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REPORT: HEALTH RESEARCH ETHICS TRAINING WORKSHOP

JULY 16-20, 2012

MINISTRY OF HEALTH AND SOCIAL WELFARE







TABLE OF CONTENT

Acronyms

Acknowledgement

  1. Background 1

    1. Goal 1

    2. General objective 1

    3. Specific objectives 1

  2. Overview of the workshop 2

    1. Opening ceremony 2

  3. Presentation 2

    1. Day One 2

      1. Overview of Health Research Ethics 2

      2. Declarations governing Health Research Ethics 2

      3. The Ethics Committee Overview 3

        1. LIBR/Ethics 3

        2. UL-PIRE 4

        3. EC Sierra Leone 4

        4. EC Mali 4

        5. EC Guinea-Bissau 5

      4. Researching with Vulnerable Population 5

    2. Day Two 6

      1. In-depth Analysis of Research Ethics Review Process 6

      2. Handling Protocol Deviations 7

    3. Day Three 8

      1. Mapping African Research Ethics Review and drug regulatory capacity 8

      2. The Research for Health and Innovations Organizer 10

      3. Ethical Issues in Public Health Research Ethics 12

    4. Day Four 14

      1. What is Quality Assurance in Research 14

    5. Day Five 16

  4. Way Forward 16

Annex

ACCRONYMS

COHRED Council on Health Research for Development

HMIS Health Management Information System

HIV Human Immunodeficiency Virus

IRB Institutional Review Board

M&E Monitoring and Evaluation

MOHSW Ministry of Health and Social Welfare

NHRS National Health Research System

QAR Quality Assurance for Research

REC Research Ethics Committee

RHInnO Research for Health and Innovation Organiser

SOP Standard Operating Procedures

ULPIRE University of Liberia Pacific Institute for Research & Evaluation

WAHO West Africa Health Organisation



ACKNOWLEDGEMENT

The West Africa Health Organisation (WAHO) and the International Development Research Centre – Canada provided financial support for this workshop as part of their Research Development Program in keeping with “WAHO Strategic Plan 2009-2013”. The Council on Health Research for Development (COHRED) provided technical support in line with National Research System (RS4H) strengthening for health.

Special thanks to all the participants, the rapporteur for their support and whole-hearted participation.

This Workshop report on Health Research Ethics in Liberia was written on the basis of the rapporteur contribution, under the supervision of the Organizing Committee of the workshop composed of the Ministry of Health and Social Welfare of Liberia, WAHO and COHRED.



BACKGROUND

According to the 10 Year National Health and Social Welfare Plan; “The Ministry would promote a culture of inquiry into the best methods of delivering health and social welfare services”. Though research is being recognized, it is still limited in terms of coordination, governance, management, and funding. Currently, there is no policy or guideline for the conduct of research in Liberia; however, this Unit in collaboration with other programs and units have recently developed a health research agenda in line with the National Health Policy and Plan (2011-2021). At present, there is no budgetary allocation for research for health in Liberia. At a very low scale, the Liberia Institute for Biomedical Research (LIBR) manages and conducts biomedical research in Liberia. Other institutions such as the University of Liberia, the Ministry of Agriculture, or the Ministry of Planning and Economic Affairs, conduct research, however there is a minimum amount of health research protocols that have gone through ethical consideration thus there is a need to conduct a basic training workshop on health research ethics amongst stakeholders conducting research for health in Liberia.



Goals:

-Strengthening the health research system in Liberia


General Objective:
- Provide basic skills in health research ethics for stakeholders
Specific Objectives:

  • To provide an introduction to health research ethics

  • To highlight the importance of ethics in research for health

  • To discuss ethical issues in research for health

  • Discuss ways to incorporate ethics review in all research for health

  • To determine ways to strengthen and sustain IRBs in the country


OVERVIEW OF THE WORKSHOP

Opening Ceremony

The workshop was officially opened by Mr. C. Sanford Wesseh, Assistant Minister for Vital Statistics, Department of Planning Research and Development at the Ministry of Health and Social Welfare. The Minister extended his thanks and appreciation to the consultants who travelled from their respective homes to Liberia, as well as WAHO, COHRED, WHO and IRBs/RECs, invited countries: Sierra Leone, Mali and Guinea Bissau and local participants for their participation in the capacity building process of health research ethics in Liberia. Moreover, he thanked WAHO and COHRED for their financial and technical support to the research unit. He also hoped that major research that has been conducted and those currently ongoing will be organized and published.

