Date 17/12/2014
Joining Report, meeting with Dr. AsadZaheer& Vice Chancellor
Date 18/12/2014
Lecture on research ethics followed by an interactive (Q and A) on bioethics and
its philosophical foundations.
Questions raised in ethics are related to ‘ought’, in particular “what ought I do?”,
“who ought I be?” and I found that the students were alive and keen to discuss
the issues in the light of the moral theories, in particular I discussed Deontology,
Utilitarianism and Virtue Ethics.Using the categorical imperative of “Do not lie” we
teased out nuanced approaches in which a particularistic, rather them an
absolutist, stance was applicable (preferable). We also touched upon religious
ethics. A greater part of the discussion was on the philosophical basis of obtaining
consent from research participants (and by extension consent in the clinical
paradigm). Having discussed the moral philosophies, albeit briefly, I moved on to
the discussion on research ethics guidelines, in particular the latest revision of the
Declaration of Helsinki and then their (students’) individual research projects.
Date 23/12/2014
The Faculty of Forensic Sciences discussed a research proposal they are preparing
(correlating human signatures with phenotype of particular group – ethnic) for
obtaining funds working in collaboration with colleagues in the U.S.
The project raised a minefield of ethical issues including, but not limited to
obtaining consent, vulnerability (its attendant issue of stigma especially in the
current environment) and benefitsof this research (to the participants,
researchers and sponsors). The project’s aims and objectives were discussed and
the ethical issues teased out and answered in the light of the project’s social value
and principles of non-maleficence, beneficence, justice and respect for persons.
The risks of harm to participants was a prominent ethical concern and although
respecting participant’s autonomy by maintaining confidentiality and anonymity
may mitigate the harm (to some extent), participants’ membership to a particular
(ethnic) group is a prominent ethical concern ( and needs to be looked at in
greater detail before proceeding to obtain REC approval).
A question was also raised in relation to compensating participants(in cash and
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kind) and the issue of undue inducements was discussed as well. It was decided
that transport, loss of earnings (for that day) are acceptable compensations. The
Faculty felt that in the light of our discussions researchers (local) would be able to
answer questions raised by their collaborators.
Members of the faculty of Allied Health Sciences had a very interesting discussion
with me on informed consent and its implications in ‘our’ population with special
focus on women, children and non-literate people. Questions were posed (and
discussed in detail) regarding assent in case of children (especially Gillick
competent children) and then to obtain consent from parents / guardians.The role
of gatekeepers was also discussed. All these were further discussed in the light of
the Declaration of Helsinki and moral philosophy.
Ethics of authorship was also discussed and how, and when (and who) to
acknowledge.
Date 24/12/2014
Discussions with the Behavioral Sciences department were related to the inertia
observed and experienced in changing practices in the local environmentfollowed
by a brief discussion on the importance of introducing research ethics into the
curriculum. Emphasis was on the rationale for doing so – to cultivate ethical
research practices/researchers. My papers (published in AJOB, Developing World
Bioethics and IJME) were provided for background readings.
The Professor of Pharmacology discussed his research project for developing an
antidote for phosphine gas released where tablets are placed in wheat and rice
storage. This research though conducted in otherdeveloping countries (India for
example; although there too no effective anti-dote has developed) has not been
conducted in Pakistan, according to the faculty. However the project is still in a
conceptual stage and detailed systematic review (an ethical and a scientific
requirement) has to be conducted along with an epidemiological study to
ascertain the social value of this project.
Related to the same project animal research ethics was discussed (as prior to
human participation animal studies would have to be conducted) and it was
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decided that so long as the research is refined, the number of animals used is
reduced and where possible replaced (by in vitro studies, computer models etc.)
these concerns can be addressed effectively.
Health and safety of the researchers was also discussed as were potential funding
sources.
Date 26/12/2014
The Faculty of Immunology discussed ethical issues regarding consent, scientific
validity and social value of research, keeping in mind the ethical requirements of
the guidelines (such as Declaration of Helsinki ).
The projects of 1st and 2nd year M.Phil. students were discussed as well and the
importance of teaching research ethics was emphasized. The greater part of the
discussion, was conducted in tandem with Biochemistry department and
‘problems’ (ethical issues) related to genetics (genetic diseases) was conducted.
The social cultural contact in which genetic researchis performed was/ is a
hindrance as confidentiality and privacy are (shared) and not individualistic – this
created problems for researchers, such as for example: after the initial meeting
with the family of the index patient subsequent meetings were cancelled, or, if the
family was willing to continue with participation in research they shifted residence
to an area/ location where they were not known, this was especially true in
villages in order to avoid stigmatization. In view of this (and maintaining sensitivity
to culture) we were able to decide upon a path which also followed the guidelines
– it is important that guidelines are interpreted in a manner that is sensitive to the
local context without undermining the ethical imperatives. Procedural
intransigence may lead to unethical practices as well. For example, the
requirement of a written /signed consent form, a requirement of most
sponsors/funders/ guidance, may (and does) exclude patients who, though willing
to enroll, were/ are excluded (thereby violating the principle of justice) because
they did not provide a written (signed) consent, for any number of reasons.
