Three days Training Programme Report on Ethics in Health Research … · 2012. 7. 31. · Page 4 of...

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Three days TrainingProgramme Report on

Ethics in Health Researchand Clinical Practice

Conducted by

The Aminu Kano Teaching HospitalEthics Committee

In collaboration with

New HIV Vaccine and MicrobicideAdvocacy Society

With funding support from SIDACTION, France and AVAC27TH -29TH September, 2011

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TABLE OF CONTENTTable of contents 2

List of Acronyms 4

Summary 5

Background information on the project 5-6

DAY 1 Tuesday 27th September, 2011Opening ceremony 7History and evolution of research ethics 7-8Principles of research ethics and its applicationInformed consent: the informed consent process and challenges with theinformed consent processRelevance and importance of confidentiality in research and clinicalpracticeCase study: Review of a protocol

DAY 2 Wednesday 28th September, 2011Recap 10Research Integrity and misconduct 10-11Formation, constitution and function of NHREC 11-12Constitution, function and management of HREC 12-13Practical challenges in protocol review 13-14Minimum requirement for protocol submission 14-15Group work 15-16

DAY 3 Thursday 29th September, 2011Recap 16Good Community engagement practice: principles and elements of theGPP

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Importance and role of Community Advisory Board 17Addressing the needs of Vulnerable Populations in Research 17-18Monitoring of Research: role and responsibility of the HREC 18-20Reflections and Closing ceremony 20

Report of programme AssessmentPre and post test analysis 21Feed back about workshop modules 22-24Evaluation of Day 1 24Evaluation of Day 2 24-25Evaluation of Day 3 25-26Logistic and admin feedback of workshop 26How skills will be utilised 27-28Recommendation how to make workshop better 28Lessons learnt 28Participants’ list 29

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LIST OF ACRONYMS

AKTH Aminu Kano Teaching Hospital

DSMB Data Safety Management Board

GCP Good Clinical Practices

GPP Good Participatory Practices

HREC Health Research Ethics Committee

IRB Institutional Review Board

NHREC National Health Research Ethics Committee

NAFDAC National Agency for Food Drug Administration and Control

NHVMAS New HIV Vaccine and Microbicide Advocacy Society

REC Research Ethics Committee

WAB West African Bioethics

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SummaryThe Ethics Committee of the Aminu Kano Teaching Hospital in collaboration with theNew HIV Vaccine and Microbicide Advocacy Society organised a 3 days training onethics in Health Research and Clinical Practice for 28 participants. The workshop washeld at the Aminu Kano Teaching Hospital, Kano between the 27th and 29th ofSeptember 2011.

The goal of the training was to enable participants manage the ethical challenges intheir routine research and clinical engagement, to equip them with knowledge andskills relevant for successful outcomes of ethical reviews and audit, as well asenhance institutional capacity for undertaking protocol (ethical) review, monitoringand audit. The objectives of the training were to:

• To teach the basic principles and philosophy underlying ethics in health researchand clinical practice

• To highlight the ethical issues in various health and clinical Research

• To elucidate the ethical research review process.

The 3 days training consisted of 15 plenary sessions with 5 resource persons. Themodalities of training included the use of lectures, groups discussions, brainstorming,quizzes, question and answer session, case studies. The entire three days wasentirely participatory in nature.

Impact of the training was assessed through the use of the pre and post tests, dailyprogramme evaluation, overall programme evaluation, as well as trainees selfassessment of skills gained.

Knowledge and skills gained: The mean score of the pre-test was 55.9% (CI: 46.2 -65.5) while the mean post test score was 80.4% (CI: 72.1 – 88.7). The difference inthe scores was statistically significant (p=0.0001). The paired t-test score was showeda highly statistical difference in pre and post test scores (56.5 vs 80.2) p<0.00001.

Overall assessment of the programme: all the participants felt the workshop hadachieved its objectives. The quality of the training was rated high. The session onaddressing the needs of vulnerable populations was also rated high. A few of theparticipants shared their concerns about the feeding arrangement as well as thepublication and communication about the programme arrangement.Participants alsowanted their ethics committee to continue the training at a regular interval, andemphasized the need for NHVMAS to monitor the participants to maturity.

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Chapter 1: Day one: Basics of Research Ethics. - 27th September, 2011

2.1 PreambleThe programme started with the introduction and opening prayer. The openingremark was given by the chairman of the ethics committee, Dr Borodo his expressedhis delighted that the training was being conducted in Kano and hope that thequality of protocol the committee will improve as a result of the workshop. DrAjuwon gave the response on the behalf of NHVMAS and explained that NHVMASrole was to act as facilitators in collaboration with the ethics committee of AKTH.

In his remarks, the Director of Administration who was the representative of theC.M.D expounded on the need for the training because no society can survivewithout research and ethics of research, he thereafter declared the workshopopened with the closing prayer.

The presentations of the day were taken and these included:

History,evolution of research ethics and current guideline for conduct ofresearch.

Principles of research ethics and its application Informed consent, the informed consent process and challenges with the

informed consent process. Relevance and importance of confidentiality in research.

