Ethics Committees in the WHO Eastern Mediterranean Region
A survey conducted by the World Health Organization in the EMRO, 2015
“Each person should apply his/her own reality to bioethics, it being a new, elegant discipline.
But if one attempts to use bioethics to disguise a country’s problems, then we should take a step back and have no more bioethics.
Whereas we need to keep moving ahead if this is an intelligent way of discussing a society’s actual, sensitive problems.“Christian Byk
The aim of this survey: to conduct a situational analysis of bioethics in the Eastern Mediterranean Region.
The goal of this project: to identify areas of progress and improvement in bioethics for each country.
Pertinent Definitions:
- National Ethics Committee (NEC): can have many different names: Committee, Council, Advisory Body, Consultative Committee or Standing Committee. In order for committees to be considered National Ethics Committees, they need to operate on the level of the Member State/Country as a whole. In many countries, there are committees that operate at a regional, state, or provincial level as well as at the institutional level, but unless government authorities recognize the committee, it should not be considered a national ethics committee.
- National Bioethics Committee:Same as National Ethics Committee
- Research Ethics Committee(REC):Institutional committeeestablished to protect the welfare of research subjects
- Bioethics Committee: a committee that systemically and continually addresses the ethical dimensions of health sciences, life sciences, or innovative health policies.
- Institutional Review Board (IRB):a body established by an institution -- a university, hospital, ministry of health or of science, a private or corporate industry, etc. -- to review activities and proposed activities within the institution and to ensure that they meet certain ethical, scientific, or professional standards. A committee, which supervises ethical and scientific quality of activities, especially research, within an institution. They usually deal mainly with human and animal experimentation, but environmental IRB's might also be considered.
Thank you for your time filling out this survey. While your responses reflect your personalview of the situation, they it will help us understand the landscape of bioethics in the region at this critical time for growth and improvement.
Q1 / Please provide us with the following contact information:Name:
Current Job Title:
Postal Address:
Email Address:
Telephone Number:
Regulation and laws for ethical issues in relation to research on human subjects
Q2 / Is there any law or policy in your country that establishes ethical standards for research involving human subjects?Yes / No / Don't Know
Q3 / Does the national law or policy cover these aspects of ethics and research?
-Informed Consent / Yes / No
-Capacity of research subjects / Yes / No
-Disclosure of Information To research subjects / Yes / No
-Voluntariness / Yes / No
-Confidentiality / Yes / No
Q4 / Are regional or international guidelines referred to in the national law/policy?
Yes / No / Don't Know
Q5 / Are ALL health research institutions required to adopt a policy regarding research ethics?
Yes / No / Don't Know
Q6 / Are there specific policies or laws governing the ethical review of sensitive topics? (Such as abortion, artificial reproductive technologies, human cloning, stem cell research, research on minors, etc.?)
Q7 / Yes / No / Don't Know
Is ethical review required for ALL research involving human subjects in the country?
Yes / No / Don't Know
Q8 / If no, please provide examples of the types of research excluded from ethical review:
Q9 / Does your country have a National Ethics Committee (NEC) or similar governing body?
Yes / No / Don't Know
Q10.1 / If yes, are you a member of the National Ethics Committee or similar governing body?
Yes / No
Q10.2 / If yes, what is your position/or rolein the National Ethics Committee or similar governing body?
Q10.3 / If no, what type of ethics committees does your country have? Please be specific.
For National Ethics Committees, please answer questions Q11-33; for others ethics committees, please answer questions Q28-Q33
Q11 / Is there a law/policy establishing the National Ethics Committee or similar governing body?Yes / No / Don't Know
Q12 / Please describe in your own words the function of the National Ethics Committee or similar governing body:
Q13 / Are there any written guidelines for selecting the members of the National Ethics Committee or similar governing body?
Yes / No / Don't Know
Q14 / What types of professionals are currently represented on the NEC? (Please check all that apply)
Physician
Nurse
Pharmacists
Dentists
Scientists (researchers)
Lawyer
Clergy (religious leader)
Ethicist (with recognized professional degree/experience)
Elected officials
Community/civil society members
Q15 / When was the National Ethics Committee established?
Please enter the year in four digit format (i.e. 2015)
Q16 / How often does the committee meet ?
Annually / Bi-Annually / Quarterly
When it is Necessary / Other (Please specify):
Q17 / In the last calendar year, how often did the committee meet?
Annually / Bi-Annually / Quarterly
When it is Necessary / Other (Please specify):
Q18 / What was the average Number of research proposals reviewed by the National Ethics Committee in the last year?
Don’t Know
Q19 / Does the committee have adopted standard operating procedures to guide their work?
Yes / No / Don’t Know
Q19.1 / If yes, are these standard operating procedures informed by regional or international standards or best practices?
Yes / No / Don’t Know
Q20 / Does the National Ethics Committee or similar governing body have the authority to guide and oversee the functioning of other Ethics Committees in the region?
Yes / No / Don’t Know
Q21 / Does the National Ethics Committee or similar governing body ensure the harmonization of standards, networking, communication, and cooperation among the other ethics committees in the country?
Yes / No / Don’t Know
Q22 / Does the NEC or similar governing body require the registration of independent ethics committees in the country?
Yes / No / Don’t Know
Q23 / Does the NEC or similar governing body require the registration of projects in the country, research or otherwise?
Yes / No / Don’t Know
Q24 / When a decision is being made, if some members of the committee disagree with the majority's decision, is the substance of the disagreement recorded and communicated?
Yes / No / Don’t Know
Q25 / What is the minimum number of members that must be present in order for proposals to be discussed? (I.e. Quorum)
Q26 / Is there an explicit rule to exclude NEC members with a direct interest in a proposal for review, from participating in its assessment?
