Can acdemic administrative bodies such as Board of Graduate study or Dean’s committee grant ethical approval to a research proposal involving human subjects?
Nowadays most scientific journals, particularly in the field of biomedical research, have made ERC or IRB approval a mandatory requirement before they consider a manuscript suitable for publications. It has been seen that many investigators submit ERC approval issued by the head of an academic body or even a post-facto ERC approval. Are these journals acting too harshly in rejecting such submissions?
Ethical considerations have changed from no rules to very strict regulations in clinical trials as well as in epidemiological research.
Most journals require appropriately documented review report and approval from a formally constituted review board (national or institutional review board or ethics committee) for all studies comprising human tissues/organs, medical records, and human subjects.
Robust reviewing of research involving human subjects is a must to protect the rights, dignity and welfare of the participants. The reviewing committee must ensure that research is done by strictly adhering to the ethical standards. The Institutional Review Board (IRB) is any committee or board formally designated by an institution to conduct periodic reviews of biomedical research. It approves and monitors clinical trials keeping in mind the safety and rights of human subjects.
Keeping this in view, the journal may reject the ERC approval issued by the head of academic bodies or post-facto ERCs if they believe that the approving body has not provided a credible or trustworthy report.
To minimize the chances of rejection, there must be careful assessment of the potential risks and benefits that may accrue to research participants. All the questions that address key considerations (both scientific and technical) in the design of research protocols must be covered.