Doctors maintain a special position with their patients. Unlike most professions, a doctor’s opinion can affect life or death decisions; thus a doctor is often viewed at a different level of authority. In an effort to find solutions to their patients’ problems, doctors often take on the researcher role. As a result, it is important to clearly separate the line between standard care and procedures conducted for research. If a doctor asks a patient to participate in a research study, even if it is clearly explained that the procedures in the study are experimental and may not offer any personal benefit, a patient may still perceive that the doctor is recommending participating in the study as part of their care. This section covers some of the common concerns that occur when a doctor wants to include a patient or client in a research study and some suggestions as to how conflicts can be avoided.
Please note: The IRB-SBS generally does not review studies that involve most medical doctors and patients except where the research method is clearly in the social and behavioral sciences (for example, an anonymous survey that isn't connect to private health information). Most of these studies are reviewed by the IRB-HSR. To determine which IRB should review your study, please see Choosing the Right IRB: SBS vs. HSR. If you have further questions, please contact our office before submitting a protocol; the submission process is different for both IRBs and submissions are non-transferable.
For doctor/patient studies, often the “who”, “where”, and “when” of the recruitment and consent process can make as big of an impact as the “what” that is presented. For example, during their session, a psychologist approaches her client about a bipolar study after she just informed the patient that he has the mental illness. The emotion of the moment combined with the setting and the messenger could confuse the participant about what is research and what is therapy. While it may not be inappropriate for the client to participate in the study, the way in which the client was informed about the study does not give the client the opportunity to make a completely voluntary decision.
In order to create a more voluntary environment, consider the following:
- “Who:” Remove the doctor from the recruitment and consent procedure. Instead, use someone who does not have an established relationship with the participant, such as a research assistant, or even a third party to recruit and obtain consent from the participants.
- “Where:” Contact participants in a location and manner where they will not confuse the message as part of a treatment recommendation. For example, a phone call or letter for the initial recruitment may help patients to better understand that they are participating in a study. For some studies, there may be justification for contacting participants in the doctor’s office and not at home (i.e. patient is abused or does not want to disclose a medical condition). Consider talking to the patient in a private office or lobby instead of an exam room.
- “When:” If a patient is dealing with a life-changing diagnosis or other challenges regarding their care, be sensitive to the timing in which you approach them about the study. Allow the patient the opportunity to consider the study in a rational manner and to have time to consult with family or friends.
For more information about working with participants who are dealing with a stressful health condition, please see Stressful Health Condition.
For many studies involving patients, medical records can be a valuable source of information. However, please note that although you may have access to medical records as a doctor, you do not have access to medical records as a researcher unless a participant grants you that access. HIPAA (Health Insurance Portability and Accountability Act) was drafted in order to protect individuals’ private health information including information recorded in medical records. HIPAA specifies certain requirements for obtaining access to medical records and how this information should be handled in order to protect privacy. The IRB is required to assure that proper authorization is given by the patient to use their private health information. The IRB can also partially or completely waive the requirement for authorization if various conditions are met as outlined in the Privacy Rule. Generally authorization can be included in a consent form, but in some cases requires additional documentation.
The IRB-SBS does not review studies where HIPPA regulations apply. These studies are reviewed by the IRB-HSR. To determine which IRB should review your study, please see Choosing the Right IRB: SBS vs. HSR.