|Year : 2013 | Volume
| Issue : 1 | Page : 14-16
Ethics committees: Aspirations and responsibilities
VS Padbidri, NY Mahaparale
KEM Hospital Research Centre, Pune, Maharashtra, India
|Date of Web Publication||23-Jan-2013|
V S Padbidri
Director Research, KEMHRC, Sardar Moodliar Road, Pasta Peth, Pune - 411 011
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Padbidri V S, Mahaparale N Y. Ethics committees: Aspirations and responsibilities. Perspect Clin Res 2013;4:14-6
| Introduction|| |
India is already recognized as the hub for Clinical Trials (CT) in the world. It is therefore absolutely essential that we have a very good "Fail Safe" system in place. For all this to happen, it is important to decide "Where do we start?" Formation of sound Ethics Committees (ECs) is a good enough place to start with. Let's see how we could make this workable.
Earlier we had only three key players in clinical research a Sponsor, PI and Institution [Figure 1]. These were communicating with each other directly; however the picture has changed now. We have additional parties for execution of CT at local level therefore EC plays critical role in monitoring CT progress/conduct.
Credibility of ECs is based on three important essentials:
- Availability of Standard or Acceptable set of guidelines issued by competent authority.
- Establishment of a Centralized Administrative set up and
- Assured Human Resources Development.
An authorized Central agency like DCGI or ICMR which will draw up guidelines. Periodic updates should address issues which crop up as science progresses.
This agency would be entrusted with the task of EC registration in the country and will help and provide guidelines to the newly formed ECs. The possibility of periodic renewals and grading could be explored. Adherence to SOPs and how each EC conducts its meetings are important issues. Carrying out audits/monitoring visits of ECs before grading them for their subsequent renewal could be a debatable point. A regular Newsletter-like publication could be a forum for members to express their opinion or seek guidance on perplexing issues.
Human resources development
This is an important element for capacity building. Periodic workshops need to be conducted on GCP, GLP, Data management etc. This will ensure uniformity and compliance. Carrying out audits of clinical trials and their admin set up could sensitize the whole system. Seminars and symposia on current topics would help us know the trend of thoughts or difficulties faced by ECs.
As per ICH GCP and Schedule Y the Responsibilities of the Ethics Committee , (EC) roughly are:
The trial site(s) may accept the approval granted to the protocol by the ethics committee of another trial site or the approval granted by an independent ethics committee (constituted as per Appendix VIII), provided that the approving ethics committee(s) is/are willing to accept their responsibilities for the study at such trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the protocol version is same at all trial sites.
- Review and accords its approval/favorable opinion to a trial protocol
- Ongoing review of the approved trials
- Revoke its approval accorded to a trial protocol: it must record the reasons for doing so and at once communicate such a decision to the Investigator as well as to the Licensing Authority.
This permits re-review of study protocol which has not received favorable opinion from the EC of that site by another EC or IEC. This explains the need of a communication platform in between ECs existing nationwide. The sponsors or investigators should report or share the opinion of other ECs who are simultaneously reviewing the same study documents.
Today we have ample examples of dropping/not considering a particular site from a study because of "delay in approval" process of the EC at that site. Is there a time frame laid down for the interval between submission of a proposal and review by an EC?
Another aspect is Patient Information Sheet (PIS) and Informed Consent Form (ICF) which is meant for a lay person non medico or even many a times an illiterate patient, needs to be modified as per EC and same is communicated to sponsor in writing as opinion. However with a reason alike "short time lines for recruitment and study completion" Sponsor/CRO simply drop that particular site and goes ahead with remaining sites to meet the "timeline". EC should request sponsor to document the specific reason for non conductance of trial at that site even after review by EC.
A proper communication channel between EC and regulatory bodies is also of utmost importance. May be the upcoming fora in India for EC will take up this task to bridge the communication and guidance link between these two.
EC may plan a Site Audit as part of the ongoing review process of trial conduct. This will assure compliance of PI and the team members with EC/Site SOP and study protocols, as well as current local regulatory directives, laws, guidelines and ethical considerations of the Declaration of Helsinki.
Such audit may be mutually beneficial to the EC (to understand the site activities), to the PI (understand EC opinion on actual site work) and also to the Institution/ Site (for understanding the knowledge up-gradation points for the staff appointed for the purpose of research). Also this will serve the platform for all these to communicate face to face.
Post trial access (PTA) to the IP prior to market release is important from both the Ethical and Scientific points. As per ICMR guidelines on Ethics 'If the drug is found effective in a patient, the sponsor should provide it to him after the clinical trial is over till it is marketed in the country. Thereafter, at a reduced rate'. We at the EC level while reviewing the PIS and ICF especially in rare disease conditions could insist on the inclusion of this clause in the documents and clearly demarket responsibilities of each party at the end of the trial. Sometimes parties involved in trial are ready to provide PTA, however the study participants refuse to travel to long distance sites/hospitals. May be a step favouring patients/study participants in such condition which gives PTA available at a nearby hospital or site needs to be considered. The process may sound simple but has many hurdles starting from training of IP handling procedures to intermittent procedures to monitor patient safety and even further may be to retain continual interest of the new hospital staff to work in conjunction.
In conclusion a lot needs to be done to get the system streamlined, but let us make a start and take the first step forward.
| References|| |
|1.||ICH GCP (E6): Section 3.1 IEC/IRB Responsibilities. |
|2.||Drugs and Cosmetic Rules 1945, Schedule Y. Requirements and Guidelines for permission to Import and/or Manufacture of New Drugs for sale or to Undertake clinical trials Section 2. Clinical trial Sub Section 1; *Approval for clinical trial; 2005. p. 2. |