how to review a protocol and provide constructive feedback - NHVMAS

HOW TO REVIEW A PROTOCOL AND PROVIDE CONSTRUCTIVE FEEDBACK: A LAYPERSON TRAINING MANUAL

INNER FRONT COVER

HOW TO REVIEW A PROTOCOL AND PROVIDE CONSTRUCTIVE FEEDBACK: A LAYPERSON TRAINING MANUAL

Who is NHVMAS? NHVMAS (pronounced 'navmas') is an acronym for the New HIV/AIDS Vaccine and Microbicide Advocacy Society. It is a civil society group - committed to mobilizing popular participation and public support for the new HIV prevention technology research and development in Nigeria. Its mission is to accelerate HIV/AIDS policy implementation and ensure accountability in the context of new HIV/AIDS prevention tools development in Nigeria. Its' vision is to see to the halt of the spread of HIV/AIDS in Nigeria by ensuring the availability of safe, effective, acceptable, affordable and locally relevant HIV prevention tools for all Nigerians as soon as they are available. The group advocates on all issues that would ensure the realization of its vision as well as monitors all HIV research activities to ensure that the rights of all heroic volunteers are safeguarded. NHVMAS is open to all Nigerians and seeks to partner with as many groups as possible. For further information, contact: New HIV Vaccine & Microbicide Advocacy Society (NHVMAS) National Secretariat: 51/52, Ijaye Road, Ogba, Lagos State, Nigeria P.O Box 56282, Falomo, Lagos, Nigeria

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Tel: +234 1 812 8565, 773 1457

How to review a protocol and provide constructive feedback – a layperson training manual New HIV Vaccine and Microbicide Advocacy Society © 2009

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Plenary 1 Plenary 2 Plenary 3 Plenary 4 Plenary 5 Plenary 6 Plenary 7 Plenary 8 Plenary 9 Plenary 10 Plenary 11 Plenary 12 Plenary 13 Plenary 14 Plenary 15 Plenary 16 Plenary 17 Plenary 18

History and Evolution of Research Ethic Basics of Research and Clinical Trials Operationalising Ethical Review of Protocols Informed Consent Risks, Benefits and Inducement Vulnerable Populations in Research Standard of Care and Prevention The Research Protocol Research Protocol Review Process Reviewing Research Protocol Providing Constructive Feedback Monitoring of Research HIV Treatment Research HIV Prevention Research Community Engagement in Research Community Advisory Mechanism Civil Society Engagement in Research The Good Participatory Practice Document

12 14 16 18 20 21 23 25 27 29 31 33 35 37 39 41 43 45

Plenary 4 Plenary 7 Plenary 8 Plenary 10 Plenary 11 Plenary 12

Appendices Pre and Post Test Questions Clinical Trial Terminology Informed Consent Checklist Protocol Protocols for Review Sections of the Protocol Constructive Feedback Game Protocol Review Questions Relevant to Commuinty Needs

46 47 51 54 55 56 57 59 61


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Content Acronymns Use of Training Kit Introduction and Ground Rules Acknowledgement Note to Facilitator

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Table of Content

Acronymns Acronyms

Meaning

ARV

Antiretroviral

CAB

Community Advisory Board

CD

Compact Disc

CIOMS

The Council for International Organizations of Medical Sciences

CSO

Civil Society Organisation

DSMB

Data Safety Monitoring Board

EDCTP

European Development Clinical Trial Partnership

GCP

Good Clinical Practice

GLP

Good Laboratory Practice

GPP

Good Participatory Practice

HIV

Human Immunodeficiency Virus

HREC

Health Research Ethics Committee

IDU

Injecting Drug Users

IRB

Institutional Review Boards

MSM

Men who have Sex wih M en

NAFDAC

National Agency for Food and Drug Control

NHREC

National Health Research Ethics Committee

NHVMAS

New HIV Vaccine and Microbicide Advocacy Society

NPT

New HIV Prevention Technologies

PLHIV

People Living with HIV

UNAIDS

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WHO

World Heal th Organisation


Use of the Training Kit Introduction This training kit is designed to strengthen the Nigerian New HIV Prevention Technology (NPT) Research and Development efforts and drive. It is an invaluable resource in providing appropriate information and training for laypersons interested in understanding how to review research protocols, the peculiar ethical issues involved in HIV treatment and biomedical HIV prevention research.

Target audience This training course is targeted at laypersons on ethics board. Secondly, this course can also be run for members of Institutional Review Boards. This training would help strengthen the capacity of these institutions to review HIV prevention and biomedical HIV Prevention Research related protocols.

Terminology A number of terminologies are quite scientific and may be new to the audience. The New HIV Vaccine and Microbicide Advocacy Society has a number of publications which you can pick up and read. These publications, especially the fact sheets, help to address the basic issues in NPT efforts as well as explain the basic sciences of the clinical trials.

Expectations for the training This training course is designed to provide individuals with the basic training necessary to help evaluate research protocols especially HIV related protocols. It focuses extensively on ensuring the protocols are reviewed from ethical perspectives that are important to research participants and their communities. The training package is structured and prepared as a trainer's manual for the Nigerian audience. It can be adapted for use in any other setting. The kit includes statements on the objectives of the training, technical information, and group exercises.

How to use the modules

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The modules are labelled for use as training tools during plenary sessions. The accompanying slides for each module (or plenary) can be found in the accompanying CD. Some of the modules also have

exercises that faciliate group work. The manual is also developed in a way that it can be used also for self training. There is therefore a self-test multiple-choice questions at the end of each module. The self tests questions can also be adapted for use as pre and post test questions when conducting group traning. If you score correcting on 6 or 7 out of 10 questions, you would be doing pretty well.

