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Informed Consent as it Connects to Tissue Research

Informed consent is defined as “the process of communication between a patient and a physician that results in the patient’s authorization or agreement to undergo a specific medical intervention” (American Medical Association). Information to be disclosed to a client includes the purpose of a procedure, alternatives and risks and benefits of the alternative treatment and of undergoing the procedure. Everybody is entitled to know what is happening to his or her body and how the doctor or health practitioner intends on using her or him. Before using human tissue for commercial purposes, one has to obtain informed consent from the patient, potential commercial application must be obtained from the patient before profit is realized and the profits realized must be shared with the patient. Human tissues and all its products should not be used for commercial purposes without the informed consent of the patient who provided the original cellular material (American Medical Association). HeLa cells have been used for research on many diseases and they have enabled scientists to find drugs and vaccines. They have profited many people but unfortunately, they have not benefited Lack’s family.

The case of Henrietta Lacks is a classic example of how all these guidelines have been violated. Despite the fact that the rules had not been put in place then, there should have been some accountability regarding the HeLa cells. Her cells were used without her knowledge and consent and this affected her family psychologically. Unfortunately, this problem is not prevalent in the United States only but other countries such as the United Kingdom have also enacted laws to ensure that doctors, other health practitioners and scientists do not exploit people for the sake of medicine and science (Biggs 144). Children and incompetent adults cannot give informed consent. Informed consent is not possible where the person is dead. However, children eventually grow up and the dead leave their relatives behind. If the person who originally gave the cells is dead, due consideration should be given to the close relatives. Informed consent should include provisions dealing with such matters. Using tissue samples without the knowledge and consent of the client is simply an act of exploitation. It is a way of telling scientists that they can do their research without protocol since there are no regulations and consequences that follow.

For an informed consent to be ethical, it should clearly define what should be included in the human tissue samples that are to be used. This includes body organs and fluids. The patient should be aware of the doctor’s reason for obtaining the tissue sample. All the donors should clearly understand what it means to donate their cells. Henrietta Lacks was not aware of what the doctors’ intentions were when he took cells from her cervix. She might not have had the right to ask the doctor questions at that time since there were no regulations concerning such issues. Her children and grandchildren were not aware of the rights offered to them under the law. Informed consent should be clearly written down and easy for everyone to understand to enable better understanding and clarity of the issues. A patient should not sign a consent form before understanding all the information contained. Patients who do not have high literacy levels should be guided and the information contained should be explained.

Informed consent should include the all workings of the procedure. The informed consent should clearly state what the procedure will involve. Some patients may consider some of the procedures as an invasion of their privacy, since the doctor will know about their lives. It should be a strictly confidential process, and should be between the doctor and the patient. If there is another party to be included, the patient should be made aware of this. This is for the sake of the patient and for the protection of his or her privacy.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Works Cited:

American Medical Association. Commercial Use of Human Tissue. 2011. Web. 9 May 2011.

American Medical Association. Informed Consent. 2011. Web. 9 May 2011.

Biggs, Haze. Healthcare Research Ethics and Law: Regulation, Review and Responsibility. United Kingdom: Routledge, 2010. Print

Skloot, Rebecca. The Immortal Life of Henrietta Lacks. New York, NY Crown Publishers, 2010. Print .