Appendix 4. Ethical concerns and accommodations
The Research and Ethics Committee of the Montreal General Hospital requested an external review of our proposal. The review and other issues, such as confidentiality and the specific wording of the Informed Consent Form, were discussed by the Research and Ethics Committee during one of their monthly meetings. The Needs Assessment proposal was reviewed and approved by the Committee on March 14th 2001. We have outlined below some of the key concerns raised by the external reviewer, William Ninacs, and the Research and Ethics Committee regarding the data collection. We explain briefly how the researchers accommodated the concerns and what actually happened during the collection process.
CONCERN: How research will be presented to patients when approached by staff
We asked nurses to phrase their request as follows: "Would you like to participate in a study to improve patient education? You will meet a researcher who will talk to you and take notes for about 30 minutes." This was acceptable.
CONCERN: Patients will feel negatively labelled
This was not a problem because of the way the research was presented by the nurses on the floor. Patients did not know that they were being interviewed because they were considered hard-to-reach. They were generally very happy to participate and to talk to us. Many needed to tell their story. Some interviews lasted up to an hour or even 90 minutes! Even though we did not ask them questions about their illness, some wanted to talk about it and to debrief what they were going through. Four patients, all from Dialysis, did not agree to the interview, three of them because they were tired or did not feel well. For the focus groups, we tried to make the atmosphere as informal and friendly as possible and did our best to accommodate the needs of those with physical disabilities.
CONCERN: Patients will not understand the questions asked
We tried to ask questions clearly, simply and to use plain language. Overall, the large majority of patients understood the questions and answered what they thought. In some cases, the language barriers or the cognitive difficulties did prevent patients from understanding questions, but this was rare. Some family members were not very good at translating the questions and the answers. One patient had such serious cognitive and speech difficulties that the questionnaire was only half-filled. Sometimes we faced interruptions but could pursue the interview later, e.g. a patient would feel ill (ex. coughing, feeling nauseous) or be overcome by sadness in the middle of the interview.
CONCERN: Patients will think researcher is a health care provider and confide health information
This was not a problem. We explained clearly at the beginning that we were not nurses, and that we would ask patients for their verbal consent to share information with their health care provider if they confided important health-related information. This was also included in the Informed Consent.
CONCERN: Patients will only answer questions, but will not be "actively engaged"
This was not the case. They did answer questions, but we also asked them to tell us what we could do better. We encouraged them to find solutions and to offer suggestions on how to improve patient education, how to improve written information, what to offer in the Health Education Centre, etc. They were actively involved in finding solutions during the focus groups. Patients did have a voice, an opportunity to talk and express their needs.
CONCERN: Methodology must be culturally-sensitive
Everything was done in English or French as needed. We were careful to proceed slowly and simply with patients who spoke another first language (with or without an interpreter).Though not part of the research plan, both researchers could do interviews in Spanish, which was appreciated. For other languages and cultures, we showed a lot of interest in the countries of origin and the different cultures. The interview with the Cree interpreter gave us insight into the language and cultural barriers faced by Cree patients.
CONCERN: Patients will face difficult power relationships in mixed focus groups
We decided not to hold mixed focus groups for this reason.
CONCERN: The extra work placed on staff will be a burden because of a shortage of human resources
In the units, we were discreet while getting the work done. A few times, we left when we were told that "this was not a good day." It was a challenge not to disturb the nurses since we needed their help in identifying hard-to-reach patients and asking for their participation. When we filled out questionnaires with nurses, we were careful to come at the most appropriate time of the day. The fact that all Pre-op nurses answered the individual questionnaires and that we had such a high level of participation of nurses in the Dialysis and Oncology Hematology focus groups reflects a high-level of collaboration. Overall, we established very positive relationships with the head nurses. The data collection process raised a high level of interest in the issue of hard-to-reach patients. It was not a problem to meet the staff at the CLSCs.
|