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Most of the modules also have reading materials for in depth study. These materials were developed by the Developing World Bioethics Journal. It was published by Blackwell Publishing Ltd in its Volume 5 number 1 2005 edition of the journals. They can be found in the accompanying CD for the manual.


Introduction and Ground Rules Introduction Exercise 1: Getting to know each other Purpose: To provide an opportunity to get to know each other and to share their expectations form the training programme Duration: 30 minutes Instructions: Think for a few minutes about your responses to each of the following questions:  Concerns: What concerns you about reviewing research protocols especially HIV related research protocols?  Objectives: What do you want to ensure you learn about research protocol review before the end of this course?  Strengths: What three strengths do you have that can facilitate and ensure trial participants' rights and community rights interests are protected during the conduct of researches? o Write your responses down in a sheet of paper. o Share your responses in the large group discussion.

Introduction Exercise 2: Determining the ground rules for the training session Purpose To develop and agree on a set of ground rules that will guide the development of an environment that facilitates learning. Duration 20 minutes Instruction Participate in a discussion on the ground rules necessary to ensure a training environment that would make you feel more comfortable talking about the new HIV Prevention technologies. These ground rules will help guide the development of norms within this training.

Exercise 3: Morning of Day 2

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Purpose To help participants to start understanding the various clinical terminologies. Duration 30 minutes Instruction Participants would have been asked to study the clinical terminology handout in the conference package overnight. At the plenary, give each participant a sheet with a clinical terminology written on it. The facilitator will read out a detailed description of the terminologies and any one who holds the right response sheet (the terminology that best answers the description read out by the facilitator) will march up to the facilitator. Participants will then assess if the match

is appropriate. All participants should have an opportunity to participate in the exercise.

Exercise 4: Morning of Day 3 Purpose To help participants further understand the various clinical terminologies. Duration 30 minutes Instruction Each participant will receive a clinical terminology sheet. This sheet is an incomplete clinical terminology word or phrase. Participants are to pair themselves ensuring that the word or phrase formed by matching their terminology sheet is appropriate. Each pair should then discuss for about a minute, what the word or phrase means. Each pair are them to come out before the plenary to explain their paired clinical terminology phrase or word.

Exercise 5: Morning of Day 4

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Purpose To help participants further consolidate on their understand the various clinical terminologies. Duration 30 minutes Instruction Each participant will receive either a clinical terminology definition sheet or an incomplete clinical terminology word or phrase. Participants are to move round the room and form triads of a complete clinical terminology phrase or word along with its definition/meaning. Each triad is then to come out before the plenary to explain the clinical terminology phrase or word better.


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Acknowledgement The production of this training kit could not have been possible without the funding support of the SIDACTION and the European Development Clinical Trial Partnership (EDCTP). We also acknowledge the great efforts of all the resource persons who have helped with the development of the various slides. We appreciate the national institutions in the country, namely the National Health Research Ethics Committee (NHREC), which have given great support to this project. Finally, for all the trainees and trainers who effectively use this training kit and find it useful, we say a big 'thank you' for making the efforts worthwhile. The content of the CD were based on contributions made by the following people: Prof Kayode Dada, Drs Adebayo Adejumo, Ajuwon, Oliver Ezechi, Jegede, Kolawole Oyedeji, Morenike Ukpong, Ms Olayide Akanni and Ms Lori Heise. Their contributions to the development of this manual is hereby acknowledged

Note to Facilitator Your role as a facilitator is key to the success of each session. Please note that you would be expected to facilitate each one hour session NOT lecture thus you have to think through how you can creatively engage your audience. Your job is to facilitate discussions amongst participants and guide the session to achieve its intended purpose in the time available. Please note that: - It is important to prepare well beforehand - Open the session by introducing yourself and explaining how the session would run within the limited time available. As the facilitator, you are responsible for keeping and managing the time effectively - Make sure that the session promotes dialogue and respectful productive interaction - Manage participants' contributions, questions and answers. No contributions, questions or answers must be treated with ignominy - Make interventions to move thinking forward and promote dialogue such as making links between contributions made by participants, bringing in different perspectives on the issues, managing conflicting viewpoints, noting were there is agreement/common ground or disagreement, noting key ideas/proposals/agreement for actions; and summing up areas of agreement and disagreement and next steps. - Please note as a facilitator, your own speaking time is minimal. You must give space to participants to err their views and perspectives - Thank participants at the end of each session It is also very important that you read and familiarize yourself with the many documents that would be used for this training. These include: -

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The national health Ethics Code (version 7.0) which can be downloaded on the NHREC website. The Goop Participatory Practice guideline developed by UNAIDS an AVAC. Can be down loaded at the AVAC website. Copies would be available at the workshop. The UNAIDS ethical guidelines for biomedical HIV Prevention research. This can be downloaded on the UNAIDS website. The Standard of Care community consensus document for NPT clinical trial participants. Can be downloaded on the NHVMAS website (www.nhv-mag.org). The Facilitator's notes in the CD accompanying this document.


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Finally, please read the objectives and content of each session. Please work around these objectives as you develop the sessions. Ensure it is as interactive as possible. Use case studies, games, group work etc to achieve a lot of outcomes from the sessions. Where lectures are the most appropriate (as would be for a lot of the sessions on the first day) please go ahead and handle it as such bearing in mind that participants are adults, have not attended lectures in a long while and staying seated for a long period of time may induce sleep. Pause occasionally during the lecture sessions to elicit contributions, views and perspectives of participants as well as questions for clarification.

