In our respectful commitment to the principles of the research consent process, we have given heavy attention to the mechanistic requirements of the process at the expense of using this formal interchange instead as a statement of a personal commitment between an eligible study participant and a study team. Consent to participate in a research study-whether for a therapeutic or a nontherapeutic trial-has formal, regulated aspects to it that convey the serious, businesslike tone of a contractual relationship between the study participant and study team.

Business-like aspects include the required presence of an expert for the trial, who will provide complete and accurate information about the study, and the decision makers (the patient-standard for adult patients and variable for pediatric patients-and significant others), who must weigh the information and help make the decision about patient enrollment. In addition, a witness is present. This person's exact function can vary but may be as circumscribed as attesting to the signatures of the included participants on the consent documents. The regulated attention given to the consent documents (content, readability, understandability) and the careful attention given to the process of reviewing the documents with the eligible patients or participants, the signing and dating of the documents, as well as inserting the time of the signing in the designated locations all add to the formal, serious tone of the consent process. These and other aspects of consent are guided by federal regulations and by the bylaws of local institutional review boards.

This focus on the consent documents includes the provision of information about potential adverse outcomes or risks, benefits of participating in the study, and the rights of the patient as a research participant. Not surprisingly, investigators view this process of information sharing as a contractual discussion and arrangement with one result being an informed study participant. As such, the consent process probably does not meet all of the needs of the research team and most certainly not the most important need of the eligible participant, which is the assurance that the investigator and study team are committed to the best interests of the potential participant. Rather and sadly so, the process may only convey the impression of a legalistic relationship existing between the two. This becomes a missed opportunity to establish an effective, trusting work relationship between the study team and the participant. Nowhere in this approach do we as investigators tell the participants that we will be responsible for protecting them and their best interests. Nowhere do we say that we are personally committed to the participants' welfare. We do not say, "I am responsible to you." Instead we say, "you have these rights." In this legalistic approach, we seem to convey that because we have informed participants of their rights, they are now fully informed and fully responsible for all outcomes.

A different view, that of the consent process being a personal commitment, represents a philosophical shift, and if we assume this view, we might manage consent differently. Certainly we would still have the expert (study team member) present-but with more attention given to the expert's role in communicating the meaning of the treatment or research, the anticipated impact on the life of the patient and family, and the role of the expert with protecting the best interests of the participant and with monitoring the clinical trial. A witness would also be present but with a role commitment that included following up with the patient and family to ensure their understanding of the consent content and to invite further discussion of concerns, worries, doubts, or feelings that emerged during the process. Commitment to the patient's welfare would go beyond the current focus on rights of a study participant. When reasonable in light of the clinical situation, the participant's invited significant others would be present so that trusted advocates for the participant can hear firsthand about the research and address their concerns related to the participant's welfare based on their knowledge of the participant's preferences, goals, and values. This more personalized approach could ease potential angst about research participation. Each patient advocate present would be able to ask questions directly or in other ways help make the consent process more transparent when the patient or significant other may not be able to do so. Doing this helps an investigator achieve a personal commitment to the participant, which is, that there will be no surprises once participation in the study begins because all has been revealed and shared. In addition, these advocates may be very helpful in recalling key aspects of the consent discussion that the patient and significant other find difficult to recall with accuracy.

We as clinical and basic investigators are well schooled in the merits of being an objective researcher. A formal consent process that gives its emphasis to a contractual arrangement helps to maintain that kind of role objectivity, but our role objectivity may not best serve patients, their family members, or the study team members and the resulting science. Tailoring the information to best suit the learning style of participants and their significant others is one way of personalizing this important interaction between them and a study team. Stating our sense of responsibility for the participant's study experience may facilitate a trusting and forthcoming level of participation. Addressing during consent both the objective and the personal aspects of engaging in a clinical trial establishes commitments to the patient and the patient's family without weakening our commitment to credible science. Doing this accords the recognition of consent as a personal commitment-the beginning of a trust relationship between the patient and the study team. Consent need not be limited to a contractual legalistic arrangement but instead be a fully executed human commitment with outcomes for which we as investigators assume responsibility.

My best to you always.

Pamela S. Hinds, PhD, RN, FAAN

Editor in Chief, Cancer Nursing^(TM)