Whilst a hospital's research ethics committee provides a form of virtual research governance (directing researchers to many documents to assist interpretation of effective research governance), the onus has been largely on the individual researcher to implement research governance as they understand it.
Dr Bhattacharya, who was an Assistant Professor at Guru Govindsingh Hospital, had set up a Human Research Ethics Committee and allegedly swindled Rs 40,000 by fabricating bogus documents.
The chair of the Human Research Ethics Committee (Medical), the Institutional Review Board of the University of the Witwatersrand in Johannesburg, outlined the reasons for the committee's belief that the research had local importance and should be conducted with urgency.
Practically speaking, this means that researchers who want to publish in journals subscribing to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals must supply information relating to research ethics committee (REC) approval, procedures used to obtain informed consent, confidentiality protections, and possible conflicts of interest.
95 Hardcover Data protection and medical research in Europe KJE6229 As part of a European Community-funded project, Privacy in Research Ethics and Law (PRIVIREAL), this volume reports on the practical operation and theoretical role of research ethics committees (RECs) and relevant international and national directives.
The report says the trans-Tasman agency should actively monitor clinical trial activity, and in particular: advise the Human Research Ethics Committees ("HREC") and the NH&MRC of regulatory requirements for clinical trials; assist HRECs in determining how specific trials should be evaluated if requested; review adverse drug reactions that are both serious and unexpected; and conduct a trial inspection program.
