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

• From the Executive Director, 2

• ACE Gives Grant to AAHRPP, 3

• New AAHRPP Tip Sheet, 6

Accreditation Spotlight:

Cedars-Sinai Medical Center

Fall 2004, Vol. I, No. 1

AAHRPPAAHRPPAdvanceadvancing human protection in research.

Thomas M. Priselac, President & CEO,

Cedars-Sinai Medical Center

What prompted Cedars-Sinai Medical Center to seek human research accreditation?

Cedars-Sinai Medical Center has always had a strong commitment to the protection of patients participating in clinical research. That’s why we initially undertook a process four years ago to improve our existing human subject protection program in order to enhance our research quality. Our goal was to achieve the highest standards in research quality and to comply with all state and federal regulations concerning the protection of human subjects. At the same time, we recognized that voluntarily undertaking the accreditation process would ensure that our program adhered to standards expected of us by our community and those set by state and federal agencies.

What benefi ts has your organization derived—or do you believe it will derive—from the accreditation process?

At the most basic level, becoming accredited ensures that our human research protection program is in compliance with state and federal regulations. But beyond that, accreditation creates an ongoing quality improvement process to effectively ensure excellence in the way that clinical research is reviewed and conducted at the Medical Center. Further, these improvement processes promote awareness of human research protection principles among everyone involved in the research process, serving to strengthen collaboration among physicians, nurses, administrators, investigators, staff, and the Institutional Review Board (IRB). We believe that accreditation will also serve to assure the public, sponsors, and other investigators that Cedars-Sinai is fully committed to maintaining safety, quality, and the integrity of our research programs. Very importantly, the accreditation

process tangibly demonstrates an institution’s commitment to subject safety and serves to build the public’s trust.

Why did your organization choose AAHRPP accreditation?

We felt that the AAHRPP accreditation standards better fi t with the Medical

Center’s vision to foster partnership among all parties involved in the research process. It was also important to us that AAHRPP is a peer-driven, voluntary accreditation agency sponsored by the leading academic and patient care societies, including the Association of American Medical Colleges, the Federation of American Societies for Experimental Biology, and the Association of American Universities.

What advice would you give to other hospitals that are considering accreditation?

Peer-driven quality enhancement must be driven by committed leadership at the highest administrative levels of an institution. Medical centers considering accreditation should start by involving physicians and investigators in setting goals to implement systematic enhancement in their institutional human research protection program prior to undertaking the application process. For example, at Cedars-Sinai we started the process by improving IRB forms and policies and procedures, as well as the way that we reviewed research protocols before examining the oversight process of ancillary committees.

Our advice to an institution thinking about becoming accredited is to perform a self-assessment of its human protection program.

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Executive DirectorA Focus on Education

Welcome to the inaugural issue of AAHRPP Advance. With this new publication, we aim to provide practical information on accreditation.

Expect to see regular features on human research protection innovations, answers to frequently asked questions on all aspects of the accreditation process, and focused, topical information—research concerns in the behavioral and social sciences, or a profi le of a smaller organization that has achieved accreditation. AAHRPP Advance will be published quarterly and is also available in a PDF version on our Web site, www.aahrpp.org.

AAHRPP’s long-term vision is to improve human research protections throughout the research community. We envision helping to level the playing fi eld; that is, to help organizations of all sizes and types in their quest for sound and ethical human research protection programs. And education is an integral component of that vision.

But what does that mean? How can an accrediting body be educative in its work?

First, AAHRPP staff, site visitors, and Council on Accreditation members operate within an educational framework. They confi rm the many sound ways in which organizations are successfully engaged in protecting human participants. But more importantly, they provide detailed and constructive feedback about areas where improvement is needed.

Second, in recent months, AAHRPP has developed a variety of teaching tools to help organizational staff make improvements to their programs, which in turn will meet the AAHRPP standards and ultimately help organizations achieve accreditation. Our commitment to the ethical and professional success of research organizations means providing educational assistance:

• New Tip Sheets help organizational staff write policies, procedures, and other supporting documents for their human research protection programs. A dozen topics are covered thus far, such as “Financial Confl icts of Interest of Investigators” and “Reporting of Unanticipated Problems, Terminations, Suspensions, and Non-compliance.” A new Tip Sheet on “State and Local Law” can be found on Pages 6 and 7.

• The enhanced Evaluation Instrument for Site Visitors provides the corresponding federal regulations and

guidance for each standard and element. For many organizations, the appeal of achieving AAHRPP accreditation is an assurance of regulatory compliance. The enhanced evaluation instrument is a clearer road map for organizations to follow and a means for gauging their own levels of regulatory compliance.

