Understanding Vulnerability
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Link to presentation Understanding vulnerability Module 9
Cases for discussion
Case 1
In 1932, the Public Health Service of the United States began a study called “Tuskegee Study of Untreated Syphilis in the Negro Male”. The study involved 600 black men – 399 with syphilis, and 201 without syphilis. The men were not told the purpose of the study – they were told that the research team was investigating “bad blood”. In exchange for their participation, they received free medical exams, free meals, and free burials. However, the men were not receiving treatment for their syphilis throughout the study, which lasted for 40 years. Keep in mind that penicillin had become the treatment of choice for syphilis in 1947 after its advent. The advisory panel that began investigating the study in 1972 found that the participants were never given the option of leaving the trial. The study was halted in October 1972.
What are the ethical issues involved in this scenario?
1. The participation of the men was free, but not informed. The participants were unaware as to the true purpose of the study, and unaware that they were not receiving any form of treatment despite that such a treatment existed.
2. The patients were not receiving the standard of care – in any research study, it is completely
unethical to deny patients the standard of care, as this is actively harmful to their immediate
health and long term prognosis.
3. The patients were not allowed to leave the trial, which means they lacked autonomy in their
participation.
4. The patients were exclusively black men in difficult socioeconomic conditions, and thus the
burden of this research was not evenly shared by the American society as a whole. It is not
acceptable to use minorities for research purposes and to prey on their difficult living conditions
as a way to coerce them into participating in a trial by offering them “treatments” and benefits.
Case 2
Researchers at Harvard University and its corporate sponsor, Millennium Pharmaceuticals, Inc., coveted the population in China’s poor rural Anhui province, as this population of 62 million people was unusually homogeneous in its genetic profile due to its being isolated by geography and poverty for 2,000 years. Essentially, genetic deviations that may cause medical disorders are more easily identified in a large DNA sample from a relatively uniform gene pool. Access to the tissue samples of such a homogeneous population can yield genetic links to diseases and blockbuster drugs to treat them and millions in biotech profits.
Xu Xiping, a native of the Anhui province, who received his post-graduate education at Harvard University, was responsible for collecting DNA samples from thousands of people not only for Millennium, but for his research as well. Nine projects were instituted that sought to find hereditary links to diseases such as hypertension, obesity, asthma and osteoporosis, schizophrenia among others. The conditions being studied did not affect poor populations in rural China, but rather are disease that concern affluent societies The investigators in this study did not obtain informed consent from all of the subjects, as many were illiterate. Also, the investigators argued that the collection of the blood samples was considered to be minimal risk research. Finally, research subjects were told they would receive free
medical treatments in return for their participation in this study. The research ethics committee at Harvard University provided only retrospective ethics approval.
Discuss the following issues:
1. Did the investigators exploit the inhabitants of this poor rural province?
2. Does illiteracy justify the fact that the researchers did not informed consent?
3. Do you agree that the risk of this study is minimal risk? What are other potential risks in
additional to the physical risks associated with the blood draws?
4. Is retrospective ethics approval adequate? If not, please explain why not.
*Please let your reflections/questions/comments related to the cases for discussion in the box bellow.
9 thoughts on “Module 9”
case 1
the ethical issues involves in that scenario are:
Exploitation occurs because groups are taken advantage of or unfairly benefited
from, often without their full understanding or consent.
in addition for this there is coercion involves the use of threats, force, or other forms of pressure to compel someone to
do something against their will.
on top of that there is social harm.
case 2
1- yes because the e disease that concern affluent societies
2- no for individuals who cannot give consent
themselves, consent from their family members, legal guardians, or other appropriate
representatives should be obtained.
3- no social harm and other
4- no should
1. Did the investigators exploit the inhabitants of this poor rural province?
case 1
yes they had exploited the participants because :
– they didn’t tell them the purpose of the study.
– no treatment was given to them.
– The patients were not allowed to leave the trial, no withdrawal right was given to them.
case 2
– this study did not obtain informed consent from all subjects, as many were illiterate.
1. Did the investigators exploit the inhabitants of this poor rural province?
case 1
yes they had exploited the participants because :
– they didn’t tell them the purpose of the study.
– no treatment was given to them.
– no withdrawal right was given to them.
case 2
– this study did not obtain informed consent from all participants.
q2:
case 1:
illiteracy is not justifiable in those cases because: the interest of the vulnerable group is not met, as the Nuremberg Code states ( The voluntary consent of the human subject is essential) also CIOMS guidelines
“Researchers must provide potential research participants with the information and the opportunity to give their free and informed consent to participate in research, or to decline to do so unless a research ethics committee has approved a waiver or modification of informed consent. Informed consent should be understood as a process, and participants have a right to withdraw at any point in the study without retribution .”
Q3- Do you agree that this study’s risk is minimal? What are other potential dangers in
addition to the physical risks associated with the blood draws?
case 1
the risks are not minimal because the treatment was not offered to participants.
case 2
the risks are minimal because blood samples were considered to be minimal risk.
in case 2
there were no other potential risks.
q4- ethical approval may still be required based on the laws and national ethical guidelines of the respective country so ethical approval from Harvard University alone is not enough
Case one
1: Yes , the investigator exploited vulnerable black population by taking advantage of lack of health care access the researcher misled them about the purpose of the study rather than lack of autonomy
2: literacy not justfy absence of informed consent, it can be maintained by simple language and they should understand their rights
3:Study can not be considered with minimal risk, participants will face the risk of living with untreated syphilis and that has another effect on different aspects of life, moreover the risk of loss of trust in medical researcher should be mentioned there.
Discuss the following issues:
1. Did the investigators exploit the inhabitants of this poor rural province?
Yes, as the diseases studied were not relevant to their community and therefore any result gained from such research will not benefit their community.
2. Does illiteracy justify the fact that the researchers did not informed consent?
No, illiteracy does hinder ones understanding thus explaining the study verbally and gaining verbal consent should have been done.
3. Do you agree that the risk of this study is minimal risk? What are other potential risks in
additional to the physical risks associated with the blood draws?
No, as blood drawing could expose patients to blood borne diseases and could pose a psychological issue for those with needle fear in an unnecessary process to them.
4. Is retrospective ethics approval adequate? If not, please explain why not.
In my opinion it is, since I think it’s still better to benefit from such information even though it was not approved beforehand, especially if the consent was gained from the previously unaware participants.
an edit to my previous comment:
2. Does illiteracy justify the fact that the researchers did not informed consent?
No, illiteracy does hinder *NOT* ones understanding thus explaining the study verbally and gaining verbal consent should have been done.