PLENARY 1

History and evolution of ethics in Research

Objectives 1. To help participants understand the history and evolution of ethics in research 2. To help participants understand how ethics committees at the national and institutional levels function and interrelated 3. To familiarize participants with issues involved in international research ethics

Materials needed 1. 2. 3. 4. 5. 6.

Data projector Laptop Session slides Flip chart Flip chart stand Case study

Training content

History of ethics o Discuss the history of research of research participant abuse o Discuss the history of scientific misconduct in research o Discuss a locally relevant research misconduct eg the Trovan trial in Nigeria  The principles of ethics o The Nerumberg case and code o Discuss Helsinki declaration o Discuss CIOMS o Ethical principles as outlined by Zik Emmanuel o Discuss locally relevant adaptations of these principles  Ethical issues and ethical philosophy  The Trovan case study in Nigeria  Critical role of laypersons on HREC

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PLENARY 2

Basics of research and clinical trials

Objectives 1. To help participants understand the basics of research 2. To help participants understand why there needs to be research 3. To help participants understand how researches are designed, conducted and concluded

Materials needed 1. 2. 3. 4. 5.

Data projector Laptop Session slides Flip chart Flip chart stand

Training content

Define research and clinical trials Describe the various steps in research conduct o Emphasis the place and importance of community engagement in research design and implementation o Emphasis the need for researches to always seek to leave the community better off o Emphasis the need and importance of communicating research findings to the research community  Discuss the different types of research o Describe observational, epidemiological and experimental research o Discuss the differences between each type of research o Discuss what ethics committee members should be concerned with when reviewing these research proposals  Describe the various phases of clinical trials o Define clinical trials o Describe the phases that leads up to the conduct of a clinical trial – laboratory and animal studies o Discuss the importance of conducting preclinical studies prior to human studies

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o Describe phases I, II and III clinical trials and why the need for them o Discuss about product licensing and why research data is important for product registration o Emphasis the role and importance of good data generation for product registration o Briefly describe regulatory agencies and their role in health product registration o Discuss phase IV trials why the need. Give examples of products whose registration had being withdrawn following phase IV studies  Discuss about the Increasing conduct of HIV related research and clinical trials in Subsaharan Africa o Describe the HIV situation in Africa and the high prevalence and incidence rate o Describe the designs of HIV prevention trials and the need for HIV seroconversion as the needed end point o Discuss why HIV prevention trials would need to be conducted in places with high HIV seroincidence o Discuss the current need for HIV treatment trials to be conducted in places with high HIV seroincidence  Emphasis the place and role of laypersons in basic research implementation o Focus on their role in ensuring risk minimization for participants and benefit maximization for their communities o Discuss their roles at the pre, intra and post study periods as members of the ethics Board and their specific roles as laypersons on ethics board


PLENARY 3

Operationalising ethical review of protocols

Objectives 1. Workshop participants would understand when a researcher needs to apply for ethics review 2. Workshop participants would understand where to apply for ethics review 3. Workshop participants would understand how to apply for ethics review 4. Workshop participants understands the role and importance of the community in research



Training content

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When does a researcher apply for ethics review Where does a researcher apply too for ethics review How does a researcher apply for ethics review o Discuss the components of an ethical review application o Highlight the need for local collaboration in international research o Discuss how to settle grievances that could arise from an ethical committee's review comments Briefly describe the operationalisation of ethics committee based on NHREC guidelines o History of NHREC o Functions of the ethics committees o Licencing of Ethics Committees o Categorisation of Ethics Committees Discuss the role of the laypersons as a community representative engaged in research

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o Describe the issues laypersons need to address when reviewing protocols o Discuss the possible challenges to engaging community in research


PLENARY 4

Informed consent

Objectives 1. 2. 3. 4.

To help participants understand what informed consent is To discuss about the content of the informed consent document To discuss the process of obtaining informed consent To highlight the complexity of obtaining informed consent in an operational environment


Data projector Laptop Session slides Flip chart Flip chart stand Activity sheet

Training content


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Reiterate the principles of ethics o Emphasis on the principle of autonomy and what this means for the research participants o Discuss the purpose of the stated principle o Highlight what is required of research to fulfill this obligation Discuss the four elements of an informed consent document Discuss the eight recognized minimal content of an informed consent document Define the processes for ensuring informed consent o Assessing comprehension of vital information through use of multiple mediums, pictures, visuals, audios o Ruling out therapeutic misconception o Emphasis the need for participant's understanding of document content NOT obtaining a signature o Ensure participants reconsent at intervals throughout the study period o Discuss assent when research involves minors

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o Discuss the importance of privacy and confidentiality o Emphasis the need for understood consent rather than the legality of the document Discuss the challenges involved with obtaining informed consent in different socio-cultural environments o Discuss possible cultural and gender challenges to the issue of autonomy o Discuss language and literacy barriers to ensuring comprehension o Discuss possible challenges (power dynamics) when physicians are the researchers o Discuss the issues of inducement and coercion in an economically challenged environment o Discuss the challenges of the political environment in perpetuating research abuse (human right abuse and delayed access to justice) o Emphasis that consent is a process that ensures understanding and NOT a form Discuss NHREC guide for obtaining informed consent Discuss the role of laypersons in ensuring the informed consent process is an active rather than a passive process

Group Work -

Using the checklist provided, critique the sample consent form and identify the elements of the informed consent document missing in the form. Why are these missing elements important?

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Facilitator to summarise the discussion and once again highlight the role of laypersons in ensuring ethical reviews of research protocol with special interest in and emphasis on the informed consent document review.


