New 2011 Metrics Data Published

Promoting continuous quality improvement of human research protection programs (HRPPs) is a top priority for AAHRPP. From data supplied by client organizations in 2011, AAHRPP has compiled an information database to help research organizations, research sponsors, and government agencies identify and support high-quality practices for their HRPPs. These benchmarking “metrics,” as they have become known, are increasingly used by organizations in their own quality improvement programs. Individual organizations, both AAHRPP accredited and non-accredited, can compare their performance on various measures with the aggregate performance of other accredited programs.

“We are pleased to see so many organizations establish an evidence-based practice for their HRPPs.  Organizations can now make decisions regarding HRPP efficiency, staffing, and training programs, based on objective data,” remarked Dr. Marjorie Speers, President and CEO, AAHRPP.

The 2011 metrics are now available on the AAHRPP website by clicking here.

IRB Review Times as a Quality Indicator

In 2009, AAHRPP began collecting IRB review times as part of the application process. The initial response from many was “we don’t collect that,” or “we can’t collect that,” usually reflecting the fact that their electronic systems were not set up to calculate review times. Three years later, the tide has turned, now collecting HRPP metrics is standard practice and people want even more information about review times.

AAHRPP looks at five parameters related to review time: time from submission of the protocol to review and time from submission to approval by the convened IRB, time from submission to review using the expedited procedure, time from submission to approval using the expedited procedure, and time from submission of a protocol to a determination of whether the research is exempt. AAHRPP uses calendar days to describe review time.

One question that arises is how to define the starting and stopping points for review times. Should the clock start when the protocol application is submitted initially—complete or not—or after all required information is received? At the other end of the review time are IRBs that cannot give final approval of a protocol until other committees send their approval, even though these IRBs might have completed their review and approved the protocol. AAHRPP’s definition is a simple one: from initial submission to the time the researcher receives approval to begin the research. Recognizing that review times are complex, involving different components and steps, AAHRPP encourages organizations to build into their analysis of review times all the elements that influence the work flow. Review times have at least three main components: time the IRB staff devotes to handling the application, time with the reviewer, and time for the researcher to respond to questions and requests for more information and to make changes. These times are not simple to calculate because protocols go back and forth between the IRB and the researcher.

Electronic systems can be configured to collect these component times. If any component appears problematic, the factors related to the workflow in that that component can be addressed, such as increase IRB staff, require reviewers to get reviews in on time, or encourage researchers to respond promptly.

Whether using the time from submission to approval, or conducting a more complex analysis of the workflow components, review time is an important quality indicator. Faster does not necessarily mean higher-quality reviews, but inefficient, sluggish systems are not beneficial to the research enterprise or research participants. Complete and comprehensive reviews conducted in an efficient manner are the ultimate goal.

Knowing, analyzing, and understanding your IRB review times, and acting accordingly to implement changes is the way to meet that goal. Organizations should track review times and formally analyze them to determine if, and where, improvement are needed including allocation of resources and personnel, education of IRB staff, IRB members, or researchers and research staff, or enhancement of electronic systems. And don’t just look at means or medians; analyzing outliers can produce valuable information, and are sometimes the situation on which the reputation of your IRB is based. Long IRB review time is the most common complaint of researchers. Being knowledgeable about your review times and able to justify or improve your metrics is an important part of quality improvement for your HRPP.

How Long Does It Take to Submit an Application?

That’s one of the most common questions we hear from organizations, whether they are considering accreditation for the first time or are preparing to apply for reaccreditation. To get an answer, AAHRPP recently invited accredited organizations to provide information on their experience with the self-assessment at the heart of the accreditation process.

Following are some highlights:

• Organizations applying for accreditation for the first time spent an average of 16.5 months completing the self-assessment, compared with 5.7 months for those seeking reaccreditation.
• Nearly 60% of responding organizations did not assign a staff member to pursue accreditation full-time. In most cases, accreditation was a team effort, involving two or more individuals working part-time.
• Organizations with 2,500 or more active protocols were more likely to devote full-time staff to work on accreditation.
• The size of the organization (number of active protocols) did not influence the average time needed to conduct the initial or reaccreditation self-assessments.

Accredited organizations offered the following tips:

• Start early (by far the most common recommendation).
• Prepare but don’t overdo it. Keep policies and information simple. Streamline whenever possible.
• Give yourself time to review all policies, procedures, and practices.
• Educate yourself on the AAHRPP standards and use AAHRPP as a resource.
• Develop a plan and a timeline and adhere to them.

Two organizations shared their different, successful approaches.

• From Vanderbilt University, which completed its self-assessment for reaccreditation in two to three months: “Each team of two took one domain and completed the self-assessment by spending one to two days a week at off-site retreats.”
• From Maine Medical Center, which completed its initial accreditation assessment in 18 months: “We posted the duties on sticky notes along the outside of my office. Every time a task was completed, we removed the sticky note. This simple process motivated everyone. The visual evidence of progress got everyone involved jazzed up to complete this monumental project.”

