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Malawi Medical Journal; 20(2):57 - 63 June 2008
Abstract
Participants’ refusal to take part in research is an unpleasant
experience that investigators face.. This paper highlights
some of the reasons why people from resource-poor
settings refuse to take part in health research. This paper
also highlights standards which investigators can adopt to
avoid unnecessary refusals and at the same time ensure
that individuals have the right to participate and freedom
to refuse. Our objective was to explore reasons why people
refuse to join research studies. We conducted focus group
discussions with people who had refused to take part in a
number of biomedical research studies but agreed to be
interviewed in this study. The study was undertaken in the
peri-urban and urban areas of Blantyre district; Bangwe,
Mpemba and Madziabango. We found nine key factors
that influence people to refuse to participate in biomedical
research. The factors are failure to follow traditional customs
, lack of study benefits, superstition, poor informed consent
procedures, ignorance of health research, fear of strangers,
lack of cultural sensitivity, poor timing, and previous bad
research experience. People refuse to participate in health
research for a number of reasons which can be overcome
if researchers embark on community engagement before
implementing their studies.
Introduction
Ethical conduct in research involving human participants has
become one of the principal challenges faced by researchers.
In recent times, increasing attention has been paid to ethical
implications of carrying out research in settings with low
socio-economic status. This trend has become particularly
central in Africa owing to an increasing number of
multinational research institutions operating in sub-Saharan
African countries.1- 4
The progress of medicine today is a result of biomedical
research which necessarily relies on successful recruitment
of human participants in order to yield meaningful results.
In this sense, human participants are instrumental in
securing data useful to researchers. A participant’s refusal to
participate in research is referred to as a non-response in a
survey.5 For the purpose of this paper, we shall use the term
‘refuser’ to refer to individuals who declined to take part in
research after being approached by research staff.
At the heart of ethical recruitment of participants in a study
is the principle of informed consent. There is a general
consensus amongst researchers, scientists and bioethicists
that acquiring effective informed consent from research
participants is a prerequisite to the conduct of an ethically
sound study6. Among other things, valid informed consent
requires that participation in research should be voluntary
and that individuals should be treated as autonomous agents7.
The requirement for voluntary participation, however, may
result in many people refusing to participate. Refusals are
likely to affect the timeline of research and also compromise
the generalizability of results,8 since it is unclear how people
who refuse differ from those who agree to participate. There
has been limited empirical research aiming to capture the
perspectives of refusers in developing countries.
Many studies have investigated the reasons why people
participate in biomedical research9-12 however, there has
been less research and little attention specifically on reasons
why people refuse to participate in biomedical research.
Most of the data available on refusals are centred on non
response13 to postal questionnaires from different surveys.
In this paper we report findings from an anthropological
and bioethics study of clinical research in Malawi. The study
explored the reasons why people refuse to join biomedical
research and examined possible strategies for minimising
refusals. The participants that were interviewed in this
study had refused to participate in a number of different
biomedical research projects before this study but agreed to
be interviewed in this study. We believe that knowledge of
participants’ perspectives and concerns with their involvement
in research can lead to better recruitment efforts, improve
the informed consent process, and enhance the overall trust
between participants and researchers4.
Many studies have investigated the reasons why people
participate in biomedical research9-12 however, there has
been less research and little attention specifically on reasons
why people refuse to participate in biomedical research. Most
of the data available on refusals is centred on non response13
to postal questionnaires from different surveys.
This paper reports findings from an Anthropological and
Bioethics Study of Clinical Research in Malawi (ABSCRM).
The study explored the reasons why people refuse to join
biomedical research and examined possible strategies for
minimising refusals. The participants that were interviewed in
this study had refused to participate in a number of different
biomedical research projects before this study but agreed
to be interviewed in this study. Knowledge of participants’
perspectives and concerns with their involvement in research
will enhance recruitment efforts, improve the informed
consent process, and enhance the overall trust between
participants and researchers4.