The Minister expressed his concern over some unresolved issues about the Ethics Committees. Some of these issues include charges levied by the Ethics Committee for revision of protocols as well as the financial strengthening of the committee.

Following opening remarks from the assistant minister, self-introductions were done by the participants. WAHO, COHRED including the IRBs/RECs and other representing participants expressed their appreciation for participation in the capacity building process in health research ethics in Liberia.



PRESENTATIONS:

Day One:

Overview of Health Research Ethics

The first presentation of the day focused on the overview of health research ethics, highlighting historical intricacies which gave to ethics in the conduct of health research. The presentation also looked at some controversial health research activities conducted in developed and developing countries as well as players involved in minimizing the condition of unethical health research.




  • Informed consent involving children


Declarations governing Health Research Ethics

The second presentation was conducted by Mrs. Mary Kasule following the end of the first presentation. Her presentation focused on various declarations governing health research ethics that can be considered by Ethics committees in rendering their judgments in the review and approval of clinical research involving human subjects.




  • The Helsinki Declaration

The presentation was followed by sharing of experiences from local IRB/RECs as well as participating countries.



The Ethics Committee Overview

LIBR/Ethics Committee

The LIBR REC overview was provided by Dr. Musu Duwuoko, the secretary of the REC.

According to her, the EC has been established for over five years, and currently serves as the acting national ethics committee upon request by the central ministry of health. SOP for the committee has been developed and published in news papers and is currently awaiting publication on the MOH/SW website upon permission.

The REC has participated in several ethics training and has reviewed many studies including clinical trials. However, the committee currently works on a voluntary basis; it receives protocols and reviews them using a SOP considering the safety of human subjects being used within those studies. The REC charges 3% percent of the total budget on non academic research protocols and charges 1% percent on academic proposals, and also decides on waiver depending on the situation. The Committee is currently working on a fixed amount that could be charged instead of charging by percentages. The overview of the EC ended with questions and answers.



Three major questions were asked:

  1. The role of the EC as compared to other IRBs in Liberia?

  2. The Ministry considerations on providing or finding a funding source for the EC

  3. Who approves the final decisions made by the EC?

The Assistant Minister of Vital Statistics responded to the first question. In his response, he made it very clear that there is no superiority in the decisions that should be made by any of the IRBs/REC, except that they function following a SOP that considers the safety of human subjects in Liberia. He also responded to the second question saying, the Ministry will try its best to provide support to the REC since it is expected to serve as a national ethics committee for Liberia.

The third question was answered by the secretary of the REC, and responded that the Ministry of Health through the Department of Planning, Research and Development provides oversight responsibility for the REC, approves and serves final communications for decisions reached by the REC.

The Committee is currently faced with challenges which includes; the lack of office space and funds for operations, and needs more capacity building.

University of Liberia Pacific Institute of Research and Evaluation (ULPIRE)

The ULPIRE overview was provided by Dr. Kennedy, the PI for the Institution. According to Dr. Kennedy, the institution was established in 2005 through a memorandum of understanding between a National Institute for Health Research based within the United States and the University of Liberia following intensive two weeks training that provided pre and post test to evaluate the participants. The Institution was established with a membership of seven persons involving groups with scientific and non scientific backgrounds to effectively provide their functions.

UL/PIRE has reviewed several protocols including clinical trials. The institution invites content depending on the content and nature of the research protocol under review, as part of its functions; the institution also charges a minimum of 250 United States Dollars for grant proposal writing. Moreover its members have attended several certificated trainings both, national and internationally.

At the end of the UL/PIRE overview, Mr. Luke Bawo, Coordinator, M&E/HMIS and Research expressed his concern over the coordination of research protocols being reviewed by the IRBs/REC to make available copies to the Research Unit for archiving for the general good of the health system.



Challenges:

  • Lack of funds for sustainability and the need for capacity building.