2.2 History and Evolution of Ethics in Research – Dr M UkpongThe facilitator started the session with the outline and the objective of the sessionand the expected learning outcome for the participants. She went on to explain thatmedical ethics could trace its roots to several early codes of ethics such as theancient Greek Hippocratic Oath that requires physicians above all to "do no harm”.Dr Ukpong further explained these early codes from the 1st century experience withCelsius, a Roman historian justifying experiments on condemned criminals throughto the 18th, 20th and to the prior World War 2 era. She made clear that all of theseactivities were carried on in the absence of formal codes or regulations to guide theethics of the conduct of clinical trials.

After the Nazi World War II crimes in which, doctors performed horrific experimentson thousands of concentration camp inmate, there was then the need for researchethics guidelines in the conduct of human trials with the Nuremberg code, WorldMedical Association guidelines, The declaration of Helsinki, The Belmont report andmany others.

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Discussions/QuestionsThe facilitator started the discussion with this question: Do you think thesemisconducts are still ongoing?Answer: Some of the participants were of the opinion that they are still ongoing,while some were not. Dr Ukpong then explained that they were still happening andgave examples of The Pfizer Trovan case study in Nigeria, among others. She furtherexplained that HREC were meant to check and improve on trial protocol for humanprotection and not the erroneous believe that they stop or undermine research.

Discussions then centred on what participants thought. Most of the participants didnot support that experiments should be carried out on humans, but one was of theopinion that experiments could be carried out if it was part of the punishment forgrievous crime. One was also of the opinion that the experiments conducted for theoverall good of the society group was more beneficial than the individual right.

Some participants also gave examples of how their protocols were improvedbecause of the review of the ethic committee.

Question: In a pharmaceutical research, do you have to have a doctor as the P.I?Answer: You need a team because it involves humans. For instance in terms ofphysical examination you need the doctor. For blood samples the laboratoryscientist. So you will need a complete team that has its roles and responsibilities.

The consensus was that it was not necessary for the M.D to be the P.I, as long as theresearch is conducted scientifically well.

Question: If we discover ethic issues on a protocol who should be responsible?Answer: Both the ethics committee and the researcher, because the IRB providesoversight, while the researcher carries out the research including the ethics issues.

2.3 Principle of research ethics and its application- Dr AjuwonDr Ajuwon started this session by defining research as “a systematic investigation,including research development, testing and evaluation, designed to develop orcontribute to generalisable knowledge (FHI, 2000)”. He further posited that ethics isa determination of what is good or bad and research ethics as the rules or code(s)that researchers need to observe in order to conduct ethically acceptable research.He further explained that all biomedical and behavioural research involving humanparticipants are guided by four universal principles namely Respect for persons andcommunities, Beneficence, Non maleficience and Justice and went on to describe thepractical application of these principles.Other topic includes:

• Vulnerable populations• Importance of ethics principles in research.

Discussion/QuestionsThe session was very interactive with the facilitator starting the discussion sessionwith the question “What makes research ethical? Participants gave their

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understanding of what made research ethical and this subsequently lead to otherquestions and discussions.

Question: Do parent really give consent for their children participation in research,or is it giving authority.Answer: There is a distinction between care and research. In research the role of theparent is to go through the information given then takes a decision, but if the childdoes not want to partake then the consent is void.

Question: Is there a child that will give consent to take blood sample for research?Can the parent not take a decision based on that?Answer: If the sample is to do with care, then you have to take the decision.

Question: What is the difference between research and care?Answer: Care is service given to patients, while research is generating data withoutsentiments in order for it to be valid.

Discussions were centred on implied consent and a child less than 5 years and cantherefore not comprehend language giving consent. However, most of theparticipants were of the opinion that if it was related to research then the child’sright must be respected, irrespective of the age of the child.

On the place of implied consent, participants were divided; some opined that whenpatients come to a teaching hospital they have given implied consent because it is aplace that for the practice of care and research, other however felt that the patientsare usually too afraid or sick and therefore their consent should not be sought inteaching rounds and other hospital practices.

The facilitator cautioned that “We should be mindful of the fact that most peoplecannot make the distinction between the teaching hospital and other hospital andtherefore the right of the patients must be respected”.

2.4 Informed Consent- Mr U Abubakar.The objectives were to:

• 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.

The facilitator explained the issues behind getting voluntary informed consent byillustrating with examples of the thalidomide study and Pfizer’s trial as researchendeavours that had been concluded without participants giving consent for thestudies. Topics taken also includes principles of ethics, the four elements of aninformed consent document , eight minimal content of an informed consentdocument, the processes for ensuring informed consent and the role of laypersonsin ensuring the informed consent process.

Discussions/QuestionsIt was quite an interesting session with participants engaged in a lot of discussionsand questions; on the component of consent in care and research and on whose

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duty it is to obtain it. It was very interactive with participants sharing theirexperiences. Some are highlighted below:

Question: what is the difference between waiver consent in research and in care?Answer: Informed consent waiver is given in care when it is an emergency situationand in research informed consent waiver can be given when the participant is nolonger alive.

Question: who gives informed consent for a research process on a married minor theparent of the minor or the husband?Answer: Participant were almost unanimous on their decision that the minor shouldtake her decision, but some were of the opinion that in the northern part of thecountry the husband will take the decision based on religious and cultural practices.

A participant gave an example of a patient whose husband refused to give consent tohis pregnant and unconscious wife. The brother of the minor then asked that thehusband divorce his sister so that he can take responsibility and give the consent.The husband did, the brother gave the consent and the minor was saved.