Methods
Design
FFor this study, a qualitative approach was adopted and data
were collected through focus group discussions (FGDs). A
total of 108 refusers were successfully recruited and they
participated in 12 FGDs, each composed of 6-12 people.
The FGD questionnaire guide was translated into the local
Why do people refuse to take part in biomedical
research studies? Evidence from a resource-poor area
Joseph Mfutso-Bengo1, Francis Masiye1, Malcolm Molyneux2, Paul Ndebele1, Abdullah Chilungo1
1. Centre for Bioethics in Eastern and Southern Africa, CEBESA,
College of Medicine, Malawi.
2. The Malawi-Liverpool- Wellcome Trust Research Programme, College
of Medicine, Blantyre, Malawi
Corresponding author: Francis Masiye, Centre for Bioethics in Eastern
and Southern Africa (CEBESA), Department of Community Health,
College of Medicine, Private Bag 360, Chichiri, Blantyre 3, Malawi
Phone: +265 1 871 911, Email: fmasiye@medcol.mw
Why do people refuse to take part in biomedical research studies 58
MMJ 20(2) 2008 www.mmj.medcol.mw
language Chichewa.. All FGDs were recorded on audio tapes
which were then transcribed and translated from Chichewa
into English by members of the research team.
Setting
The study was conducted in Blantyre District, in the
Southern region of Malawi. The specific sites were in the
peri-urban settings of Madziabango and Mpemba health
centre catchment areas, and Bangwe Township which is a
very densely populated urban area. These locations were
selected for this project because several medical research
projects have been conducted there in the past.
Recruitment
Refusers were identified by project staff from the registers
for the various trials which were ongoing at the time. These
registers were maintained at the three sites by the project
staff for the various projects. Each project register had
details of all the participants involved in the study as well
as those who declined to participate after being invited to
enrol. Health Surveillance Assistants (HSAs), who are part
of the community, were then tasked with the responsibility
of following up the refusers in their homes in order to
inform them about the current project and to invite them
to visit the health centres or other specific locations for the
FGDs. Once the individuals had gathered for each FGD our
research team ensured that they all met the eligibility criteria
for refusers... Verbal consent was obtained from those who
agreed to participate in the FGDs. It was difficult to find
sufficient refusers willing to take part in the focus group
discussions. Therefore some FGDs had to be rescheduled.
Data analysis
Analysis of the FGD transcripts was carried out manually
and electronically using computer software N6*. We analysed
the contents of the transcribed texts to identify patterns and
themes that emerged from the data.15 A comparison of major
themes was then made in the final stage of analysis.
Research Ethics Committee Approval
The study was approved by the College of Medicine Research
Ethics Committee (COMREC).
Results
Demographics
Overall, there were more women than men in the refusers’
FGDs. Of the 108 participants, 21% were males and 79%
were females.. There were no significant differences in
average age between the male participants (31 years) and
the female (30 years).. Between the peri-urban and urban
respondents, there was a slight difference in the average
duration of education - 7 and 9 years respectively.
Description of findings
We identified ten different self-reported reasons why people
had refused to take part in various health studies. These
were:
• Failure to follow traditional customs
• Fear of strangers
• Superstition
• Poor informed consent procedure
• Lack of study benefits
• Ignorance of health research
• Lack of cultural sensitivity
• Poor timing
• Previous bad research experience
Failure to follow traditional customs
The overall perception of the participants is that traditional
procedure has a big impact in making people decide whether
to take part in a study or not. They reported that failure to
conduct community engagement and failure to follow the
right protocol during recruitment of participants would make
people refuse to take part in research. The procedure they
suggested as a better practice was for interested researchers
to first seek consent from their chief or community leader
and then conduct sensitization meetings and a community
gathering where the whole community would be briefed
about the study. If the chief says yes to a research project
to take place in the area, his/her subjects would equally
feel secure to accept and take part in it. For example one
participant from Mpemba said
In response to the question ‘why is community engagement
important?’ several participants self-reported that community
engagement would give them a chance to understand more
information about the study and be able to ask questions
to the researchers before deciding whether to accept or
decline the research. They also reported that people refuse
to participate in studies when they are taken by surprise and
not informed in advance about the study. This leaves the
communities unprepared to decide whether to participate or
not. One participant said
Another participant said
Participants also argued that another advantage of
community engagement is that it would dispel rumours and
misconceptions that circulate in their communities.
