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 committee established 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 personal view of the situation, they it will help us
understand the landscape of bioethics in the region at this critical time for growth and improvement.
1
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:
2
Q9
Q10.2
Does your country have a National Ethics Committee (NEC) or similar governing body?
Yes
No
Don't Know
If yes, are you a member of the National Ethics Committee or similar governing body?
Yes
No
If yes, what is your position/or role in the National Ethics Committee or similar governing body?
Q10.3
If no, what type of ethics committees does your country have? Please be specific.
Q10.1
For National Ethics Committees, please answer questions Q11-33; for others ethics committees, please answer questions Q28-Q33
Q11
Q12
Is there a law/policy establishing the National Ethics Committee or similar governing body?
Yes
No
Don't Know
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
When was the National Ethics Committee established?
Q15
3
Q16
Q17
Q18
Q19
Q19.1
Q20
Q21
Please enter the year in four digit format (i.e. 2015)
How often does the committee meet ?
Annually
Bi-Annually
Quarterly
When it is Necessary
Other (Please specify):
In the last calendar year, how often did the committee meet?
Annually
Bi-Annually
Quarterly
When it is Necessary
Other (Please specify):
What was the average Number of research proposals reviewed by the National Ethics Committee in the last year?
Don’t Know
Does the committee have adopted standard operating procedures to guide their work?
Yes
No
Don’t Know
If yes, are these standard operating procedures informed by regional or international standards or best practices?
Yes
No
Don’t Know
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
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
Q24
Q25
Q26
Does the NEC or similar governing body require the registration of projects in the country, research or otherwise?
Yes
No
Don’t Know
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
What is the minimum number of members that must be present in order for proposals to be discussed? (I.e. Quorum)
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
4
Q27
What were the 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):
5
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
Q28.1
Q29
Q29.1
I will answer the following questions for:
National Ethics Committee
Other (please specify):
What documents does the ethics review committee require from investigators 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:
Are there penalties for non-compliance with the regulations and decisions of the national ethics committee?
Don’t
Yes
No
Know
If yes, what are the penalties?
Withdrawal of funding
Suspension of research
Reporting to national regulatory or other bodies
Other, please specify:
6
Q30
Q31
Q32
Q33
Are there policies in place to monitor on-going research?
Yes
No
Don't Know
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):
Are the ethics review processes different for research originating from a different country?
Yes
No
Don't Know
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
Q35
Q36
Q37
I will answer the following questions for:
National Ethics Committee
Other (please specify):
Are there any training and/or capacity building opportunities provided to members of the ethics review committee?
Don't
Yes
No
Know
Is the training required or optional for members of the review committee?
Don't
Required
Optional
Know
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
7
Q38
Q39
Q40
Q41
Q42
Q43
Q43.1
Does the committee engage the service of consultants from time to time for technical support?
Yes
No
Don't Know
Do you have an operating budget for ethical review
activities?
Yes
No
Don't Know
What is the estimated annual budget?
Don't know
What is the budget used for? Please give 3-5 examples:
Is there any clerical and/or administrative support for the ethics review committee?
Yes
No
Don't Know
Do members of the ethics review committee get compensated in some way for serving on this committee?
Yes
No
Don't Know
If yes, how are they
compensated:
8
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
Q45
Neutral
Disagree
Strongly Disagree
Not applicable
I feel comfortable with the decisions of the National Ethics Committee or similar governing body in my country.
Strongly Agree
Q46
Agree
Agree
Neutral
Disagree
Strongly Disagree
Not applicable
If my country does not have a National Ethics Committee or similar governing body, it should establish one.
Strongly Agree
Agree
Q47
Neutral
Disagree
Strongly Disagree
Not applicable
My country faces many ethical issues in research.
Strongly Agree
Agree
Q48
Neutral
Disagree
Strongly Disagree
Not applicable
My country faces many ethical issues in practice.
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree
Not applicable
9
Please share your thoughts on how we can move forward:
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.):
10