• In addition to one-day workshops that focus on the self-assessment, AAHRPP now offers pre-accreditation consultations. Tailored to an organization’s individual needs, the consultations are typically held once the self-assessment is complete and an organization is preparing to

apply.

AAHRPP takes pride in being customer-focused. Our evaluation instrument, standards, procedures, and application instructions are all in the public domain and provide a wealth of information to organizations seeking accreditation. But more importantly, AAHRPP will provide the assistance organizations need to navigate the accreditation process. That help occurs at many points during the process: prior to submitting an application, in preparation for the site visit, and in response to the site visit report or Council on Accreditation comments.

Finally, I am pleased to announce that AAHRPP will hold a two-day accreditation

conference in early 2005. Accreditation will be the focus: the standards and elements, federal and other regulations that govern research, and the development of policies and procedures for high-quality human research protection programs. The conference, like our accreditation program, will be geared to a wide variety of audiences: organizations both large and small, and myriad disciplines, from clinical to public health to social science research.

The conference will be a prime opportunity for research staff to network with their peers around timely and topical themes. Logistical information will be released in the coming months, so please consult our Web site periodically for details. If there are particular topics that you would like to see addressed at the 2005 conference, I encourage you to communicate them to me or other members of the AAHRPP staff.

I hope you fi nd this to be a useful publication. AAHRPP’s long-term strategy—to facilitate and disseminate innovations in the fi eld of human research—will best be reached through our short-term tactic, an accreditation process based on education and peer review. §

From the

““

We envision helping to level

the playing fi eld; that is, to help

organizations of all sizes and types in their quest for

sound and ethical human research

protection programs.

Marjorie A. Speers, Ph.D.

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& OrganizationsThe Secretary’s Advisory Committee on Human Research Protections Accreditation Subcommittee fi nal report is available online. http://www.hhs.gov/ohrp/sachrp/mtgings/mtg03-04/accreditation.html

The Center for Information and Study on Clinical Research Participation has been formed to educate and inform the public, patients, medical and research communities, the media, and policy-makers about clinical research participation. CISCRP was co-founded by Roni Thaler, president, and Ken Getz (formerly of CenterWatch), board chair. www.ciscrp.org

The Forum for Institutional Review Boards/Research Ethics Boards in Canada and the United States (FOCUS) has issued a report from its fi rst conference in 2003, “Report on an International Conference on Canadian and American Perspectives on Quality Improvement and Performance Evaluation in Systems of Human Research Protection,” available at www.ncehr-cnerh.org: choose English version; then Publications pull-down menu; 2003 Focus Report.

The American Anthropological Association Statement on Ethnography and Institutional Review Boards was recently adopted by the AAA Executive Board. The statement aims to interpret for policy-makers, IRBs, and ethnographers the Common Rule in its application to ethnographic research. www.aaanet.org/stmts/irb.htm

Send brief items for consideration to Todd Bentsen, tbentsen@aahrpp.org.

In response to requests for networking opportunities with staff from accredited organizations, AAHRPP is listing contact people who are available to discuss their experiences with the accreditation process.

Baylor Research Institute, Dallas, TXElizabeth H. Cothran, MS, CIP, Director, Offi ce of Research Subject Protection, elizaco@BaylorHealth.edu, (214) 820-9991

Catholic Medical Center, Manchester, NHDonna Bennett, BSN, MS, Administrative Director of Research, donnabennett@cmc-nh.org, (603) 663-6726

Cedars-Sinai Medical Center, Los Angeles, CAEifaang Li, DVM, MPH, Director of Research and Compliance, eifaang.li@cshs.org, (310) 423-3783

Chesapeake Research Review Inc., Columbia, MDAmy Schwarzhoff, BS, CIP, Director, aschwarzhoff@irbinfo.com, (443) 283-1510

Copernicus Group IRB, Cary, NCTammy Sayers Lesko, BS, CIM, Director of Quality Assurance and Regulatory Compliance, tlesko@cgirb.com, (888) 303-2224 x147

Dana Farber/Harvard Cancer Center, Boston, MAJane Russell, BBA, Quality Assurance Offi cer, jrussell@partners.org, (617) 632-3764, or Deborah Barnard, CIP, Director, Offi ce for Protection of Research Subjects, deborah_barnard@dfci.harvard.edu, (617) 632-3029

Fox Chase Cancer Center, Philadelphia, PASusan J. Niskey, FACHE, Associate Administrator, sj_niskey@fccc.edu, (215) 728-5504