Fear of strangers
Participants reported that people refuse to participate
in health studies when researchers are strangers in the
community. One participant reported
“they should first inform the leaders of the community like
the chief and when they accept, the people would also accept
the research. But if they just come from wherever they come
from and start the research without involving our community
leaders, people will not accept it because they are not aware.”
“some researchers just arrive without informing the chief
and the people. We can refuse because we have not been
informed.”
“the researchers were coming here all over a sudden.
They would just send a short message that we are coming
tomorrow and moreover among the visitors was a white
person. It is better maybe if they can start telling the
people this week that next week visitors will come.”
“it will be difficult for us to accept their research if they
just come without even wearing a uniform and being
people we have never seen them here before.”
MMJ 20(2) 2008 www.mmj.medcol.mw
59 why do people refuse to take part in biomedical research studies
Another respondent reported
However, several participants reported that they would be
comfortable to associate themselves with ordinary villagers
and local doctors they know.
Superstition and blood drawing
People refuse and express reservations if studies constitute
interventions that involve drawing of blood. This is tied to
beliefs where by blood is seen as a weapon used in witchcraft
for inflicting pain or sending pestilence to people. Belief in
and fear of witchcraft is the norm amongst most Malawians.
16 17
Other people also associate the drawing of blood with
rumours about blood sucking.18 They also fear that more
blood would be drawn from their bodies. Several participants
emphasized that studies that involve drawing of blood are
very risky and have a greater potential for refusal. One
participant observed
On the other hand, some participants said that they were
discouraged to take part in studies that involved taking of
blood simply because they were told that they would be given
presents if they consented to donate blood. For example,
one participant said
Other fears that were reported concerning drawing of blood
and dispensation of drugs include drawing more blood for
sale, and rumours that drugs being dispensed are intended to
make people barren or sterile. Participants said that people
see this as a government conspiracy to reduce population
growth. For example, one participant said that;
Poor informed consent procedures
Participants reported that people refuse to take part in studies
when researchers fail to explain clearly about the objectives
of their research. One participant said
Lack of study benefits
People decline to participate in research that does not provide
benefits which can either accrue to the individual or to the
area as a whole. Participants reported that they would like to
participate in studies that would benefit them and not just
to join studies only for altruistic reasons. For example, one
participant said
Ignorance of health research
Ignorance and lack of understanding about research are
some of the factors that would influence people’s refusal to
participate in health research. One participant observed
Another participant questioned
Analysis of the interviewees’ responses also shows that
many people especially from the rural areas are ignorant
about certain procedures in health research. One participant
who refused to take part in a malaria study expressed
discontentment over the use of medicated bed-nets. The
participant said
Similarly, several participants were not aware of the
rationale behind re-taking of blood samples every year
especially in longitudinal studies. One participant expressed
disappointment and said
Lack of cultural sensitivity
Several participants shared the view that they refused to
take part in studies where researchers were not respectful to
them. Participants observed from a number of studies that
“people in the villages here are afraid to see strangers moving
from house to house, everybody would run away because we
have never seen such people in our community, for example,
there was this group of researchers that was going around the
villages with a white man distributing drugs and mosquito nets.
For us villagers, we rarely see white people in our homes. So it
was difficult to accept the drugs and mosquito nets which they
brought to us because we could not trust them.”
‘In magic, blood is revered and feared for the miraculous power
it possesses and confers. Blood is believed to unleash power.’
