CONCEPTUAL FRAMEWORK
3.2 MEERWEIN MODEL OF THE INFORMING PROCESS
On the other hand, the Meerwein Model of the informing process concentrates only on the aspect of how a prospective trial participant processes the information he or she would have received from the investigator in arriving at a decision on whether to participate in a study or not. Figure 3.2 presents a diagrammatic representation of this model. The modeldefines three main dimensions of the informing process. These include (a) the information itself, (b) the emotional dimension concerned with rapport between the researcher and the participant, and (c) the interactional dimension which is concerned with the capacity and willingness of the
research staff to perceive and discuss emotional needs, concerns and complaints of trial participants and to deal with these (Tomamichel et al., 1995). The Meerwein model has been utilised for this study because it deals with important aspects of the researcher-participant relationship that impact on informed consent, namely, communication of information, negotiation skills and the environment in which the information is conveyed.
Reception of information Comprehension of
information
Utilization of comprehended information in coming up with decision
Decision to participate or to refuse
Provision of information by investigator
Figure 3.2 Meerwein Model of the informing process
Based on the Psychosocial Schema and the Meerwein Model of the process of informing, a conceptual framework has been developed for this study which incorporates aspects from both.
This study has further adopted a framework presented by Bhutta (2004) and modified it so as to present a more detailed conceptualisation of the informed consent process. The conceptual framework adopted for this study takes cognisance of the behavioural steps as outlined in the psychosocial schema and the important dimensions that impact on the decision to participate in a study, as outlined in the Meerwein Model of information processing. Figure 3.3 below shows the conceptual framework that has been adapted for this study. The framework shows that informed consent is a process that includes various steps and key elements of the information to be shared by the researcher with the potential participant in a manner that can be adequately grasped and acted upon (Bhutta, 2004). The various stages and key elements are detailed below.
Information provided:
The quality of theinformation
provided Emotional
dimension:
Rapport between researcherand participant
Interactional dimension:
Willingness of researcher to discuss emotionalneeds, concerns and complaints of trial
INFORMING PROCESS
Fig 3.3 Conceptual framework for the process of obtaining informed consent.
In the first stage, the researcher invites the potential participant to a discussion. Once the potential participant accepts this invitation, the investigator then proceeds to the second stage of informing the participant. This stage is viewed as a process in itself as it is composed of various mini-steps. The informing stage needs adequate time on the part of the potential participant to process the information without duress. The Meerwein Model of information processing assumes importance at this stage as it illustrates the factors that play an important role at this stage of informing the potential participant.
Utilisation of the information in coming up with a decision to participate or to refuse
Factors on Information provided Emotional dimension
Interactional dimension
Provision of information by investigator
Reception of information by prospective participant, asking of questions and answers from investigator Comprehension of the information by prospective participant
Follow up
End of contact Agreement to participate (written verbal, witnessed or
recorded)
Assessment of understanding
The Process of Informing
Invitation of potential participant by researcher to adiscussion
Adapted from Bhutta, 2004: The framework combines Faden and Beauchamp’s pychosocial schema and the Meerwein Model of the informing process.
Other influencing actors: type of study, patient provider relations, trust, past experiences, of research, amount of research in setting etc
As the first mini-step at this stage, the researcher provides sufficient and clear information to the potential participant about the research and the participant’s rights in a way that can be understood by the potential participant. Such information includes the purpose of the study, the procedures involved, the risks and benefits, issues such as maintenance of confidentiality, and other important elements that are emphasised by all the international ethical codes and
regulations. Participants also need to be adequately informed of the purposes of the study procedures as well as the implications of the procedures on themselves as persons. They also need to be clearly informed that this is research and not routine care, and have the differences between research and routine care explained to them as necessary. The information has to be clear, and sufficient (Tomamichel et al., 2000). Where possible, the potential participants may request more time to process the information and even to consult other persons. Such requests need to be granted as a way of showing respect for the potential participant.
In the second mini-step at the informing stage, the potential participant receives the information and is given the opportunity to ask questions and has the questions responded to adequately. In the third mini-step, the potential participant should have reached a state of comprehension. He or she has understood what is being asked of him or her. This state may result from the fact that the information was presented in a way that is simple and yet conveys the essential
information that is essential for the potential participant to research an informed decision. This stage is probably one of the most important as it plays a crucial role in determining whether one comprehends or not. Among other things, comprehension can be assured through several factors including the simplicity of the information, the discussive nature of the conversation as well as a conducive and friendly environment. The environment should be such that the potential participant feels at ease, he or she is satisfied with the discussion, and he or she is not worried after the discussion (emotional dimension). Whether the potential participant
understands or not also depends on the interaction with and the researcher. The potential
participant needs to be satisfied with answers to their questions, they should be able to express their worries, fears, objections and concerns, and feel that these have been addressed
adequately. The potential participant also needs to feel that they have found the discussion helpful (interactive dimension). This stage is influenced by the broader context which is made up of various factors such as type of study, patient provider relations, trust, past experience of research, amount of research in that setting and other factors.
The third stage is crucial in the informed consent process. This stage involves the utilisation of all the information that has been provided by the researcher. This stage is very dependent on the previous stages. Having processed the information received, the potential participant now moves to the next stage, which involves making a decision about whether to participate in a study or not. If the potential participant refuses to participate, then the researcher terminates the contact without use of coercion or undue inducement. The next stage involves the reaching of an agreement between the researcher and the participant. This agreement can be in writing, verbal, witnessed or recorded.
After this agreement, it is crucial for the researcher to assess that the participant has adequately understood that they have agreed to participate in a study and not in a programme that is providing routine care. The researcher can achieve this through various ways including administering a short questionnaire or asking the potential participant to explain in their own words. The researcher also needs to determine whether the participant is aware of the study procedures that are being used in the study, the purpose of those procedures as well as the personal implications of those procedures. If the researcher identifies some areas that need reinforcement, he or she can assist the participant accordingly. The next stage is that of follow- up, which involves reminding the participant that they are participating in a study and that they are free to withdraw at any time. Some of the aspects of the above framework were used to
guide the development of the tools and the pilot intervention and also in the discussion of findings.