The main role of the National Bioethics Committee (NBC) would be of an advisory body dealing with all aspects of bioethics in the health sector in the country. The Committee would promote and facilitate ethical health services delivery and health research. It would be an umbrella body linked with the ethical review bodies in organizations and institutions like the Pakistan Medical and Dental Council (PMDC), the Medical Training and Teaching Institutions and the recently constituted Good Clinical Practices (GCP) committee of the Ministry of Health’s Drug Division.  

·        The Committee will have two Sub-Committees: 

        i).         Research ethics committee-will address ethics in research 

        ii).        Medical ethics committee- will address ethics in medical practice and education

·        The Committee would function independently. 

·        It will be approved and notified by the Ministry of Health. 

PATRONS

 ·        The Minister Health and Secretary of Health would be the patrons. 

CHAIRMAN

 ·        Director General Health, Ministry of Health, would be the Chairman.

 SECRETARY

The Secretary will coordinate the meetings. Look after day-to-day business of the committee. Keep Liaison with national research organizations and international ethics committees.   

SECRETARIAT

PMRC will provide a secretariat for the Committee and will take on the responsibility of arranging regular meetings of the committee and implementing its decisions and recommendations.

OPERATIONAL COSTS 

• PMRC will bear the cost of the maintenance of the secretariat from within its recurrent budget;
• A Fee will be charged from the Research Project Proposals, which come up for ethical clearance to the Committee. PMRC will maintain the Account and present it to the Committee from time to time.
• The DG Health would approach WHO EMRO to allocate some funds in the WHO and Government of Pakistan’s Joint Review Mission (JPRM) funds for the operations of the Committee.

MEMBERS OF THE NBC

·        It will have 20-21 Members

·        Of these Regular members will be 90% and Co-opted 10%

·        Members will be from both sexes and of a wide age range

·        There will be representation from the Provinces

·        PMRC, PMDC and Pakistan College of Surgeons and Physicians (PCSP) will have

         ex-officio permanent representation on the committee

·        Membership will be for 3 to 5 years, which may be renewed once.

·        The Ministry of Health (MoH) will be the approving authority of the membership. 

Composition of the NBC

The following is the distribution of membership among various categories of stakeholders: 

        Catyegory                                                  Number     

·        Representative   (PMDC, CPSP, PMRC)    3(ex-officio)

·        Universities/Medical colleges                   2

·        Bio Scientists                                            2

·        Academics                                                2

·        General Practitioners                                1

·        Nurses                                                       1

·        WHO                                                          1(ex-officio)

·        Journalists                                                 1

·        Social Scientists                                        1

·        Lawyers                                                     1(ex-officio)

·        Religious Scholars                                     1

·        Industry                                                      1

·        Human Rights Commission                        1

·        Co-opted members                                    2

·        Surgeon General/DGMS, Pak Army           1

         Total                                                           21 

TERMS OF REFERENCE ( TOR ) OF THE NATIONAL BIOETHICS COMMITTEE ( NBC )

The committee will prepare and revise national guidelines on health research in Pakistan and will

recommend to the Ministry of Health (MoH) for approval of the ethical guidelines for scientific contents and

ethics of health research in Pakistan.

The committee will advise the Government of Pakistan, or any other body which so desires, on all matters

pertaining to the ethics of research involving human subjects.

The committee will principally review proposals for research to be carried out in the area of Federal authority

and, if required or desired, the Provincial governments. 

The Committee will prepare an annual report for the Ministry of Health.

The Committee will participate in national and international discussions on the ethics of health research. 

The Committee will grant accreditation to other ethics committees, which conform to satisfactory standards of

evaluation and supervision of health research. 

The Committee will monitor and coordinate activities of other accredited research ethics committees, which

conduct or supervise research.

The Committee will advise national and international research collaborators on matters related to the ethics of

health research in Pakistan.

The NBC will approve only those studies, which have already been cleared for scientific quality from technical

bodies, and which conform to national and international acceptable ethical standards for research.

The committee shall make use of external expert advisors, whenever required.

The approval of research projects shall be time-limited according to the stated duration of the projects.

All serious adverse events encountered during the course of research shall be promptly reported to the NBC.

The NBC shall be involved in decisions to prematurely stop the research for ethical reasons, if so required,

after interim analyses.

