-3783

A poster and brochures about research at Cedars-Sinai Medical Center, printed in

English, Spanish, Farsi, and Russian

1. What resources does AAHRPP offer to help my organization with the self-assessment process?

AAHRPP offers one-day workshops that focus on navigating the self-assessment and accreditation process: departments and staff that should be involved, necessary resources, projected length of time for completion, and how to use the Evaluation Instrument for Site Visitors. The workshops are geared to staff members leading or substantially involved in completing the self-assessment. Brief information on conducting the self-assessment is also available at www.aahrpp.org, under “Accreditation step-by-step.”

2. I learned recently about the new preliminary applicant option. What does that entail?

The preliminary applicant process is separate from the accreditation process. Organizations submit the preliminary application, and the application is reviewed by AAHRPP staff. A comprehensive written report is produced and returned to the organization within 60 days. Based on this feedback, corrections can be made in order to produce a fi nal application, although organizations are not obligated to accept staff advice. Preliminary applicant status has no bearing on the site visit process or fi nal accreditation determination.

3. What is the advantage for my organization to pursue the preliminary applicant option?

The preliminary application process is for organizations that would like a written, in-depth review prior to submitting a fi nal application. Many organizations are spending unnecessary amounts of time “tweaking” their applications. Using this option can give organizations an idea of whether they are on the right track and can help alleviate fears.

4. What materials are submitted for preliminary applicant review?

Applying as a preliminary applicant involves all of the preparatory steps for applying for accreditation, namely the self-assessment. A preliminary application comprises four sections: Preliminary Applicant Form, Overview of the Human Research Protection Program, Element-by-Element Index to the Supporting Documents, and the Supporting Documents.

5. What’s the additional cost in applying as a preliminary applicant?

There is no additional cost. When the preliminary application is submitted, organizations pay the application fee. One year from the date the preliminary applicant report is received by the organization, annual fees commence. This means that annual fees usually begin 4 to 6 months sooner for preliminary applicants than for those pursuing the formal accreditation process directly.

6. My organization needs to develop policies and procedures and other written materials used in research review. Are there resources to help?

Yes. On the “Education and resources” section of the AAHRPP Web site, the “Tips” section provides assistance on 14 topics that organizations typically need assistance with, from Financial Confl icts of Interest of Investigators, to Exemptions, to State and Local Law. §

Position Available Washington, DCAAHRPP seeks Assistant Director

for Accreditation

Responsibilities include review of applications, support to site visit teams, report writing and review, and support to the Council on Accreditation. Technical assistance and training for applicant organizations are also responsibilities of this position. Travel is required.

Qualifi cations: bachelor’s degree; master’s or doctoral degree preferred. At least three years experience in conducting research, research compliance, or IRB management.

Inquiries: accredit@aahrpp.org, or (202) 783-1112.

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Winter 2004

conducted at the Hilltop campus. The Hilltop IRB chair performs nearly all reviews using the expedited procedure; about 5 percent have full IRB review.

Theodore Cicero, Ph.D., vice chancellor for research at Washington University, hears the frustrated sentiments of behavioral and social science researchers on his campus, “who don’t believe that they should have to go through IRB review,” he said. “They say, ‘We’ve done it this way for ages, and we’re effective in communicating with our research participants.’” And Cicero, of course, has to counter these arguments. “I tell investigators, ‘I want to be able to defend whatever you do, so it’s important that we know what you’re doing.’”

Cicero said the accreditation process, particularly the self-assessment, was a very useful exercise for Washington University researchers. In particular it pointed up how differently review was being conducted between the Hilltop and medical campuses. “Hilltop realized quickly why certain standards were in place—particularly those having to do with record keeping, minutes, expedited review, and education,” Cicero said.

The process helped behavioral and social science researchers realize that the review process took their concerns into account, said Cicero, and that it was not as cumbersome as they thought. “Their initial perception was that they were being judged by the same criteria as research with high-level risk,” he said.

Cicero plays a constant, active role in winning over behavioral and social science researchers to the importance of IRB review. “I’ve made the argument to behavioral researchers that I want them to maintain the highest possible standards, which means that internal review is necessary to ensure there could be no potential adverse outcomes,” he said. “I’ve been able to convey that the IRB is here to help them in their pursuit of research and that it will be as unintrusive as possible.”

‘One More Hoop to Jump Through’

Vanderbilt University maintains a centralized oversight system, with one human subjects offi ce overseeing four IRBs, one of which is behavioral and social science. This IRB has members with relevant expertise and reviews research from both the university and the medical center;

investigators range from experienced Ph.D.s and M.D.s to students. This IRB developed its own application to focus investigators on behavioral and social science issues in human research. Vanderbilt was awarded Full AAHRPP Accreditation in October.

“We see an extremely broad group of research studies, and trying to fi t behavioral and social science research into the health sciences model is extremely diffi cult,” said Todd Ricketts, chair of the IRB’s Behavioral Sciences Committee and assistant professor in the Hearing & Speech Sciences Department. “We see everything from psychological experiments to ethnographic studies to research in religious studies to international research, and what we do fi rst is make the determination that it’s a good study,”

he said. “There is no level of risk that’s reasonable if the study doesn’t tell you anything.”

Ricketts sympathizes with the frustrations that researchers in the behavioral and social sciences feel: that IRBs don’t take their issues into account, that IRB review really doesn’t apply to low-risk studies, and that it slows down the progress of their research. Through his fi ve-year role on the IRB, Ricketts said he’s taken action. “One of my goals for some time on the IRB is to fi gure out what causes the frustration and try to reduce it,” he said.

