2023-03-29T07:10:51
Accreditation
Any clinical trial of a new or existing drug or medical device needs to be carried out at a centre
where facilities for carrying out such trials exist, and the investigators carrying out the trial are
competent and have experience in the successful conduct of such trials. In addition, the institute
ethics committee (lEC) of the institute where the trial is to be carried out should understand the
ethics involved in clinical trials and should consist of persons from different walks of life.
When a clinical trial is carried out under such conditions, it gives confidence to the volunteer and
patients participating in the trial that they will not be subjected to any unjustified or hazardous trial.
It also gives confidence to the drugs regulator and the government that the trial is going to be wellrun, and a sense of confidence to the public and the civil society that the clinical trials being carried
out are justifiable, both on ethical and scientific grounds.
To ensure implementation of these concepts, it is proposed to introduce a system of accreditation for
the following:
a) Institute ethics committees (lECs)
b) Principal investigators (PIs) of clinical trials
c) Centres desirous of carrying out clinical trials.
Clinical trials will only be allowed to be conducted at those centres which have been accredited in
all three areas as above. These centres could be in the public or the private sector. Conducting
clinical trials at centres that have not been accredited would be illegal and will not be recognized by
the Drugs Controller General of India (DCGI).
The accreditation process will be supervised by a Central Accreditation Council (CAC). Details of
the composition and functioning of the CAC are given subsequently. The criteria to be followed for
accreditation of IECs, PIs and the centres where clinical trials are to be carried out are given below.
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Institute ethics committees
IECs are presently being registered by the Indian Council of Medical Research (ICMR). The
process of accreditation of IECs will be a further step to ensure that these committees are effective
and independent in the performance of their duties. There is a separate chapter in this report on
IECs. In this chapter, the emphasis is on accreditation.
These recommendations will cover all IECs, to include
- all institution-based IECs in universities, colleges, research organizations and nongovernmental organizations (NGOs) of repute;
- hospital-based committees; and
- central IECs.
Any organization conducting research studies on human subjects and having a registered IEC
should apply for accreditation to the CAe. On successful accreditation, the CAC will issue a
certificate of accreditation. The CAC will forward the list of accredited lECs to the DCGI and keep
the DCGI updated on the certification process, including any complaints received, cancellation or
non-renewal of certification every three years.
The criteria for accreditation of lECs will include:
- Adequacy of structure and membership
- Appropriateness of the standard operating procedures (SOPs) and consistency in their
implementation
- Completeness of the review process
- Adequacy of the after-review procedures
- Adequacy of administrative support for IEC activities
- Efficiency of the systemic recording and archiving process.
Principal investigators of clinical trials
The principal investigator (PI) could perhaps be called the key stakeholder in the conduct of clinical
trials, because it is he/she who decides, after study of the background information, whether a
clinical trial is justified or not: and subsequently, whether a trial is to continue or be stopped. He/she
plays a key role in determining whether a side-effect has been induced by
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the drug on trial or not, and plays a part in determining the compensation, if justified, in case of
injury or death of a trial participant.
Criteria for accreditation
It is therefore very important that even though we need more clinicians versed in the ethical practice
of clinical research, the criteria for assessing whether a clinician is fit to be an accredited PI must be
rigidly enforced. These are elaborated below.
Minimum qualifications
- The PI or co-PI should either be a physician registered with the Medical Council of India
(MCI)/State Medical Council, or a dental surgeon registered with the Dental council of India.
- The investigator should have a recognized qualification in the concerned specialty before
participating in a particular clinical trial.
Should have had training in Good Clinical Practice (GCP) and national/international guidelines
before being part of clinical trials
- Be well-versed in the regulatory requirements for clinical trials
- Be well-versed in obtaining informed consent and should be able to resolve all queries of
participating subjects
- Have a clear understanding of ethical issues involved in human representation, patient rights and
risks
- Have an understanding of the regulatory environment
- Have knowledge in the area being studied in a particular trial
- Possess leadership qualities to be able to lead the whole clinical trial team.
Experience
- Practical experience of at least three years in handling similar groups of patients or study cohorts
under supervision and mentoring before being allowed to be a PI
- Been a co-investigator in at least two successfully-completed studies in the relevant field in the
past.
Training and certification
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The investigator should have had the requisite training on clinical research ethics, rights and
responsibilities to be able to run clinical trials competently. In order to have an adequate pool of
such trained principal/co-investigators, a course should be initiated for investigators to become
certified clinical investigators, who will be registered at a central registry and reaccredited every
three years.
Number of clinical trials a PI could undertake
It is recommended that this decision be taken by the PI and the IEC. Leaders in the field may be
able to manage several trials simultaneously whereas the same may not be true of PIs who are not
so proficient.
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