Some form of ethical follow-up in the form of annual report and/or a more frequent reporting of selected

indicators will be required of research projects reviewed by the Committee.

The Principal Investigator (PI) shall be required to submit final report of ethical aspects of the project to the

NBC.

In the absence of appropriate mechanisms to investigate allegations of scientific fraud, the Committee may be

the most appropriate body to address these issues.

There must be a mechanism to financially support the working of the committee. This may be done:

         i)        By allocating some budget for the ethical committee in the proposed budget of the study

        ii)        The PMRC may provide some funds from within its allocated budget

The PMRC will forward the recommendations and decisions of the Committee to the relevant quarters for

implementation.

COMPOSITION OF THE NATIONAL BIOETHICS COMMITTEE ( NBC)

PATRONS:                                    Minister, Health

                                                     Ministry of Health, Government of Pakistan, Islamabad

                                                     Secretary, Health

                                                     Ministry of Health, Government of Pakistan, Islamabad

CHAIRMAN:                                   Director General, Health

                                                     Ministry of Health, Government of Pakistan, Islamabad 

MEMBERS EX-OFFICIO:             

1. President,

    College of Physicians & Surgeons of Pakistan (CPSP)

2. President,

    Pakistan Medical and Dental Council (PMDC)

3. Executive Director,

    Pakistan Medical Research Council (PMRC), (Member/ Secretary)

4.  WHO representative in Pakistan

5.  President,

     Supreme Court Bar Association (as a representative of Lawyers)

Universities/ Medical Colleges:                          

6.   Dr. Mohammed M. AminDean,

      Shifa College of Medicine, Pitras Bukhari Road, Sector H-8/4, Islamabad

Bio Scientists:                           

7.   Dr. Anwar Nasim

      Adviser Science

      COMSTECH Secretariat, 3-Constitution Avenue, G-5/2, Islamabad

 8.  Dr. S. Qasim Mehdi

      Director General, Biomedical & Genetic Engineering Division

      Dr. A.Q. Khan Research Laboratories, GPO Box 2891, 25 Mauve Area, G-9/1, Islamabad.

 Academics: 

9.    Prof. Dr. Zulfiqar Ahmed Bhutta

       Prof. Of Paediatrics & Child Health, Department of Paediatrics, and Director Neonatal Services,

       Aga Khan University Hospital, (AKUH), Stadium Road, P.O. Box 3500, Karachi-74800 

10.   Dr. Maqbool H. Jafary

        Director,

        Novartis Medical Centre for Asia- Pacific,15, West Wharf Road, Karachi-74000

General Practioner:           

11.    Dr. Sharriatullah Siddiqui

         President,

         College of Family Medicine, Karachi

Nurse:                                            

12.    Mrs Faiz Alamzeb,

         Principal,

         Postgraduate College of Nursing, Peshawar, NWFP

Journalist:                                 

13.    Mr. Shaukat Ali Jawaid

         Chief Editor (Pulse International), Managing Editor (Pakistan Journal of Medicine),

         Chief Executive, Professional Medical Publications, Karachi. 

Social scientist:                     

14.      Prof. Dr. Anis Ahmed

           Vice-Chairman of the Institute of Policy Studies, Nasr Chambers, Block 19, F-7, Islamabad.

           Meritorious Professor of Islamic and Comparative Religion, Editor-in–Chief of West and Islam

           (quarterly journal, Islamabad)

           Chairman of the Foundation of the Faithful, an NGO committed to development of education,

           human resource development, and social welfare

Religious Scholar:

15.       Dr. Asmatullah

            Assistant Professor, Islamic Research Institute, Islamic University, P. O. Box 1035, Islamabad

Industry:                                     

16.       Mr. Haider Karrar

            Managing Director, Biogenics Pakistan (Pvt.) Limited, Karachi                                   

Human Rights Commission:                           

17.       nomination being sought from Punjab

Health Departments:               

18.       Balochistan Health Department (a nominee)

19.       NWFP Health Department (a nominee)

20.      Maj. Gen. Masood Anwar

           Commandant, Armed Forces Institute of Pathology (AFIP), Rawalpindi.

           A Nominee of Surgeon General / DGMS, Pak Army: