|Year : 2014 | Volume
| Issue : 1 | Page : 1-2
Accreditation of research in India: One step at a time
Director, Medical & Regulatory Affairs, Pfizer Limited, Patel Estate, Off SV Road, Jogeshwari (W), Mumbai-400102, India
|Date of Web Publication||7-Jan-2014|
Director, Medical & Regulatory Affairs, Pfizer Limited, Patel Estate, Off SV Road, Jogeshwari (W), Mumbai-400102
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Potkar C. Accreditation of research in India: One step at a time. Perspect Clin Res 2014;5:1-2
Public assurance of clinical research in India has been an important area of discussion in the recent past. The Supreme Court proceedings, Parliamentary Standing Committee report, and media articles around research controversies have led to numerous discussions and debates in this area. There are several proposals ranging from clinical trial registrations, regulatory reforms, trial inspections, and registration of ethics committee that have been discussed. Some of these (for instance, trial registrations and registration of ethics committees) have already been implemented in the recent past. Accreditation of research is currently being discussed as a critical ingredient of future research ecosystem.  In this article, we discuss a few considerations on accreditation and their implications.
The term accreditation implies credibility or authority when recognized standards have been met. International Accreditation Forum defines accreditation as independent evaluation against recognized standards to ensure impartiality and competence to carry out specific activities. International Organization for Standardization (ISO) defines accreditation as "third party attestation related to conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment task."  The term certification is often used interchangeably with accreditation where it implies third party attestation related to products, processes, systems, or persons.
An accreditation system involves defining objectives, developing capacity, and evaluating programs using a set of validated assessment criteria including internal self-assessment and external evaluation. The basic unit of accreditation in clinical research is human research protection programs (HRPP). Basic components of HRPP include: (a) research design; (b) assessment of risks and benefits; (c) informed consent; and (d) recruitment of participants.
Institute of Medicine (IOM) in their report on "Preserving public trust: Accreditation and human research participant accreditation programs" has outlined various considerations for setting up an accreditation system.  This report in 2001 is contextual for US research, but is a must pre-read for all stakeholders interested in creating an accreditation system in India.
In this report, they have described three models of accreditation. The first views accreditation as a supplement to governmental regulation. The entities already regulated by government seek accreditation as a mark of excellence as above and beyond regulations. In the second model, accreditation substitutes private regulation for public regulation. This is illustrated by accreditation of higher education as well as Joint Commission Accreditation of Healthcare Organizations. The third model does not create its own standards, but ensures with compliance with standards on the basis of interpretation of regulatory standards determined by the government or another entity.
While India selects the right model of research accreditation, there are several other steps in program design. These include setting accreditation standards, setting up a nodal agency on the lines of National Accreditation and Assessment Council (NAAC for higher education under University Grants Commission) or National Accreditation Board for Testing and Calibration Laboratories (NABL under Department of Science and Technology) or National Accreditation Board for Hospitals (NABH under Quality Council of India) with trained resources, setting up pilots, defining success measures, and including academic as well as industry-sponsored research within its scope.
There has been some institutional experience on accreditation process in India with independent organizations including Association for Accreditation of Human Research Protection Programs (AAHRPP) , and Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP).  This experience from institutional stakeholders around preparations and the process of seeking accreditation is important and should be taken into account while developing recommendations on any future system.
Accreditation is not a quick fix. This must be a long-term strategy. The IOM report also outlines areas that accreditation cannot help with. For example, identifying, investigating, and sanctioning violations will remain a regulatory responsibility. Educating research stakeholders is another area (investigators, Institutional Review Board (IRBs), etc.) that will need to be addressed through certification based on standard curricula.
Certification, research monitoring, and accreditation are three key elements in designing future research ecosystem on a strong foundation of public trust. Certification of individuals based on minimum standard curricula will create an entry criterion for stakeholders to participate in research and a provision for annual re-certifications will ensure continuing training of stakeholders. A structured program for research monitoring and inspections with dedicated trained resources would help address ongoing oversight of studies. Accreditation is the third and probably the most long-term strategy of the three that will provide the final step in developing culture of quality in research.
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