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Informed Consent and Medical Research

The presentation on obtaining informed consent from the medical research subject was delivered by Rachel Scott, Jessica Zipper and Alison Solley.
  1. Overview of Informed Consent
Consent must be:
  1. Specific as to the proposed intervention, and
  2. Informed.
Exceptions to requirement for consent:  
  1. Medical Research-Special precautions and considerations apply on the subject of consent to medical procedures. In general, none of the above mentioned exceptions apply to consent to research.
   

#1-The Procedure: Gaining Approval for a Proposed Research Project

Most hospitals, universities and other institutions where research is conducted have established formal committees for reviewing proposed research plans.

Institutional Review Boards (IRB's)-Research review committees in institutions that receive federal funding for the research. Strict federal ethical guidelines must be met in order to earn the Board's approval. The main requirements governing IRB decisions include that:

(1) Risks to subjects are minimized.

(2) Risks to subjects are reasonable in relation to anticipated benefits and

the importance of the knowledge that may reasonably be expected to result.

  1. Selection of subjects is equitable.
  2. Informed consent will be sought, as required.
  3. Informed consent will be appropriately documented.
  4. Adequate provision is made for monitoring the research to ensure the safety of subjects.
  5. Appropriate provision is made for monitoring the research to ensure the safety of subjects.
  6. When vulnerable subjects are involved, appropriate additional safeguards are included to protect the rights and welfare of these subjects.
Upon examining these criteria, the IRB may approve the proposed plans, require modifications, or disapprove the plans.

#2-The Procedure: Obtaining Informed Consent from Research Subjects

The procedure should include making known to the subject:

--A description of procedures the subject will be asked to carry out;

--A description of possible risks and discomfort;

--A description of possible benefits;

--A description, when appropriate, of possible alternative procedures;

--A description of the extent to which data will be confidential;

--A description of compensation and medical care available in studies involving risks to the subject's well being;

--Instructions for contacting appropriate people (i.e. the researcher, a medical doctor, or a mental health worker), in the event of questions or personal problems related to the research;

--A statement that participation is voluntary and that the subject has the right to discontinue participation at any time without penalty.

Researchers should present this information in writing. The subject should sign an assurance that the information has been presented and understood. Researchers should understand that a subject gives up no legal rights through this procedure and that a minor's informed consent must also be agreed to by a parent or guardian.

--Who should obtain consent for medical research procedures?

Most institutions require the subject's consent to be obtained by someone directly involved in the study, so that the patient is fully informed.

Patients who are not capable of giving their consent may be research subjects but only where there is no substantial risk to them and where the knowledge sought cannot be gained by capable persons. However, where true consent by the subject is not possible, research cannot proceed until another person has consented on his/her behalf.
Questions to Ask Before Participating in a Genetic Research Study

* What is the purpose of the study? What are the names of the investigators? Who would be my contact person? What agency is funding the research?

* What are the benefits of participating in the in this research? For myself or family members? For others?

* What are the general risks of participating in this research? Are there any physical risks? What are some of the personal issues that could cause harm to me or my family?

* Will treatment be provided if unexpected problems arise while I am participating in the study? Who will pay for this treatment?

* May I bring a friend or family member to help me, either while deciding to participate or while participating? Will special services be available for me if needed?

* How will costs associated with participation in this research be handled? Is there compensation for the time involved? Will the cost associated with travel/child care/special services be reimbursed? What additional health costs may be associated with participation? Will my insurance company be billed for any of the procedures?

* What will happen to the stored DNA sample or any of my genetic information after this project is completed? What will happen if I decide to withdraw from the project? If this research plan changes in the future, if additional steps are added, or if new findings emerge, will I be notified and asked to sign another consent form? Will any of my genetic information be distributed?

* What happens if you need to have other family members involved in the study? How will they be contacted and by whom? What will happen to cells, DNA, or personal genetic information if they choose not to participate in the study?

* What will happen to my results? Will I receive them? If so, how? May I choose not to receive them ? Who will get the results? Who will see them? How will confidentiality of the records be maintained?

* How will the results be communicated to participants? If genetic services, tests, or treatments are developed from this research, how will I be told about their availability? How will I be informed if you publish information about me or my family? What happens if I do not participate in the research?
 