“most people fear that their blood will be drawn out if they
participate in research”.
“People were discouraged to participate in the study because they
heard that participants who gave a bottle of blood in exchange
were given basins and wrappers.”
“at first I had refused to participate in the Onchocerciasis study
because there were a lot of things being said about it, that the
government wanted to make sure that many people are not
having many children since many of us are not going for family
planning [Participant is talking about distribution of
Mectizan drugs]. Many of us got scared with these stories.
But when we saw this other lady with skin itches all over her
stomach, we saw that what others were saying is not true. So we
changed our minds.”
“What people expect to hear is how the research would
be conducted and how the study will benefit them. If they
see that indeed things can improve, they can say yes, let the
study take place, mainly when they see that the study will be
beneficial in uplifting their health.”
“Sometimes it also depends on how the researchers explain
their research to people. If they do not explain it clearly,
people will not understand it and it will be difficult for them
to participate.”
“The other thing that researchers from the urban areas
should know when coming here is that they will be meeting
people from the village. And we lack understanding in most
things. It is important therefore to take time to explain to
us and come to an agreement. We should first be told the
purpose of the research before starting to conduct it so that
we should have time to think about it otherwise if we are
rushed we would refuse.”
“don’t researchers know that some of us never went further
with school? Instead of explaining properly so that we
understand, he sometimes spoke in English and that used to
confuse us as to what he really meant”.
“the white man tells me to sleep under a mosquito net that has
got medication in it. What if I wake up in the morning only
to find sores all over my body?”
“they can get blood today. A year can elapse before coming
again and request to take your blood again. You wonder as to
what they did with the blood they took the first time. People
refuse to participate because of that.”
Why do people refuse to take part in biomedical research studies 60
MMJ 20(2) 2008 www.mmj.medcol.mw
researchers were either disrespectful or did not know how to
approach the people. One participant said
Participants also noted that researchers overlooked the
importance of approaching husbands in studies that
targeted women. Researchers did not involve husbands of
the women they sampled during the consent seeking process.
This resulted in either many women refusing to participate
or husbands deterring their wives from taking part. One
participant said
Several participants were also dismayed and refused to join a
Mectizan drugs studies because researchers were measuring
people’s heights with a rigid ruler (wooden rod) to determine
dosage. Mostly a wooden rod is used to measure the height
of a dead body for funeral purposes. For example, one
participant said
Poor timing
Participants reported that there are certain periods of the year
when they are engaged in their fields with farming activities.
These moments are not convenient for rural participants to
enrol in research studies. They said that most people refuse
to take part during the rainy season when they work in their
farms. One participant from Madziabango said
Previous bad research experience
Participants reported that they would reject studies when
they look back at what similar previous studies had done to
them. If studies have not been helpful people would refuse
to join them. Similarly, they would decline to participate if
such studies harmed people’s lives. Many people reported to
have refused to take part in studies in which HIV testing was
involved due to psychological reasons. One participant said
Discussion
Several reasons why people refuse to participate in health
research have been revealed in this study. Many of these
might also be applicable to refusers in other similar settings.
Researcher
(Investigator)
Community Consultation
(Community Leader)
Community Sensitization
Community Ownership
Informed Consent
(Individuals)
(Married Couples)
Study Starts
Community Involvement
Community Permission
End of Study
Community Feedback
Figure 1: Community Engagement
Researcher
(Investigator)
Community Consultation
(Community Leader)
Community Sensitization
Community Involvement
Community Permission Community Ownership
Informed Consent
(Individuals)
Married couples
Study Starts
End of Study
Community Feedback
“researchers must talk to the people with love and patience.
They ought to know how to approach the people. They should
not threaten them. If people are threatened, they will not
listen to them. But if they talk to them with love, they would
definitely understand.”
“husbands of many women are very troublesome. Women
may be shouted by their husbands if they accept to take part
in a study right at the hospital. It would have been good if
researchers approached married couples in the villages and
explained to both of them together”
“on the issue of the rod, the dead are measured with a stick.
