The Institute of Health Sciences (IHS) adopts a set of standard operating procedures (SOP) of the Ethics Review Board to safeguard the rights and welfare of human subjects involved in research. IHS Ethics Review Board (IRB) is a standing committee established by the Director under the auspices of the Board of Directors.
The purpose of the IRB is to safeguard the safety, rights and welfare of human subjects involved in research. IRB is charged with reviewing any proposed research projects that involve human subjects, approving and monitoring those that meet the criteria, verifying that the human subjects are adequately protected, and requiring modification to or even vetoing all human subject research.The IRB adheres to ICH GCP Guideline E6, the Helsinki Declaration (1996), as well as relevant international conventions. In addition, it has adopted SOP that abide by a series of state and local regulations concerning the procedures of ethics review of biomedical research and clinical trials involving human subjects.
The IRB provides guidance and renders assistance to researchers of IHS and those involved in the projects on the ethical and procedural questions that arise in clinical research involving human subjects, to ensure that relevant provisions on privacy protection, data confidentiality and governmental regulations are properly followed. In addition, the IRB provides the ethical guarantee necessary in order for the IHS to continue to receive support from governmental agencies, foundations and industries for its human subjects research.
According to the requirements laid out in "Procedures on
the ethical review of biomedical research involving in
human subjects" promulgated by the Ministry of Health, the IRB at IHS has the authority to review all research projects at IHS that involve human subjects. Any such projects, regardless of their source of funding, are subjected to ethical review, if any one of the following is true:
a. projects funded by the Institute, or
b. any research conducted or directed by any employees of the Institute or their proxy, using properties or facilities of the Institute, or
c. research conducted elsewhere, but involves any employees of the Institute or their proxy, and their responsibility in the Institute, or
d. research that involves the use of non-publicized information within the Institute, in an effort to ascertain or contact trial candidates or potential trial candidates.
By its own judgment, the IRB at IHS can accept ethical review and subsequent approval of research projects involving human subjects in parts of Shanghai outside of IHS, such as multi-center clinical trials in affiliated hospitals of Shanghai Jiao Tong University School of Medicine or research units under Shanghai Institutes for Biological Sciences.
The IRB should review and monitor any and all types of research projects involving human subjects. Any such IHS projects are subject to prior review by the IRB.
The IRB is charged with the following:
1) To review all research projects involving human subjects.
2) To require researchers, as one of the conditions to pass the initial review or subsequent review(s), to provide or revise experimental procedures and informed consent documents.
3) To approve new research projects and extend previously approved ones.
4) To reject new research projects.
5) To use any necessary means to monitor the implementation of reviewed and approved projects, including, per regulation, at least one interim review every 12 months, and to ascertain the execution of approved experimental procedures and the informed consent process.
6) To conduct audit when necessary.
7) To insure that any change of plans in any approved projects is reported to the IRB in a timely manner, and that no material changes occur for research plans without prior approval by the IRB.
8) To insure that adverse events that occur during the implementation of approved projects or of other related projects are reported to the IRB in a timely manner.
9) To suspend or to terminate the implementation of any approved research projects, if unanticipated problems occur during implementation that endanger the subjects or if there exists a serious and persistent conflict with any governmental regulations or IRB requirements.
10) To review and to monitor the use of experimental products (experimental drugs, biological organisms and equipment) for treatment of serious or fatal diseases.
The IRB will notify the principal investigator (PI) of the research project regarding the decision on its approval, rejection, suspension or termination. For the disapproved, suspended and terminated projects, the notification will contain reasons for such decisions clearly stated. IHS is also notified for the above decisions.
IHS and other involved institute(s), if applicable, can respond to said decisions, and may veto, suspend or terminate an approved project, if it is determined that the project is not completely in accordance with the regulations of the IHS (or involved institute). However, if the IRB at IHS decides to reject, suspend or terminate a project, the institute cannot approve it. The PI of the project can petition the Research Ethics Commission of the local authorities to review the project, but not without first filing with the Commission the written notification of decision by IRB.