Consent Should Be Emphasized, Rather

¶ … consent should be emphasized, rather than the forms and documentation relating to them. This means that competent human participants should be taken through a process that ensures their informed consent prior to signing forms that indicate such consent. A further recommendation in this section is that professionals should be guided on how to ensure that sufficient disclosure is provided for informed consent. It is for example highly important that participants fully understand the type of experimentation and risks involved before engaging in the research process. It is also important that participants remain informed throughout the research and that their consent remain informed, should more than one stage be involved.

In rehabilitation research, patients involved fall into the category of vulnerable participants, as they are generally institutionalized, at least for a time. It is therefore very important that they be aware particularly of any risks associated with the research conducted. The highly emotional nature of the rehabilitation process may for example result in consent before fully understanding the risk factors. The researcher should then engage in active listening and questioning procedures in order to ensure that the risks are fully understood and agreed to. It may also help to have a research team in such cases, rather than only one or two researchers. The team can then provide input regarding the decision to include the participant.

An example of a case where current policies do not adequately cover the risk factors is Maggie, a young mother and alcoholic who came to the rehabilitation center for assistance. She was in danger of losing not only her job and her home to her habit, but also her family. During her conversations with the counselor, Maggie was very emotional, confessing that she missed her daughters terribly. It was deemed unwise for her to see her young children at this early stage. The girls may be frightened to see their mother in such a state, and Maggie may lose hope in the face of further time apart from them, thus defeating the purpose of her rehabilitation.

This was unknown to a researcher who wanted to test a new rehabilitation drug specifically on long-term alcoholics. As a reward for her participation, he offered Maggie some time away from the center. Maggie of course jumped at the chance without further considering the risk factors to either her physical or emotional health. The counselor working with Maggie should have joined the informed consent process, and would have been able to help her make a better decision.

Recommendation 5.4 states that mechanisms should be in place to protect the privacy and confidentiality of patient records. Confidentiality is of utmost concern, especially for vulnerable patients.

In the rehabilitation profession, the history of drug and alcohol use is of utmost sensitivity and privacy to both in- and outpatients. Those visiting the facility trust its professionals with their deepest secrets, some of which they are utterly ashamed of. It is therefore highly important to maintain confidentiality also when research subjects are approached for participation in tests. This correlates with the informed consent issue.