And they measure you with a stick too. This is not good.”
“during the farming period, people are busy. They have no
time for research. It is important to know the time people
are free to do things like research.”
“I refused to participate in the AIDS research because I
felt that if they found the virus in my blood I would be
a worried person and cannot live peacefully in my home
knowing that any day I will die.”
MMJ 20(2) 2008 www.mmj.medcol.mw
61 why do people refuse to take part in biomedical research studies
Participants in our sample were those who had previously
refused to take part in a number of different biomedical
research activities.
Participants in our sample reported that they would refuse
to participate in a study where the researchers failed to
follow the traditional custom. Figure 1 below illustrates
the traditional custom that participants want researchers to
follow. Following the traditional custom would benefit the
researcher because it would minimise unnecessary refusals.
What participants are referring to as traditional custom is in
fact community engagement, which we have modified to suit
the needs of all participants. This is illustrated in Figure 1.
Community engagement is a process of engaging community
members in research through consultation, sensitization,
involvement and providing feedback. In Figure 1, the steps
for community engagement show a lineal pattern with one
entry point for the researcher which is the community leader.
Participants agree that the researcher has to go through the
community leader. If the community leader accepts the study
then he or she should sensitize the community by organising
a meeting to involve them in the study. The community
involvement meeting should be attended by the researcher,
community leader and all the community members. Among
other things, during this meeting, the researcher is expected
to introduce and brief the community members about the
study. Community members should also have a chance to ask
the researcher questions where they do not understand. The
community can give its permission whether they want the
study to be conducted in their community. This also ensures
that the community members have ownership of the research
project. Informed consent process follows community
involvement. Single people can be invited to participate
individually while married persons can be interviewed as a
couple to facilitate joint decision making. Participants feel
that when all this is successfully carried out, then the study
can begin.
Participants stressed the importance of observing the
community engagement for successful recruitment and
informed consent. This demonstrates that people would
like to participate in studies if they are satisfied with the
rationale and information about the study. There is wide
acknowledgement of the need for community engagement
in biomedical research, particularly in developing countries.
Currently, engaging communities has become a critical aspect
of planning and implementing biomedical research. The
current international research ethics guidelines also talk of
community engagement as an ethical requirement for research
involving human subjects, particularly with marginalized
populations.19 Genuine community engagement offers
hope of enhancing recruitment, retention, and participant
satisfaction.
In addition to concerns with strangers, participants also
expressed discomfort with studies that involved drawing
of blood. These concerns can be addressed by adhering to
the village protocol in Figure 1. It would dispel any myths
about the study. Furthermore, the issue of fearing strangers
would not arise when researchers participate in community
engagement.
Our results raise an interesting point regarding the informed
consent procedure: poor informed consent with vague
explanation of objectives will discourage participation.
This brings up a long-running debate about how much
information about the study should be disclosed to
prospective study participants. There is no consensus on
this. If we argue that the information should be ‘as much
as possible’ then we beg another question; how much is ‘as
much as possible?’ According to the Belmont report, genuine
informed consent requires that participants should be given
sufficient comprehensive information and they should be
allowed to have enough time for consideration. They should
also be offered an opportunity to ask questions. This result
shows that the conduct of informed consent remains a big
challenge in settings with limited resources. More research
is needed about participants’ perceptions and experiences in
health research in settings with limited resources in order
to improve the informed consent processes. However, we
feel that adoption of the community engagement procedure
would demystify the conduct of informed consent in
resource poor settings.
Another important theme that emerged from this study
was the importance and application of the principle of
beneficence. Participants reported that they would not
participate in research studies which do not either benefit
them or the community. Participants also reported that some
studies set bad precedents which demoralise their future
participation in similar studies. Resource poor settings remain
potential targets for exploitative research.