PLENARY 5

Risk, benefits and inducement

Objectives 1. Define what constitutes risk, benefits and inducement to research participants 2. Highlight the challenges there are defining these terms



Training content 

Define the terms risks o Emphasis on the need to minimize risk in research o Discuss the importance of risk analysis o Discuss the concept of minimal risk Define the term inducement o Define the term inducement o Discuss the challenges with inducement balancing undue inducement and exploitation o Discuss how to make inducement ethical

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Discuss about compensation for research related injuries

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Discuss the role of laypersons in addressing these issues while reviewing a protocol


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 Define the term benefit

PLENARY 6

Vulnerable populations and research

Objectives 1. Workshop participants would understanding the ethical issues and challenges involved in reviewing, planning and conducting clinical trials among vulnerable groups 2. Workshop participants would understand the importance of such research among these groups and potential risks to the participants 3. Workshop participants would understand the role of laymen on ethics board in developing strategies for reducing the risks of harm to participants in such studies.


Data projector Laptop Session slides Flip chart Flip chart stand Activity sheet


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Define the groups o Define adolescents and the peculiar challenges in enrolling them in trials o Define PLHIV and the peculiar challenges in enrolling them in trials o Define sex workers, MSMs, drug users, women, prisoners and the peculiar challenges in enrolling them in trials o Discuss these peculiarities vis a vis HIV research Define how and why they may be involved in clinical research Discuss about transgender issues and challenges with research Discuss the role of laypersons in promoting the interest of these vulnerable group of persons


Group work - Addressing prejudices Share a short research protocol with participants and give 5 minutes for workshop participants to read the protocol.  Read to workshop participants, the report of an ethics committee on the reasons why a research protocol which otherwise would not have being approved for conduct in the general populace was approved for conduct amongst sex workers.  Discuss with workshop participants o What was unethical about the planned study o What are the possible reasons why the ethics committee approved that study for conduct amongst sex workers o What could they as individuals have done differently o How should laypersons or community representatives handle their prejudices when thinking for a common good (discuss about religious, cultural and personal prejudices)  Summarise the discussion and once again highlight the role of laypersons in protecting the interest of all persons irrespective of their personal prejudices and preferences

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Plenary 7

Standard of care in research


Define standard of care Identify where this is often addressed in a protocol Discuss the differing standards between developed and developing countries Discuss the approriate standard of care in research



Training content  Define what standard of care means o Define standard of care for trial participants o Define acceptable standard of prevention in HIV prevention trials as highlighted by the UNAIDS document o Discuss the standard of care for research participants as defined in local documents o Discuss community involvement in defining standards of care. Refer to the GPP document  Identify where this is discussed in the research protocol o Discuss what should be highlighted in the research protocol when defining the standard of care for research participants o Discuss how laypersons should address the standard of care for research participants especially in a multisite research involving developed and developing countries

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 Discuss the differing standards between developing and developed o Present arguments for differing standards


o Allow participants to discuss and share their perceptions on the issue

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 Highlight the role of laypersons on ethics committees to ensure adequate care for trial participants and long term benefit for communities

PLENARY 8

The research protocol


Help workshop participants to understand the need for a protocol for every research Introduce participants to the components of a protocol Discuss the process of developing a protocol Introduce participants to how to review a protocol and provide constructive feedback


Data projector Laptop Session slides Flip chart Flip chart stand Activity sheets

Training content Describe the minimum component of a research protocol Describe the five stages of protocol development o Emphasis the points for possible consultation with the potential research community in the protocol development stage o Discuss the importance of community involvement in research protocol development  Discuss the importance of a protocol  Brainstorm with participants what constitutes an ethically acceptable research. Note responses on a flip chart and discuss these.  

Group Work

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Divide the participants into groups. Each group to be provided with a short protcol Each group should study the protocol and identify missing components of that protocol Each group to present their findings in a plenary Faciliator to summarise discussions and conclude session


PLENARY 9

Research protocol review process

Objectives Participants would get to understand how protocol review is handled and communications with applicants is communicated



Discuss the protocol review process o Highlight how records must be kept for all protocol reviewed by the ethics committee o Highlight documentation procedures for ethics committee o Highlight communication mechanism between committee and researcher o Highlight the need and importance of an ethical clearance certificate o Discuss the roles and responsibilities of the ethics committee to the researcher and the research participants for all approved research protocol

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Discuss the national guidelines on the review process o Exempted o Expedited review o Full NHREC review

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Discuss international guidelines on review process

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Discuss the role of laypersons in the protocol review process o Attend protocol review meetings o Ensure the rights of participants are protected o Ensure the rights of the community is protected. This is an exclusive role of the


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Training content

layperson o Highlight socio-cultural issues that need to be addressed in the protcol implementation process

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Sharing experience 

Identify 3 or 4 participants who have being engaged with research protocol review.

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Ask them to share their experience and discuss how protocols are handled in their institutions.

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Ask participants at the workshop to share lessons on handling of protocols by HRECs and discuss how they would facilitate improvement in the current modus operandi of their committee.


PLENARY 10

Reviewing the research protocol

Objectives Participants would identify relevant sections of the research protocol that requires inputs from the laypersons

Materials needed 1. 2. 3. 4. 5. 6. 7.

Data projector Laptop Session slides Flip chart Flip chart stand Research protocol Activity sheets


Review the sections of a protocol o Discuss the 18 sections of a research protocol o Highlight the importance of each section

Each group to scheme through each of the listed sections of the protocol listed in the sheet provided as a guide for research protocol review.

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Apply dots to represent your feelings/thoughts about the need for laypersons to review (read in details and provide comments) any of the sections of the protocol.

