Informed consent and harm prevention in APA psychological research ethics

Professional Ethics, State Laws, And Board of Psychology Rules Governing Psychological Research

Boundaries of comfort and discomfort

The American Psychologists Association (2010)

ethical code states that psychologists should make reasonable efforts to minimize any discomfort, pain, illness or infection to human subjects where the harm is "foreseeable and unavoidable" (p. 6). They do this by making sure that any research that involves harm to human subjects is preceded by research on animal subjects so that the anticipated results of the study will justify the performance of the experiment on human subjects. Furthermore all studies should not involve unnecessary physical or mental suffering or exposure to harm. The experiment should not be conducted if there is reason to believe it may lead to death or disability injury to the subjects Mitscherlich & Mielke, 1949, pp. 46-47()

Studies that introduce pain or discomfort to the human subjects can only be conducted under two conditions. The first is where the anticipated benefit to the subject outweighs these risks and secondly is where interests, other than those of the subject, are sufficient to justify the risks involved in the study. However, in both instances, the rights of the subjects need to be protected Fulford & Howse, 1993, p. 89.

This information should be disclosed to the subjects to allow each of them to give informed consent to participate in the research study American Psychologists Association, 2010, p. 6(; the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978, p. 6)

This is in line with principle a of the APA code of ethics, the principle of beneficence and non-maleficence which states that psychologists should strive to create benefits for those with whom the researchers work with and they should take care not to do any harm American Psychologists Association, 2010, p. 3.

If the research is expected to cause any kind of pain or discomfort to the human subjects, the psychologists should not use deception American Psychologists Association, 2010, p. 11()

The line between the boundaries of comfort and discomfort for research participants is drawn where unforeseen harm occurs in the research participants or if the study is expected to cause death or disability of the participants Pickworth, 2000, p. 331.

Where the research participants do not provide informed consent, the line is drawn since informed consent is required to conduct any study that may cause harm to the human subjects Singh, 1998, p. 63()

Elements of informed consent

In order to obtain informed consent from research participants, they should be provided with information regarding the research study using a language that is, according to the American Psychologists Association (2010)

, "reasonably understandable," (p. 6) by the subjects. The research participants should be given information regarding the purpose of the study being conducted, its expected duration and study procedures. The participants should also be made aware of their right to decline to participate in the study or to withdraw from the study once they have begun to participate. If there are any foreseeable consequences for declining or withdrawing from the study, they should also be mentioned to the study participants. The research participants should also be told all reasonably foreseeable factors which may influence their unwillingness to participate in the study such as potential risks, discomfort or any adverse effects. Any prospective benefits of the study as well as the limits of confidentiality should be made known to the research participants as well as who they should contact in case they have any questions about the research or their rights as participants to the study. If there are any incentives for the participants to participate in the study, they should also be made known to the participants. The researchers should also allow the participants to ask any questions in order to get clarification on issues regarding the study (p. 10).

In studies that use experimental treatments, the participants should be made aware of the experimental nature of the treatment, the presence of a control group, services that will or will not be available to the control group, how subjects will be assigned to the treatment or control groups, available treatment alternatives if the individual does not wish to participate or withdraws once the study has begun, and any compensation for participating in the study including any reimbursement to the participant (p. 10). This is similar to what is stated by the U.S. Department of Health & Human Services (2012)

that informed consent is the "critical communication link between the prospective human subject and an investigator," (para 4).

All research participants need to be of sound mind and legal age in order to give informed consent. For participants who are legally incapable of giving informed consent, researchers may provide an appropriate explanation, seek the assent of the individual, or get consent from a legally authorized person while keeping in mind the person's preferences and best interests American Psychologists Association, 2010, p. 6()

except where the law does not permit this which would then require the researcher to take reasonable steps in the protection of the rights and welfare of the individual.

This is in accordance with the Nuremberg code which states that individuals need to give voluntary consent for any research study. All persons who have the legal capacity to give consent should be given the right to exercise their free power of choice without using any elements such as force, duress, fraud, deceit, overreaching or other forms of coercion or constraint. They should be provided with sufficient knowledge and comprehension of the elements of the study which enable the subjects make an "understanding and enlightened decision," (para 2).

Saybrook IRB policies and procedures

The Saybrook institutional review board (IRB) policies and procedures require the researcher to seek approval from the research supervisor and the Saybrook IRB in order to conduct their research study. The researcher needs to be involved in the Saybrook IRB review and approval process by completing the Saybrook IRB application, seeking approval for the research study from the supervisor, sending the approved application to the Saybrook IRB, ensuring the research supervisor notifies the Saybrook IRB that they have reviewed and approved the research study, and then lastly responding to feedback received from the Saybrook IRB Saybrook Institutional Review Board, 2012, p. 7()

In completing the Saybrook IRB application form, the researcher need to specify which category the study falls in. First is the exempt category where the study has little to no contact with human subjects and has low to no levels of risk. The second category is the expedited category where there is minimal to moderate human contact and low to moderate levels of risk. The last category is the full category where there is moderate to maximum human contact with moderate to high levels of risk. The Saybrook IRB policy specifies how each of these categories is reviewed Saybrook Institutional Review Board, 2012, pp. 7-9()

The Saybrook IRB procedure begins with sending a copy of the application to the chairman electronically in order to determine the appropriate level of review of the application then the review commences. The third step is conducting the review then categorization of the outcome as accept, conditional, pend or deny. The principal research and research supervisor are then notified of the outcome of the review and notified of approval Saybrook Institutional Review Board, 2012, pp. 11-12()