National Medicines Regulatory Authority (NMRA)

Accreditation of Ethics Committees

Subcommittee on Clinical Trials (SCOCT) is in the process of reassessing the already recognized Ethical Review Committees. If interested, any other functioning ERC can apply for accreditation with SCOCT by furnishing the details requested in the questionnaire given herewith.

Questionnaire for ERCs

The Research Ethics System

• What is the legislative and regulatory framework under which your ERC functions?
• Are there specific SOPs (Standard Operating Procedures) approved by the relevant authority?
• Is it confined to approving protocols submitted by members of your institution or does it accept protocols from outside?
• Is there an appropriate and sustainable system in place to monitor the quality and effectiveness of research ethics review?
• Are there procedures to harmonies standards with other ERCs in Sri Lanka?
• Are there mechanisms to ensure that ERCs’ activities are coordinated with national regulatory authorities’ oversight of drugs and medical devices?
• What types of research studies are reviewed? Please give a rough %?
  • clinical trials
  • interviews, survey, and focus research
  • research with biological samples
  • studies involving medical records or other personal information
  • research of health care systems
  • quality improvement research

Establishment of the ERC

• Who is the appointing official?
• Are appointments made according to SOPs?
• If not, is it ensured that ERC composition has a multisectorial and multidisciplinary membership?
• How many members are in the ERC?
• How many non-scientific and non-medical members are in the ERC?
• Does the ERC include members who are not affiliated with your institute?

Adequate Staffing, Facilities, and Financial Resources to Allow the ERC to Carry Out Its Responsibilities

• Does the ERC have support staff adequate in number and training to carry out the ERC’s responsibilities?
• Does the ERC have adequate resources for the staff to fulfil its assigned functions, including office space and equipment and supplies (e.g., computers, stationery, telephones, photocopying machines) to conduct administrative business, to store all committee files, and to keep documents secure?
• Does the ERC have access to appropriate space for the committee to meet and adequate means for members to communicate as needed between meetings?
• Does the ERC have adequate financial resources to permit the committee to produce high quality work?
• Are the ERC members compensated for their time and effort on the ERC?

Policies Governing the ERC to Ensure Independence of the ERC’s Operations and Decision Making Process

• Do the ERC’s policies specify that its decision-making process is free from bias or influence?
• Does the ERC ensure that investigators and funders (who may attend an ERC meeting to answer questions about their research protocols and associated documents) are not present when the ERC discusses their studies or reaches decisions about them?
• Does the ERC ensure that ERC members do not participate in decisions about protocols submitted by their close colleagues?
• Do the ERC’s policies specify that high-level officials of the entity creating the ERC, or of any organization that sponsors or conducts the research reviewed by the ERC (such as the director of an institution), do not serve as members of the ERC?

Training of ERC Members on the Ethical Aspects of Health-related Research with Human Beings, and How the ERC Conducts Its Review of Research

• Are the ERC members provided with training in the following aspects when they join the committee and periodically during their committee service?
• the role and responsibilities of the ERC, and the ERC’s relationship with other relevant entities, according to relevant international guidelines (e.g., GCP)
• the full range of ethical considerations relevant to research with human participants
• how such ethical considerations apply to different types of research
• basic aspects of research methodology and design (for members who lack such background)
• how different scientific designs and objectives may affect the ethics of a research study
• the various approaches for recognizing and resolving the tensions that can arise among different ethical considerations and modes of ethical reasoning
• using resources prudently to maximize committee members’ training opportunities.

Mechanisms to Make ERC Operations Transparent, Accountable, Consistent, and of High Quality

• Does the entity establishing the ERC employ reliable means to evaluate whether the staff and members routinely follow the ERC’s policies, rules and SOPs with special attention to whether the ethical considerations articulated in international guidelines and national standards are being considered and applied consistently and coherently?
• Are these evaluations conducted at regular, pre-defined intervals, using a pre-defined format by knowledgeable and unbiased persons?
• Are internal assessments supplemented periodically by independent external evaluations?
• Is there a mechanism for researchers, research participants, and other interested parties to lodge complaints about the ERC? Such complaints should be reviewed by an entity other than the ERC itself, and appropriate follow-up actions should be taken.

Standards and Guidance for Members of the Research Ethics Committee

• Does the ERC base its decisions about research protocols on a coherent and consistent application of the ethical principles articulated in international guidance documents and human rights instruments, as well as any national laws or policies consistent with those principles?
• Does the ERC make clear the specific ethical guidelines on which it relies in making decisions and make them readily available to researchers and the public?

Decisions on Research Protocols by ERC

• Are decisions on research protocols designated for full review based on a thorough and inclusive process of discussion and deliberation by all members of the ERC?
• How are decisions made? By consensus or by voting?

Are There Written Policies Specifying the Following?

• ERC’s membership
• Committee governance
• Review procedures
• Decision-making communications
• Follow-up
• Monitoring
• Documentation and archiving
• Training
• Quality assurance

Does the ERC Provide Guidance for Researchers?

• Submitting an application - qualifications required, student applications, collaborative/multicentre trials etc. -
• Conduct of research -
• Any changes made to research protocol -
• Safety reporting -
• Ongoing reporting and follow-up -
• Termination/cancellation of a study -