Overview of EC Sierra Leone

The overview of the REC/IRB was done by Dr.Taqui representing Sierra Leone at the workshop. He stated that challenges faced by IRBs/REC in Liberia are cross cutting issues for other participating countries. But he strongly advised on the development of a national policy and or legislature that can guide the implementation of various IRBs/REC in Liberia as it will also help other countries. According to him, in Sierra Leone, there is an independent REC that operates according to the WHO ethical guidelines. The committee provides quarterly and annual report to the Ministry of Health on the progresses made as well as and challenges. The Committee charges a fixed amount depending on the nature of the research.


Challenges:

The REC lacks funds for sustainability and needs capacity building.


Overview of EC Mali

The overview of the REC/IRBs was done by Dr. Coulibaly representing Mali at the workshop. According to him, Mali has 15 research institutes comprising of a national research committee for health, national ethics committees and other IRBS. The national ethics committee has membership that is inclusive of political and non political representations. The Minister of Health approves the final decisions reached by the national ethics committee as well as oversees the selection of the membership of the national ethics committee.


Challenges:

The committee as explained by Dr. Coulibaly is currently faced with many challenges including lack of financial assistance, lack of cooperation between the national ethics committee and other IRBs/REC.


Overview of EC Guinea-Bissau

The overview of the EC/IRBs was done by Dr. Menezes representing Guinea-Bissau at the workshop.

In her presentation, she extended thanks to the organizing committee and participants for the good work being initiated. According to her, the conduct of research has previously been done by the westerners not taking into account rules and guidelines to govern the conduct of research in Guinea Bissau. Moreover, studies previously conducted did not meet the consent of the participants being involved. Based on these unethical practices, the Minister of Health gathered a five man committee considering specific areas of background and institutions to coordinate the conduct of health research. Members of the Committee are recruited by the Minister of Health with consultation from IRBs/EC.

Currently, the Committee receives support from WAHO and COHRED in terms of capacity building.


Challenges

The committee currently does not have an office space, lacks capacity building opportunities and guidelines to review protocols as well as finance to effectively implement their functions.


Researching with Vulnerable Populations

The last presentation of day one session focused on the topic researching with vulnerable populations and was done by Mrs. Mary Kasule. The presentation provided a clear definition of those described as vulnerable groups as well as the reasons for conducting research with vulnerable groups, including children. Several challenges were highlighted considering the conduct of research involving children:



  • looking at their changing developmental stages

  • proxy consent and complex requirements

  • Limited decision making, capacity and understanding

  • Enrolment of healthy children/subjects

  • Street kids and dilemma with age of consent

Moreover, the presentation also looked at research with pregnant and pregnable women that involve challenges such:

  • Women within reproductive age/pregnable

  • Clinical trials involving pregnant women

  • Effects of research substances/drugs on developing foetus

Guidelines used in the conduct of ethical research were also discussed focusing on guidelines used in the United States. Issues about research with women in some settings were discussed focusing on the African setting/context. Also, the issue of research with prisoners, research with people of limited mental capacities, persons with limited access to health care and research with illiterate people who are easily convinced, coerced and have therapeutic misconceptions was highlighted.

The last presentation ended with a case scenario that brought the participants together and appointing a chairperson to lead the discussion. The scenario focused on pregnancy in Health Research, testing a vaginal microbicide for its ability to prevent new HIV infections. Upon the revision of this scenario, about six questions were discussed by the participants considering that they were members of an ethics committee who had the responsibility to peruse this study protocol and reach a final decision.



Day Two:

In-depth Analysis of the Research Ethics Review Process (PPT# 1)

By: Mary Kasule



The presentation covered:

  • Ethical requirements for the conduct of research, which include Social and scientific value, Scientific validity, Fair subject selection, Favourable risk benefit ratio, Independent review, Informed consent and Respect for subjects (potential and enrolled)

  • Roles of a Research Ethics Committee: To Promote good research, Scientific and ethical review in one sitting (there were experiences from Liberia, Sierra Leone and Mali), Flag “Bad Science” (“Bad science is unethical”), Ensure the conduct of ethically sound research as good research can promote health.

  • Four Principles of Ethical Review: Independence (Free of outside interference), Competence (having members with requisite expertise), Pluralism (Expertise, Various backgrounds, Local community representatives, Former study participants, Diversity - Sex, Age and Cultural Background), Transparency

  • Research Ethics Committee must ENSURE that: SOPs & Guidelines are used in the process principles, Quality in decision making, Consistency, Provision of a sense of direction, Minimal confusion and unnecessary delays in the processing of proposals.

