Two More Earn AAHRPP Accreditation: Major Clinical Research Center in India and CRO in U.S.

AAHRPP has accredited two more organizations, including a third institution in India and a second contract research organization (CRO).

Please join us in congratulating the newly accredited organizations:

• Jehangir Clinical Development Centre Pvt. Ltd., Pune, India
• Celerion, Lincoln, Nebraska

More information is available in this news release.

AAHRPP Welcomes Summer Korean Fellows

The two-month fellowship is a collaborative effort of AAHRPP and the Korean Association of IRBs (KAIRB). The training program supports two fellows from the field of human research protection to work with staff at AAHRPP to learn how to build their own human research protection programs (HRPPs). Fellows will explore how to initiate quality improvement programs that enhance protections for participants, as well as how to meet the AAHRPP-accreditation standards.

“The concept of ‘shared responsibility’ and expanding from a focus solely on the IRB to an organization-wide HRPP is becoming widely accepted in South Korea,” explains Sarah Kiskaddon. “Koreans are eager to see U.S. models that achieve high performance standards for their HRPPs. We are training professionals who can share their knowledge with other organizations at home.”

Four More Earn AAHRPP Accreditation

AAHRPP has accredited four more organizations.

Please join us in congratulating the four newly accredited organizations:

• Children’s Hospital Los Angeles in Los Angeles, California
• Ochsner Clinic Foundation in New Orleans, Louisiana
• Opus IRB in Roswell, Georgia
• Rush University Medical Center in Chicago, Illinois

More information is available in this news release.

Two More Earn AAHRPP Accreditation

243 have now attained the “gold standard” for research protections


Washington, D.C., March 15, 2012―The Association for the Accreditation of Human Research Protection Programs, Inc. today announced that it has accredited two more organizations: Boise VA Medical Center in Boise, Idaho, and VA Puget Sound Health Care System in Seattle, Wash.

All told, 243 organizations have now earned accreditation, including institutions in 46 states, the District of Columbia, Puerto Rico, Canada, China, India, Korea and Singapore.

The latest accreditations come as AAHRPP marks 10 years since the issuance of the first accreditation standards in 2002. “Our progress has been remarkable,” said Marjorie A. Speers, Ph.D., AAHRPP president and CEO. “A decade ago, accreditation was virtually unheard of. Today, it is synonymous with high-quality research and ethical treatment of research participants.”

Speers gives much of the credit for AAHRPP’s success to the research enterprise. “Accreditation has taken hold because the research community genuinely cares about protecting participants,” she said. “Despite the challenges of the past decade, the research community has stood firm and embraced the rigors of accreditation.”

Accreditation is available to U.S. and international organizations that conduct biomedical, behavioral or social sciences research involving human participants. The list of accredited organizations includes community and teaching hospitals; VA facilities, universities; institutional review boards; research institutes and contract research organizations.

About the Association for the Accreditation of Human Research Protection Programs, Inc.

A nonprofit organization, AAHRPP works with groups that conduct human research in order to raise the level of protection for research participants. AAHRPP accredits organizations that can demonstrate that their participant safeguards exceed U.S. federal requirements. The accreditation program uses a voluntary, peer-driven, educational model. To learn more about accreditation, visit www.aahrpp.org.

WHO Publishes Standards for Ethics Review

The World Health Organization has published “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants,” a compilation of 10 standards that are applicable to the ethics review of health-related research with human participants. The document delineates general principles and norms that all research ethics systems are expected to follow. They are intended to help ethics committees achieve high-quality performance and to provide a common language that establishes specific outcomes against which achievements can be benchmarked. It can be found at http://www.who.int/ethics/publications/en/.

President’s Bioethics Commission Releases Report on Human Subjects Protection

On December 15, 2011, the Presidential Commission for the Study of Bioethical Issues released a report entitled, Moral Science: Protecting Participants in Human Subjects Research. In the wake of the revelations of controversial PHS-supported research in Guatemala from 1946 to 1948, the Commission was charged by President Obama with assessing the current rules for research participants. In general, the Commission concluded that the “US system provides substantial protection for health, rights, and welfare of research subjects” in the US and internationally. Additionally, the Commission made 14 recommendations. The recommendations include improving accountability though enhanced public access to information on research protocols, expanded research into effectiveness of the human research protection system, enhanced treatment and compensation for research-related injury, making the ethical underpinnings of the regulations more explicit, addressing investigator responsibilities, expanding ethics education, respecting equivalent protections, promoting community engagement, ensuring capacity to protect human participants and ensuring ethical study design, among others. The complete report can be found here.

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.

Latest AAHRPP Accreditations Include First Organizations in India

AAHRPP has accredited seven more organizations--including our first organizations in India. Four of the seven newly accredited organizations are outside the U.S., underscoring our progress in moving toward one standard worldwide for research protections.

Please join us in congratulating the seven newly accredited organizations.

• Creighton University, Omaha, Nebraska, USA
• Diex Research Sherbrooke, Inc. & Diex Research Montreal, Inc., Sherbrooke, Quebec, Canada
• IRB Services, Aurora, Ontario, Canada
• Kasturba Hospital, Manipal, Manipal, India
• Manipal Hospital Bangalore, Bangalore, India
• Texas Health Resources, Arlington, Texas, USA
• The University of Alabama, Tuscaloosa, Alabama, USA

You can read the official announcement in this news release.

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.

Global Benchmark for Human Research Protection is Raised

Eight Exemplary Organizations Earn AAHRPP Accreditation

WASHINGTON, D.C., March 16, 2011— The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is pleased to announce that eight new organizations have been awarded Full Accreditation at the most recent meeting of its Council on Accreditation. AAHRPP’s accreditation program is the field's primary vehicle for setting uniform, high standards across the research enterprise―in both the private and non-profit sectors. Accreditation internationally recognizes individual HRPPs that have demonstrated their commitment to providing strong protections to research participants and is capable of delivering on that promise.

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.”