Hunter Holmes McGuire Veterans Affairs Medical Center,Richmond, VA, Franklin J. Zieve, MD, PhD, Associate Chief of Staff for Research, frank@vadiabetes.org, (804) 675-5151

New England Institutional Review Board, Wellesley, MACarol Saunders, RN, BSN, President & CEO, csaunders@ccrp.com, (781) 431-7577

Newton-Wellesley Hospital, Newton, MAHope Violette, Manager, Offi ce of Research, hviolette1@partners.org, (617) 243-6493

University of Iowa, Iowa City, IAMartha Jones, MA, IRB Chair/Director, Human Subjects Offi ce, martha-f-jopnes@uiowa.edu, (319) 353-3052

University of Minnesota, Minneapolis, MNMoira A. Keane, MA, CIP, Director, Research Subjects’ Protection Programs, keane002@umn.edu, (612) 626-5654

Washington University in St. Louis, St. Louis, MOTheodore Cicero, PhD, Vice Chancellor for Research, cicerot@wustl.edu, (314) 362-7010

Western Institutional Review Board, Olympia, WADavid G. Forster, JD, MA, CIP, Assistant Vice President, Offi ce of Compliance, dforster@wirb.com, (360) 252-2428

AAHRPP-Accredited

American Council on Education Supports AAHRPP AccreditationThe American Council on Education (ACE) has provided a $25,000 unrestricted grant to AAHRPP in support of its voluntary accreditation program.

“On behalf of the 1,800 colleges and universities and the higher education-related associations, organizations, and corporations that ACE represents, we are very pleased to support AAHRPP’s efforts to protect research participants,” said David Ward, ACE president. “Our universities and colleges conduct a variety of research—from clinical to behavioral and social science research. We believe AAHRPP’s peer-reviewed, educational approach is the right vehicle for organizations to demonstrate their commitment to research protections,” he said.

ACE, the major coordinating body for all the nation’s higher education institutions, seeks to provide leadership and a unifying voice on key higher education issues and to infl uence public policy through advocacy, research, and program initiatives. www.acenet.edu.

News notes

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HRPP University of Minnesota Student IRB

The University of Minnesota has a novel approach to the review of student-initiated research projects: the university formed an IRB panel in 2003 devoted

solely to student research review.Prior to this new committee’s formation, the university’s

panel for behavioral and social science research (one of seven panels) was experiencing an intense workload, along with a situation that was proving to be a bit diffi cult, said Moira Keane, director of the university’s Research Subjects’ Protection Program.

“Panel members were looking at big, federally funded research protocols, submitted by very seasoned faculty, alongside more novice proposals from students, whose research is heavily weighted toward the behavioral and social sciences,” said Keane. “It was diffi cult for the committee to be helpful to a novice researcher, as the proposals were less sophisticated and less well prepared. The students needed more coaching than the committee’s resources would allow,” she said.

Keane says that credit for the novel approach goes to Carol Siegel, assistant director of research protection. She and Siegel had, for some time, contemplated the addition of a second behavioral/social science panel to help deal with the workload. But adding another panel did not respond to the student research situation.

Siegel’s idea for a student panel seemed to be an approach that might work. Keane says that the program was pilot-tested a year-and-a-half ago, with appropriate fi ling and recognition from OHRP. “If it didn’t work, we agreed that we would regroup. But it was an immediate success,” said Keane.

This panel, like all at the university, is duly constituted under Minnesota’s Federalwide Assurance. The chair, J. Michael Oakes, has served on a number of IRBs, both internally and externally, and also serves on the university’s behavioral/social science panel. Keane says that the student-researcher perspective is important, so several student members serve and the nonaffi liated member is a professor at a local college, bringing yet another student-oriented perspective to the process. Keane says that it’s a “good and useful exercise” for students to serve on the IRB, both

“because their interests are appropriately represented and because student projects often involve studying and surveying other students.”

In addition, two regional university campuses with active student research programs, Morris and Duluth, are represented on the panel. Meetings are held monthly utilizing interactive television, which allows distant members to fully participate. The student panel reviews only

those protocols that require full review. Expedited review is handled by the committee chair or his designated expedited reviewers; when the workload demands it, some projects may be reviewed through other expedited review systems. Review of exemptions is handled through a separate process.

The panel works closely with advisors, who are required to sign off on student research applications. The panel makes a particular effort to be instructive in its written comments, and is part of a larger, university-wide effort to emphasize the ethical conduct of research, and to weave that emphasis into the undergraduate and graduate curriculum.