  • Decision Making: either by Consensus or Voting, advice that is non-binding may be affixed or appended to the decision; in a case where decisions are conditional, clear suggestions must be provided for revision.

  • Criteria for Review and Approval: Proposed research must be critically and thoroughly examined; at a minimum level, address six core issues (scientific design and study procedures, recruitment of research participants, community considerations, Care and protection of research participants, Informed consent, and Confidentiality issues).

Ethics Committees must only grant approval when all these questions have been answered.

  • There’s a need for RECs to have moral reasoning: The absence of moral reasoning could lead to reliance only on tools and guidelines and this may result in ECs using them selectively, to punish and destroy enemies, against community and national interest and blind reviews.

  • If ethics review is done properly, the achievements will include: Comprehensiveness in application of ethical standards, attentiveness to local concern, gateway for publications, avoidance of scandals and confidence.

  • Common problems with Research Ethics Committee: Lack of Written Procedures, No documentation of IRB activities, inappropriate use of Expedited Review, Limited expertise, etc.

  • Conclusion: Research is becoming more and more complex and an Ethics Committee is an important component within a system. A well-trained, active and objective Ethics Committee is very important to research that involves human participants. Thus exhaustive and considerate review by the Ethics Committee will ensure : the protection of the rights and welfare of participants the integrity of data, continued trust of the research enterprise


Handling Protocol Deviations (PPT#2)

By: Mary Kasule



  • The extremes of scientific fraud

  • BreastCancer
    1. Dr. Bezwoda- Wits
    2. Dr Poisson- Canada

  • JOHN HOPKINS TAKES THE BLAME (Ellen Roche)

  • University of Pennsylvania 2000 (Jesse Gelsinger)

  • Cameroon study of Tenofovir for HIV prevention

  • Tenofovir study- Cambodia

  • Nigeria: Trial of Tenofovir as a prophylactic against HIV

  • Why does scientific misconduct matter?

  • Morally wrong

  • Waste of resources

  • Potentially harmful

  • Erodes public confidence

  • Endangers independent science



  • Some consequences

  • Publications are declined or retracted (Auvert et al: HIV & Circumcision- publication was declined by the Lancet in 2005 and the Lancet also retracted Jon Sudbo 2006)

  • Researcher can be suspended and barred from receiving funds for the conduct of research (Dr Bezwoda and Dr Poisson)

  • Conclusion: Research is a very expensive venture. The cost to develop one product over a period of 10-12 years is about US$800million to US$1 billion, thus mal-practices by researchers lead to such amounts being wasted.

Lesson Learned

  • It is possible to do a review of a protocol if you have time.

  • The ethics committee should work along with the medical board so as to have a better coordination.

  • Protection of the participants (subjects)

  • Members of the REC are to be familiar with the guidelines so that subjective views are not imposed on the proceedings

  • During the revision of a protocol, all points should be taken into consideration before approval.

The day two of the workshop was officially closed by Min. Wesseh with a remark thanking everyone for attending and stressing the importance of the workshop.

Day Three:

Mapping African Research Ethics Review and drugs regulatory capacity

By: Boitumelo Mokgatla Moipolai



Background

  • Marc is a 3 year project aimed at creating a cloud of web based African map of:

  • Research ethics review capacity

  • Research ethics review capacity building efforts

  • Medicines regulatory authorities

  • Supports ethics review capacity building

Marc Mapping Steps

  • basic contact and procedural information

  • extended capacity information-standardized

  • Upload of RECs documents, e.g. SOP’s, Research Protocol checklist, Application forms etc.

  • REC access only information - used by RECs only

Progress to date

  • One hundred and sixty nine (169) RECs mapped

  • Website launched-www.researchethicsweb.org

  • Social network for RECs was funded by NIH and have been launched

  • Mapping of Medicines Regulatory authorities which was funded by Pfizer has commenced.

Levels

  • Level 1- This level includes Basic information: organization information, Administrator profile, resources etc.

  • Level 2 – This captures capacity information: REC/IRB contact information, REC/IRB organization information, supplementary information etc.

REC Documents

  • This is where documents, application are posted in other languages apart from English.


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