Daily Archives: June 9, 2021

How could the researchers have avoided this unfortunate situation?

A group of researchers, consisting of anthropologists, geneticists, and physicians, identifi ed a rare genetic disease in an indigenous population of Native Americans (the Beewoks) living on coast of western Canada. People who have the disease (known Wajan’s disease) have 12 fi ngers and 12 toes, white hair, blue eyes, and enlarged hearts. People with Wajan’s disease usually die before age 25 as a result of heart failure. The Beewoks do not regard this condition as a disease. They believe that people who are born with this condition are blessed by the gods and have special gifts of empathy, prophecy, and spiritual healing. They also believe that people with this condition have been a part of the population since the beginning of time. The Beewoks also believe that….

Do you see any potential ethical and social problems with this gene therapy study?

A pharmaceutical company is developing a gene therapy protocol for male pattern baldness. The product is a cream that contains a retrovirus similar to the viruses that cause the common cold. The virus contains a gene that promotes hair growth. To be effective, the cream needs to be rubbed on the bald skin and not removed (by washing) for at least three hours. In animal studies, the cream has successfully grown hair on bald rodents with few side effects, other than some respiratory symptoms similar to the common cold. The company would like to begin phase I trials on healthy, adult men with male pattern baldness.

• Do you see any potential ethical and social problems with this gene therapy study?

• If you were an IRB member,….

How would you react to this for your children?

It is the year 2010 and scientists have discovered a gene that confers an increased risk (25%) for ADHD. A group of educators are proposing that the state enact a law requiring mandatory screening for this gene, because studies have shown that early intervention for ADHD can yield excellent results. If a child tests positive for the gene, parents can be educated about the condition and what steps to take to provide an appropriate environment for their child, including possible treatment with medication. The educators argue that this screening program will be very cost-effective, because about 10% of all children have ADHD, the test is inexpensive, and the state can save a great deal of money on special education programs and medication through early intervention. How would you….

Should the team bring up the issue of genetic tests for H.T. or possibly family members?

H.T. is a 44-year-old white male hospitalized for impaction. He is mentally retarded and has physical deformities, which have been present since birth. He has one “normal/functional” limb, his right arm, and three abnormal ones (short, clubbed, stiff, drawn in). His family lives far away from town but wants to transfer his care to the outpatient service; they like the care he has received while a patient at the hospital. After examining the patient and seeing his niece, the attending physician begins to wonder whether H.T. has a genetic syndrome. A resident also comments that he has seen other members of the family (nieces, nephews, and siblings) who have a very similar appearance (face, skin, hair, body size, and build). H.T. is currently living with his niece. The….

Would it be ethical to conduct the research under the conditions set forth by the tribal leaders?

You are planning to conduct a study on the women’s attitudes toward birth control in a developing nation. The population you are planning to work with has a tribal governance structure: All research projects must be approved by the tribal leaders. You present your proposed research project to members of the tribe, describing the protocol and consent process. You plan to conduct a medical history and physical exam on each woman. You will also conduct a thirty-minute interview in which you ask them questions about their sexual behavior and attitudes toward sex. Each woman will also receive tests for HIV, chlamydia, herpes, and other sexually transmitted diseases. The tribal leaders give their tentative approval to the research with the understanding that if the research subject is married, her….

Do you see any ethical problems with the CRO’s plans?

A contract research organization (CRO) is planning to move its operations to a developing nation in Southeast Asia. The CRO specializes in conducting phase I trials (i.e., dosing studies) on healthy subjects for pharmaceutical companies. It is moving its operations to this country to save money on labor costs and to take advantage of a less burdensome regulatory system. The research subjects will be paid $5 per day for participating in research, which is about the average daily pay in that country. The CRO has no plans to compensate research subjects for injuries. Health care in the Southeast Asian nation is very limited. Most of the drugs tested by the company are likely to be used to treat chronic diseases that affect people in developed nations, such as….

What are some of the potential ethical problems with this study?

Investigators sponsored by the NIH and private foundation are conducting an HIV vaccine trial in a sub-Saharan African nation. In the trial, HIVnegative adolescents will be randomized to receive either an experimental vaccine or a placebo. They will be instructed on ways to prevent HIV infection and provided with condoms. They will be followed for fi ve years to see if either group has a higher HIV infection rate. They will be tested for HIV on a regular basis and interviewed concerning their sexual activities and other risky behaviors. If they develop HIV, they will be treated according to the standard of care in the sub-Saharan nation, which includes access to only some of the HIV medications available in the developing world. Subjects who develop HIV will receive….

Should the IRB approve this study?

A U.S. researcher is collaborating with researchers in a developing nation in South America studying a hereditary disorder found only in an isolated population living deep in the jungle. The South American researchers are planning to send genetic samples to the U.S. researcher for analysis. They hope to identify genes associated with this disorder. The South American researchers have a protocol and consent form, which have been approved by a local IRB. They have submitted an amendment to their local IRB to include the U.S. researcher as a co-investigator. In order for the U.S. researcher to collaborate with the South American researchers on this project, the IRB at his institution must also approve the study. The U.S. researcher submits a proposal to his IRB. The South American consent….

Should the study go forward

Malaria is a devastating disease in Africa and in many developing countries. Nearly one million Africans die annually from the disease. Plasmodium falciparum is a protozoan parasite, one of the species of Plasmodium that cause malaria in humans. It is carried by Anopheles mosquitoes. P. falciparum malaria has the highest rates of mortality. Acute malaria in pregnancy is associated with increased mortality, spontaneous abortion, and deformities. The current treatment for malaria is chloroquin and sulfadoxinepyrimethamine. The use of these two drugs has resulted in the development of P. falciparum that is more than 50% resistant to these drugs. Moreover, the two drugs lower the development of acquired immunity to malaria. Therefore, there is a great deal of need to develop a new drug for pregnant women. Another drug,….

Should Dr. Langston share any fi nancial gains with the local population?

For as long as anyone in the local population can remember, members of a South Pacifi c island community have used a native plant known as pongopongo to cure fevers. Dr. Langston and his collaborators have learned about the plant while studying the population. They have collected and analyzed leaves from the plant and found that they contain powerful, broad-spectrum antibiotics. A compound isolated from the pongo-pongo plant even kills bacteria in cultures that are resistant to most antibiotics. Dr. Langston is planning to patent the compound isolated from the pongo-pongo plant, conduct animal studies, and if these are successful, conduct clinical trials. He hopes that one day the compound will play an important role in fi ghting bacterial infections, especially infections resistant to most antibiotics.

• Should….