The student panel has managed nearly 300 projects since its inception, providing clear relief for the workload problem of the behavioral/social science panel. Keane says that panel also enjoys a more uniform workload now, as it reviews proposals that are relatively similar in terms of sophistication level.

Members of the University of Minnesota’s student IRB panel—devoted solely to review of student-initiated research protocols—meet in July. Monthly meetings utilize interactive television (background) to allow members on other campuses to fully participate.

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

Innovations

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AnswersAAHRPP New Preliminary Applicant ProceduresIn addition to established application procedures, organizations seeking accreditation can now apply as preliminary applicants. In this new category, an organization submits a preliminary application to AAHRPP. AAHRPP staff conducts an in-depth review of the preliminary application and provides a comprehensive preliminary application report to the organization. Based on this feedback, the organization makes corrections in order to produce a fi nal application. Once the fi nal application is submitted, the accreditation process begins. The preliminary applicant category is independent of the accreditation process, including site visits or fi nal accreditation decisions.

For more information, visit www.aahrpp.org.

1. How long is a site visit?Site visits vary in length, depending on the size and complexity of the program under review; they are usually two to four days long.

2. Who are the site visitors, and how will they be chosen for my organization?AAHRPP retains a pool of more than 70 expert site visitors, who are actively engaged in a variety of professional disciplines. Site visit teams are assembled based on expertise and setting; at least one team member comes from a research setting analogous to the organization being reviewed. A behavioral or social scientist, for example, would be included for a university conducting behavioral and social science research.

3. How are site visitors trained?Site visitors are selected based on the research knowledge and expertise they bring to the process. AAHRPP conducts a training program with all site visitors in the interpretation and use of the Evaluation Instrument for Site Visitors. In the fi eld, new site visitors are matched with experienced ones for hands-on practice.

4. What happens during a site visit?After introductions between the site visit team and members of the organization, site visitors, generally working in teams of two, review records and conduct interviews of IRB members, staff, and chairs, as well as investigators and research staff. Site visitors also interview key organizational offi cials, such as those who review contracts, manage fi nancial confl icts of interest, lead departments involved in research, and provide legal advice.

5. How are investigators selected for interviews? Does AAHRPP select them or does the organization?AAHRPP selects interviewees, although sites may suggest individuals to be interviewed. Investigators are selected who refl ect the ranges of experience, protocol volume, types of ongoing research, and research risk levels at the organization.

6. If an investigator is not available for an interview, can there be a substitute?Yes. AAHRPP provides the agenda in advance of the site visit to allow the organization to prepare. If selected interviewees will be unavailable, AAHRPP works with the organization to either alter the interview times or select substitutes. Feedback about the site visit agenda is welcome.

Site Visits

7. Do site visitors interview other research staff?Yes. In addition to investigators, site visitors will interview coordinators, co-investigators, students, and other research staff.

8. Do site visitors interview sponsors or CROs?AAHRPP interviews representatives from sponsors and contract research organizations when the organization’s interactions make them part of the human research protection program.

9. If another IRB reviews some or all of our research, how does it participate in the site visit?Organizations that use external IRBs are responsible for ensuring that those research review functions meet the AAHRPP Standards. External IRBs’ involvement in a site visit is determined on a case-by-case basis, factoring in the organization’s policies and procedures for working with external IRBs, the degree of reliance on them, and whether the IRBs have been previously site visited by AAHRPP. If AAHRPP chooses to involve external IRBs, it may conduct record reviews and interviews of staff, members, and leadership.

10. How does the draft site visit report work, and what does our organization do once the site visit is completed?At the end of a site visit, the team provides a detailed review of its observations to organizational offi cials. Within 30 days, AAHRPP provides a draft copy of the site visit report to the organization, which then has 30 days to correct factual errors and describe programmatic changes. Site visitors review the organization’s response and incorporate additional observations into the fi nal site visit report. The Council on Accreditation reviews this fi nal report to make an accreditation determination.

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State and Local Law

Related Accreditation Elements: I.3.FState and local laws, in addition to federal regulations, may infl uence IRB decisions. Policies and procedures should defi ne how the organization interprets applicable laws. State and local law may include constitutional law, statute, regulations, and case law. Organizations should obtain legal counsel to decide what laws are relevant. Organizations should write policies that take into consideration the types of research subject to the human research protection program and the legal jurisdictions in which the research takes place.

Recommended Content:General:

1. Describe how investigators and IRBs may access legal counsel for assistance in applying laws other than federal regulations.

2. State that federal regulations on the protection of human participants must be followed.

3. State that state and local laws must be followed when they provide additional protections to those provided by the federal regulations.

