Ethics Committee Registration

Pristyn Research Solutions

Ethics Committee Registration

As per Drug and Cosmetic act Amendment 2013 released on 08 Feb 2013 (GSR 72(E) dated 08 February 2013, notification issued by the Ministry of Health and Family Welfare (Department of Health), Government of India.), it has become mandatory to get all Ethics committee registered within 45 days of the release of guidelines. To ease this process of registration, regulatory branch of the OSSINC has started the services of EC registration

In this we would provide:

  • SOP Preparation as per new Guidelines.
  • Training and certification on ICH GCP and Schedule Y with Recent updates to all members.
  • EC dossier preparation and submission to the Ministry of Health.
  • Coordinating with the requirement of Ministry of Health
  • Reply of clarification and Amendment required by ministry of health
  • Preparation of Chairman Profile and Member’s profile.
  • Provide format for IEC functioning as per ICMR and FERCAP guidelines.
  • Free Service for First year after registration.
  • Guidance on proper functioning of EC.

Composition, Functions and Operations

The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include:

  1. At least five members
  2. At least one member whose primary area of interest is in a nonscientific area
  3. At least one member who is independent of the institution/trial site. Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter. A list of IRB/IEC members and their qualifications should be maintained.
  • The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).
  • 3.2.3 An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present.
  • 3.2.4 Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion and/or advise.
  • The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC
  • An IRB/IEC may invite nonmembers with expertise in special areas for assistance.

Procedures

The IRB/IEC should establish, document in writing, and follow its procedures, which should include:

  • • Determining its composition (names and qualifications of the members) and the authority under which it is established.
  • • Scheduling, notifying its members of, and conducting its meetings.
  • • Conducting initial and continuing review of trials.
  • • Determining the frequency of continuing review, as appropriate.
  • • Providing, according to the applicable regulatory requirements, expedited review and approval/favorable opinion of minor change(s) in ongoing trials that have the approval/favorable opinion of the IRB/IEC.
  • • Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favorable opinion of the trial.
  • • Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see 4.5.2).
  • • Specifying that the investigator should promptly report to the IRB/IEC:
    1. Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4)
    2. Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2).
    3. All adverse drug reactions (ADRs) that are both serious and unexpected.
    4. New information that may affect adversely the safety of the subjects or the conduct of the trial.
  • • Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning
    1. its trial-related decisions/opinions.
    2. The reasons for its decisions/opinions.
    3. Procedures for appeal of its decisions/opinions

Reference: CDSCO website;