Question: Can school principals give informed consent for school children/what isthe place of community consent?Answer: What the principal gives is access but cannot give consent. If the child is lessthan 18years, then student has to go home to get consent. The same goes with thecommunity. The gatekeepers can only give access, but the consent must come fromthe participants.

Question: Is there provision for e-consent in a research?Answer: Yes, you can get consent electronically for research but not for care.

2.5 Confidentiality - Dr AjuwonConfidentiality is the “the art of keeping secret” and the non disclosure ofinformation to a third party. In the context of research, confidentiality means “theprocess of protecting or safeguarding the information provided by researchparticipants”. With these explanations, Dr Ajuwon stared the session.

He went on to give details on the importance of understanding the concept ofconfidentiality in research and on the imperativeness of understanding whyconfidentiality is important in biomedical research. Other topics included: How tomaintain confidentiality, the confidentiality assurance form, how investigators cangain the trust of participants and the challenges and dilemmas faced in keepingconfidentiality.

Discussions/QuestionsDiscussions were centred on situations like” if in the course of your study youdiscover that a girl has been raped what should you do” , “if in the course of yourresearch you find a pregnant girl who does not want her mother to know” and onthe issues surrounding keeping the status of HIV positive persons from theirpartners.

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Participants were divided in their reactions; some were of the opinion thatinformation obtained in the course of research were confidential and should not bedivulged, while some felt that if that if such information were discovered then theLaw enforcement agents should be informed, while for the pregnant girl the motherhas a right to know.

Drs Borodo, Ajuwon and Oyedeji facilitated the discussions and answered that oneach of the given examples counselling was the best approach. They informed theparticipants that counselling was not a single session but a process and that theyshould show beneficence and thus, there should be balance between harm andgood. For the pregnant girl if she is below 18 years then they mother should knowbut with counselling. Dr Borodo also enlighten the participants that for the case ofHIV+ person, that the physician can after sessions of counselling and some months,he/she can then inform the partner.

Question: are we really keeping information secret when eventually the result of theresearch will be made public?

Answer: confidentiality means that personal information should not be divulged in away that people can identify who the participants were. Access should not be givento unauthorised persons.

Why is it important? (a)So that people will be willing to participate in research andwilling to give information.(b) To protect the safety of the participants.

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Chapter 2: Research Protocol Review: Day Two 28th September 20113.1 RecapThe day’s activities commenced with a recap of what participants had learnt, by arepresentative. He gave a slide presentation of what participants had learnt theprevious day.

3.2. Scientific misconduct - Dr OyedejiMisconduct in scientific research means fabrication, falsification, plagiarism, or otherpractices that seriously deviate from those that are commonly accepted withinscientific community for proposing, conducting, or reporting research. Theconsequences of scientific misconduct can be severe at a personal level for bothperpetrators and any individual who exposes it. In addition there are public healthimplications attached to the promotion of medical or other interventions based ondubious research findings. However misconduct in research does not include; honesterror or differences in interpretations or judgment of data, also sexual and financialmisconduct does not constitute research misconduct. Other topics include: Misconduct in Publication, Requirements for authorship, Scientific Integrity, Integrity in research, Integrity in disseminating research findings, Four areas in which research integrity is required, The characteristics of responsible Conduct in research, Causes of research misconducts among others.

The facilitator also gave the examples of professors who had conducted scientificmisconduct with its attended consequences.

Discussions /QuestionsParticipants’ discussions were on the issue of who a health professional was and whoshould really monitor human subject research the Doctor or the social scientist?They also discussed on the need for a standard of care for all researches conductedin the country.

Question: are your sponsors also authors?Answer: Sponsors can be acknowledged, but are not authors.

Question: should a field worker be acknowledged.Answer: No because it was a contract and they were paid.The facilitator emphasised that only if you collaborated in the research should yoube an author.

Question: how can the ethics committee ensure that you idea is protected by themand not plagiarised?

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Answer: Committee members sign a form of confidentiality and are therefore boundby it.

3.3 History and constitution of NREC- Dr AjuwonIn his presentation the facilitator explained that prior to 2007 there were attempts inthe 1980s to establish a research regulatory agency. It was however not very activebecause of limited interest, lack of funding and low levels of research activities. TheNigerian Code was established with the mission of promoting the highest ethical andscientific standard for Health research in Nigeria.

The Nigeria code was developed in 2006 as a result of the history of research abusesin local and international research environments, the health reforms in Nigeria andthe need to protect research participants. Other topics in this session include: thestructure of NREC which consists of 15 members, functions of NREC and highlights ofthe Nigerian Code.

Questions: How can one get the guideline?Answer: it can be downloaded from the website.

Question: does NREC have a specific role to educate the ethics review committeeAnswer: The West African Bioethics programme and other bodies like NIMR;NHVMAS are engaged in the training of member of ethics committee.

Question: What is the minimum training every professional should receive everyyear?Answer: Facilitator said the code was silent on this but that the information will bepassed to the authorities.

Question: what about the right of the researcher or protection of the research, is itin the guideline?Answer: There are various groups in the research process that must be protectedfrom exploitation from the various players in the research, the material transferagreement. (M.T.A) is one example for the protection of researchers.

