Elements of Voluntary Informed Consent

Federal law requires that consent statements contain the following:

1. An explanation of the purpose of the research, the expected duration of the subject's participation, and a description of the procedure. There is no need to describe the details of the design, especially if this will affect the subject's responses in ways that jeopardize the validity of the research. It is necessary only to describe what the subject will experience in terms the subject understands. Jargon, legalistic terminology, and explanations that are irrelevant to deciding whether to participate should be avoided.

2. A description of any foreseeable risks or discomforts.

3. A description of any benefits reasonably to be expected.

4. A description of the alternatives to participation, where appropriate.

5. A description of how confidentiality or anonymity will be maintained.

6. A statement of whether compensation for harm is available.

7. Indication of whom to contact for answers to questions about the research subject's rights, or in case of a research-related injury. These persons should include both the investigator and an appropriate administrator of the institution.

8. Indication that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled, and that the subject may discontinue participation at any time.

Common sense dictates that other elements be included as well: 
9. If the research is sponsored (and especially if it is sponsored by an organization that not everyone approves of), the investigator should disclose the identity of the sponsor.

10. Where appropriate, the researcher should be identified personally. In some cases this might be a rather self-disclosing statement. For example, "I am a graduate student at Foster University, and as you probably know, I'm one of your fellow members of Alcoholics Anonymous. Because of my relationship with AA, it is a goal of mine to understand the processes that make it successful. I am doing my master's thesis on the relationship between some aspects of how people feel about themselves and how they have experienced the various parts of the AA program."

Finally, good communication and good sense require that openness and honesty also characterize the ongoing relationship with subjects, gatekeepers, and others in the research setting. In field settings (e.g., work places, schools, hospitals), such communication may occur not only with subjects but also with other key individuals within the setting--such as union representatives, managers, and parents--and others who are part of the setting but not subjects. The researcher should be open to discussion of problems that the research raises for the various interests represented within a particular setting. Any communication with the press about the research should be cleared through the gatekeepers of the organization. Sensitivity and willingness to accommodate these interests, however inconvenient for the researcher, will certainly pay off in the long run. Insensitivity to such concerns has often resulted in a researcher being asked to leave the field setting part way through the project.

Effective Consent Statements

While consent statements should explain the research to be undertaken and should fulfill legal requirements, they should also be simple and friendly in tone. Not surprisingly, some consent statements are written in scientific jargon, telling the subject more about the design than the subject cares to know, yet failing to mention things that a person would need to know in order to decide whether to participate. Others are written in harsh, legal-sounding language. An effective consent statement should translate a scientific proposal into simple, everyday language, omitting details that are unimportant to the subjects.

The following example illustrates how one may translate a technical description of a research design into an adequate consent statement. In this example, a researcher has been given permission to study taste perception at a Veterans Administration Hospital, and has designed the following study of taste perception. Here is the project, as described in scientific language that would be inappropriate for a consent letter:

Eating disorders (e.g., cravings and aversions) have been observed among psychiatric patients receiving lithium treatment. A research psychologist at a Veterans Administration hospital proposes that acuity for detecting and recognizing the four basic tastes (sweet, sour, salty, and bitter) be measured and that preferences be determined among patients undergoing lithium therapy and a group of matched controls. The research will test the hypothesis that lithium-medicated subjects have altered taste perception thresholds and taste preferences. The substances to be tasted will consist of pure water, and small concentrations of the following substances diluted in water: sucrose (sweet), salt, citric acid (sour), and quinine sulfate (bitter). These substances are normally used as food additives at higher levels of concentration. Three small samples will be presented simultaneously, two identical and one different, with position varied so that odd and identical samples are tried equally often. Paired comparisons and an hedonic rating scale will be used to measure taste preference. Data acquired through taste testing will be analyzed in relation to age, sex, smoking history, duration of lithium administration, and current lithium concentration. Five sections per subject, each 10 to 15 minutes long, are required. Three threshold tests for each of the four taste substances will be conducted on separate days. On the fifth day, preference testing will be conducted.

How can this be translated into a friendly letter that contains all of the required elements of consent, is easy to understand, friendly, and contains no unnecessary detail or jargon? Remember, the consent letter need not describe the study as it would be described to a scientist; rather, it should describe generally why the study is being done and what the subject will experience. An appropriate letter probably should devote no more than two sentences to each of the following points of information:

1. Identification of the researcher. 
2. Explanation of the purpose of the study. 
3. Request for participation. 
4. Explanation of research method. 
5. Duration of research participation. 
6. Description of expected benefits. 
7. Mention of the subject's right of refusal without penalty. 
8. Mention of freedom to withdraw own data. 
9. Explanation of any risks. 
10. Discussion of compensation for harm. 
11. Description of any feedback and benefits to subjects. 
12. Information on how to contact the researcher and a research administrator. 
13. Indication that subjects may keep a copy of the consent.

The following would be an appropriate consent letter. Note the simplicity, friendliness and lack of jargon:

(Letterhead of the Researcher's Institution)

Dear Patient,

I am a psychologist who specializes in the study of taste perception. I am currently working with the staff of your department, under a grant from the Veterans Administration, to see if we can learn ways to enhance your enjoyment of the food served to you here. We need your help in a new study of how sensitive people are to different tastes and which tastes they prefer. The results of this study may help doctors and dietitians, here and at other hospitals, plan diets to improve health, and may add to the understanding of taste perception.