If your organization conducts or reviews research that involves children, defi ne when a person is a child

1. State that, under the applicable law of the jurisdictions in which the research will be conducted, persons who have not attained the legal age to consent to treatments or procedures involved in the research are considered children according to the federal regulations.

2. As applicable, reference and describe the laws that defi ne:

a. Age at which an individual is an adult (i.e., age of majority) and is able to consent to treatments or procedures involved in the research.

b. Exceptions to the above age, such as the ability to provide consent as an adult after marriage, joining the armed forces, birth of a child, or emancipation.

3. If decisions need to be made on a case-by-case basis, describe the process for making such determinations.

If your organization conducts or reviews research that involves children, defi ne who can serve as a guardian

1. State that individuals authorized under applicable state or local law to consent on behalf of a child to general medical care are considered guardians according to the DHHS regulations.

2. Describe who these persons are.

3. State that individuals authorized under applicable state or local law to consent on behalf of a child to general

AAHRPPTip Sheets

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medical care when general medical care includes participation in research or to participate in research are considered guardians according to the FDA regulations.

4. Describe who these persons are.

5. If decisions need to be made on a case-by-case basis, describe the process for making such determinations.

If your organization conducts or reviews research that involves adults unable to provide consent, defi ne who can serve as a legally authorized representative

1. As applicable, reference and describe the laws that:

a. Authorize an individual to provide consent for another person, such as laws concerning guardians, surrogates, or powers of attorney.

b. Authorize an individual to consent for health care-related procedures for another person, such as a health care proxy, health care surrogate, or health care guardian, when applicable to the research setting.

c. State that individuals or other bodies authorized under applicable law to consent on behalf of a prospective participant to his or her participation in procedures involved in the research are considered legally authorized representatives, according to federal regulations.

2. Describe who these persons are.

3. If decisions need to be made on a case-by-case basis, describe the process for making such determinations.

Other Relevant State and Local Laws:

1. Describe other laws when they are relevant to the research context, such as:

a. Additional protections for humans involved in research

b. Additional protections for vulnerable populations involved in research

c. Educational services

d. Genetics testing

e. HIV testing

f. Informed consent

g. Limitations of waiver of informed consent

h. Mandatory reporting of abuse

i. Mandatory disease reporting

j. Mental health services

k. Medical records

l. Privacy and confi dentiality

2. For each law, explain how IRB members, IRB staff, and research staff should apply it.

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Cedars-Sinai, from Page 1 ...

One way to do this would be to establish systems that review all elements of the human research protection program—and to do it by certain deadlines. This process will ensure that policies and procedures refl ect current practices for protection of human subjects established by

the institution, as well as adhering to state and federal requirements. This review prepares an institution for the accreditation application, and during this learning process, further self-improvement continues in an ongoing manner.

Finally, we encourage institutions to avail themselves of AAHRPP’s services in preparing for accreditation, such as the workshops and pre-accreditation consultations. Our institution was able to get questions answered as we proceeded through the self-assessment phase. With AAHRPP’s assistance, an institution will experience a more transparent process. §

AAHRPPAdvanceAAHRPP Advance is published

quarterly by the Association for the Accreditation of Human Research

Protection Programs, Inc.® (AAHRPP®)

Executive DirectorMarjorie A. Speers, Ph.D.

EditorTodd P. Bentsen

Assistant Director, Marketing& Communications

DesignWieder Communications

PrintingFederation of American Societies

for Experimental Biology

Minnesota student IRB, from Page 6 ...

Keane reports that the educational orientation of the student panel is helping advisors, who are able to provide better advice to the students that they coach and teach. “The practice of this committee has really enhanced the quality of research proposals,” she said.

Another unanticipated benefi t was a positive impact on student research in international settings. Minnesota students often study abroad and initiate small research projects: a study of voting patterns or political issues for political science majors, for example, or ethnographic research conducted by anthropology students. Keane says the panel has helped students become more sophisticated in cross-cultural issues.

“Overall, the work of this panel helps demystify the IRB process, particularly in behavioral and social science areas,” says Keane. “We are bringing the next generation of researchers along, so that dealings with the IRB don’t seem like a burden or a hindrance, but are just part of doing research.”

“We wouldn’t go back to what we had before,” concludes Keane. “For a certain set of our research projects, we’ve found a good chemistry.”

Information: Moira A. Keane, MA, CIP, Director, Research Subjects’ Protection Programs, keane002@umn.edu, (612) 626-5654. §

www.aahrpp.org