3.4 Composition, Functions & Management of Institutional Ethics Committees - DrMM Borodo.The objectives of this plenary was to highlight the composition of Ethics ReviewBoards with reference to NHREC guidelines, to introduce the various forms of reviewprocesses with their advantages or otherwise and the management components ofinstitutional review boards.Dr Borodo elucidated that the successes of IHRECS is the greatest strength of NHRECin achieving the national objectives of the national health research code. He furtherexplained that it was desirable and indeed necessary to establish institutional Ethicsreview board so as:(a) To operationalize the functions of NHREC at institutional level,

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(b) Protect the research rights of all stakeholders.

Guidelines for registration of NRECs and their compositions were also made explicit.Other topic presented includes:

o Functions and operations of the IRECs,o Why Protocol review,o Types of ethical reviews which includes- (Full or Standard review, Expedited

review and Exempt review).

He further explained when and why each of these types of reviews could apply, theoversight function of the IREC and the need and functions of good record keepings ofan IREC.

Discussion/QuestionsThis session discussion was centred on whether it was desirable to have multipleethics committee in one organisation. There was a consensus that there should bemore and that the composition should be for that of care and research. Participantsagreed that the review of protocol by the IREC was to protect and improve researchwork and to guide against duplication of research work. Although one of theparticipants was of the opinion that the disadvantage of protocol review was thedelay.Question: What are the roles of the I.R.B in a proposal that is destined to fail?Answer: it is the duty of the committee to review the protocol and give constructivefeedback, but if in the course of the review the protocol is deemed to beunsalvageable then the committee can reject such protocol.

Question: Whose bears the cost of care for a participant involved in a research?Answer: The facilitator also explained that in the protocol the researcher shouldstate what the standard of care is and that in the course of the study; the researchershould bear the cost for the minimum standard of care or would have put in placemechanism for referral.

Question: what do IRECs do about publicised articles that they know did not getcommittees approval for the study.Answer: if for instance the journal or other people write to the committee about thepublished article, it will then be investigate, but that the committee does not goabout witch hunting people.

3.5 Practical Challenges in Institutional Health Research Protocol Review- Dr M.MBorodoThe facilitator began the session by engaging participants on what was a protocol,participants gave their opinions of what it was, and then he asked “what will youconsider an ethically acceptable protocol”.

Dr Borodo posited that Medical practice ethics is as old as medical practice itself withthe Hippocratic oath and its variants are its manifestations, but that health researchethics is however a relatively newcomer, with its pace of development oftenfacilitated by unpleasant health research scandals and gave some examples that

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included the Nazi war crimes during world war II, Thalidomide use in pregnantwomen, Tuskegee syphilis studies(I and II) in USA and Guatemala, the MilgramExperiment and the Trovan Meningitis study in Kano, Nigeria.Other topics included:

The birth of new Health research ethics guidelines, The birth of Nigerian health ethics code, Health research Ethical Committees, Operation of AKTH HREC, Challenge in Protocol Review, Researcher/Protocol related challenges, HREC Committee Members Related Challenges, Administrative Challenges, Challenges of Oversight functions, Harmonizing these Challenges and ways forward.

Discussions and questions:Question: can you use sample or data you used for a research for another research?Answer: write to the I.R.B to inform them of the additional work you plan toconduct. You can also get a blank approval.

Question: is it okay to report conflict of interest in terms of findings of research.Answer: yes, it is advisable that you include your sources of funding and anypotential conflict of interest.

3.6 Minimum requirement of a Protocol submission. –Dr M.M BorodoA research study or a clinical trial needs a carefully structured, written plan in ordernot only to ensure its smooth running and successful conclusion but also to gain thecompulsory agreement of an ethical committee. Such a plan is called a protocol. Itconsists of several stages.

The facilitator explained that the need for a protocol was because research is asystematic work that aims at adding to generalisable knowledge and is therefore aserious undertaking that must be adjudged to be properly planned and executed. Aprotocol also serves as a mutually acceptable reference document for allstakeholders that allows for monitoring progress and overall appraisal of theprocess. Other topics are: the minimum requirement for a protocol which consists of an

introduction; a statement of aims, objectives, hypotheses and the calculation ofsample size; a detailed account of the methodology, which itself is divided into anumber of sections including the methods used in the statistical analysis of thedata.

Study products; Study procedure; Assessment and management of safety; Statistical considerations; Data handling; Study monitoring; Human subject protection

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Publication and result dissemination plan.

Discussions and QuestionsQuestion: is the administrative secretary a member of the ethics committee?Answer: it depends on the institution: in some they are and in some they are not butcoordinate the activities of the committee.

Discussions were on the compensation of members of the committee.The facilitators and some of the participants gave examples of what was obtained intheir institutions. Some said they pay both local and extended members whileothers said they don’t pay members but serve light refreshment. Some also said thatthey charge for the submission of protocols

3.7 Group workParticipants were divided into 6 groups and were given a protocol with a check list toreview the protocol and give their suggestions for the improvement of the checklists.A representative Dr M. Abubakar was nominated to present the group work and theother participants were asked if they agreed with the position of the group on the 12items on the checklist.

