Case Studies- Discussion Points
Case study 1 : Principles of Research Ethics
Developing a vaccine for Malaria
1. Is the use of a placebo appropriate in this context?
Ans. The use of a placebo is not appropriate in the context because
children are loosing lives due to malaria. An effective research and study
on symptoms will provide a vaccine and its effect on children will help to
develop the vaccine for further process.
2. Is the study design appropriate to demonstrate the efficacy of the
vaccine?
Ans. The study design is good up-to some point as it was mentioned that
after vaccination the team will leave the village without any further
consideration. It cannot help in demonstrating the efficacy of vaccine.
3. Should the researchers provide treatment for malaria cases in the
community?
Ans. Yes, the researchers should provide treatment for malaria cases in
the community to have wider range of participants and more
information can be gathered by the effects/working of vaccine.
4. Should the researchers provide information on how to prevent
illness?
Ans. yes, the researchers should provide information on how to prevent
illness so, that children can take precautions with utmost care by their
parents.
5. The case study does not indicate that any provision has been made
for an ethical review by the country where the research is being
conducted. If the North American partners insist that the review
conducted in North America is adequate, what should the host country
do? If the host country does not have the capacity to provide ethical
oversight, what options are available?
Ans. If research conducted by North America partners insist that the
review conducted in North America is adequate, the host country should
adapt the review and studies of the North America and develop a
vaccine in their respective laboratories.
Case Study 2: Informed Consent
Development of a New Microbicide
 In this case REC should:
1. Recommend that the study be terminated.
Ans. Until and unless the study and reviews are said to be useless it
should not be terminated.
2. Retrain the site investigator and the study staff in the informed
consent process.
Ans. Enabling the site investigator and the study staff to teach new skills
and to do a different job in the informed consent process which is
approved.
3. Rely on the site investigator’s knowledge of the study population.
Ans. The information of the study population according to the
knowledge of the site investigators may be relevant or vice versa
because it may be truth, pseudo truth or false statements.
4. No action. Signed consent forms for each participant are on file.
Ans. Most of the consent form is paraphrased and several essential
elements are omitted. And that consent form is signed by all participants.
Case Study 3: Research Ethics Committee Considerations
Testing a New Vaccine for Malaria
1. Is the study methodology appropriate?
Ans. No, the study methodology is not appropriate because instead of
making humans get bitten by anopheles mosquitoes, take the humans
who are already been effected with it, which will be helpful for the
research and effectiveness of the vaccine.
2. Should the study be reviewed and approved phase by phase?
Ans. The study should be reviewed but the phase stages should not be
appropriate which is not an appropriate measure to take action directly
upon humans rather than any other sources.
3. Are the protections for participants sufficient?
Ans. No, the protections for participants is not sufficient because the
researchers itself making them to take mosquitoes bites voluntarily for
research instead of already effected people.
4. Should Phase 1b be eliminated?
Ans. If phase 1b is eliminated, phase 1a should also be eliminated then
only phase 1c should only be implemented as making people to take
bites of mosquitoes may cause huge harm to lives of humans. And
effectiveness of vaccination is unknown.
Case Study 4: Community Participation
HIV Vaccine Study with At-Risk Groups
1. Can this injecting- drug user population (community) be included in
this study? Why or why not.
Ans. The injecting drug user population should be included in the study
because as people who inject drugs are 22times more at risk of HIV
compared with the general population.
2. What measures can the research staff take to ensure that informed
consent is given freely by all participants?
Ans. The measures to be taken for informed consent are
 To use a private room
 Should not be present for any discussions
3. If you believe that the potential participants will not be able to give
voluntary informed consent, what could be done to change the
informed consent process.
Ans. Only those informed consent should be taken who are willing to
volunteer and those who are not willing should not be enrolled.
Case Study 5: Inducement/Compensation
A Trail for Malaria Prophylaxis
1. Is there undue inducement in the study?
Ans. Yes, there is undue inducement in the study as main factor is been
neglected which automatically leads to the other external factors which
makes humans lives at stake.
2. Is the use of placebo justified?
Ans. No, the use of placebo is not justifies because of it people may feel
safe about getting vaccinated and its the fake trust which is given to the
participants.
3. Are the safeguards adequate?
Ans. Yes, the safeguards are adequate but the volunteers should be
informed about what kind of treatment they are going to
receive/undergo.
4. Do the benefits justify the study?
Ans. Up to some point the benefits justify the study instead of taking
good immune people, take those people as participants who are already
been effected with the disease which will help them to cure and for
research process of vaccination too.
5. What information should be provided to participants before
enrollment?
Ans. All the information should be provided to participants before
enrollment like what kind of treatment, its effects, working of
vaccination, what it actually does to the human body and any side
effects.
6. Is the selection of the study site at a transmigrant settlement
appropriate?
Ans. Yes, the selection of the study site at transmigrant settlement is
appropriate because each countries food vitamins differs from each
other. So, a study on these transmigrants would help the researchers to
give advice or review to other country’s if they trail succeeds.
Case Study 6: Social Risks
Comparison of Female and Male Condoms
 How should the REC advise the researchers?
