Meetings & Minutes

AFROGUIDE: A Pan-African and International Project on Guidelines for Health Research in Africa

The AFROGUIDE Project on Guidelines for Health Research in Africa was launched by experts and policymakers from Africa and the international community during a roundtable on health research facilitated by the Good Clinical Practice Alliance – Europe and the Cameroon Bioethics Society at the "Science with Africa" conference organized by the United Nations Economic Commission for Africa and the African Union in Addis Ababa, Ethiopia, on March 4–7, 2008.

African countries suffer from a disproportionately high percentage of the global disease burden while possessing remarkably low investment in health research. Clinical trials and other directed research engagements are particularly important for finding new prophylactic, diagnostic, and therapeutic interventions that will address prominent diseases on the continent, such as HIV/AIDS, tuberculosis, malaria, sleeping sickness, and cancer. This health research needs to be supported by clear guidelines in Good Clinical Practice, informed consent, ethical review, genetics, pediatrics, and other areas, taking into account the specific needs of African communities and the continent as a whole.

The project partners represent high level expertise in health research and health policy. They include the Good Clinical Practice Alliance – Europe, a Brussels-based not-for-profit organization with leading expertise in the creation of guidelines in ethics and clinical research as well as model law development and adaptation; the Cameroon Bioethics Society, based in Yaoundé, which has played a parenting role since the late 1980s in the development of ethics and research on the African continent; and Science for Development, a not-for-profit organization with expertise in the application of science to needed areas of development in policy and in society.

The primary objective of the AFROGUIDE Project is the development and implementation of model laws and guidelines for health research in African countries with the aim of strengthening African legal and regulatory systems for health research while advancing the development of health policy on the continent.

This overall objective is achieved through the following specific objectives:

• developing a comprehensive database on existing guidelines and legal frameworks in the context of health research in all African countries, including frameworks on ethics, biomedical research, clinical trials, and gene research;

• achieving stakeholder support, in particular from African countries, through the organization of meetings in Africa, Europe, the U.S., Asia, and Latin America;

• drafting guidelines with experts from African countries, international institutions, and industry in the fields of clinical trials, ethics, pediatrics and special populations, biomedical research, and genetic research;

• supporting the development of a model law to be adopted at the African level and implemented into national legislation and practices; and

• supporting the development of political will to realize the adaptation and implementation of the guidelines into the policies and practices of African countries.

The project objectives will be achieved through the following work packages:

WP1 (Survey) This work package gathers comprehensive information about the existing guidelines and legal frameworks on health research in all African countries. The information is collected and organized on a publicly accessible Internet database.

WP2 (Fundraising) This work package focuses on raising the necessary financial resources for the project. The resources are used to finance the secretariat and to organize the meetings, including flight and accommodation costs for the African and international participants. The project follows stringent rules on transparency and conflict of interest.

WP3 (Networking) This work package brings together leading stakeholders by developing communication, education, and interaction structures. Networking structures provide for an essential capacity-building structure to ensure cross-fertilization and impact across all regions and sectors of the Africa communities.

WP4 (Guidelines Development) This work package concerns the development of model laws and guidelines from the inception of ideas, through drafting in working parties and across consultations, to their editing and cross-referencing and publication and translation.

WP5 (Guidelines Implementation) This work package implements the model laws and guidelines into law, policy, and practice at the continental, regional, national, and local levels. It also provides for adaptation, feedback, and eventual revision of the original model laws and guidelines.

The AFROGUIDE Project advances and facilitates health research across Africa, contributing to the development of health across African communities.

Submitted by Francis P. Crawley
Executive Director, Good Clinical Practice Alliance – Europe

An Overview of Recent SACHRP Actions

The Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) met on March 27 and 28, 2008. Agenda items over the two-day period were essentially 1) discuss issues surrounding research and quality assurance activities; 2) evaluate the recommendations of the Subcommittee on the Inclusion of Individuals with Impaired Decision-Making Capacity in Research (SIIIDR); 3) review recommendations on research in disaster areas; and 4) review recommendations from the Subpart A Subcommittee.

