Informed Consent

Informed consent is a central ethical principle in collecting data from people. Awareness of the need for informed consent arose from the Nuremburg trials of Nazi scientists, who had used concentration camp prisoners for horrifying medical experiments. The Nuremburg Code, developed after the trials, established subjects' right to give voluntary informed consent prior to participation in research. The Program Evaluation Standards and the Guiding Principles for Evaluators both reinforce evaluators' obligation to obtain informed consent for data collection.

Informed consent is based on the principles of respect and autonomy. Individuals have the right to choose whether to participate in a study and may discontinue their participation at any time. Informed consent means that the person being asked to participate knows what a reasonable person in the same situation would want to know before giving consent. Consent forms typically describe the purposes of the study, what participants will be asked to do, potential risks and benefits to participants and others, and the confidentiality of the information collected; they also inform people of the voluntary nature of their participation and their right to withdraw.

A good informed consent form is clear and understandable, free of jargon, and provides an appropriate level of detail for the respondent. The nature of the interaction between the respondent and the person obtaining consent is important. The form should be provided in a friendly and open, but respectful, [Page 200]manner that encourages the recipient to ask questions or express concerns. Precautions should be taken so that the respondent does not feel intimidated by any perceived higher status of the person giving the form. When data are collected from individuals whose culture or norms differ from those of the evaluator, representatives of that group should be recruited to ensure that the form addresses concerns that those respondents might have regarding privacy, confidentiality, or other issues and uses language and terms that are familiar to the respondents.

Particular care should be taken to help individuals who may feel pressured to participate recognize that their choice is voluntary. In evaluation, these groups are common sources of data and include prisoners, employees, and recipients of services who may feel that their eligibility for services could be threatened by failure to participate. Other groups, such as children, developmentally delayed adults, and persons with mental illness or senility, may be unable to give full informed consent. They may assent to participate, but parents or other guardians must also give full consent.

When data are collected through surveys or telephone interviews, voluntary consent is obtained when the respondent chooses to complete the survey or phone interview. However, evaluators should ensure that the cover letter or instructions contain sufficient information for respondents to be informed and recognize their right of refusal.

Informed consent is often neglected in evaluation. Evaluations take place in public programs where data are often collected routinely, and clients may unknowingly be assigned to different services, later used for evaluation, by service providers. Nevertheless, evaluators should remain sensitive to the principles of informed consent and actively balance its requirements with other ethical obligations.

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