Indian Society for Clinical Research (ISCR) has issued code of conduct for clinical research in India. A set of 12 norms were unveiled here at the 7th annual ISCR conference being held in Bengaluru from January 10 to 11.
Dr Suresh Menon of ISCR said that the key objective of 12 rules, to be adhered by the clinical research industry, is that the 200 members of ISCR representing from across the clinical research spectrum are committed to ethical, scientific and regulatory compliance during the process of human studies.
Of the 12 norms, the first is to ensure compliance to all applicable regulations in the country during the design, conduct, monitoring and reporting clinical research. Second is to confirm the scientific merits by giving adequate consideration during review of literature ad available treatment options to patients after approval by regulatory agencies.
Third is maximization of public interest where ISCR members will participate in research with the objective of protecting public interest and will help to bring in effective disease management options to patients after approval by regulatory agencies. Fourth is to ensure protection of autonomy, rights, dignity and privacy of participants by maintaining the required confidentially of participants. The participation of individuals in a trial must be voluntary and based on a well informed consent. In this regard, members of the ISCR would ensure that the briefing would be given both verbally and in writing in the language that the participants know and understand.
Fifth is the consideration to risk-benefit ratio in favour of the participants. All research carries some risk to the patients and therefore while designing any scientific research proposal, ISCR members would carefully review the risk benefit ratio to patients. They would ensure adequate risk mitigation plans. Therefore, the participants will be informed of the risk of participating in the trial.
Sixth is the stringent monitoring of trial conduct where the members will ensure trained participants are part of the team and take adequate corrective and preventive measures to address any deviations. Seventh is the conflict of interests as the ISCR members will need to adhere to the principles laid down by the Indian Council of Medical Research and Indian Good Clinical Practices (GCP) while conducting patient studies.
Eighth is the support promotion of ethical research where guidelines are adhered to and self regulations are ensured. Ninth is the accountability and transparency where ISCR members will ensure maintaining records and support the independent quality assurance framework. Tenth is the post trial access as mandated by the local regulatory authorities. The 11th code of conduct is to build the research capacity of all stakeholders while conducting research through training, monitoring and creation of networks. The last norm deals with the support of research certifications and stakeholder accreditations to raise the standards of human study work in the country.