Background/Rationale
Research ethics continues to be a matter of critical importance as the practice of research and medicine changes owing to new technologies, emerging diseases and global trends towards increased funding for research involving human participants especially on “poverty-related or neglected diseases”.
Historically, research participants and research institutions have been exposed to abuse and are inadequately prepared to handle complexities that characterize justice and beneficence desirable for research involving human participants and communities. This is ever so important in the less developed world where regulatory systems are either very weak or non existent in majority of cases.
AMANET was awarded a grant by The Bill and Melinda Gates Foundation aimed at strengthening institutional ethics committees in Africa among its networked institutions to improve their functioning and enable their members to update their understanding of ethical principles that govern human health research. This workshop will be the fifth of a series of eight to be conducted for Anglophone and Francophone institutions. The workshops are uniquely packaged for individuals who sit in ethics review committees (ERCs)/Institutional review boards (IRBs) or have administrative roles in such committees.
Precedence:
AMANET continues to champion the need for training in biomedical research ethics to various stakeholders of research in Africa. With regard to health research ethics for ethics review committees, the following workshops have been organized by AMANET:
1.
Workshops on Ethics in Health Research in Africa, in Kenya (Kisumu, 2001), Ethiopia (Addis Ababa, 2001, 2007), South Africa (2002, Pretoria), Gabon, (Libreville, 2002), Sudan (Khartoum, 2003), Cameroon (Yaoundé, 2003), Tanzania (Dar es Salaam, 2005, 2006 and 2007), Senegal (Dakar, 2008), Ghana (Accra, 2008) and Uganda (Kampala, 2008).
2.
Workshop on Standard Operating Procedures for Ethics Review of Health Research in Africa, 17-21 February 2003, Entebbe, Uganda;
3.
Workshop on Advanced Ethics in Biomedical Research that Involves Human Subjects, 1-3 December 2004, Zanzibar, Tanzania; and
4.
Workshop on Protection of Human Research Participants: Writing of Standard Operating Procedures for Ethics Review Committees in Eastern Africa: 29-31 August 2005, Dar es salaam, Tanzania.
Reports on the above activities are available in the various issues of the AMANET Newsletter available online at: www.amanet-trust.org.
Workshop Pedagogical Methods
The workshop will apply participatory approaches including overviews, case studies, discussion groups, panellists, and student presentations and other interactive and adult teaching/learning methods. To broaden discussions special panels for some of the topics will be convened. Lecture type presentations will be followed by question and answer sessions. Experienced facilitators have been carefully selected from within Africa.
Workshop Participants (Selection)
Participation in this workshop is partially by invitation to selected networked institutions actively involved or expecting to be involved in the near future in the implementation of AMANET and/or Malaria Clinical Trials Alliance (MCTA) supported clinical trials in Africa. A few places may be available for applicants outside these criteria. Each Ethics Committee or review board may nominate up to 3 of its members for the workshop. Committee members who attended any of the previous AMANET Basic HRE workshops in this series will not be eligible for the upcoming workshop.
Participation of the nominated candidates in the AMANET online Discussion Forum will be considered in the selection process. The discussions will be continued in group sessions at the workshop. Thus candidates will be expected to contribute their comments and views on the ethical topic under discussion in advance of the workshop. The online Discussion Forum can be accessed via the AMANET website. A final list of participants satisfying the selection criteria will be drawn from these nominations.
Workshop Objectives
This workshop aims to provide a general overview of the ethics of health research in the international sphere as well as in Africa. Examples and case studies pertinent to Africa will be used. The following are the highlights of the topics to be covered:
·
History of ethics in health research, codes and regulations, principles of ethics
·
Ethics Committees, Models for ethics review, Legislative options and provisions
·
Standard Operating Procedures for ethics committees
·
Roles and functions of the PI, the sponsor, the monitor, DSMB, and regulatory agencies
·
Analysis of risk / benefit, distribution of benefits and burdens, what is owed to research participants, and the communities, ancillary care
·
Role and conduct of informed consent, voluntary consent, inducements /coercion, adequate information, deception, and debriefing
·
Databases & Storage of samples, Material transfer agreements and benefits for source, confidentiality and publications, EC reports, oversight functions,
·
Research with children, pregnant women, handicapped and institutionalized participants, refugees, prisoners, impoverished communities
Workshop Outcomes
By the end of the five day workshop, it is further hoped that:
1.
Participants will be brought up to date with the ethical issues around current research practices;
2.
Participants will be able to support the functioning of local EC and plan its activities, provide informed guidance to investigators, including oversight supervisory role, and able to consult for unique ethical dilemmas.
Language:
The workshop will be conducted in English; there will be no translations to other languages.
Workshop Reports:
Three participants will be nominated to be rapporteurs for the workshop. Proceedings will be recorded for publication in the AMANET newsletter and will be available for participants.
AMANET Scholarship
Selected participants will be awarded scholarships by the AMANET, which will cover costs for economy class airfares (where needed), visas, tuition and accommodation and meals. Participants should meet all their home country transit costs.
Timelines:
This call sent out on or before 18 August 2008
Nominations should reach AMANET secretariat no later than 05 September 2008
Institutions will be informed of list of selected participants by 01 October 2008
Nominations (with brief CVs and one-half page justification) should be submitted by email to:
The Managing Trustee,
African Malaria Network Trust,
302 Ring Street, Off Rose Garden Road, Mikocheni A
PO Box 33207,
Dar es Salaam, Tanzania.
E-mail: info@amanet-trust.org
Fax: +255 22 2700380
Acknowledgements
The workshop is supported by a grant to AMANET from the Bill and Melinda Gates Foundation on strengthening institutional health research ethics in Africa. |
