The Committee will need substantial administrative and secretarial assistance from the ZU.

Mandate:  The Ethics Review Committee is responsible for reviewing all (medical or social science) research proposals involving human participants, whether as individuals or communities, including the use of fetal material, embryos, and tissues from the recently dead, supported or undertaken by ZU faculty, staff or students to ensure that they are conducted ethically.

Reporting: The Committee shall report annually or more frequently, as necessary, to the Dean.

Composition: The Committee shall consist of a minimum of nine and a maximum of thirteen members with diverse backgrounds and expertise (ethics, law, medicine, social sciences, research methodology, etc.). Genders and all levels of seniority should be represented.  At least 25% of members should be external (not from ZU).

Method of Appointment of Chair and Members

The chair should ideally have served as a member of an ERC for at least a year. 

The Dean and or the Chair of ERC should announce that new members of the ERC are needed either via a university-wide email or through a bulletin. The chair and members can recommend external members.

Members should be appointed based on their knowledge, experience, and ability to represent the interests of human subjects and most importantly their ability to give time to ERC.

Responsibilities: The Ethics Review Committee shall:

• Review research proposals to ensure that they comply with ethical principles and standards, such as respect for autonomy, beneficence, non-maleficence, and justice.
• Evaluate the risks and benefits associated with research, including the potential risks to human subjects and the potential benefits to society.
• Assess the informed consent process to ensure that participants have been fully informed about the nature of the research and that their consent is voluntary and informed.
• Review the recruitment process to ensure that it is based on science and is fair and indecent free from inducement and coercion.
• Monitor the conduct of research to ensure that it is being carried following the ethical principles and standards.
• Ensure that researchers maintain the confidentiality and privacy of research participants and their data.
• Review any complaints or concerns raised by participants or others regarding the research.
• Guide researchers regarding ethical issues arising during the research process.

Meetings

• The committee will meet every second Wednesday of the month, additional meetings may be called in exceptional circumstances.
• Meetings can be face-to-face, online, or hybrid.
• A quorum shall consist of one-third of all members, however at least one external member is mandatory.
• Confidentiality of the Committee’s proceedings should be preserved.
• Members of the Committee should declare their conflict of interest, for example when testing the product of a company of which the member is an advisor.
• Members should report incidences of misconduct or noncompliance of TOR by any member, promptly to the chair/ secretary.

Decisions of the committee

In making decisions on applications for the ethical review of research, the committee will do the following:

• Submission of the study is acknowledged via email/letter and a number is assigned.
• All studies submitted two weeks before the next meeting date will be reviewed in the coming meeting (those submitted less than two weeks before the next meeting will be reviewed in the following month).
• The study proposal will be circulated to all members however two members will be assigned as primary reviewers.
• ERC review will be sent to PI within eight weeks after submission.
• In exceptional circumstances, a Rapid (time-sensitive) review will be done within five working days.
• Once the review decision is sent to the PI, it is expected that the PI should respond within 2 months, if no response from the PI is received at the end of 2 months,  a letter will be sent to the PI stating ‘that if in the next 1-month, the PI does not respond the study will be considered to be abandoned by PI’ and will be marked as ‘Null and Void’in the Submission record.
• A member should withdraw from the meeting for the decision procedure concerning an application if a conflict of interest arises; the conflict of interest should be indicated to the chairperson prior to the review of the application and recorded in the minutes.
• Non-binding advice may be appended to the decision.
• In cases of conditional decisions, clear suggestions for revision and the procedure for having the application re-reviewed should be communicated to the applicant.
• A negative decision on an application should be supported by clearly stated reasons.

The Committee may:

• Approve the research to proceed without requiring any amendment.
• Revoke approval if dissatisfied with the conduct of the research or the researcher.
• Defer consideration of a research proposal to a subsequent meeting if substantial modification is required or where significant additional information is needed.
• Require clarification or modification of parts of the research submission.
• The Chair will normally be granted authority to approve the amendments without requiring further deliberations by the full Committee.
• Reject the research proposal in whole or in part.
• The Chairperson may invite additional non-voting attendees and may also co-opt additional members by mutual agreement.

Documentation and Archiving

1. The agenda of the ERC meetings.
2. The minutes of the ERC meetings.
3. The correspondence by ERC members with applicants or concerned parties regarding application, decision, and follow-up.

Chairperson

Expertise: The chairperson should have research expertise that the committee will be reviewing. This may include knowledge of ethical principles and guidelines, relevant laws and regulations, and experience in research design and methodology.

Leadership skills: The chairperson should have strong leadership skills and be able to guide the committee in its decision-making processes.

Impartiality: The chairperson should be able to remain impartial when reviewing research proposals and making decisions.

Availability: The chairperson should be available to attend committee meetings and be willing to dedicate the time needed to review research proposals thoroughly.

Communication skills: The chairperson should have excellent communication skills and be able to clearly and effectively communicate with committee members, researchers, and other stakeholders.

Integrity: The chairperson should have a strong sense of integrity and be committed to upholding ethical principles and guidelines.

Tenure: The Chairperson will be appointed for a duration of 2 years and may get an extension for one more term.

Selection:

• Secretary

A secretary will be selected by the chairperson.

The secretary will be responsible for organizing the meetings, agenda formation, and maintaining records of minutes of meetings.

Knowledge of ethical principles: The Secretary should have a good understanding of ethical principles and their application in various situations.

Experience in ethics review: The Secretary should have experience in conducting ethics reviews, preferably in a similar field or industry.

Attention to detail: The Secretary should have excellent attention to detail, as ethics reviews often involve reviewing large amounts of data and information.

Impartiality: The Secretary should be impartial and able to objectively evaluate ethical issues without any bias or conflict of interest.

Communication skills: The Secretary should have strong communication skills to effectively communicate with members of the ethics review committee and other stakeholders.

Professionalism: The Secretary should be professional and able to maintain confidentiality in all matters related to the ethics review.

Education and Training: A relevant educational background and training in ethics, law, or related fields are preferred.

Internal and External (not associated with ZU) Members

Overall, the selection of members for the ERC should prioritize individuals who have the necessary expertise, experience, independence, and diversity to ensure a rigorous and fair review process for research proposals involving human subjects

• Members of the ERC should be:
  • Expert in relevant fields such as research methodology, ethics, medical, or social sciences.
  • Experienced in conducting or reviewing research involving human subjects.
  • Available to attend meetings regularly and to review research proposals within the established timeline.
  • Independent and unbiased in their decision-making.
  • Able to Communicate and write clear and concise reports, to express their opinions clearly and effectively, and engage in constructive dialogue with researchers.
  • Able to maintain Confidentiality and handle sensitive information with discretion and professionalism.

Tenure: The Members will be appointed for a duration of 3 years and may get an extension for one more term.

Standard Operating Procedures (SOP) Ziauddin University Ethics Review Committee (ZU-ERC)