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Use a green dot if the section should be revised by laypersons, red dot if you disagree and blue if you are undecided

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Facilitator to synthesis comments of the different groups. Where there is disagreement, try to help participants work and reach a consensus.

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The section on human subject protection as well as the informed consent SHOULD be


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Group Work Protocol Review for Laypersons

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reviewed by the laypersons. It is the responsibility of the laypersons to ensure the informed consent addresses the eight minimual elements of an informed consent. 

Discuss how they can make inputs into sections where they do not have the expertise

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Discuss how they can ensure adequate protocol reviews by the entire ethics committee

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Ask participants to brainstorm on the possible importance of protocols including a research related budget when submitting their protocol for review. Discuss the pros and cons.


PLENARY 11

Providing constructive feedback

Objective Discuss with workshop participants how to provide constructive feedbacks when reviewing a protocol

Materials needed 1. 2. 3. 4. 5. 6. 7.

Data projector Laptop Session slides Flip chart Flip chart stand Research protocol Activity sheet - Constructive feedback Game


Discuss about giving constructive feedbacks when recommending protocol amendments o Giving constructive feedback o Charactieristics of constructive feedback o Ways to make feedback constructive o Ways to give constructive feedback

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Highlight the role of layperson as community representatives on the ethics board, in facilitating this process.

Facilitators should provide charts to each group of three workshop participants.

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Each chart should have a statement which is a negative criticism of a protocol. Each group should convert those statements to positive statements.

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Each group then reads the negative statement and their positive reconstruction of the statement to the entire plenary when the group work is over.


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Group Work 1 - Constructive Feedback Game

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Allow for inputs and discussions

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Finally, discuss the role and importance of engaging the community in research design , implementation, monitoring and dissemination of results as being ethically imperative. Highlight the role of layperson as community representatives on the ethics board) in facilitating this process

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Group Work 2 Protocol Review and Providing Constructive Feedback 

Each group and ask them to review the protocol shared out during pleanry 8 again

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Provide participants with the sheet on protocol review questions relevant to community needs

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Each group to provide constructive feedback to the researchers after reviewing the protocols

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Allow each group to work for 20 minutes

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Present these constructive feedbacks at the plenary

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Allow for inputs and discussions

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Summarise discussions and lessons learnt and the end of the session.


PLENARY 12

Monitoring research

Objectives 1. Workshop participants understands their role and importance of research monitoring by ethics committees 2. Workshop participants understand the role and place of laypersons in research monitoring



Define why it is important to monitor research o Emphasis that the objective of research monitoring is to ensure research participants protection o Highlight that research monitoring starts from the protocol review stage prior to implementation o Identify elements of the research to be monitored during trial conduct o Highlight elements of the research that needs to be monitored once the study is concluded

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Identify the legal structures for monitoring research o Discuss international guidelines o Discuss Good clinical and laboratory practice documents o Discuss the UNAIDS/WHO document o Discuss the GPP o Discuss the National food and drug regulatory agency regulations o Discuss the national ethics committee regulations


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Training content

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Define the role and composition of the DSMB in monitoring international multisite research o Discuss the importance of local ethics committee following up DSMB reports about trials conducted in their centre

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Define the place for community oversight and monitoring of research o Elicit from participants how they can provide oversight for research conducted within hospital settings o Elicit from participants how they can provide oversight for research conducted within the community o Discuss how they can provide constructive feedback on observations made during research monitoring


PLENARY 13

HIV treatment research

Objective The session would highlight the peculiar issues there are with the conduct of HIV treatment clinical trials




Discuss HIV infection and the need for treatment o Discuss how HIV can be contracted o Discuss HIV management including opportunistic infection treatment, nutritional support, infection prevention and psychological support o Briefly discuss HIV treatment - when to commence, resistance, possibilities for switches o Discuss national treatment guidelines Discuss the peculiar issues with ARV therapy (treatment success monitoring) o Emphasis that HIV treatment is for life o Highlight that treatment interruption is not successful and such researches should not be encouraged o Discuss the why and how of treatment monitoring

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Discuss the role of laypersons in ensuring the proper design and conduct of HIV treatment o What should laypersons look out for in HIV treatment protocols o What type of HIV treatment researches should be encouraged o Discuss possible national priorities for HIV treatment research


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 Highlight the importance of continued treatment research

PLENARY 14

HIV prevention research

Objectives 1. Workshop participants would understand the need for New HIV prevention Technologies (NPT) 2. Workshop participants would understand what are NPTs 3. Workshop participants would understand the peculiar issues related with these researches?


Data projector Laptop Session slides Flip chart Flip chart stand Case study


Discuss HIV prevention and the need for more research. o Discuss the need to expand HIV prevention options o Discuss the limitation of existing tools

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Highlight the importance of continued HIV prevention research. o Discuss additional tools for HIV prevention identified by recent research o Discuss ongoing HIV prevention research

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Discuss the peculiar issues with past, ongoing and future HIV prevention research. o Brainstorm on how the HIV disease burden in sub-saharan African can be turned into an asset for development o Discuss ARV access in HIV prevention trials o Discuss the possible future challenges for ARV access in ARV based HIV prevention trials

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 Discuss the role of laypersons in ensuring the proper design and conduct of HIV treatment


research in Nigeria. o Ask participants to identify their role in facilitating trial participants care and community benefits from HIV prevention research. o Discuss the role of laypersons in facilitating future access to ART for trial participants.

Divide participants into three groups

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Ask each group to discuss the part of the case study for 10 minutes.

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One group should present to the plenary and the others make input

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Present the plot twist and allow each group to discuss again 5 minutes.