 
 
 

*Questions were compiled from the Alliance of Genetic Support Groups*

The Tuskegee Syphilis Study

-Conducted by the US Public Health Service from 1932-1972

-Subjects were sharecroppers and laborers from Macon County, Alabama

-Goal: To observe the long term effects of syphilis

The Disease: Syphilis

-It is a venereal disease spread during sexual intercourse. It can also be passed from mother to child during pregnancy

-Signs of the disease may never reappear even though the bacteria continue to live in the person. But about 25% of those origionally infected, symptoms will flare up again in a late or tertiary stage syphilis

-Almost any organ can be attacked, such as the cardiovascular system, producing leaking heart valves and aneurysms, balloon-like bulges in the aorta which may burst leading to instant death

-Penicillin was found to be a treatment

- 1930, Macon County had 27,000 residents-82% Afro-Americans

-Public health officials arriving on the scene announced that they had come to test people for "bad blood"

- 36% of the Afro-American population had Syphilis

-Racial connotations

-"There is bound to be danger that the impression will be given that syphilis in the South is a Negro problem rather than one of both races"

-PHS officer assured that Afro-Americans would not be attacked

-Origional treatment converted

-Of the 1,400 patients in the Macon County study, not one of them had received the full course of treatment prescribed as standard therapy for syphilis

-Everyone found to have syphilis would have to be treated

-Autopsys were needed

The subjects only thought that they were being treated for "bad -blood" and receiving money for burial

-Most medical experts supported the study

-The American Heart Association was an exception

-Dr. Vonderlehr

-1943 the participants were not considered patients that needed treatment, they were experimental subjects and were denied antibiotic treatment

-Dr. Irwin J. Schatz objected to the study

-Peter Buxtin objected in 1966

-1969 - blue ribbon panel

-Dr. James Lucas-PHS physician-study was "bad science"

-Buxtin Contacted the Associated Press

-Press ran stories exposing the study on June 26, 1972

-Three-fourths of the participants died from complications of syphilis

-Only 74 participants were still living

-Survivors became blind and crippled

-The government settlement

-May 1997, President Clinton apologized for the Tuskegee Syphilis Study

 

Ethical Issues

-----Deception and Informed Conscent

"bad blood"

subjects did not know that they were part of a study at the

beginning

Was this justified?

 

Case Study

Nancy Lowe is a physical therapist who works in a pain management clinic. The clinic has received a federal grant to explore the effectiveness of Transcutaneous Electrical Stimulation (TENS) for treatment of low-back pain. The research protocol calls for four options to be explored, including TENS with hotpacks,, TENS with ice, ice alone, and hotpacks alone. Her protocol calls for randomizing her patients to one of these four treatments.

Since hotpacks, ice, and Transcutaneous Electrical Stimulation are normally employed in the treatment of low-back pain, the investigators believe that the research protocol does not need to include informed consent, but does require approximately an equal number of patients to be assigned to each of the four treatment options noted.

Nancy Lowe also decides to forgo the informed consent with the research project because patients when given a choice will always elect to avoid ice treatment. Most people find it too uncomfortable.

Donald Taylor, a construction worker, has injured his back on the job. When he comes in for treatment at the pain management clinic, Mr. Taylor is assigned to have ice and TENS. He inquires of Nancy Lowe if he has a choice. How should she respond?
 
 



 

Informed Consent and Medical Research-Write-up

 The presenters outlined the history of informed consent and discussed the procedure that researchers must follow to obtain it legally and ethically. Also, questions the patient should ask researchers before giving consent were noted, and a detailed discussion of the Tuskegee Case-a case indeed relevant to the issue of informed consent-followed.

In general, the principle of informed consent says that, "no medical intervention done for any purpose…should take place unless the patient has consented to it" (Hebert, 1996). The idea of informed consent stems from the fundamental ethical principle of autonomy, which gives the patient the right to knowledge of his own medical condition, and requires that the physician respect any decision made by the patient in regard to his own health care. In consistence with the autonomy principle, the goal of informed consent is to fully educate the patient on his condition, thereby enabling him to make the best decision for himself (Hebert, 1996).

