Question

The Immortal Life of Henrietta Lacks Book Discussion

The Lacks' are still dealing with the aftermath of HeLa, demonstrating the importance of understanding how genomics are changing the scope of what it means to be informed and what it means to give consent.

What issues regarding informed consent were identified in the Immortal Life of Henrietta Lacks? What has been done to correct these issues since the time of Henrietta Lacks.

What concerns do you have about issues surrounding genetic information? Answer this question from a personal or professional perspective.

Answer 1

1)What issues regarding informed consent were identified in the Immortal Life of Henrietta Lacks?

The Immortal Life of Henrietta Lacks, revealed the ethical dilemmas and complex social issues interlaced with HeLa cells and medical research more broadly: concerns of consent, privacy and compensation, among others.

The collection, storage, and research use of biospecimens and data, however, raise deep questions about informed consent, oversight, large-scale data sharing, privacy and confidentiality, commercialization, access to research results, and the ability to withdraw.

*Consent is surely one ethical issue; privacy is another. Ms. Lacks was publicly identified as the source of HeLa cells decades ago. Recently, researchers sequenced the genome of HeLa cells, published their results and posted them in a public database – this affects the privacy rights not only of Ms. Lacks but also of members of her family. In addition to being concerned about privacy and consent, we should also consider if people who provide tissues for research benefit in any way.

2)What has been done to correct these issues since the time of Henrietta Lacks?

The definition of a human subject would be modified to include living individuals about whom an investigator “obtains, uses, studies or analyzes biospecimens” regardless of identifiability.

▪ With few exceptions, consent would be required for research use of all biospecimens—regardless of whether they were originally collected for research, clinical, or other purposes and whether they are deidentified (notably, consent would not be required for secondary research use of nonidentified private information, such as medical records).

▪ Consent would not be needed for each specific study, but rather could be obtained through broad consent for future unspecified research.

▪ The government would develop a broad consent template covering the storage of biospecimens and data for secondary research, as well as the use of stored materials for specific studies.

▪ In addition to basic elements of consent, additional required elements would cover commercial use and profit from study of biospecimens, return of individual research results, optional recontact, and widespread sharing, among others.

▪ Secondary use of biospecimens to establish a biobank would be exempt, subject only to limited IRB review to ensure that initial broad consent has been obtained and specified privacy and security safeguards are in place.

▪ Research using materials that have been stored for secondary use would be exempt from the regulations and required only to have safeguards in place (with no IRB review). Investigators could use a to-be-created decision tool to make the exempt determi nation themselves.

3.What concerns do you have about issues surrounding genetic information?

Each new genetic test that is developed raises serious issues for medicine, public health, and social policy regarding the circumstances under which the test should be used, how the test is implemented, and what uses are made of its results. Four ethical principles which can use in such issues are:

*Autonomy

Autonomy can be defined as self-determination, self-rule, or self-governance.In the context of genetic testing and screening, respect for autonomy refers to the right of persons to make an informed, independent judgment about whether they wish to be tested and then whether they wish to know the details of the outcome of the testing.

*Confidentiality

Confidentiality as a principle implies that some body of information is sensitive, and hence, access to it must be controlled and limited to parties authorized to have such access.Rules of confidentiality appear in virtually every code or set of regulations for health care relationships

*Privacy

A state or condition of limited access to a person.A entirely different standard of privacy protects personal information.

*Equity

The concept of equity serves as the underpinning for a variety of legal doctrines and statutes.