Review procedure of Institutional Review Board constitutes meeting preparation,meeting procedure,elements of the review,decision-making,those events eligible for expedited review and the follow-up review.
Ethical principles including the Declaration of Helsinki for clinical research have been established, and the institutional review board (IRB) and informed consent are important for protecting the rights and interests of participants.
To compare clinical research articles published before and after 2002 (July 2000 to December 2001 and January 2003 to June 2004) in six Chinese medical journals and assess for proportion of reporting on informed consent and on ethics committee approval.
specially discusses that the strengthening of patient's consciousness of right is of significance to set up hospital ethical committee,and otherwise, hospital ethical committee safeguards patient's right.
The role and operational procedures of Ethics Committees(EC) have been clearly delineated in GCP of our country and some international guidelines, such as Declaration of Helsinki, the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, and WHO Operational Guidelines for Ethics Committees for Biomedical Research Review, etc.
Surveying and Evaluating Ethical Review Practices——a complementary guideline to the operational guidelines for ethics committees that review biomedical research
The opening section of this paper briefly describes the present regulatory environment regarding human subjects research, followed by an overview of the Institutional Review Board (IRB) process.
In this article, we describe the structure, peration, and institutional framework within which an ethics committee fulfills its missions, with emphasis on the consultation process.
Originally established as an instrument of ethical self-regulation in the medical profession, the ethical committee soon advanced to a statutory institution and is now on the way to becoming the body charged with judicial control in medical research.
This development implies the need for changes in both position and function of the ethical committee, but these have not been made with due consideration for all the developments there have been.
Stem cell banks should receive the lines previously derived by other groups and hESCs should be provided for groups that justify their use in a research project previously approved by an ethical committee.
In Germany, ethics committees are established at the medical faculties of universities as well as at the Chamber of Physicians of the different states (Landes?rztekam-mern).
(2) All research projects must be evaluated by ethics committees having as members lay people and investigators possessing the qualities of competence and judgement.
A concise ethical framework, rather than rigid guidelines (that may not be applicable to all trauma studies), may be a more useful point of reference for investigators and ethics committees or institutional review boards.