Plenary 4: Group WorkInformed Consent checklist

Items in the informed consent form Present Absent1 Title of the research2 Name(s) and affiliation(s) of researcher(s) of

applicant(s)3 Sponsor(s) of research4 Purpose(s) of research5 Procedure(s) of the research6 Compensation7 Consequences of participants’ decision to

withdraw from research and procedure fororderly 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 andcommunities when the research is over

10 Post research benefits11 Any apparent or potential conflict of interest12 Detailed contact information including contact

address, telephone, fax, e-mail and any othercontact information of researcher(s),institutional HREC and head of the institution

Checklist 1- All groups agreed that it was presentChecklist 2-Group 6 disagreed because the name of the I.P was not on the protocol.

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Checklist 3-All groups agreedChecklist 4- All groups agreedChecklist 5-All groups agreedChecklist 6-Some of the participants did not agreedChecklist 7- All groups agreedChecklist 8- There was no consensus; some were of the opinion that it was notenough modality for providing treatment.Checklist 9- Modality for the checklist should be clarified because this research is notfor care.Checklists 10- All agreedChecklist 11- there was a discussion on whether the conflict of interest was for theresearcher or the participant.Checklist 12- Some were of the opinion that all of the information was not present.

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Chapter 3: Community Engagement in Research -Day Three 29th September, 2011

4.1 The day started with a recap of the previous day activities by another participant.She gave an account of topics taken which includes:

4.2 Good community engagement practice: Principles and element of the GPP. – DrAjuwonThe Good Participatory Practice GPP which is in its 2nd edition is a guideline thatprovides trail funders, sponsors and implementers with systematic guidance on howto effectively engage with stakeholders in the design and conduct of biomedical HIVprevention trials . It describes a wide range of activities that trial sponsors, researchsites and communities can use to work towards:

o Equitable partnershipso Shared understandingo A commitment to the process of biomedical HIV prevention research

The guideline was borne as a response to the controversies and debates of the pre-exposure prophylaxis PrEP trials in Cambodia and Cameroon.

Discussions

This session had some of the participants questioning the source of thecontroversies; they asked if the female sex workers were told not to take measuresto protect themselves. The consequences of stopping the research was alsodiscussed some of the point raised are:

Knowledge from that research will not be gained

Resources from the stopped trials were wasted

Participant were given false impressions

The stopped trials made people to have a low impression of scientists.

There is the perception that these types of trials can only be conducted in developingcountries.

All elements of the protocol should have been made open to the participants.

4.3 The importance and role of Community Advisory Board - Dr OyedejiA CAB is typically composed of non-scientist community members who share acommon identity, history, symbols and language, and culture. They serve as a liaisonbetween participants and researchers. In this role they can help in the developmentof materials that explain the study to the participants and can also indicateparticipants’ concerns to the researchers.

The facilitator empathised on the need for researcher to engage community advisoryboards because “cultural evolution is required, in both the scientific community and

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the public at large, to improve significantly the inadequate response of society to thehuman predicament.”

Some other examples of CAB activities include: Acting as a an advocate for the rights of human participants for example by

conveying to them their rights to refuse or their right to full disclosure ofinformation about risks and benefits of engaging in the study.

Providing feedback on research and trial protocols, by reviewing criteria forparticipation, refining informed consent forms and processes, advisingresearchers on the recruitment and retention of volunteers and assisting inthe translation of informational materials into local languages

Disseminating information about planned trials in the community

Advising investigators on the needs and perspectives of potential trialvolunteers

4.4 Addressing the needs of vulnerable population in research. - Dr Ajuwon.Several specific groups have been shown to be especially vulnerable to researchstudies, especially with regards to HIV. Among these groups are MSMs, Sex workers,IDUs, PLHIV, Women, Children and Adolescents.There are ethical issues andchallenges involved in reviewing, planning and conducting clinical trials amongvulnerable populations and this was the thrust of this session.

The facilitator explained the reasons why adolecents should engage in HIVprevention research, social and ethical challenges involved in engaging adolescentsfor HIV research, the Minimum legal ages provided by the Child’s Rights Act 2003(CRA 2003) and 1999 Nigeria Constitution and the issues in the capacity foradolescents to consent. Other topic includes:

Research and empowerment of adolescents, assent from children toparticipant in research,

Ethics review of protocols for research in children,

points to be considered when engaging children in research,

Ethics of enrolling PLWAs in clinical trials,

Situations to take into consideration when engaging PLHIV in research.

Ethics of women enrolment in research

Reasons to include women in research

Points for HREC to consider in protocol review that involves recruiting womanfor research

Ethics of enrolling Sex Workers, MSM, and IDUs in research

Ethics of enrolling prisoners in research

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Discussion/QuestionsParticipants also opined that divorce women should be considered as vulnerablepopulation and that physiological and anatomical factors were also reasons for theexclusion of women from research.

Question: what makes MSMs vulnerable? Is it right to say that some of thesecategorization is driven by politics, do we not have other vulnerable population?Answer: they are vulnerable because they are criminalized. The categorization isbased on Nigerian context; we live in a global community so the categorizationshould be accepted as generalization. There are indeed other vulnerable groups likeorphans, widows, albinos etc.

Question: do prisoners have the right to consent or reject to be in a participant in aresearch?Answer: as long as they are human being they still have the right not to participantin research. The fact that the prison authorities give an approval to the researcherdoes not translate to consent.