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Allow for a group presentation and others to make inputs

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Facilitator to highlight the challenges of IRBs in taking decisions on cases with no clear cut guidance in existing documents as (s)he summarises discussions.


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Case study

PLENARY 15

Community Engagement in Research

Objectives 1. Workshop participants would identify approaches of community engagement 2. Workshop participants would understand the importance of community engagement in research 3. Workshop participants would understand the challenges to community engagement 4. Workshop participants would understand critical aspects of research where community engagement is most needed



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Define community.

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Identify features of community.

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Discuss 6 principles of community engagement.

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Discuss the approaches to community engagement. o Define community involvement o Define community consultation o Define community partnership o Discuss the various sections in ethical documents that highlights the need for community engagement in research

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Discuss the goals of community engagement.

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Discuss the challenges to community partnership. o Challenges for communities


o Challenges for researchers


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Discuss the various context for community engagement. o Informed consent development o Addressing confidentiality in research o Balancing risks and benefits for research participants

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PLENARY 16

Community advisory mechanisms

Objectives 1. Workshop participants would understand what a Community Advisory Board is 2. Workshop participants would understand the place and role of the community advisory structures and how to ensure their functionality



Training content    

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Define community advisory mechanism. o Discuss the history of community advisory mechanism engagement in research Discuss the composition of the CAB Define their role and functions. Define how to ensure their autonomy. o Ensuring CABs are independent voices o Facilitating trainings independent of the research o Funding autonomy Facilitating bidirectional relationship with the community and the research team. o Discuss the need for this bidirectional relationship o Discuss the mechanism to support this relationship o Discuss the use of multiple community engagement mechanisms in the community in addition to CABs Define layperson's role in facilitating community input throughout the life cycle of the research. o Discuss laypersons engagement of existing community engagement structures o Discuss laypersons role in ensuring research engage these structures


PLENARY 17

Civil society engagement in research

Objective Workshop participants would understand how civil society organisations can be constructively engaged in research.




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Define civil society. o Define what civil society means o Describe the various types of civil society o Describe the various functions of civil society Share lessons on constructive civil society engagement. Share lessons on destructive civil society engagement. Discuss the pros and cons of engaging civil society in research. Define ways to facilitate civil society engagement in research and protocol development.

Group Work


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 

Break the participants into three groups. Ask a group to describe how as laypersons they can advocate for civil society engagement in a protocol development and implementation during protocol review; the second group to discuss how they can assess degree of civil society engagement in protocol implementation during research monitoring; the third group discuss how civil society engagement in research can be made constructive rather than deleterious Each groups would present at the plenary Allow for discussions on each group work

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PLENARY 18

The Good Participatory Practice Document

Objective Workshop participants would get familiar with the GPP document


Data projector Laptop Session slides Flip chart Flip chart stand The Good Participatory Practice Document

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Understand the history of the GPP



Discuss the objectives of the GPP.



Discuss the components of the GPP.



Discuss how the GPP can facilitate the work of laypersons on ethics committees. o As review guideline o A monitoring guideline


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Appendices

PRE AND POST TEST QUESTIONS Please pick the most appropriate response

ID______________________ 1. Informed consent is important because a) It enables the participant to understand vital information on the proposed trial b) It provides the participant will all the information regarding remote risks c) It enables the investigator to recruit participants of his choice d) It promotes clinical research 2. Informed consent refers to: a) Principle of autonomy b) Voluntary but uninformed decision-making c) A voluntary decision to participate in research, by a competent individual who has received and understood the necessary information d) Permission to participate in research 3. Capacity to consent to trial participation may not be diminished by: a) Poverty b) Source of research funding c) Lack of understanding d) Cultural barriers e) Situational pressure 4. What gives ethical validity to the procurement informed consent? a) Detailed documentation of the process b) Capacity of the participant to consent c) Quality of the disclosed information d) Quality of the interaction between the prospective participant and the recruiting physician/investigator

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5. Which set of the following information need not be disclosed to a prospective participant to procure informed consent? a) All the possible risks associated with participation; possibility of active deception by the investigators; confirmation that the study has an ethics review committee's approval b) That the study involves research; sources of funding; anticipated benefits and potential risks c) The discomfort that may be associated with participation; the right to withdraw from participation at any stage without reprisals; institutional affiliations of the researcher d) Aims of the trial; methods to be used in the trial; possible conflicts of interest


6. Which set does not represent vital elements of informed consent? a) Capacity to consent; voluntary decision to participate; adequate comprehension of the provided information b) Ability to withdraw from the trial without reprisals; full comprehension of the provided information; documentation of informed consent c) Full disclosure of relevant information; capacity to consent; voluntary decision to participate d) Adequate comprehension of the provided information; capacity to consent; voluntary decision to withdraw from the trial at any stage 7. When is active deception of prospective participants necessary? a) Never b) When no other research method suffices c) When deemed indispensable d) For security reasons 8. Can the requirement for informed consent be waived? a) Yes, at the discretion of the investigator b) No, unless a designated ethics review committee approves c) Never d) Yes, with the consent of the participant 9. What are some of the hindrances to achieving genuine informed consent internationally and in Nigeria? a) Poverty, illiteracy and implicit forms of coercion b) Disease burden, forgetfulness and cultural barriers c) Language barriers, confusion and lack of capacity to consent d) Incentives, situational pressure and health care professionals'assumed beneficence 10. Who cannot consent to trial participation in Nigeria? a) Healthy but poverty stricken volunteers b) Healthy volunteers below the age of 18 c) Mentally stable but sick adults d) Medical students

