Principle D: Obtaining Informed Consent

Except in minimal-risk research, the investigator establishes a clear and fair agreement with research participants, prior to their participation, that clarifies the obligations and responsibilities of each. The investigator has the obligation to honor all promises and commitments included in that agreement. The investigator informs the participant of all aspects of the research that might reasonably be expected to influence willingness to participate and explains all other aspects of the research about which participants inquire. Failure to make full disclosure prior to obtaining informed consent requires additional safeguards to protect the welfare and dignity of the research participants. Research with children or with participants who have impairments that would limit their understanding and/or communication requires special safeguarding procedures. (APA, 1982, pp. 5-6)

Discussion

There is a downside for persons who volunteer for psychological research. At the very least, it costs them their time. More seriously, they may be asked to endure some form of unpleasantness, such as a physically aversive stimulus (see Principle G); their anonymity could be threatened (see Principle J); or there could be some harmful effect of participation extending beyond the conclusion of the experiment, such as reduced self-esteem resulting from performing poorly on a required task (see Principle I). On the upside, participants may benefit in terms of a positive educational experience (e.g., college students learn how a theory predicted their behavior as subjects), improved well-being (e.g., alcoholics drink less following treatment), and financial compensation. Prior to exposing someone to the experimental protocol, the investigator is obligated to make clear to that person all such anticipated costs and benefits. The investigator must be careful not to omit any detail of the nature of the research that could affect the person's choice to be a participant in the investigation. The greater the cost to the person as participant, the greater should be the explicitness of the agreement.

Sometimes, in order to obtain valid data, it may be necessary to keep participants uninformed about (i.e., conceal) certain aspects of the research. Concealment occurs in research in which participants are covertly observed in public or private situations. In these cases, the investigator has a special obligation to shield the unknowing participants' identity (see Principle J). In another example of concealment, the investigator may keep secret certain aspects of the inquiry so as to minimize demand characteristics, such as participants knowing the research hypothesis and then acting in ways to support it (the "good subject effect:" Kimmel, 1996, p. 70). It is important to realize that concealment presents a serious ethical dilemma: participants may have chosen not to take part in the experiment had they been fully aware of the true nature of the research. In the planning stage of a study intending to use concealment, the investigator has a special obligation to obtain counsel about its ethical implications (see Principle A); he or she should also confer with colleagues about methodological and theoretical issues in hopes of devising an alternative procedure that can produce valid data without compromising the principle of informed consent.

As part of obtaining informed consent, the investigator is obligated to make clear to persons that participation is truly "voluntary," and that they are free to withdraw at any time from the research without negative repercussions (see Principle F). This includes the right to withdraw their data after it has been collected. In addition, the investigator should use language that is understandable to potential participants, and he or she should document the agreement in writing. Once the investigation is under way, the investigator must ensure that any reasonable expectations by participants stemming from the agreement are realized. One implicit expectation is that they will be treated respectfully.

"Special safeguarding procedures" for persons with limited understanding include the legal responsibility of obtaining informed consent from the participant's parent or guardian. In cases where the person "is capable of making some reasonable judgment concerning the nature of the research and of participation in it," he or she should be part of the decision-making process along with the parent or guardian (APA, 1982, p. 34).

Background Information

Violation Example

To solicit participation in her experiment, Sally provides Grade 1 teachers at a local elementary school with informed consent forms to be distributed to the parents. Parents are asked to read the form and to indicate their approval by signing and returning it to Sally via the teachers. Only children whose parents sign the form are eligible to participate. The form explains the rationale for the research, stating that the literature shows that child abduction is a problem in our society, the vast majority of young children are susceptible, and that abductions may be prevented by teaching children to resist enticements. It describes the skills to be taught: upon being enticed by stranger, a child says "No, I have to go ask my teacher" and then quickly runs away towards the school. It tells how some children will see a video designed to teach these behaviors, while other children will see a neutral film, and explains why this 2-group procedure is necessary. It notes that both videos are available for prescreening by the parents from the school library. Finally, the form briefly mentions that the children will be tested on what they learned.

Non-Violation Example

To solicit participation in her experiment, Sally provides Grade 1 teachers at a local elementary school with informed consent forms to be distributed to the parents. Parents are asked to read the form and to indicate their approval by signing and returning it to Sally via the teachers. Only children whose parents sign the form are eligible to participate. The form explains the rationale for the research, stating that the literature shows that child abduction is a major problem in our society, the vast majority of young children are susceptible, and that abductions may be prevented by teaching children to resist enticements. It describes the skills to be taught: upon being enticed by stranger, to say "No, I have to go ask my teacher" and then to quickly run away towards the school. It tells how some children will see a video designed to teach these behaviors, while other children will see a neutral film, and explains why this 2-group procedure is necessary. It notes that both videos are available for prescreening by the parents from the school library. It details how the children will be tested on what they learned:

While the children are silently working on their homework, a new student teacher will remove the children from class, individually, under the pretense of participating in sports. The student teacher will pretend to forget something and leave the child alone in the school yard. A stranger will approach the child, make small talk, and then attempt to lure the child into his car by promising treats. When the stranger walks away (with or without child), the student teacher will call out the child's name and the stranger will move quickly out of sight. The child will then be returned to class. The roles of student teacher and stranger will be played by graduate students of the senior researcher, who is a specialist in child psychology.

The form goes on to inform parents about the likelihood of certain risks associated with this testing procedure (e.g., the child fearing the adult offering the enticement, and coming to fear all strangers in general). It outlines the ways in which the investigator has attempted to minimize natural hazards during testing (e.g., selecting a location away from street traffic). Finally, the form encourages the parents to contact Sally should they have any concerns before making their decision.

Analysis

The first item is problematic because informed consent requires that the investigator not omit any detail of the nature of the research that could affect the person's choice to be a subject in the investigation. The most controversial aspect to Sally's experiment is the Generalization Probe. Thus, the parents should be fully aware about what it entails and its associated risks before giving their consent. This may reduce the number of volunteers, a motivation to keep the details sketchy, but it is the ethically responsible thing to do. Otherwise, some parents could be very upset were they to learn, after the fact, that their child had actually been enticed by a real stranger.

The form in the second item does describe the particulars of the testing procedure so that the parents can make a more fully informed choice. In addition, Sally making herself available for questions about her study is a good practice in that some parents may have initial concerns that she had not anticipated. Should she be able to address their concerns before the experiment begins, she might gain approval that otherwise would have been denied.

In both items, the second one especially, Sally risks giving away too much about her experiment, threatening its internal validity. For example, the parents, given what they know about Generalization Probe from the informed consent form, may prepare their children in various ways for the confrontation with the stranger in the schoolyard. Children's responses during the Generalization Probe could be influenced by what they were told by their parents. Sally has decided to take this risk in order to obtain fully informed consent from the parents. (The informed consent form may instruct parents not to forewarn their children, but there is no guarantee that they will comply.)