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Ethical Challenges

5. Current and Unresolved Issues

Consent

What constitutes valid informed consent?

The principle, Respect for Persons, is implemented through voluntary informed consent.  The elements of informed consent are stated in the Code of Federal Regulations. Consent requires that adequate information is given to allow research participants to make an informed decision.  Most agree this requires a determination that the potential subject has the capacity to consent, along with disclosure of the research purposes and procedures, risks and benefits and alternative procedures available. Participants must be informed that they can withdraw from the research without penalty, and that confidentiality will be maintained. But, how much information should be disclosed?  How should it be communicated?  How does one assure comprehension?  How much does a reasonable person want to know? Investigators are faced with the ethical dilemma of providing enough information to allow a potential research participant to make an informed choice but not providing so much information that the potential subject is overwhelmed or scared away, or that the results are compromised.

Example 1


To develop a curriculum module to educate teens about consequences of substance use and abuse, research staff recruit teens and parents to participate in focus groups. The focus groups are tasked with identifying knowledge content (i.e. what teens need to know). Each study participant is to be paid $20 at the end of each session. After lively discussion at the first focus group sessions, the researchers are surprised that only 20% of parents and 10% of teens return for the second session. When they phone the no-shows, the researchers learn that several participants are concerned that sharing their knowledge about the local drug scene and drug use may suggest that they are too involved for comfort and may get into trouble with authorities. The researchers promise confidentiality, urge continuation in the study and double the incentive to $40. A day prior to the third scheduled focus group meeting, the investigators phone the no-shows again. They make it clear that they have the option of dropping out but repeat that discussions are confidential and that they consider input from people who know the teens drug use and the local community important to the development of a valid educational program on drug use and abuse. How many times should investigators ask subjects to continue in a study? Are the researchers improperly coercing the participants? In this example, can confidentiality be assured?

The Code of Federal Regulations states that Informed Consent should include:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others, which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.