Minutes of the Meeting of the National Health Research Ethics Committee, 6Th Floor Conference

MINUTES OF THE MEETING OF THE NATIONAL HEALTH RESEARCH ETHICS COMMITTEE, 6TH FLOOR CONFERENCE HALL, FEDERAL MINISTRY OF HEALTH, AUGUST 1, 2007

1.0Present

1. Prof. C. AdebamowoChairman
2. Prof. R. UmehMember
3. Dr. A. AdejumoMember
4. Dr. P. U. AgomoMember
5. Mr. M. T. GwazaMember/Fed. Ministry of Science & Tech. Representative
6. Mrs. Y. OseniMember/Rep. Pharm. T. Mora
7. Mrs. O. N. OgbechieObserver/Rep. Head, Department of Food & Drug Services

(H/DFDS)

1. Dr. BabaObserver/Rep. Head, Department of Hospital Services (HS)
2. Dr. T. FakeyeSecretary

1.1Absent

1. Dr. N. NjepuomeMember, Dept. of Public Health
2. Dr. Yahaya HashimMember (Development Research and Planning Centre (DRPC))
3. Rep. SCIAMember (Supreme Council for Islamic Affiars)
4. Rep. CANMember (Christian Association of Nigeria)
5. Dr. Hashim YusufuObserver (National Agency for Food, and Drugs

Administration & Control)

1. Dr. (Mrs) C. EzeigweObserver (Fed. Min. of Environment)
2. Mrs. C. P. MainaObserver (Fed. Min. of Education)
3. Audu A. MohammedObserver (National Univ. Comission)

1.2Secretariat

1. Dr. M. S. Bello
2. Mr. Ali Ahmed Gubio
3. Mr. Aminu A. Yakubu

1.3In Attendance

1. Mr. A. Kadiri
2. Dr. T. Ayanbgayi
3. Mr. O. Aduagba

Para / Discussion / Action By / Timeline
2.0
2.1
2.2 / Opening
The meeting started at 12.30 with a brief opening remark from the chairman. In his remark he recounted the recent restructuring in the Ministry under which Dr. T. Fakeye is now the NHREC secretary.
Introducing himself, the new NHREC secretary, recalled that his first assignment with the Ministry was a consultancy to assist the Ministry to develop health research systems in the early ’90, when he was instrumental in the development and implementation of a National Health Systems Research Programme with a Research Proposal Review Committee. the work was sponsored by the CCCD/USAID. Shortly afterwards his contract with the FMoH was regularized, when he became a staff of the FMoH, in charge of the International Health Division. While most of his work since then had been in areas outside research, his experience as a lecturer and for the period he served as a consultant on health research systems, he had gained invaluable experience that will have prepared him well to be able to quickly grasp the workings of the research division and take appropriate necessary actions to Strengthen the National Health Research Systems under the on-going health sector reform process of Nigeria.
3.0
3.1 / Reading and adoption of minutes of last meeting
The minutes were read and adopted following a motion moved by Bashir Umar and seconded by Dr. P. U. Agomo with the following amendments:

• Para 4.4, last line to read “ resource poor settings”