Alternatives to a written consent were discussed. In view of this (and other
examples) it was decided respecting (following) the spirit of the guidelines rather
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than just the procedural requirements is essential, if ethics is to become a viable
practice. For this then an essential step is to familiarize the researcher with moral
theories/ philosophy in a sustained (stage-wise) manner during their training as
postgraduate students.
Practical problems relating to maintaining confidentiality (and hence obviating
unethical practices) while being sensitive to the possibility of stigma were also
discussed. Another important issue discussed was that of broad consent – for
research to be conducted in future, on collected samples.
The Faculty of Hematology discussed their research students’ research projects
and in particular it was decided, in the light of our discussions to rewrite the
informed consent form. This is important as the present form/letter does not
mention participants’ rights to withdraw from research, compensation for
research related injury/ies, risks of harm (which may be minimal such as in
venipuncture, or not), potential benefits and post-research provision of
information regarding research results/ intervention, researchers’ contact details
etc. The importance of incorporating research ethics (as discussed earlier, as well)
as part of the training programme of researchers was also emphasized by the
29/12/14
faculty members.
The discussions were centered around why and how to introduce research ethics
into the curriculum of post-graduate researchers. It was decided at the outset that
the research ethics module should(ought to) be a core module and that perhaps
also not restricting it to research, rather a broader area of study –Bioethics, with
an emphasis on research ethics. The benefit of this would be that physicians,
researchers, health – care professionals (HCP) would have better understanding of
ethical concepts and practice that they can extend into their clinical practice, once
their post-graduate training concludes.
How to inculcate ethical practice in HCPs who were studying at post-graduate
level, that is “How to keep morality alive?”: in this regard it was emphasized that
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the supervisors, co-supervisors who advise and act as mentors (and also rolemodels), need to be made aware/enhance their awareness with regards to ethical
research (and clinical practice). I emphasized enhance HCP’s awareness, for it may
be that the HCPs are unaware of ethical requirements of research and not
deliberately/practicing unethical research. The training of supervisors and
advisorscan be through workshops and seminars while that of the P-G students
will be through didactic interaction/small group tutorials using case studies,
thought experiments and role play. The purpose is to internalize ethical practice
and for this, in addition to the above, observing students’ interaction with patients
is essential. This can/ought to be performed by their supervisors (who are aware
of the ethics of this practice, hence training the trainers is imperative).
Assessing the students through TOACS/OSCE etc. may be useful, although I agree
that ethics is not a ‘box-ticking’ exercise – what is more important is observing
interactions in their ‘natural’ environment (that is their daily /routine practice) by
supervisors and advisors.
The introduction of ethics is to develop essential skills in HCPs. The aim of this
module is to highlight the philosophical underpinnings of research ethics guidance
and introduce students to the principles of conducting ethical research. This aim
will be met by the following:
1. To introduce students to approaches to research ethics (based on
Deontological, Utilitarianism, Virtue ethics, Religious ethics and then on the
guidance from Nuremberg code to Belmont Report to Declaration of Helsinki and
CIOMS).
2. To be able to identify an ethical issue and recognize relevant ethical
considerations and develop a respectful understanding of alternative (others’)
views.
3. To cultivate critical reasoning skills so as to enable them to handle a wide array
of ethical issues, now and in future.
4. To analyze the requirements of conducting ethical research in the light of
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ethical approaches.
5. To understand the influence of the socio-cultural context on research ethics.
This was discussed by me with the group of faculty members and again with
medical education –Dr. Amina Ahmad. Following this on the 29th, as a taster
session I, in the light of the three prominent moral theories (approaches) to ethics
posed a question to the faculty. The question was ‘whether lying is permissible or
impermissible’. Without going into the details of the very significant and insightful
discussion suffice it to say that a number of reasons/rationale were given by the
discussants which were then analyzed in the light of Deontology, Utilitarianism
and Virtue Ethics (as well as religious ethics). The moral stances ranged from
30/12/14.
absolutism to particularism in relation to obtaining consent and the moral rule“do not lie” (lying is impermissible).
31/12/14
Report writing.
Meeting with Dr. Amina Ahmad was very fruitful – and it was decided that
knowledge, skills and attitude/behavior ought to be developed. Three main
competencies that need to be emphasized is knowledge, skills and attitudes. In
case of knowledge inculcating principles of research and principles of research
ethics – informed consent, patient selection, risk benefit analysis and post-trial
provisions; in case of skills, cognitive and communicative skills, decision-making
and critical appraisal skills were emphasized upon; in case of attitudes and
behavior inculcate the philosophy and attitude of respect.
It was decided that initially a workshop that is being held in the last week of
January
2015 will incorporate ethics of developing a research proposal, ethics of
authorship and scientific writing. This will be a sensitizing session for the trainers
and for this I will prepare a framework of principles to be presented at the
workshop. A subsequent workshop will be conducted at the end of Hilary/early
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Trinity term (March-April) 2015 that will elaborate on these principles (principles
sent earlier in January), discuss cases and proposals in the light of the course
designed by me (these may be similar to the courses designed for the Department
of Continuing Education on Research ethics and Human Values in Biomedicine by
me).
A discussion was also held with the Vice –Chancellor and it was proposed by him
that an International Conference should be conducted on Human Values and
Biomedicine in 2015.
This report has been prepared by Aisha Y Malik on her assignments from 17/12/14 – 31/12/14 at the
University of Health Sciences, Lahore, Pakistan.
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