“Investigators feel that, ‘Well, of course we’re doing the right thing relative to research and are being as ethical as possible, but the IRB is just one more hoop to jump through,’” said Ricketts. “We’ve worked hard to foster a collaborative effort with investigators—that the IRB is here to try and help and to make things go as smoothly as possible.”

“I think it’s helpful for the IRB to have a scapegoat in this process, which is the federal regulations,” Ricketts added. “We tell investigators, ‘First and foremost, we are here to protect human subjects. The only way we can make it clear that we’re accomplishing that is to get down on paper the procedures you are using, and make sure they’re appropriate.’”

Protocol analysts on the IRB are also an important resource for Vanderbilt investigators, guiding them through regulatory questions and issues prior to protocol submission, i.e., is this research involving human participants, and is it eligible for exemption? These analysts interact with investigators from a variety of disciplines, as well as students working to fulfi ll their degree requirements.

• Appropriate composition of the IRB, including scholarly expertise appropriate to the research fi eld or methods used in the research protocol (e.g., psychology, anthropology, sociology, political sciences, economics).

• Use of consultations to supplement expertise on the IRB.

• Use of the expedited procedure to review research involving no more than minimal risk and exemptions, when it is ethically appropriate.

• Applying the criteria for IRB approval appropriately, especially as they relate to scientifi c review.

• Use of waivers or alterations of the informed consent process, when appropriate. The goal is for behavioral and social science IRBs to be comfortable in granting waivers appropriately.

• Use of waivers of informed consent documentation, when appropriate. Again, the goal is for behavioral and social science IRBs to be comfortable in granting such waivers appropriately.

• Knowledgeable investigators who have the capacity to carry out their ethical obligations to protect participants.

AAHRPP will hold its fi rst annual accreditation conference in Atlanta, March 13-15, geared to IRB professionals and chairs, institutional offi cials, regulatory compliance professionals, project managers, researchers, and sponsor representatives.

Conference attendees will:• Learn to identify the key aspects of the accreditation process and

acquire the skills to complete each phase.• Learn to identify the common problems organizations are

experiencing in meeting the accreditation standards and ways to address them.

• Become familiar with innovative practices to improve protections for research participants.

Plenary Session TopicsPast, Present, and Future: Where Accreditation Fits in the Big PictureAccreditation as Continuous Quality ImprovementThe Role of Accreditation in Improving Protections in Clinical TrialsGovernmental Perspectives on Accreditation

Is It Worthwhile?

Ultimately, why should organizations conducting behavioral and social sciences research seek accreditation?

“Because rules change and committees change,” said Vanderbilt’s Ricketts, “and IRBs need to constantly re-evaluate what they’re doing. One thing accreditation does is to formally make everyone take a hard look at what’s working and what isn’t.”

Vanderbilt Protocol Analyst Jenni Beadles adds that accreditation is verifi cation from an outside source that the processes in place are appropriate and sensitive to the needs of behavioral and social scientists. “It’s an affi rmation that you’re doing the right thing, and, importantly, investigators get affi rmation that the IRB is doing the right thing,” she said.

“

“

The [accreditation] process helped behavioral and social science researchers

realize that the review process

took their concerns into

account.

continued next page ...

continued on Page 8 ...

Breakout Sessions—Procedural IssuesFocusing on policies and procedures pertaining to select accreditation standards, based on common fi ndings, such as:• Defi ning and managing non-compliance• Suspensions and terminations— when and what to report• Writing an HRPP plan for your institution• Protecting vulnerable populations• Industry/organization interactions

Breakout Sessions—Innovative PracticesHighlighting innovative activities that help organizations meet select accreditation standards, such as:• Educational programs for IRBs

and investigators• Participant outreach activities• Innovative informed consent procedures• Use of central IRBs• Handling institutional confl ict of interest

Breakout Sessions—Accreditation ProcessDealing with various aspects of accreditation, such as:• Making the case for accreditation• Writing succinct policies and procedures• Conducting a self-assessment• Using accreditation as leverage within your institution• Marketing accreditation to industry sponsors

Topics for Pre-Conference Workshops, Sunday, March 13Workshops involve in-depth instructionHRPPs for Behavioral and Social Science ResearchWriting Policies and ProceduresRegulations: IRB IssuesRegulations: Drugs and Devices

Information/Registration:www.aahrpp.org

What does AAHRPP look for in the human research protection program relative to behavioral and social science research?

AAHRPP Conference:

March 13-15, 2005

2005

Quality Human Research Protection Programs

Behavioral and social science, from Page 1 ...

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Executive DirectorMarjorie A. Speers, Ph.D.

EditorTodd P. Bentsen

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Ricketts said that IRB operations have become much more effi cient and streamlined in his fi ve years of service. Some changes are small but signifi cant: for example, investigators now receive an e-mail confi rmation of receipt of a protocol. “I hand-delivered a protocol in my fi rst year at Vanderbilt; it got lost, and I didn’t know it until two months later—they had no record of it. You’d know about it now.”

Now, the IRB also has administrative targets known as measures of success: the goal is 7 to 10 working days from submission to decision notifi cation for an exempt study or one reviewed using the expedited procedure; if there is full committee action, the goal is action within 15 working days.

Ted Cicero at Washington University said that accreditation demonstrates that the same ethical standards apply, no matter what the research discipline. “It’s important for behavioral and social science studies that there be reasonable interpretation of the federal regulations, particularly if the risk level is very small,” he said. But at the same time, he added, “meeting certain basic standards is important.”

Accreditation is recognition of an effi cient, ethical, high-quality human research protection program for the behavioral and social sciences. §