The Role of Accreditation in an Emerging Market

With its favorable business climate, sizable treatment-naive population, and large number of English-speaking professionals, India is one of the most promising emerging markets for clinical trials. But as the volume of trials has increased, so have reports of abuses and concerns about inadequate protections for research participants.

Public outcry is on the rise, and there are calls for increased government regulation. In response, some are taking the lead and turning to the same organization that helped resolve similar issues in the West: AAHRPP.

Last month, two hospitals—Kasturba Hospital, Manipal and Manipal Hospital, Bangalore—became the first institutions in India to attain AAHRPP accreditation. In keeping with AAHRPP standards for accreditation of non-U.S. organizations, the hospitals met their own nation's requirements as well as those of the United States.

Officials at both hospitals say their decision to seek accreditation was based primarily on AAHRPP’s emphasis on quality and track record of building public trust.

“Prospective participants and the public in general are looking to the research enterprise to take responsibility for ensuring that research is conducted safely and ethically,” says K. Laxminarayana Bairy, M.D., Ph.D., director of the Manipal Centre for Clinical Research at Kasturba Hospital. “AAHRPP accreditation offers assurances that we comply with the highest standards and are committed to quality research.”

Pratibha Pereira, M.D., head of the Department of Clinical Research at Manipal Hospital, agrees. “Accreditation demonstrates that we have the systems in place not only to protect research participants but also to advance research more efficiently and effectively,” she says. “That helps build public trust and confidence―in India and around the world.”

India’s appeal as a hub for clinical trials rests, in part, with its demographics. With nearly 1.2 billion people, India ranks second only to China in total population. Much of India’s population is clustered in urban areas, making it easy and inexpensive to identify and enroll participants in clinical trials. In addition, more than 70 percent of India’s population is classified as being similar in ethnicity to Western peoples, so research results have broad application.

Another advantage is the absence of a language barrier. English enjoys the status of “subsidiary official language” and is widely considered the preferred language for commercial communications. And the Indian government has embraced the international research enterprise.

Perhaps the greatest challenge has been ensuring adequate oversight in the face of double-digit growth in research trials. AAHRPP, with its emphasis on common, higher standards worldwide, can play a significant role in protecting participants in India and facilitating high-quality research that has the potential to benefit the public good.

Top Five Most Frequent Required Revisions to Accreditation Elements in Step 1 Review of Application Materials

After analyzing all Step 1 application reviews completed from October 2009 to June 2011 using the revised standards, AAHRPP has developed a list of the most frequently identified deficiencies found in Step 1 Review of Application Materials, which evaluates an organization’s written policies and procedures. Here are five areas to focus on when preparing your application for accreditation:

Current Number of Accredited Organizations by Type

As of September 9, 2011, there are 234 accredited organizations encompassing over 1,000 components. To see a full list of the accredited organizations please visit www.aahrpp.org.

Maine Earns Its First Two Accreditations

Washington, D.C., September 15, 2011 - The Association for the Accreditation of Human Research Protection Programs, Inc. ® (AAHRPP®), announced today that it has awarded Full Accreditation to the following organizations: 

• Maine Medical Center, Portland, Maine
• VA Maine Healthcare System, Augusta, Maine

AAHRPP Achieves a New Milestone

International expansion and diverse organizations setting the example

Washington, D.C., June 16, 2011 – The Association for the Accreditation of Human Research Protection Programs (AAHRPP) announced today that it has awarded five organizations with Full Accreditation. Setting new milestones, in its tenth year, AAHRPP has accredited its first organization in China, first psychiatric hospital, and first federal central IRB. The list also includes two top medical colleges and teaching hospital.

AAHRPP has accredited 223 programs

WASHINGTON, D.C., December 16, 2010—The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is pleased to announce that it has accredited the human research protection programs (HRPPs) at three additional organizations, including a private research organization, a prominent children’s hospital, and a renowned university.

Miami Research Associates (MRA) continues the trend of accreditation by leading industry private research sites. Established in 1996, Miami Research Associates is the largest physician-owned multi-specialty clinical research center in the United States. MRA has successfully conducted over 1,000 clinical trials in Phase’s I through IV. The staff consists of over 35 board-certified physician investigators and more than 38 Association of Clinical Research Professionals—certified clinical research coordinators.

These diverse organizations bring the total number of accredited HRPPs to 223, representing nearly 1,100 entities. Following is a list of the newly accredited organizations:

• Miami Research Associates, Miami, FL
• The Children’s Hospital of Philadelphia, Philadelphia, PA
• Yale University, New Haven, CT

“This addition to the increasing group of accredited research organizations is evidence of the growing public perception that earning AAHRPP’s gold seal is the right and smart thing to do for government, nonprofit, and for-profit organizations,” said Marjorie A. Speers, Ph.D., President and CEO of AAHRPP. “It also increases the number of accredited options for industry sponsors, researchers, and participants.”