Our results showed that people in peri-urban areas would
refuse to participate in health research owing to ignorance and
lack of understanding about certain concepts and procedures.
Researchers need to know the level of understanding
about health research of their potential participants. The
significance of using community engagement as a way of
informing the community about the study should therefore
not be underestimated. During community engagement, the
researcher can find out if there is need to educate potential
participants about certain procedures involved in the study.
Finally, another factor which contributes to people’s refusal
to take part is the concern that some researchers are not
conscious of local culture. Results show that participants
were disgruntled with researchers who were not friendly,
hospitable and lacked skills to properly approach participants.
Several participants from Mpemba and Madziabango said
that they were not happy to see researchers measuring heights
of people with a rod which is normally used to measure
corpses. Researchers should know more about the aspects
of culture of the people they would be investigating, and try
to anticipate the ways in which their actions and props like
measuring rods might be interpreted locally. A number of
researchers seem to be in a hurry to implement their studies
while neglecting the welfare of their participants. This
compromises the ethical conduct of research. Knowing the
culture, daily lifestyles, and opinions of participants would
help researchers know when and how to best approach their
participants.
Recommendations
The traditional customs suggested by the refusers constitute
the first step towards minimising refusals. We believe that
adequate community engagement will minimise refusals.
Why do people refuse to take part in biomedical research studies 62
MMJ 20(2) 2008 www.mmj.medcol.mw
We offer the following specific recommendations as principles
of community engagement which we have developed as a
result of this study.
Four Principles of Community Engagement in
Research
1. Community consultation
• Brief the community leaders (chiefs, political leaders
and religious leaders) about the research project
- organize a meeting with them
- introduce the research project to the leaders
- explain in detail all the procedures involved in the
research
- outline any risks and benefits to individual participants
and to the community
- allow the leaders to ask questions about the
research project
- make sure you cover the topics listed in (3) below
- obtain their permission to conduct the research
project in their community.
• Alternatively, you may approach the community
through meeting with a Community Advisory Board
(CAB) where one exists
- members of the CAB can then explain the project
to community leaders and seek their permission
for the research project to be conducted in their
community
When permission has been granted, the researchers,
community leaders and members of the CAB can organize a
community sensitization meeting.
2. Community sensitization
• organize sensitization workshops for community
members
- inform them about the proposed research
- encourage a shared effort between researchers
and participants
- ensure that the research activities are responsive
to the needs of the community
- make sure that members of the community
understand what the research is all about
- define clearly the role that will be played by the
community members
- clarify any risks and any compensations
- allow community members to ask questions
about the project.
[Important: you should avoid providing information that
might lead to stigma and discrimination. For example,
if a research project is about HIV/AIDS and one of the
recruitment criteria is that potential participants have to be
HIV positive, this fact should not be made known to the
whole community, as they would then know that people
recruited in the study are HIV positive. A common solution
to this problem is to design the study so that both HIV+ve
and HIV-ve individuals are enrolled, and enrolment then
does not imply any individual’s HIV status.]
3. Community Ownership/partnership/involvement
• Regard local communities participating in research as
partners or ‘owners’.
• This partnership should begin before the conduct of
the research project and should continue during and
after the completion of the research project.
• Agree in advance with the community leaders about
what will happen after the research is over
• During any study, it is likely that the researchers will
need to respond to urgent needs of the community
or of individuals. As far as possible, agree in advance
with donors, Ethics Committee and community
leaders about the possible form and extent of such
assistance.
4. Feedback
• When results are available, feed these back to research
participants and their community.
• Make this effort, even if results may not be of
immediate benefit to participants, and despite the fact
that it may be difficult to trace all who took part in
the study.
• Community feedback is another way of fostering
ownership (in this case, ownership of results).