4.0 / Matters Arising from Minutes of Last Meeting
4.1
4.2
4.3
4.4 / Submission of Code to FEC and for Gazetting:
Further to the last meeting, the chairman observed the need, following approval of the code by NCH at its 50th meeting in January 2007, the NHREC secretariat should make efforts to prepare a memo for the submission of the code to FEC for approval.
There was need however for the committee to take a further look at the code for some important inputs. A key observed area was the absence in the code of clear channel of lodging complaints by research participants and communities.
Responding to this observation, the chairman informed the meeting that the code stipulates that consent forms should contain information on where research participants can complain, and also a section that stipulates that HRECs can institute investigation into the work of a research following complaint by communities or individuals. Thus the meeting resolved that information about channels of complaints for participants and communities should be made more explicit. / WABTP/NHREC Secretariat
4.5
4.6
4.7 / NHREC Visit to Western IRB
Chairman informed the meeting that WABTP was unable to provide this support due to various reasons including the slow response to mails by the Western IRB, and the fact that WABTP got a bit overwhelmed putting together the Masters in Bioethics Programme with the University of Ibadan.
However he informed the meeting that efforts will be made to explore how this can be actualized soon. WAB was to work towards June 2008 for this activity / WABTP/NHREC Secretariat
4.8
4.9
4.10 / Public Responsibility in Medicine and Research (PRIM&R)
The Chairman informed the meeting that WABTP undertook to sponsor the NHREC secretary and the Administrative Officer at the Public Responsibility in Medicine and Research (PRIM&R), in 2006. However due to some administrative reasons, only the administrative officer was able to attend.
The meeting was further informed that information for the PRIM&R meeting for 2007 has been sent to the e-mail list of NHREC. It was however agreed that in addition, that the NHREC secretariat should send hard copies of the call for application for the PRIM&R to all departments. / NHREC Secretariat
4.11
4.12
4.13 / Health Research Ethics Society of Nigeria (HRESON)
The association was constituted at the NRHEC training seminar in December 2006 in order to help promote health research ethics in Nigeria. However, not much progress has been made with the association. The chairman recalled that WABTP has committed to support the society and link it with similar associations in the global community.
The secretary of the association has been responsible for coordinating the activities of the society and it was agreed that he will be contacted in order to ensure that progress is made. The chairman reiterated the commitment of WABTP to support the society until it is firm on its feet. / Mr. S. T. Abolarinwa
5.0 / Increasing NHREC visibility
5.1
5.2
5.3 / Registration with UNESCO
In furtherance of NHRECs registration with UNESCO, the meeting observed that most of UNESCO’s support has been for francophone African countries and very little in the Anglophonecountries. The meeting agreed that NHREC should write a letter to UNDP making these observations and suggesting that some effort should be made to bring more activities to the Anglophone countries.
It was agreed that the chairman will draft the letter to UNDP which the NHREC secretariat will then process for the HMH. / Chairman
5.4
5.5
5.6
5.7 / Media Advocacy
Several activities had been planned including site visits to HRECs to promote visibility of NHREC activities. A notable activity was for the representatives of NHREC to appear on a live TV show in order to discuss issues regarding research ethics and promote human participant protection in the country. The meeting agreed that it will be strategic to time the live appearance with the launching of the code. In addition it was suggested that both print and electronic media should be used to for this advocacy.
Funding for these activities was considered by the meeting. The chairman informed the meeting that WABTP is unable to sponsor such activities in full, but will however consider providing part support following commitments by the FMoH. He added that NHREC members can make themselves available for interviews and WABTP/NHREC will provide support for such interviews.
NHREC secretariat was asked to bring up cost estimates for the various options for the advocacy for consideration. / NHREC Secretariat
5.8
5.9 / NHREC Registration with OHRP & FWA
The chairman informed the meeting that NHREC is now registered with the Office of Human Research Protection (OHRP) of the United States of America, and have also secured a Federal Wide Assurance therefrom. With the OHRP registration, NHREC is empowered to review US funded researches while the FWA also empowers NHREC to oversee US funded researches including grant holding to commissioned US funded researches.
6.0
6.1 / Registration of Ethics Committees
The meeting was informed of the meeting between the FMOH and NAFDAC where it was agreed that by January 2008, NAFDAC will consider enforcing a decision that it will only consider applications for approval of clinical trials whose protocols were approved by an NHREC approved ethics committee. In order to institute this properly, it was agreed that there was a need for NHREC to embark on wide advocacy to get HRECs to register. The NHREC secretariat was asked to send out calls for institutions to register with NHREC. / NHREC Secretariat
7.0
7.1
7.2
7.3 / NAFDAC and Clinical Trials
A member observed that the role of NAFDAC in nullifying the relevance of an ethical approval issued by a certified HREC for the conduct of clinical trials was limiting to the works of HRECs. The meeting observed the need for NHREC to work closely with NAFDAC to explore how these “grey” areas can be administratively managed in way to ensure the promotion of adherence to the national ethics code without any overt to ‘clash’ between the activities of NHREC and NAFDAC.
A key first step agreed by the meeting is to ensure that NAFDAC is made a standing member on the committee. To achieve this, it was recommended that of the provision for three nominees, of the Hon. Minister, it may be advisable that one position be allocated to NAFDAC.
In addition it was agreed that the NHREC secretariat should present for the Minister’s consideration for an inter-agency meeting. This forum will be useful to promote inter agency work and will provide a discussion ground between NHREC and NAFDAC. / NHREC Secretary
8.0
8.1
8.2
8.3
8.4 / Consideration for upgrading NHREC
Following a lengthy discussion on the advantages of ensuring that a uniform framework for research ethics was established, the idea of upgrading NHREC to status where it will be more empowered to take up the interest of other sectors including, science and technology, agriculture and environment was held. An appropriate structure was debated as to whether it should be a body under the Presidency or an standing agency under the FMoH.
It was however cautioned that NHREC should for the present concentrate more on: publicizing itself and its functions; resolving the potential clash in roles between it and NAFDAC; and ensure the submission of the code to the FEC and its gazetting. The timing for presentation of this proposal to the Hon. Minister, it was observed was important and should be considered first.
The meeting therefore agreed that it will focus more on advocacy, generating awareness, and strengthening the implementation of the code. Thus two important tasks are: to get the maximum approval for the code; and clarification of roles as it relates to clinical trials between NHREC and NAFDAC.
Regarding funding, the secretary informed the meeting that NHREC can benefit more from the Ministry budget cycle by developing well costed plans of action that the NHREC secretariat can use as a basis for budgetary request. For the year 2007, the meeting was informed that some funds are being processed to undertake some key activities for NHREC. However it was agreed that for 2008 the committee should work to develop a comprehensive workplan. To this end, a 2008 budget sub-committee was nominated to constitute the following:

