Risks and Benefits
Evaluating Risks and Benefits – Module 3 – Dr Shaza Abbas
The video lecture can be also downloaded from here.
Case Study 1
A drug company plans to do Phase I safety study on healthy subjects for a drug designed
to reduce the damage from severe frostbite. Animal and toxicological studies indicate that
the drug has no serious side effects. The researchers want to work in North Sudan
because it is far less expensive to run a Phase I study there than in any Western country, and
in past studies, they have found it easy to recruit and retain subjects in rural areas. They
have adopted culturally appropriate informed consent procedures and will offer subjects
compensation for any injury that might occur as well as payment that is generous but not
extravagant by local standards. In addition, the company has committed itself to funding
a network of badly needed local health clinics in the areas from which subjects are recruited.
Discuss the risks and benefits including fair subjects’ selection.
Case Study 2
A researcher wants to investigate a new method for identifying posttraumatic stress
disorder PTSDs confined to a single region with increased suicidal rates among females.
The study will require several visits to the homes for psychological assessment.
Although PTSDT afflicts both men and women, but appears to affect women more
severely, and thus females 18- 50 years will be recruited for this study. The researcher,
however, wants to conduct the study secretly and is proposing visiting the houses during
men’s working hours. Men usually leave for farming during the early day hours. The reason
for this is that women in that country are not allowed to talk to strangers. While it may be
possible to recruit an adequate number of women, it will require extensive negotiations
with village elders, driving up the time and expense of the study and risking suspicion and
hostility in the host communities.
1. Identify the risks in that study.
2. Are there any direct benefits to participants in the study?
3. Is the risk-benefit ratio acceptable in this study?
4. How can the risks be minimized.
*Please let your reflections/questions/comments related to the cases for discussion in the box bellow.
5 thoughts on “Module 3”
case study 1
there is no direct benefits from that study (its from risk to risk), because the researchers want to work in North Sudan because it is far less expensive to run.
at that time All research must have a favorable risk-benefit ratio In research where there are no potential direct benefits to research participants, the risks must be minimized and appropriate in relation to the social scientific value of research.
on the top of that according to my experience in doing research there are many cases like this in Sudan specially with ongoing war several NGOs conducting research with no commitment on ethics issues, but some of them has for example British council they have code standard which involve vulnerable safeguarding and protection.
case study 2
1-Identify the risks in that study:
social risk: especially the study involves sensitive or stigmatized topics.
Loss of confidentiality: the is no any steps to protect participants’
privacy and trust.
2- yes there is direct benefits, because A researcher wants to investigate a new method for identifying posttraumatic stress at same time the rates of suicidal increasing among females in the research context.
3- unacceptable, but what acceptable is collateral Benefit is a benefit arising from being a subject, even if one does not receive the experimental intervention.
4- risk will be minimized by comparison of the probability and magnitude of harm or discomfort anticipated in the research with that encountered in daily life or during the performance of routine physical or psychological examinations or tests.
in conclusion my question here is as you known there is some type of research called covert research, how it will be conducted with ethical consideration?
Case 2
1-psycholological risk due to discomfort feeling.and social discomfort that women are asked on absence of men.
2-Benefit includes identifying those suffering from stress.
3-I don’t think benefit outweigh the risk.
4-Qualified personell
case 1
risks:
1- there is a physical risk (minor) although animal and toxicological studies indicate that
the drug has no serious side effects there are some side effects even if they are minimal.
benefits
1- Potential of Direct benefits: from intervention.
2- Collateral benefits.
3- Benefits to the society
as the payment for participants is considered an inducement but not a benefit.
case 2
1- this study has social and psychological risks for the female participants.
2- Benefits to the society, Altrusim.
3- from my perspective the risk-benefit ratio is not acceptable due to the troubles for the female participant.
4- minimizing the risk by letting elderly trusted personnel attend the data collection, or by helping the community by offering medical and psychological help to medical personals in medical center free of charge.
Case 1 : Risks : the participants may not fully understand the process and the purpose although culturally approbriate consent procedure are adopted. Moreover participant may feel pressured to join due to financial necessity .
Benefits : if the drug is effective it could lead to significant advancement in treatment options.
Fair subject selection can be applicable by recruitment of participants equally and without bias and ensure the transparency by clear clarification about risk benefits.