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11. When is assent mandatory in procuring informed consent? a) When the prospective participant is a minor b) When the prospective participant is unconscious c) When the prospective participant has a mental disability d) When the prospective participant is a mature minor who is capable of making appropriate decisions about trial participation

12. Who gives consent in cases of minors who have no parents or guardians? a) Consent can be waived, as it is not necessary b) Nobody c) A social worker d) Legal guardians 13. Which of the following scenarios may lead to role confusion in participant recruitment? a) Recruitment by community leaders b) Recruitment by a trial investigator c) Recruitment by the participants' relations d) Recruitment by an investigator who is also a physician who has been providing medical care to the prospective participant 14. When does a community leader's authorisation of participants'recruitment replace an individual participant's consent? a) Never b) When the community's interests are at stake c) When the proposed trial is likely to benefit the community d) Always 15. What role does a community/local leader's authorisation play in the recruitment of participants? a) It gives the proposed trial ethical validity b) It fosters respect for the local customs and expectations c) It ensures that the community members volunteer in large numbers d) It plays no role 16. Vulnerable populations are those best characterised as: a) relatively poor persons b) persons experiencing emotional distress c) non-citizen residents of a foreign country d) persons who stand in severely unequal power relationships with others e) persons who are mentally incompetent

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17. Prisoners are considered a vulnerable population for each of the following reasons except for: a) the fact that their incarcerated status places them in unequal power relationships b) the fact that prisoners are easily influenced by rewards and incentives c) the fact that prisoners can never give informed consent under any circumstances d) the fact that prisoners may have very options to distinguish themselves from others e) the fact that prison guards may mistreat prisoners who do not choose to participate in research studies


18. Research involving vulnerable populations must always: a) leave the participants better off than they were before b) address questions that cannot be answered by conducting research on other, non-vulnerable populations c) follow local standards of care d) involve participants residing in developing world countries e) secure informed consent (directly or by proxy) from research participants 19. The following documents must be made available to the REC for review prior to trial approval: a) trial protocol b) written informed consent forms c) information on serious adverse events from the Data Safety and Monitoring Board (F) d) declaration of conflict of interest of the researcher where appropriate e) participant recruitment procedures

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20. Acceptable recompense for trial participation includes: a) reimbursement for transport b) reimbursement for lost earnings c) extensive medical services d) reimbursement for inconvenience and time spent as a result of their participation in research e) free medical services either related or unrelated to research participation

Clinical Trials Terminology Arm – A group of participants in a clinical trial who all receive the same investigational product or placebo. Other arms or groups in the trial receive a product or placebo. Benefits – Advantages available to a participant as a result of being in a trial. Examples include education, counseling, free condoms, and medical assessments including physical exams and laboratory tests, etc. Risks – The possibility of loss or injury. Clinical Trial – A research study to answer specific questions about an investigational product administered to human research participants. Data Safety and Monitoring Board (DSMB) – An independent committee composed of community representatives and medical and statistical experts that review data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. They can recommend that a trial be stopped if they feel that the safety of participants is in jeopardy or if they determine that a study will not be able to answer the research question. Double-Blind Study – A clinical trial in which neither the participants nor the study staff knows which participants are receiving the investigational product intervention and which participants are receiving placebo (or another therapy). Randomized Trial – A study in which participants are randomly (i.e., by chance) assigned to one of the trial arms. Efficacy – The ability of a drug, vaccine, microbicide, behavioral intervention or other treatment to produce the desired result. This is determined during Phase III clinical trials. Endpoint – Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. Incidence – The number of new cases of a given disease or infection during a given period in a specified population. It also is used for the rate at which new events occur in a defined population. It is differentiated from prevalence, which refers to all cases, new or old, in the population at a given time.

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Prevalence – The total number of cases of a given disease or infection in a specified population at a designated time. It is differentiated from incidence, which refers to the number of new cases in the


population at a given time. Inclusion/Exclusion Criteria The medical, behavioral, and/or social standards determining whether a person may or may not be eligible to enter a clinical trial. Informed Consent – The process of learning the key facts about a clinical trial and then deciding whether or not to participate. Participant Confidentiality – Refers to maintaining the privacy of trial participants including his/her personal identity and all personal medical information. Phase I Trial – A study to assess the safety of an investigational product in human research participants. Generally small in size, involving 10 to 100 participants. Phase II Trial – A study to assess the safety of an investigational product in a larger number of human research participants. May also assess indicators or correlates of whether the product is efficacious. Generally involves 300 or fewer participants. Phase III Trial – A study to assess the efficacy of an investigational product. Also assesses the safety of the product in a large number of human research participants. Generally involves several hundred to several thousand participants. Placebo – An inactive substance (may look like the real investigational product) against which an investigational product is compared to determine safety and efficacy. Protocol – A detailed written plan for conducting a clinical trial. Study Objective – The purpose of the study, what researchers hope to learn. Study Population – The individuals who participate in a clinical trial. Study Site/Unit – The physical location where a clinical trial is conducted.

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Study Sponsor – The institutions and companies funding a clinical trial

Plenary 4: Group Work Informed Consent checklist

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Items in the informed consent form 1

Title of the research

2

Name(s) and affiliation(s) of researcher(s) of applicant(s)

3

Sponsor(s) of research.

4

Purpose(s) of research

5

Procedure(s) of the research

6

Compensation

7

Consequences of participants’ decision to withdraw from research and procedure for orderly termination of participation

8

Modality of providing treatments and action(s) to be taken in case of injury or adverse event(s)

9

What happens to research participants and communities when the research is over

10

Post research benefits

11

Any apparent or potential conflict of interest.

