Dealing with a stressful health condition can be disruptive on multiple levels not only for the patient but for the care giver(s) as well. Financial strain and emotional strain, compounded with dedicating extra time to therapists and doctors can make life more challenging for patients and their families. Thus it is important to make sure that if research study will study a population with a stressful health condition or include individuals in the study, the study needs to minimize the impact it has on the patient and not cause undue burden.
Though a patient may be dealing with additional challenges, often they are willing and interested in participating in studies in order to further support efforts to find answers. Thus it is important that the relationship between the researcher and the patient participant isn’t abused. Consider the following potential risks that may occur when working with a patient population. Please note that these are general risks; it is important that you are well informed of the specific nuances that define the needs of the population you will study and these needs are communicated to the Board in the protocol form.
Coercion and/or Perceived Coercion
For a patient dealing with a stressful health condition, his or her doctor, clinician, therapist, etc, plays a vital role in the care of the patient and the patient often will make decisions based on advice given by the medical professional. For that reason, it is important that the patient understands the difference between research and therapy. For more information, please see Doctor/ Patient Relationships in a Research Study.
Misunderstanding Benefits
This concept relates to the first bullet point. Patients will often mistake the opportunity to participate in a research study as an opportunity to receive the cure. The patient needs to have a clear understanding that they are participating in research, that there are risks, and there is a possibility that the intervention will have no benefit.
Wasting Time and Resources
As mentioned in the introduction, patients may be dealing with additional strain because of their condition. When you consider your data collection methods, think about the patient and their ability to complete the tasks. Will they have the health and energy? Do they have time? Will participating incur extra costs (i.e. travel, lodging, meals)? Make sure that this information is clearly explained in the consent form so that the participant can make an informed decision about participating. Part of the Board’s consideration about wasting the participant’s time will relate to the researcher’s ability to glean meaningful data from the participants, predicate to the researcher’s level of experience. If you are a new researcher and the study is training research, the Board may ask that you limit your interventions.
Missing Other Therapy Opportunities
If your study involves testing a new therapy, you may require that your participants stop any other therapies in order to test your therapy accurately. This may put the patient at a disadvantage, particularly if the patient is a young child. Please consider ways to minimize any delays and clearly disclosed this information in the consent form.
Lack of Awareness and Sensitivity
The Board expects that if you are studying participants with stressful health conditions, you will be well-informed about their condition. Not only will you be able to approach the participants with greater sensitivity, you will be better at anticipating potential risks and adverse events.