Ethical data behind Clinical trials:3

Ethical Guidelines:
The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.

  • Clinical trials are closely supervised by appropriate regulatory authorities.
  • All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial.

Ethical Committee:
The sponsor or investigator should seek the opinion of an Independent Ethics Committee regarding suitability of the protocol, methods and documents to be used in recruitment of Subjects and obtaining their informed consent including adequacy of the information being provided to the Subjects. The Ethics Committees are entrusted not only with the initial view of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring for the compliance of the ethics of the approved programmes till the same are completed. Such an ongoing review is in accordance with the declaration of Helsinki and all the international guidelines for biomedical research.

Institution Review Board/Independent Ethics Committee (IRB/IEC): 5
It is an independent body constituted of medical professionals, scientific and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and wellbeing of human subjects involved in a trial by among other things, reviewing, approving and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
The IECs should specify in writing the authority under which the Committee is established, membership requirements, the terms of reference, the conditions of appointment, the offices and the quorum requirements.

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

  1. Determining its composition (names and qualifications of the members) and the authority under which it is established.
  2. Scheduling, notifying its members of and conducting its meetings.
  3. Conducting initial and continuing review of trials.                                                  
  4. Determining the frequency of continuing review as appropriate.
  5. Providing, according to the applicable regulatory requirements, expedited review and approval or favourable opinion of minor change(s) in ongoing trials that have the approval or favourable opinion of the IRB/IEC.
  6. Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval or favourable opinion of the trial.
  7. Specifying that no deviations from or changes of the protocol should be initiated without prior written IRB/IEC approval or favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical.
  8. Administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)). 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.
    2. Changes increasing the risk to subjects or affecting significantly the conduct of the trial.
    3. All adverse drug reactions (ADRs) that is both serious and unexpected.
    4. New information that may affect adversely the safety of the subjects or the conduct of the trial.
  9. 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

ICH GCP: 4,5 Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subject.

Role of FDA: The Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy, and quality of drugs, biologics and many other medical products.The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective. Safer, and more affordable, and helping the public get the accurate, science-based information they need to medicines to improve their health.

However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safely and effectiveness. FDA staffs members meet with researchers, and perform in spections of clinical trials study sites to protect the rights of participants and to verify the quality and integrity of the data.