4.5 Monitoring of research: role and responsibility of HREC.- Dr OyedejiThe facilitator explained that monitoring was the act of overseeing the progress of aresearch, and of ensuring that it is conducted, recorded, and reported in accordancewith the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice(GCP), Good Laboratory Practice (GLP), Good Participatory Practice (GPP) andapplicable regulatory requirement(s) eg NHREC, NAFDAC

It is also imperative that to monitor research in order to protect and ensure thesafety of trial participants. He reiterated that during protocol review it wasimportant to ensure the followings;

o all ethical concerns are addressed before research initiation includingdiscussions and negotiations with communities

o Adequate capacity exist for the research and to advocate for upgrade ofcapacity

o All regulatory requirements are met

o DSMB is constituted before trial initiation when need be

o SOPs for all trial related events exists

o Minimium standard of care and adequate prevention packages are in placefor the research. These include sighting of MOUs for all referral care plans.

o Agreement on post trial related activities before intitiation

o Study outcome dissemination plan exist

Ethics committees were also responsible for ensuring that ensuring that the correctversion of the approved protocol is in use during the research, that all research

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related events are recorded and documented appropriately, adequate human andinfrastructural capacity continue to exist, all regulatory requirement continue to bemet, DSMB is active/functional, protocol amendements are approved by HREC andthat the MOU for standard of care continue to exist and is functional.

They should also ensure that post the research, the correct archiving of trial relateddocuments, follow up of research participants is completed as outlined in theapproved protocol., ensure adequate capacity continue to exist at the research siteand all regulatory requirements are met at study close out, finally, study outcomeshould be appropriately comminicated to research community as agreed before theresearch.

Other topic taken includes:

The legal structures for monitoring research in the country

The Data and Safety Monitoring Board

Composition of DSMB

Role of DSMB

When is it appropriate to use DSMB

Ccommunity oversight and monitoring of research.

Discussion/ Questions

Participants gave their understanding and impression of what a responsibilities of amonitor was. Discussions were also on whether ethics committees could or shouldpay unscheduled visits in other to monitor researches. Some of the participants wereof the opinion that unscheduled visits will be more beneficial while other felt it maybe counterproductive. There were also discussions on who should provide the fundsfor monitoring.

4.7. Reflections and Closing CeremonyThe closing stared with reflection of the workshop. Participants gave their

impression of the training, most were glad that the training had taken place becauseit has equipped them with skills to engage in research. Participants also wanted theirethics committee to continue the training at a regular interval. One of theparticipants emphasized the need for NHVMAS to monitor the participants tomaturity.

The training ended with the closing address by Alhaji Kabiru who represented theCMAC of the institution; in his address he thanked the ethics committee for thecollaboration with NHVMAS. Dr Ajuwon also gave the vote of thanks on behalf ofNHVMAS, where he commended the management of the institution for theirsupport, the ethics committee for their commitment and the participants for their

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objectivity, interactions and participation. The training then came to an end with theclosing prayer.

4.8. Presentation of Certificates

The chairman of the Aminu Kano teaching hospital ethics committee Dr Borodopresented certificates of completion to participants who successfully completed theprogramme.

4.9. Next Steps

Over the next four months, NHVMAS shall follow up with a sample of the trainees toassess the use of the acquired skills and knowledge.

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Chapter 4: Report of Programme Assessment

Pre and post test analysisThe lowest pre-test score was 13.3% while the highest score was 86.6%. Tenparticipants (45.5%) scored less than 50%. The lowest post test score was 26.7%while the highest score was 100.0%. Two (8%) participants scored below the 50.0%pass mark. Four participants scored 100.0%.

The mean score of the pre-test was 55.9% (CI: 46.2 -65.5) while the mean post testscore was 80.4% (CI: 72.1 – 88.7). The difference in the scores was statisticallysignificant (p=0.0001). The paired t-test score was showed a highly statisticaldifference in pre and post test scores (56.5 vs 80.2) p<0.00001.

Table 1: Pre and post test resultss/no Code word Pre-test (%) Post –test (%)

1 8879 66.7 14 (99.3%)

2 22735 - 13 (86.6%)

3 ST 60.0 15 (100%)

4 IBRAHIM 66.7 13 (86.6%)

5 ABMKY 13.3 4 (26.7%)

6 1763 46.7 12 (80%)

7 ICE 46.7 10 (66.7%)

8 TANDA 33.3 11 (73.3%)

9 MIY 53.3 14 (99.3%)

10 KBOSUMA 86.6 13 (86.6%)

11 SJD 40.0 7 (47%)

12 2005 77.3 14 (99.3%)

13 14672 53.3 12 (80.0%)

14 SL - 12 (80.0%)

15 9610 40.0 12 (80.0%)

16 HAMZA 80.0 14 (99.3%)

17 SHE46 86.6 13 (86.6%)

18 BOX - 15 (100%)

19 TSQ 86.6 15 (100%)

20 DMR - 14 (99.3%)

21 GRZ 53.3 8 (53.3%)

22 LPO6 - 8 (53.3%)

23 1128 - 10 (67%)

24 SAM 60.0 15 (100%)

25 R 1957 22.7 9 (60%)

26 MR 80.0 -

XYZ 53.3 -

28 AAZZ 22.7 -

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1. Feedback about each workshop moduleAll the modules were rated highly by participants. None of the participants rated anyof the modules poor. See table 2. The most popular module was Principles ofresearch ethics and its application, followed by the module on Relevance andimportance of confidentiality and the group work. The modules with the best ratinghowever were the module on Relevance and importance of confidentiality andResearch integrity and misconduct.