For the first agenda item, the advisory committee heard testimony from a panel consisting of Donald Berwick, MD, MPP (president and CEO of the Institute for Health Improvement), Brent James, MD, MStat (executive officer for the Institute for Health Care Delivery Research and chief quality officer for Intermountain Health Care), Carolyn Clancy, MD (director of the Agency for Health Research and Quality), Christine Grady, MSN, PhD (head of the Section on Human Subjects Research Department of Bioethics at the National Institutes of Health Clinical Center), and Nancy Neveloff Dubler, LLB (director of the Division of Bioethics at Montefiore Medical Center and professor of bioethics at Albert Einstein College of Medicine's Department of Family and Social Medicine).

After presentations, the advisory committee members and the public were allowed to question the panelists and offer further comment. Although much of the discussion pulled from the "Keystone study" between Johns Hopkins and the Michigan Hospital Association and the HHS Office for Human Research Protections' (OHRP) actions there and their impact, the committee remained focused on not trying to figure out who was right or wrong in that case, but focused on what the committee can do to assure that healthcare providers can provide the necessary ethical quality improvement while also protecting the rights of patients and research subjects. There was a general consensus that there were "quality improvement operations" and "quality improvement research" and that, instead of regulations, HHS could provide guidance on the differentiation as to when a quality assurance/improvement activity is research or not.

The SIIIDR then presented its summary of activity and recommendations. It reviewed a summarized version of the comments received from the RFI posted by OHRP, the comment period for which ended in July. The chair of the subcommittee (David Strauss, MD) presented its recommendations, which consisted of no additional regulations, but requested guidance be issued by OHRP that addresses several key issues. The first was that a concept of "consent capacity" be defined; the second was that detailed recommendations should be drafted related to identification of individuals who may lack consent capacity, understanding that this was not directed to specific clinical diagnoses, but to a current state of capacity independent of diagnosis. Additional items included a request for further clarification of what a "Legally Authorized Representative" is, and the role of surrogate decision makers. The subcommittee also recognized many local levels have a void in this area, and discussed the need for the development of a "model state legislation" or other appropriate approach. The committee also recommended that the drafters be cautious that such guidance not be an inhibitor of enrollment.

For research in disaster areas, the advisory committee recommended that HHS create policy in this area. It was generally recognized that research involving humans in the aftermath of disasters was critically important for individual and societal benefit, and that HHS should be proactive to promote its planning. The committee members were (and requested such regulations be) cognizant of the concerns that research not distract from the provision of aid in disaster areas. Additionally, they asked that regulation provide the mechanism to protect subjects while still allowing research to be executed in a time-sensitive manner. They also recommended that the process involve relevant input from potentially affected governmental agencies and other stakeholders, as well as the public.

Daniel Nelson, MS, CIP, and Elizabeth Bankert (of Dartmouth College, filling the expiring term of Felix Gyi, PharmD, CIP, of Chesapeake Research Review), cochairs of the Subpart A Subcommittee, re-presented the assumptions of the committee about inappropriate interpretation/application of the Subpart A regulations imposing administrative burden without meaningful human subject protections, also noting that associated practices do not enhance the safe and ethical conduct of research due to diversion of resources. The subcommittee had previously worked on a list of 29 recommendations to Subpart A and furthered its review of a few of these items to the full advisory committee. Specifically, additional clarifications on each of the criteria for exemption were determined to be needed and discussed, and changes were requested to the requirements for institutional review board roster change reporting to OHRP. Additional recommendations will be presented at a later date on waiver of documentation of consent.

It is always important to note that the discussions and decisions made at SACHRP are neither law nor guidance. They are facilitated to produce recommendations in an advisory capacity to the Secretary of HHS, who will act accordingly.

Submitted by David Vulcano, MSW, LCSW, MBA, CIP
Vice Chair, ACRP Association Board of Trustees