Strong oversight from the NBC and Provincial Ethics Committees,
supported by regular training & accountability mechanisms is essential
ISLAMABAD: The composition and functioning of many Ethics Committees (ECs) or Institutional Review Boards (IRBs) in medical institutions across the country are inadequate and need urgent reform. Some of these committees lack formal meetings, have untrained or inexperienced members, and do not maintain proper documentation.
To ensure transparency and improve their performance, all ECs must be registered with Provincial Ethics Committees or the National Bioethics Committee (NBC). This registration should be periodically renewed—ideally every two to three years—based on their performance and adherence to established guidelines.
Ethics Committees are responsible for evaluating and approving research projects. However, numerous issues have been observed during the manuscript submission process to biomedical journals. For instance, several ECs, even those affiliated with tertiary care facilities, have been found issuing handwritten amendments to approval letters, including unauthorized addition of authors. In one case, a medical university was found issuing fictitious EC approvals for research projects.
The Government of Pakistan established the National Bioethics Committee (NBC) in 2003. Initially, the NBC organized training sessions for EC members and issued guidelines for the composition and operation of these committees. Provincial Ethics Committees were also formed. Although NBC meetings were irregular, they managed to develop several important guidelines. After some members retired in 2014, new members were inducted. In subsequent years, many functions of the NBC were delegated to Provincial Committees, while the NBC retained responsibility for multicenter and internationally funded studies.
In the absence of effective oversight, the performance of many ECs has become inconsistent and concerning. It is imperative that their functioning be systematically reviewed and improved. Below are key steps that must be taken:
Key Measures to Improve the Functioning of Ethics Committees
- Membership Composition:
Committees should have diverse and balanced representation, including researchers, legal experts, allied health professionals (e.g., nursing), community members, and non-medical individuals. To preserve independence, the head of the institution should not chair the committee. Ongoing training in research ethics and regulatory requirements should be mandatory for all members. - Governance and SOPs: Each EC should operate under well-defined Standard Operating Procedures (SOPs). These should detail the processes for project review, approval, monitoring, and documentation. Conflict of interest policies must be in place. Committees should meet regularly with full quorum, and properly recorded minutes should be maintained. Every approved study must be documented with a reference number and date.
- Scientific and Ethical Review:
Research proposals must undergo rigorous scientific and ethical scrutiny. The methodology must be sound, and a thorough risk-benefit analysis must be conducted. Informed consent must be obtained from all participants in a way that ensures they understand the study. Additional safeguards should be implemented for vulnerable populations such as children, prisoners, and pregnant women. - Documentation: Meeting minutes should be signed by all present members. Records of all approvals and rejections must be maintained and archived properly, ensuring accessibility for future reference.
- Ongoing Monitoring: Ongoing studies must be reviewed at regular intervals—either annually or biannually. Protocol deviations, serious side effects, and adverse events must be reviewed and reported in a timely manner.
- Compliance with Ethical Guidelines: Ethics Committees must adhere to national and international standards, including the ICH-GCP guidelines, the Declaration of Helsinki, and applicable local regulations.
- Training and Coordination:
The National Bioethics Committee should take responsibility for organizing ongoing training programs for EC members. While several institutions in Pakistan now offer training in bioethics, there is a lack of coordination and collaboration among them. This must be addressed to strengthen national capacity.
The integrity and credibility of biomedical research rely heavily on the effective functioning of Ethics Committees. It is essential that appropriate measures are taken to improve their composition, governance, and monitoring. Strong oversight from the NBC and Provincial Ethics Committees, supported by regular training and accountability mechanisms, is the need of the hour.