Table 2: Feedback about each workshop moduleItem Excellent

(N) %Verygood

Good Fair Poor NoResponse

Plenary 1: History and evolutionof research ethics.

(5) 20% (13)52%

(5)20%

- - (2) 8%

Plenary 2: Principles of researchethics and its application.

(6) 24% (13)

52%

(4 )16%

- - (2 ) 8%

Plenary 3: Informed consents,the informed consent processand challenges with the consentprocess.

(11)44%

(8) 32% (4)16%

(2)8%

- -

Plenary 4: Relevance andimportance of confidentiality.

(11) 44% (11)44%

(3)12%

- - -

Plenary 5: Research integrity andmisconduct.

(8) 32% (16)64%

(1)4%

- - -

Plenary 6: Formation,constitution and functions of theNHREC.

(4) 16% (13)52%

(7)28%

- - (1) 4%

Plenary 7: Constitution andfunction of HREC in ethicalconducts of research.

(3) 12% (16)64%

(4 )16%

- - -

Plenary 8: What happens in ourIRB: the protocol review process.

(6) 24% (12)48%

(7)28%

- - -

Plenary 9: Minimumrequirements for protocolsubmission.

(7) 28% (13) 52% (3)12%

- - (2) 8%

Plenary 10: A protocol: need andoutline of a research protocol.

(10) 40% (11 )44%

(2)8%

- - (2) 8%

Plenary 11: Elements of aprotocol review and informedconsent checklist.

(11) 44% (9 ) 36 % (4)16%

- - (1) 4%

Plenary 12: Good communityengagement practice: principlesand element of the GPP

(8) 32 % (11 ) 44%

(6)24 %

- - -

Plenary 13: Importance and roleof community Advisory Board.

(7) 28% (11) 44%

(7)28%

- - -

Plenary 14: Importance and roleof civil society in research.

(4) 16% (13) 52%

(5)20 %

- - (3) 12 %

Plenary 15: Monitoring ofresearch: role and responsibility

(8) 32% (10)40%

(6)24 %

- - (1) 4 %

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of HRECPlenary 16: Addressing the needof vulnerable population

(11) 44% (10) 40%

(2)8 %

(1)%

- (1) 4 %

Plenary 18: Responsibility ofresearch to participants,communities and the ethicscommunity.

(6)24 % (14)44%

(3)12 %

- - (2) 8%

Plenary 18 and group work:Unethical conduct and informedconsent.

(6) 24% (14)56%

(3)12%

- - (2) 8%

Plenary 19: Mock HREC protocolreview session

(6) 24% (14)56%

(3)12%

- - (2) 8%

Plenary 20: Lessons learnt (6) 24% (15)60%

(3)12%

- - (1) 4%

2. Evaluation of day 1Most of the participants felt the workshop provided them with new insight and thatparticipating in the workshop was a good use of their time. Also, 87.0% ofparticipants felt the workshop was well organised. See table 3. The poorest ratingwas for time allocation for informal discussions with about 47% of participantsfeeling the time allocated for informal discussion was not adequate.

Which session did you like most today?Most of the participants liked Principles of research ethics and its application themost.Why?Because it was very educative and the presentation were explicitWhich session did you like least today?Almost all of the participants did not like the presentation on inform consent.Why?The facilitator read to the slidesHow do you think each session could be improved?Almost all felt the all the sessions were okay although some felt that facilitatorsshould keep to time.What did you like most about the entire programme today?Most of the participants enjoyed the interactive nature of the sessions.

What did you like least about the entire programme today?Almost all of the participants had none; one did not like the sitting arrangement,while some felt keeping to time was a challenge.Did you have any logistic challenges? What was it?All had none

Any other comments?“You are doing okay”.“Thank you all and God bless”.

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3. Evaluation of day 2Which session did you like most today?

Some of the participants liked the sessions on scientific misconduct; informedconsent and protocol review the most, while the greater percentage of theparticipants liked all of the sessions.

Why?Most likes all the sessions because was” well delivered presented and very practical”Some said it was “educative and engaging”Which session did you like least today?Almost all of the participants answered none.Why?-How do you think each session could be improved?“Improve the timing and avoid repetition”,“Limit interventions or question to maximise time”.What did you like most about the entire programme today?Most of the participants liked the entire programme; here are some of theircomments:“The whole organisation of the programme”“That everyone was interactive and contributing”,“The physical exercise was interesting”“The interaction between the facilitators and the participants.”What did you like least about the entire programme today?Most answered nil, although a few did not like the duration of the training.

Did you have any logistic challenges? What was it?None

Any other comments?Most of the comments were “Satisfactory and Excellent work”. One of the

participants had the following comments: “in future it is better to carry-out theprogramme outside the hospital premises”“The feeding did not consider diabetic individual”

4. Evaluation of day 3Which session did you like most today?Most of the participants liked the session on addressing the needs of vulnerablepopulations and monitoring the most.