We conducted feedback sessions about the results in our
study sites. We wrote a letter to the Clinical Officer-in-charge
of each of the health centres, informing them about our
schedule for the dissemination of results. We also requested
the local HSAs who had helped us with the recruitment
of participants to inform all the five categories of people
we had recruited. We prepared power point presentation
slides together with printed handouts in the local language,
Chichewa. About 80% of the participants were present
during the dissemination of results. Participants appreciated
this feedback. They reported that this was the first time they had seen
researchers disseminating results to the community in which they had
conducted their research.
Conclusion
We believe that most ‘refusers’ would have been willing
to participate in research if the above principles had been
carefully followed. Our findings require validation in a larger
sample from other settings in Malawi and other developing
countries, but meanwhile researchers need to take into
account the concerns raised by the refusers we interviewed.
Most of these concerns could be minimised by engaging the
community, both before research is initiated and after it has
been completed.
Acknowledgements
We would like to express our sincerely thanks and gratitude
to The Wellcome Trust for funding this study.
MMJ 20(2) 2008 www.mmj.medcol.mw
63 why do people refuse to take part in biomedical research studies
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The Centre for Bioethics in Eastern and Southern Africa
(CEBESA) in collaboration with College of Medicine
Research and Ethics Committee (COMREC), National
Health Science Research Council (NHSRC), and Pharmacy
Medicines and Poisons Board (PMPB) hosted a two day
workshop on “ Enhancing Clinical Trial Oversight in Malawi”
on the 19th and 20th June at Nkopola Lodge in Mangochi.
The workshop was funded by the European and Developing
Counties Clinical Trials Partnership (EDCTP) through a
grant on strengthening national capacities in ethical review
and clinical trial monitoring. The aim of the workshop was
a critical look at research oversight in Malawi particularly in
light of the implementation of sections of the PMPB Board
Act of 1988 related to clinical trials. The workshop brought
together stakeholders in health research from various
institutions including University of North Carolina, Malawi
Liverpool Wellcome Trust, University of Mzuzu, Kamuzu
College of Nursing, Centre for Reproductive Health, College
of Medicine and Blantyre Malaria Project. Also present at
the workshop was Medical Rights Watch a medical student
led organization whose goal is to promote and protect the
rights and responsibilities of patients, research participants
and health practitioners in Malawi.
Professor Joseph Mfutso-Bengo, Director of CEBESA and
organizer of the workshop welcomed all the participants.
The workshop was opened by the Principal of the College
of Medicine, Professor Broadhead and was followed by
an oversight of COMREC by the Postgraduate Dean
Professor Eric Borgstein. Paul Ndebele of CEBESA gave an
introductory presentation on regulatory oversight of clinical
trials. Mr. Aaron Sosola, Deputy Registrar of PMPB, gave
a perspective of the PMPB, the PMPB Board Act and the
systems and procedures that have been put into place by
the Board regarding clinical trial monitoring. The workshop
gave an opportunity for the PMPB to update stakeholders
on the introduction of the clinical trial monitoring program
which requires all research institutions to register their
clinical trials with the Board. It was made clear that ethics
and review committees (COMREC, NHSRC) and drug
regulatory agencies (PMPB) have separate and distinct
areas of focus. However there was consensus that further
discussions need to be held amongst the stakeholders to see
how best to harmonize the PMPB clinical trial monitoring
with other existing systems. Participants discussed important
issues related to the conduct of clinical trials this included
whether submission of clinical trials should be concurrent or
consequential to PMPB and ERCs, how the PMPB’s Clinical
Trial Review Committee can function efficiently, how ERCs
and PMPB can cooperate, how to update researchers on
the new measures and prepare research sites for the new
developments. Participants were given the opportunity
to review and comment on PMPB documents and make
recommendations on the documents.
At the end of the workshop participants were familiar with
PMPB legislation for clinical trials, and the PMPB tools and
procedures to be used for regulating research. This workshop
sensitized stakeholders on the impending new measures
and gave the opportunity to stimulate what is hoped to be
Report on the workshop “Enhancing Clinical Trial
Oversight in Malawi”