Unfortunately, "legal consent" may not always be the same as "ethical consent."

For example, the patient's signature on a consent form following a rehearsal of facts by the physician may be considered legal consent. However, for true ethical consent to take place, the physician must feel that the patient understands his situation in its entirety, and that the decision the patient makes based on this understanding is actually the best decision for that patient (Hebert, 1996).

Consent by the patient must be "specific as to the proposed intervention." For example, if a pregnant woman signs consent for a Caesarian section, the physician has no right to go ahead and perform a tubal ligation while she is in surgery. A woman who chooses to have a tubal ligation while under anesthesia for the C-section must sign two consent forms-one specific to each procedure-prior to sedation. Consent by the patient must also be fully informed-that is, the patient must be told the details of the procedure, the risk factors, the likelihood of success, and so on (Hebert, 1996).

As is usually the case, some exceptions apply to the principle of informed consent. For one, the patient may choose to request that the physician forego the details of the procedure. Secondly, incapacity of the patient limits the attainability of consent from the patient; in this case, consent should be obtained by someone on the patient's behalf. Also, in an emergency situation consent is not required, due to the fact that most patients in the state of emergency are incapable of giving it. Lastly, the physician may exercise his "therapeutic privilege" to exclude information he feels may cause the patient harm. All of these exceptions have their limitations, and must be used under suitable circumstances so as to avoid medical malpractice (Hebert, 1996).

In the case of obtaining informed consent from subjects participating in medical research, none of the above mentioned exceptions apply. Because participation in medical research is voluntary, the subject must be completely informed of all risks and details. Here an important distinction should made between clinical practice and clinical research. Clinical practice is always geared toward the benefit of the patient, and is considered to be therapeutic. On the other hand, clinical research does not presume to help the patient participant; research is conducted in the hopes that its findings will benefit other patients in the future. For this reason, research is considered non-therapeutic, and patients participating in it must commit on a voluntary basis (Hebert, 1996).

Consent was not always required of medical research subjects. For example, Nazi physicians were known to perform cruel experiments on unwilling subjects. In response to such violations of fundamental human rights, the Nuremburg Code was introduced in the aftermath of World War II. Essentially, the Nuremburg Code states that voluntary and fully informed consent of the human subject is mandatory (Hebert, 1996).

Today, researchers must meet strict guidelines before experiments are permitted to be conducted. Most hospitals, universities, and other institutions where research takes place have formal committees that evaluate research proposals. In institutions that receive federal funding for the research, the committee is likely to be called an Institutional Review Board (IRB) (Polit, 1995). The main requirements governing IRB decisions include that:

Upon examination of the research proposal with respect to these criteria, the IRB may choose to accept, reject, or require modifications to the plans. If acceptance is granted, the researcher must then conform to more strict guidelines-those governing the information that must be given to the human research subject. These procedures include making known to the patient: The above information should be presented to the patient in writing, and the patient's signature should indicate that the information has been read and understood. The patient gives up no legal rights by signing a consent form and can leave the research project at any time (Bruchak, 1997). In the case of minors or otherwise incapable individuals, consent may be obtained by a parent, spouse or other close family member, or from an appointed proxy (Hebert, 1995). Lastly, informed consent should be obtained by someone directly involved in the study, to ensure that the patient is fully educated.


The most important thing for medical researchers to strive to avoid is placing the interests of science before the well being of the patient. Next, the Tuskegee Syphilis Case will be discussed. In this case, science was indeed placed before the subjects' best interest.

This case was conducted by the US Public Health Service from 1932-1972. The subjects were mostly sharecroppers and laborers from Macon County, Alabama. The goal of the study was to observe the long term effects of syphilis. Syphilis is a venereal disease spread during sexual intercourse. It can also be passed from mother to child during pregnancy. Some signs of the disease may never reappear even though the bacteria continue to live in the person. About 25% of those originally infected have symptoms flare up again in a late or tertiary stage of the disease. Almost any organ can be attacked, such as the cardiovascular system, producing leaking heart valves and aneurysms, balloon like bulges in the aorta which may burst leading to instant death.

