AAHRPP Accreditation

Kasturba Medical College and Hospital, Manipal are engaged in clinical trials for the last 10 years. Many of the trials are global. All these trials are coordinated by the Manipal Centre for Clinical Research (MCCR), Manipal Academy of Higher Education, Manipal. These trials are approved by Drugs Controller General of India and Institutional Ethics Committee. 

To further safeguard the trial subject the MCCR applied for AAHRPP accreditation.  As a prerequisite for this application, nearly 26 standard operating procedures and documents, many of which were not there earlier, were created. In the process the team members namely investigators, study coordinators, Human research protection programme members are being trained on these SOPs as well as ICMR guidelines, Schedule Y and ICH and GCP guidelines.

What is AAHRPP and what are its benefits?

AAHRPP is the sole non-governmental organization in USA, which was established to promote accreditation as a way to improve the quality of research and protect research participants. Organizations that attain accreditation do so voluntarily. They agree to adhere to research standards at par with the best institutions where research is conducted.

The Benefits of Accreditation

Accreditation benefits research organizations, participants, and the research enterprise as a whole. The accreditation process requires organizations to take a comprehensive look at their human research protection programs (HRPPs) -to identify and address any weaknesses and to build upon their strengths. The result is a more cohesive HRPP, with the systems in place not only to protect research participants but also to advance research more efficiently and effectively.

 Following are some of the advantages of having an AAHRPP accreditation:

·         The highest possible standards and protections. AAHRPP's high ethical and professional standards provide the most comprehensive protections for research participants. These standards exceed US federal/ DCGl/ lCMR requirements for safeguarding participants and extend to all research studies over seen by an organization's HRPP.

·         An assurance of quality. Accreditation is evidence of a quality research program. The AAHRPP seal indicates not only that an organization safeguards research participants but also that data are reliable and credible and the organization has made a commitment to continuous quality improvement.

·         Improved efficiency, effectiveness. AAHRPP requires organizations to take an unprecedented view of their research protection programs-to make sure not just that policies and procedures are in place but also that they are documented and translated into practice. As a result, accredited organizations tend to have more streamlined and effective policies and procedures. These organizations also typically keep better records and are more likely to avoid costly shutdowns and problematic inspections.

·         A competitive edge. Sponsors and other funding agencies recognize that accredited organizations have more efficient operations, provide more comprehensive protections, and produce high-quality data. Increasingly, accreditation is expected to be a condition of research support.

.         Government recognition. Regulatory agencies are more likely, for example, to target non accredited organizations for inspections. With its commitment to quality and accountability, accreditation also is a viable alternative to further regulation.

.         Public trust, confidence. 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. Since accreditation is a voluntary, objective measure of quality, participants are more likely to choose organizations that have earned the AAHRPP seal.