Elements of Voluntary Informed Consent

Federal law (Post-2018 Common Rule 46.116) requires that consent statements contain the following:

"(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 that 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 that 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; and

(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

(i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies."

Other elements to be included as well:

The identity of any entity sponsoring the research.

The researchers and their affiliations.

"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. "(by Joan Sieber, Department of Psychology, CSUEB)

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:

Identification of the researcher.
Explanation of the purpose of the study.
Request for participation.
Explanation of research method.
Duration of research participation.
Description of expected benefits.
Mention of the subject's right of refusal without penalty.
Mention of freedom to withdraw own data.
Explanation of any risks.
Discussion of compensation for harm.
Description of any feedback and benefits to subjects.
Information on how to contact the researcher and a research administrator.
Indication that subjects may keep a copy of the consent.

by Joan Sieber, Department of Psychology, CSUEB

Consent Letter

"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:

When signed consent is intrusive or would adversely impact the participant or study. 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.
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