Penicillin was found to be a treatment between 1941 and 1943. In 1930, Macon County had 27,000 residents of which 82% were Afro-American. Public health officials arriving on the scene announced that they had come to test people for "bad blood". Around 36% of the Afro-American population had syphilis. Because of this fact, there were many racial connotations. Researchers feared that people may begin to believe that syphilis was only a Afro-American problem. Public Health officials promised that Afro-Americans would not be attacked.

The study was headed by a team of doctors, but not one of the doctors was in Macon County the whole time that the experiment was taking place. Eunice Rivers was a black woman who was in charge of the experiment while the doctors were out. The doctors sometimes were gone for years at a time, leaving Eunice in charge of all the patients. When they did return, however, they could not go to the files to see the progress because there were extremely bad records of what was going on. With only one person in charge of so many people, Eunice did not have time to keep accurate files.

Of the 1,400 patients in the Macon County study, not one of them had received the full course of treatment prescribed as standard therapy for syphilis. Everyone found to have syphilis would have to be treated. Most medical experts supported the study. However, the American Heart Association was an exception. They wanted clarification of the scientific validity, then subsequently expressed great doubt and criticism concerning the tests and procedures. Dr. Vonderlehr (one of the Tuskegee doctors) remained convinced that the study was valid and would prove that syphilis affected Afro-Americans differently than those of European descent. In 19943 the participants were not considered patients that needed treatment, they were experimental subjects and were denied antibiotic treatment. Dr. Irwin Schatz objected to the study as did Peter Buxtin in 1966. In 1969, a blue ribbon panel of doctors was called to discuss the case. The outcome of the meeting was that the study was to continue. Dr. James Lucas of the Public Health Service stated that the study was "bad science". Buxtin contacted the Associated Press and the AP ran stories exposing the study on June 26, 1972. Three fourths of the participants died from complications of syphilis. Only 74 participants were still living at the time the story broke. Many of the survivors became blind and crippled. The government settlement gave living syphilitics $37,500 each and $15,000 to the families of the deceased. In May of 1997, President Clinton apologized for the Tuskegee Syphilis Study. 


Jessica Zipper's portion of the presentation included a case study that involved a research study and three treatment options available. The controversy arose when one of the patients asked if he could receive a different treatment than the one that the doctor had prescribed. In a discussion, we decided that the doctor could either tell him no, there were no other options, or she could tell him to use the other ways to treat his ailing back. However, we also decided that since the medical facility was a clinic type setting, then maybe the man was aware of the studies and should be able to get different treatment elsewhere. One other point that we emphasized was the fact that his ailment was simply a sore back. Since he is in the construction business, we figured that he may have had these pains before, or knows someone with the same problem. By using common sense and perhaps talking to other back-pain sufferers, we concluded that he could find out how to treat the pain without doing the ice treatment that was assigned to him by the clinic.

The other section of this presentation included giving important questions that one must ask themselves before participating in a research study. The basic gist of the questions were as follows:

The purpose of this section of the presentation was to give the class questions to think about that may benefit and perhaps safeguard them in the future. This information was compiled from a Web page published by the Alliance of Genetic Support Groups.
 


Reference List

Bruchak, K.T. (1997). Making treatment decisions: informed consent. [On-line]. Available: http://nisc8a.upenn.edu/psychosocial/family/consent.html

Hebert, P.C. (1996). Doing Right: A Practical Guide to Ethics for Medical Trainees and Physicians. New York: Oxford University Press.

Polit, D. F., & Hungler, B. P. (1995). Nursing Research: Principles and Methods (5th ed.). Philadelphia: J. B. Lippincott Co.

Fourtner, A.W., C.R. Fourtner and C.F. Herreid. "Bad Blood:" A case study of the Tuskegee Syphilis Experiment.[On-line]. Available : http://nisc8a.upenn.edu/psychosocial/family/consent.html

Veatch, Robert M and Flack, Harley E. Case Studies in Allied Health Ethics.

Prentice-Hall Inc. 1997.

"Healthtouch-What is informed consent?" Alliance of Genetic Support Groups

Http://www.healthtouch.com/level1/leaflets/agsg002.htm