In this study, we will find out how readily persons detect and identify sweet, sour, salty, and bitter tastes, and what tastes are preferred. This information will be analyzed in relation to some information from patients' medical records. Persons participating in this study can expect to spend twenty minutes on each of five different days. Participants will be asked to taste plain water and samples of water mixed with small amounts of some safe substances that normally are used to season food; they will be asked to answer some questions about how the samples taste and which ones they prefer. There is no foreseeable risk or discomfort. Participants' identity and personal information will remain confidential. After the study, all participants will be invited to a presentation on how taste perception works.

Your participation in this study is strictly voluntary. You may withdraw your participation at any time. Your decision as to whether to participate or not will have no effect on any benefits you now receive or may wish to receive in the future from any agency. For answers to questions pertaining to the research, research participants' rights, or in the event of a research-related injury, you may contact me directly at 555-1212, Dr. John Smith, Director of Research, at 555-1313, or Dr. Mary Doe, Hospital Director, at 555-1414.

Sincerely yours,

Mary Smith
Research Psychologist

Please indicate your consent to participate by signing one copy of this letter and returning it to me. The other copy is for you to keep.

I have read this letter and consent to participate.

Signature: _________________________________ Date: _____

It is important to note that this letter not only fulfills the legal requirements for a consent statement, but it is also clear, friendly, and respectful of the recipient. Irrespective of whether the researcher is a Nobel Prize winning scientist or a senior in college, the consent letter should treat the potential subject as an equal. Fanfare about the importance of the project is inappropriate. The letter should make an accurate, but brief, statement about the likely scientific importance of the research. Information about the scientific legitimacy of the project is conveyed through the name of the research institution on the letterhead and mention of the researcher's official capacity below the signature (e.g., student, Professor of Sociology, Director). It is my personal opinion that the use of professional titles and degrees after one's name (e.g., Ph.D.) is unnecessary self-approbation. In any case, the letter should convey respect and an honest desire to communicate the information that the reader needs to know in order to make an informed decision about whether to participate.

Consent: Signed, Oral or Behavioral?

Signed consent proves that consent was obtained; in the case of some risky research, it may even be desirable to have a witness sign also.

Most IRBs require signed consent, except in the following situations:

1. When signed consent is intrusive or inconvenient and subjects can behaviorally refuse (e.g., by hanging up on a phone interviewer or by throwing out the survey that was received in the mail). In some cases, a letter or statement providing the information required for informed consent may be sufficient. For example, when phone surveys are conducted using random digit dialing, the researcher does not know the name or address of the subject, thus assuring anonymity; the subject, upon learning about the survey from a brief verbal description, can very easily say no, or simply hang up. The process of getting signed consent may be unduly cumbersome for both parties, and if the research is on a sensitive or private topic, getting signed consent may constitute a greater invasion of privacy than the survey itself. Similarly, while a survey mailed to respondents should include a cover letter that contains all of the information required for informed consent, it is generally deemed unnecessary for the subject actually to sign and return a consent form. Returning the survey is the subject's way of consenting. Throwing it away is the subject's way of refusing.

2. When signed consent would jeopardize the well-being of subjects. For example, if the research is on criminal behavior, being recruited and agreeing to participate is evidence of one's illegal activity. When the research focuses on illegal or highly stigmatized aspects of the persons being studied, it is not in the subject's best interest for the researcher to provide a paper trail that reveals the identity of the subjects. Such information could be subpoenaed by a local law enforcement authority, or stolen by potential trouble makers, placing subjects at serious risk. Examples of research in which subject lists might be subpoenaed include studies of drug users or drug dealers, prostitutes, pornography producers, white collar criminals, illegal aliens, and so on. Sometimes, certain information about persons, were it become known, could also lead to personal, social, or economic discrimination, blackmail, or simply to embarrassment and worry. Having AIDS, being gay, having had an abortion, having been exposed to high levels of radiation, all such characterizations are potentially stigmatizing to individuals. Consequently, in research on populations which are vulnerable to stigmatizing effects, a signed consent form may well pose more danger than protection to the subjects who participate.

Consent as an Ongoing Process

The researcher should regard the relationship with subjects as an open communication process, and willingly answer questions from subjects and gatekeepers at any time. Especially in field research where the researcher returns to the site on many occasions, it is easy for the researcher's welcome to wear thin. In organizational settings, the researcher should provide employees, administrators and all other interested parties with a written statement (in layman's language) about the topic of the research, with updates now and then, reporting on the current phase of the work. The research team might also invite members of the organization to drop in at break time for a snack and discussion, questions, or complaints. The advantage of such openness and cordiality are enormous. Even the most sensitive research team gets in the way sometimes, and causes unexpected inconvenience to ongoing operations. If people become irritated, but have no avenue for complaining, tensions may grow until they reach a breaking point, and the research is halted. In contrast, openness to any observations and complaints means that problems can be solved before they become serious.

by Joan Sieber, Department of Psychology, CSUEB

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