1. Stop the research to protect women.
Ans. The research should be terminated to protect women from getting
assaulted by their partners for participating in the study
2. Amend the informed consent form and re-consent all participants.
Ans. With the necessary changes in the form, ask participants consent
whether interested to enroll or not.
3. Continue the study, but orally inform participants of the risks.
Ans. Continue the study, but orally inform participants about the risks
which would help them to overcome and take necessary precautions.
4. Continue the study as designed.
Ans. Don’t continue to study as designed because the problems are
raised as being assaulted by their partners which will lead to
controversies
5. Add messages about domestic violence to the intervention and
report the violent episodes to management at the plantations.
Ans. Without these trails, no controversies would take place and
domestic violence too. With mutual understanding between partners
should consult doctor and take necessary precautions.
Case Study 7: Respect for Persons
Sexually Transmitted Infections among Commercial Sex
Workers
1. What steps can the research staff take to ensure that the informed
consent is freely given by all participants?
Ans. Should personally approach and ask the participants whether
forcefully enrolled or enrolled by their own interest. Or before starting
the process ask who are interested can stay and rest can leave the trail.
2. If a woman chooses not to participate in the study, what can be
done to protect her from retaliation by the manager?
Ans. If a woman chooses not to participate in the study, the manager
should approach and ask for reasons like whether she doesn’t want to
be exposed(like taking an interview) or any other reasons stopping them
from participation.
3. If you believe that the women will not be able to give voluntary
informed consent, what alternatives could you suggest to the Ministry
of Health?
Ans. If women are not willing to voluntary for the informed consent the
alternative can be given like their identity or personal information won’t
be shared with anyone and no interviews would be taken, it is just for
the records of ministry of Health so, that certain precautions can be
taken for Health of participants.
Case Study 8: Beneficence and Justice
Study on Condom Use
 What is the best way to proceed?
1. Continue the study as designed.
Ans. The continuity of the study as designed should be proceeded
according to the interest of the participants.
2. Terminate the study at this point.
Ans. The study should be terminated at this point due to the number of
participants interest shown towards it.
3. Suspend the study. Seek assurance that female condoms will be
made reasonably available if proved successful.
Ans. The study should be suspended because of the lack of access to the
products of the study and what is the use of this knowledge, when
products are not available.
Case Study 9: Individual versus Community Consent
The impact of Vitamin A on Diarrhea in Children
1. How should the researcher handle this problem?
Ans. The researcher should freely and openly communicate with the
parents of the participants and talk about why the study is initiated and
takes place with the will of the informed consent or else it won’t enroll
them.
2. How critical is signed informed consent in this setting?
Ans. Without the signed informed consent, no research can take place. It
plays an important role as an agreement between the participants ans
researcher.
3. Is it acceptable to obtain consent from the village chief or is
individual consent necessary?
Ans. Yes, it is acceptable to obtain consent from the village chief or is
individual consent is necessary because further procedure cannot be
taken place.
4. Is informed consent culturally bound or is it a universal principle?
Ans. The informed consent is a universal principle because for research
human participation is important.
5. Are there circumstances when informed consent is unnecessary?
Ans. Yes, there are circumstances when informed consent is
unnecessary where first trail should be done on animals.
6. Does it protect the researcher or the participant?
Ans. No, it does not protect the participants from the study.
7. Can the IRB waive informed consent in such instances?
Ans. Yes, the REC can waive the informed consent in some instances.
Case Study 10: Research Involving Minors
Comparing Childhood Vaccination Regimens
1. Should the sponsor of the study provide the Ministry of Health with
the control treatment as well as the study product?
Ans. The sponsor should provide the Ministry of Health with the control
treatment as well as study product as new and current vaccines are to
be given to the children the effectiveness and side effects are to be
controlled and studied.
2. Should the study be conducted only in the Heath Units and not in
private clinics?
Ans. Yes, the study should be conducted in the Health Units rather than
in Private clinics, if something goes wrong the immediate facilities may
not be available and parents are not educated well are been observed.
3. Is the enrollment plan, to be conducted in very busy clinics, realistic?
Will there be enough time to explain and obtain informed consent?
Ans. According to a particular procedure the plan will be executed, firstly
the announcement will be made and parents will be acknowledged
about the study. Consent form will be filled and in the given slot time
the participant should be waiting for their turn.
4. Can researchers assure that the individuals accompanying the
children have legal responsibility for the child? What should
researchers do in case where legal responsibility is uncertain?
Ans. If legal responsibility is uncertain, the researcher should take action
on guardian if evidence is not evident enough, the child should be given
into safe hands and good care of the child should be monitored by
researcher or Health unit.
5. Can researchers assure that parents will allow the children to
provide blood samples? Can researchers assure that children return to
the clinic for follow-up blood sampling or adverse events?
Ans. If proper knowledge is given about the study, then the parents will
not object and will intimate the condition of the children.
6. How should researchers ensure the control of the blood samples
during transport to central laboratory and out of the country?
Ans. Proper packaging may not harm the blood sample or any particular
measures which will protect them while travelling long distance.
7. Should children with adverse events be referred to the Ministry of
health hospital or a private hospital?
Ans. The children with adverse events will be referred to the Ministry of
Health hospitals as it was said by the researchers at the time of
enrollment like to the governments children’s hospital for treatment.