Why?Good presentation, active participation by the audience and new insights were alsoprovidedWhich session did you like least today?Most said none

How do you think each session could be improved?More audiovisuals – Projectors and speakers

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Proper time management

What did you like most about the entire program today?It was very interactive and opportunity to exchange/explore ideas also, the friendlynature of the organizers.

What did you like least about the entire program today?Nil

Did you have any logistic challenges? What was it?Nil

Any other comment?Most of the participants had none but a few opined that “similar workshops shouldbe organized to sustain learnt/discussed issues”

5. Logistics and administration of the workshopThe quality of the training was rated very high: none of the respondents rated thequality of the training less than good. Communication with participants prior toarrival and preparation of participants for the training prior to arrival got the lowestratings. See table 3.

Table 3: Rating of logistics and administration of the workshopPROJECT EVALUATIONItem Excellent Very

goodGood Fair Poor

1. Publicity for the training 3 6 5 7 22. Communication with participantsprior to arrival

1 3 6 6 6

3. Preparation of participants for thetraining prior to arrival

7 4 6 5

4. Feeding 10 10 3 15. Hospitality 13 9 26.Responsiveness to logisticchallenges

7 9 4 1

7. Quality of the training 15 10 38. Training Materials 9 8 6

9. Networking opportunity 3 11 5 1 1

6. Do you think the programme addresses the objectives: All the respondents feltthe objectives of the training were addressed.

7. What skills did you gain during this workshop: Some respondents shared aboutthe new skills they had acquired through the training. These include those listedbelow. Procedure of informed consent. Community engagement in research More effective communication skills

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Importance of monitoring research Ethical issues involved with research Proposal writing and reviewing How to set up an HREC in institution Protocol development Better understating of the roles and responsibilities of ethic committees.

8. How participants intend using skills gained: participants indicated how the skillsacquired will be utilised, some are highlighted below: Conducting research Improving daily clinical practice Dissemination of acquired knowledge to the public In the reviewing of protocol Establishment of HREC

9. Recommendations to make this workshop better: A few suggestions were madeas to how to improve the workshop. These include: Establishment of HREC More interaction. Make CD copies of manual Make the training mandatory for all HREC in the locality Make meals more adult and diabetic friendly – less pastries Allow for time to walk around and exercise More practicalization and group works Time management Better publicity Manual should be number according to the session taken. Reduce the content for a 3 days’ workshop or extend the number of days; the

topics are too many for the short duration of the programme. Four days isideal

10. Other comments Generally the training is good. A very good and educative workshop Attendance should be made compulsory for all ethics committee members A well organised workshop. Very happy to be part of it Organisers were sensitive to prayer time. The workshop was well packaged Organise this workshop periodically

Comments by participantsI have no regret coming for this workshop because i am now better informed thenwhen i came in.

Excellent initiative which should be incorporated in schools and colleges curriculum

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Lessons learnt

1. Cultural sensitivity: in planning for programmes in the Northern regions,consideration should be given for cultural and religious differences.

2. Collaboration is empowering: The collaboration between the two organisationswas symbiotic. The ethics committee of the Aminu Kano teaching benefited fromyears of NHVMAS experience in the field. NHVMAS in turn, benefited from theirability to reach out to other institutions in their locality. This new collaborationhas provided leverage for both organisations to partner in the future.

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PARTICIPANTS REGISTRATION FORMS/N NAME Email ADDRESSES PHONE NUMBERS1 Sanki Adamu Musa [email protected] 080681403142 Bolaji B. Preh [email protected] 08058906886

3 Rose A. Abbah [email protected] 08065461384

4 Dr. Bilkees Akinfenwa [email protected] 08029155318

5 Sunday N. Wabare [email protected] 08054271496

6 Salihu Tanko .T. [email protected] 080608608377 Dr. Muhammad Hamza [email protected] 08035053139

8 Ibrahim Musa Idris [email protected] 080396857539 Dr. Mohammed Riyad [email protected] 08033475691

10 Suleiman Jibril Dadinkowa [email protected] 08033568536

11 Zubaidah. A. Jibril [email protected] 08035908673

12 Dr. Hanifah D. Abubakar [email protected] 07069618008

13 Aminu B. Mohammad [email protected] 0803580188014 Ibrahim Abdullahi [email protected] 08062619252

15 Mohammed Idris [email protected] 0813339429316 Mohammed A.M [email protected] 08033900019

17 Saleh Idris [email protected] 08034458154

18 Saad Deen Saad [email protected] 08060384800

19 Dr. Yusuf Nuru [email protected] 08091346377

20 Lawal Haliru [email protected] 0803689621021 Ahmad M. Yakasai [email protected] 08065419097

22 Ramad Faro [email protected] 0703800887923 Dr. Ezelagbo Anako [email protected] 08053137690

24 K.B Marama [email protected] 08035907413

25 Ibekwe E.C [email protected] 08033154002

26 Oyedeji K.S [email protected] 08025187261

27 Ajuwon A. J [email protected] 0803489256128 Baraatu Kabir [email protected] 08066171698

29 Ahie 0703970630030 Abdullahi Ahmah

31 Sule Shibu

32 Dr. Mustapha Abubakar

33 Mr. Mulid Kabir Sulaiman [email protected] 08036364603

3435

Dr. A.A ShesheMrs Aisha Adaranijo

[email protected]@yahoo.com

0803590545108033738087

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