1. Prof. Adebamowo
2. Dr. T. Fakeye
3. Dr. P. U. Agomo

/ 2008 Budget Sub-Committee
9.0
9.1 / NHREC Collaboration with WABTP for Capacity Building
The chairman informed the meeting of the Masters in Bioethics Course under the WABTP for which NHREC had sent calls for universities and research institutes to nominate members of ethics committees to make use of this opportunity. Other similar opportunities are obtainable in universities in Canada, South Africa and the United States of America. He added that NHREC will continue to support that institutions nominate individuals that are members of ethics committees to apply for this course with University of Ibadan
10 / Important Actions for NHREC
10.1
10.2 / Issuance of guidance
The chairman informed the meeting that the while the NHREC secretariat continues the process of obtaining the necessary approvals for the code, there is need for NHREC to develop a Q&A section on its website to answer recurring questions relating to the code and its application. In addition, it will begin to work on the SOP for NHREC which is to provide detailed application information on the code. / WABTP/NHREC Secretariat
10.3
10.4 / Certificate of confidentiality negotiation with FMOJ
This certificate is to provide for cover for those researching into rather illegal activities of research participants. For those whose key area of expertise is research into the factors associated with illegal actions, this certificate will exonerate them from the burden to disclose the information on whatever illegal action he/she comes across in the conduct of his/her research. / Chairman
10.5
10.6 / Position paper on the Pfizer “Trovan Trial” Case
A proposal for NHREC to develop a position paper on the Pfizer “Trovan Trial” case in order to provide the Hon. Minister with a guide in case she may need to make public statements on the matter was considered. In his contribution, a member suggested for the committee in considering this proposal, to look at existing global discussions on the Trovan Issue. The committee therefore agreed to develop a paper for consideration of the Hon. Minister to empower her to make informed contributions in appropriate avenues. / Chairman
11.0
11.1 / Review of 2007 Workplan:
The NHREC workplan was reviewed and comments made as in table 1.
12.0
12.1 / Closing
In his closing remark, the chairman thanked key officers in the Ministry including Dr. A. Nasidi, Dr. J. M. Adekeye, Dr. M. Mafe for pioneering and supporting the strengthening of NHREC this far. He thanked the secretariat for its hard work and the committee members for arriving on time and staying till the end of the meeting. He wished all journey mercies.
In addition the NHREC secretary further thanked the chairman for carrying all along and making the meeting easy to follow ensuring that all members participated. He urged the committee to concentrate on ensuring maximum effectiveness of the committee which is important for getting all the necessary support from all stakeholders needed to achieve the goals of the committee, including its plan for upgrading to an agency. He thanked all participants for attending the meeting saying that efforts will be made to ensure that the committee meets as regularly as possible, preferably quarterly.
The meeting closed at 6.00pm

Table 1. NHREC 2007 Workplan Reviewed

Activity / Comment
Pursue the ratification of the National Code for Health Research Ethics through the government processes and gazette the Code / NHREC Secretariat is to pursue FEC approval and later on gazetting of the code
Update data on currently available HREC and their distribution within country / This is an on-going process
Print, Launch and Widely Disseminate the Code on health research ethics / It was agreed that the printing and launching will be held back for sometime and try its timing with
Establish a web registration interface for the HRECs in Nigeria / This has been established
Develop Ministry’s (Research Division’s) capacity to host NHREC website
Organize a training program in Informed Consent for members of Health Research Ethics Committee in Nigeria / The first has been organized in June-August 2007. The second bath is coming on in October and NHREC secretariat is to plan to send out invitation
Develop prototype forms and agreements for researchers and HRECs / These have been developed and are on the NHREC website @
Develop Sub-codes for vulnerable populations and SOPs / The technical sub-committee is yet to work on this. The meeting agreed that NACA be contacted to explore collaboration in developing HIV/AIDS sub-codes
Register NHREC with OHRP, WHO, UNESCO, FDA etc as the national ethics regulatory agency in Nigeria / OHRP, UNESCO registrations concluded. NHREC secretariat is to follow up on registration with WHO
Sensitization workshop for biomedical community and other stakeholders / This is awaiting budgetary approval.
Registration of HRECs throughout the country with NHREC / This is an online process and is on-going.
Organization of international exposure for members of NHREC – most probably a 3 day visit to Western IRB in the United States / The meeting agreed to begin to work towards the visit to the Western IRB for June 2008.
Evaluation of HRECs in each of the six zones in the country by NHREC members / This is awaiting budgetary approval.
Field monitoring of implementation of projects approved by NHREC / The protocols approved so far by NHREC are fairly straightforward carrying minimal risk as such not requiring field monitoring. This activity was thus not of immediate importantance.
Detailed Documentation on budget of NHREC activities
Work with stakeholders like the FMS&T, FMOE, Planning etc on developing a National Bioethics Commission to encompass the interests of all stakeholders and prevent development of individual programs in each of these units of government with resultant inefficiency / This was debated extensively and the meeting agreed to focus on advocacy and awareness creation while taking the process for developing the mechanism for upgrading NHREC to an agency in the near future.
Press interviews on health research ethics / This is to be planned to coincide with the launching of the code following its approval by the FEC and gazetting

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