Yes / No / Don’t Know
Q27 / What werethe main issues that have been discussed during the last meeting of the committee (most recent)?
The criteria for selecting the study population
Acceptability of the study design and study instruments including adequacy of control group and acceptability of active or placebo control
Procedures or documentation to obtain informed consent from potential subjects, including clarity and comprehensiveness of documentation and certificate of consent
Level of risk in the research, for example adequacy of the toxicological and pharmacological data concerning the types and intended dosages of drugs or devices to be used
Right of the subject to withdraw from study without prejudice to his/her further medical treatment or access to effective health services
Medical or health risks and benefits to the study participants or community
Confidentiality procedures in the research or study, that may lead to identification of individual subjects
Potential conflict of interest on the part of the investigator
Undue inducement to participate in research on the investigators behalf
Acceptability of the level of medical care/health services provided in light of risk to subjects
Undue inducement to participate in research on the subject’s behalf (compensation to study participants apart from legitimate compensation for travel or lost earnings)
Research having a direct or potential benefit in the present or future, for people in the sup-group, geographical region, or country to which the research is being conducted
Research procedures that are disrespectful of local culture
Research results that may not be made available at the conclusion of the study
Proportionality of potential benefits to risks for study participants and others
Other (please specify):
If your country does not have a NEC, please answer Q28-Q33 for a research ethics committee or bioethics committee you are familiar with (hospital ethics committee, institutional review board, independent bioethics committee etc.):
Q28 / I will answer the following questions for:National Ethics Committee / Other (please specify):
Q28.1 / What documents does the ethics review committee require frominvestigators for the review of a proposal?
Application form
Research protocol
Brief summary of protocol
Case report forms, questionnaires, or other documents used in collecting data
Safety, pharmacological, toxicological data on products under investigation, if applicable
Investigator’s curriculum vitae
Participant recruitment materials
Description of procedures for obtaining and documenting informed consent
Information sheets or other forms of information for potential research participants
Statement of compensation provided to participants
Statement of legal liability or indemnity, if applicable
Statement of conflict of interest from investigator
Documentation of approvals of other ethical review committees or regulatory authorities
Other, please specify:
Q29 / Are there penalties for non-compliance with the regulations and decisions of the national ethics committee?
Yes / No / Don’t Know
Q29.1 / If yes, what are the penalties?
Withdrawal of funding
Suspension of research
Reporting to national regulatory or other bodies
Other, please specify:
Q30 / Are there policies in place to monitor on-going research?
Yes / No / Don't Know
Q31 / What types of mechanisms are applied to monitor on-going research?
Annual ethical review of previously approved projects
Required periodic report from primary investigator
Unannounced audit of research by representatives of the ethics committee
Other (please specify):
Q32 / Are the ethics review processes different for research originating from a different country?
Yes / No / Don't Know
Q33 / In reviewing collaborative research, would the ethics review committee disapprove of a project that did not have realistic prospects of serving the health needs of the population? For example, would it insist that research conform to a list of national health priorities, or that proven interventions after trials be made available for free or at a reduced cost to the population?
Yes / No / Don't Know
Ethics Training and Capacity Requirements
Q34 / I will answer the following questions for:National Ethics Committee / Other (please specify):
Q35 / Are there any training and/or capacity building opportunities provided to members of the ethics review committee?
Yes / No / Don't Know
Q36 / Is the training required or optional for members of the review committee?
Required / Optional / Don't Know
Q37 / Are the ethics committee members familiar with the following? Check all that apply:
CIOMS/WHO International Ethical Guidelines for Biomedical Research Involving Human Subjects
Declaration of Helsinki
The Nuremberg Code
Hippocratic Oath
Others? Specify
Q38 / Does the committee engage the service of consultants from time to time for technical support?
Yes / No / Don't Know
Q39 / Do you have an operating budget for ethical review activities?
Yes / No / Don't Know
Q40 / What is the estimated annual budget?
Don't know
Q41 / What is the budget used for? Please give 3-5 examples:
Q42 / Is there any clericaland/or administrative support for the ethics review committee?
Yes / No / Don't Know
Q43 / Do members of the ethics review committee get compensated in some way for serving on this committee?
Yes / No / Don't Know
Q43.1 / If yes, how are they compensated:
Please choose the answer that is most reflective of your personal thoughts on the issue of National Ethics Committees:
Q44 / If my country has a National Ethics Committee or similar governing body, I believe it is efficient and effective as it currently functions.Strongly Agree / Agree / Neutral / Disagree / Strongly Disagree / Not applicable
Q45 / I feel comfortable with the decisions of the National Ethics Committee or similar governing body in my country.
Strongly Agree / Agree / Neutral / Disagree / Strongly Disagree / Not applicable
Q46 / If my country does not have a National Ethics Committee or similar governing body,it should establish one.
Strongly Agree / Agree / Neutral / Disagree / Strongly Disagree / Not applicable
Q47 / My country faces many ethical issues in research.
Strongly Agree / Agree / Neutral / Disagree / Strongly Disagree / Not applicable
Q48 / My country faces many ethical issues in practice.
Strongly Agree / Agree / Neutral / Disagree / Strongly Disagree / Not applicable
Please share your thoughts on how we can moveforward:
Q49 / Please use the space below to describe 3-5 major challenges your country faces with National Ethics Committees or similar governing bodies:Q50 / Please use the space below to describe 3-5 major challenges your country faces with regards to bioethics:
Q51 / Please use the space below to describe 3-5 major ethical issues your country faces in health care (example: organ transplantation, stem cell research, contraception, abortion, etc.):
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