Genetic Research—Stored Samples and Consent for Future Use

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Genetic Research—Stored Samples and Consent for Future Use

This assignment will require you to apply lessons from genetics, research, and the basic ethical theories in your answer. It examines intersections of genetics and research in a particularly challenging context: how to conduct genetic research involving use of stored tissue samples.

Imagine that there is no legal guidance from the federal government on whether researchers need to obtain consent for research using stored tissues and, instead, the decision is left entirely to each institution’s ethical discretion.You are a part of your institution’s IRB and it has in the past approved a study that used blood samples to examine hereditary transmission of obesity. The researchers have stored the blood samples for several years, and the participants signed a blanket statement that allows “researchers to use stored blood samples for all future related studies.” Now, these same investigators want to share those blood samples with a research team from a university in another state and to collaborate on the linkage between obesity, depression, and schizophrenia using these same samples. They say that they should not have to obtain consent from the “owners” of the blood samples for this new study.

Your institution needs to decide whether to permit this study to move forward without consent, and what its policy is going to be moving forward with this and other studies.

Research this controversy and use two outside academic articles or newspaper articles in your answer.

You have three models to choose from. Evaluate each models for its ethical implications and its pros and cons. Then, decide which model your IRB will adopt and why. Use research ethics and ethical principles/theories in your answer.

The three models are:

  1. Continue using blanket consents where the patient signs one initial consent with donation, and researchers can then use stored samples for any use in future.
  2. Continue using blanket consents where the patients signs an initial consent with donation, but researchers can only use stored samples for related studies (for example, only studies dealing with obesity)
  3. Require consent before each new use of a stored tissue sample.

The format should be a professional memo to your colleagues on the IRB.

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