12

Detailed contact information including contact address, telephone, fax, e-mail and any other contact information of researcher(s), institutional HREC and head of the institution.


Present

Absent

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Plenary 7 Protocol on NPT study

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Plenary 8: Protocol for review


Plenary 10: Sections of a research protocol Protocol content requiring community review

1

Title

This is concise information about the study. It tells briefly what the study is all about

2

List of abbreviation

Gives information about all the meaning of the acronyms used in the written protocol

3

Investigators

Lists all the full names and qualifications of all the persons participating in the research as investigators

4

Protocol summary

This is a summarized version of the protocol which gives you the pertinent information about the protocol. It should contain the study objective(s), methodology, study population, sample size

5

Introduction

(Background information, description of study product or device, animal and laboratory studies, other human studies)

6

Objectives

Define the primary and or secondary and tertiary (exploratory) objectives

7

Methodology

This describes the study design how the study would be conducted, where the study would be conducted, how research participants would be recruited, number of study participants, duration of the study

8

Study population

Defines who would be recruited, the inclusion criteria and exclusion criteria. Guidelines are based on such factors as age, type of disease, medical history and current medical condition amongst others.

9

Study product/device

Regimen, mode of administration, product formulation, how the product would be supplied and how the use and dispense of the product would be accounted for, what other products/procedures can or cannot be used with study products/device


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Content

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Study procedure

Enrollment procedure (how would you consent participants), how would do conduct clinical visits, how do you conduct follow-up visits, how does participant exit research, clinical and laboratory evaluations, specimen collection, specimen handling, specimen disposal

11

Assessment of safety

Safety monitoring, clinical data review

12

Clinical management

How do you define adverse events, when and how do you modify drug dose, when do you discontinue study product or discontinue a trial participant on a product/devise, how do you manage adverse events

13

Statistics

Data analysis process

14

Data handling and record keeping

Data handling, data safety, confidentiality issues

15

Research site monitoring

Plans by the research team to ensure monitoring of trial implementation and quality assurance on data collected

16

Human subject protection

HREC review, protocol registration, risk benefit statement, informed consent process, participant confidentiality, special population, compensation, communicable disease reporting

17

Result dissemination

Plan to share the results with the research participants and the general public after the research

18

Informed consent form

This usually comes in the form of an appendix. It should give details of the research including objectives, methodology, inclusion and exclusion criteria, risks and benefits of research, plans for compensation, who can be contacted about the research and how to address grievances or concerns about the research at the minimum


PLENARY 11 Constructive feedback game Convert these negative feedbacks to positive feedback 1. How do you imagine people in this community will participate in this type of research. Have you ever seen women attend antenatal clinics run by men? The PI of this study is a man and you plan to conduct vagina examination for women. You are simply planning to fail. 2. Did you ever receive training in a medical school? Do you know what an informed consent is? All you have written here is a long essay about the study. Please send a proper informed consent form for review. 3. What do you want to do with 25mls of blood taken from every patient? Did you not read that most people in this community are anaemic? Now you want to take 25mls from people who are already anaemic. Do you want to kill people from this community? 4. The principal investigator for this study is from Britain. Do you mean all the data and sample will be exported to Britain? Can you not get a Nigerian to conduct this study? With all the human resources in this country, you cannot find a Nigerian to head this study? 5. This protocol is meaningless. Can you send a revised protocol for review if you mean business. I advice you to write a protocol for a completely new study. Otherwise go and meet Prof Haruna to help you. 6. I am very dissapointed with the quality of this proposal. I always had so much respect for medical doctors. It is obvious from this proposals that you only plan to waste people's time for selfish interest data collection and paper publication. What do you give back to this community, nothing. And you expect we will allow you to come again for another research after this time wasting effort? You even make us to pay for procedures.

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7. Do you think your child can participate in this type of research? Even you, will you participate in this research? Why then do you want to do this type of research in our community taking blood from a child 5 different times in a single day for 3 days. You must be heartless.

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PLENARY 12: Protocol Review Questions Relevant to Community Needs 1.

Is the research question clear and relevant to your community?

2.

What efforts have been made to ensure the proposed research addresses the health needs or priorities of the population/communities in which the study will be conducted?

3.

What reactions do you anticipate from your local community, government, local leaders, community based organisations and non governmental organisations regarding the proposed research?

4.

What changes to the concept/protocol would you suggest in order to achieve community support and ownership of this study in your local community?

5.

What potential concerns/controversies do you foresee with the proposed research plan?

6.

What is the duration of the study? How long will participants be in the study? Hen is the study expected to end?

7.

How frequent are clinic visits? What is involved in clinic visits? What is the anticipated duration of the clinic visits?

8.

Does the protocol include plans for treatment of study participants and partners?

9.

If participants are expected to use certain forms of therapy, will that create a barrier for participation?

10.

Does the protocol include assessment regarding incidents of social harm?

11.

What study regimen might expose participants to social harm?

12.

What are the incentives for study participation? Are they coercive? Are they adequate?

13.

What study requirements make it difficult for participants to remain in the study for the duration of the trial? How can those potential barriers be overcome?

14.

Are the inclusion and exclusion criteria reasonable? Are there criteria that should be added or deleted?

15.

What sections of the consent forms may require further explanation or support materials to ensure comprehension by prospective participants?

16.

Do the informed consent support materials assist in imporving comprehension?


18.

How soon will the study results be available and what plans are in place to ensure that the results are disseminated to the study participants prior to publication?


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What efforts will be made to ensure that any successful intervention or product will be made available to benefit participating study population/communities?

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