|NIH Guidance on Informed Consent
For Gene Transfer Research
Conflicts of Interest
NIH GUIDELINES: "Which members of the research group and/or institution will be responsible for contacting potential participants and for describing the study to them? What procedures will be used to avoid possible conflicts of interest if the investigator is also providing medical care to potential subjects?"
Non-financial Conflicts of Interest: All researchers can be viewed as having non-financial conflicts of interest because they benefit from publications and grants, which are generally facilitated by positive research results. The resulting pressure to complete a study and publish impressive results could compromise the integrity of the research and the rights and safety of participants in various ways. Investigators need to be aware of the pervasive and subtle nature of such conflicts.
If an investigator is also the personal health provider of the potential research participant, there may be an additional conflict of interest. A physician's duty is to honor the best interests of the patient. An investigator must do what is best for the study. These two objectives are not always consonant. Further, potential participants may be reluctant to question the advice of a health provider on whom they depend for care.
Many participants in gene transfer research first learn of the study from an investigator as part of a therapeutic encounter. Therapeutic relationships may develop before, during or after the study. Such relationships may influence both participants' and researchers' understanding of the goals of the study. Researchers should address this nonfinancial conflict of interest both before and during the conduct of a trial in order to ensure that differences between research and treatment are understood.
Financial Conflicts of Interest: Investigators may have equity, patent and other commercial interests in the products they research and develop, thus creating a financial conflict of interest that could influence their communication with potential research participants and the conduct of the study.
Potential participants should be told who is sponsoring the research study, whether the investigators are receiving compensation from the sponsor to conduct the research, and whether there are any potential conflicts of interest. Investigators should be required to disclose possible financial conflicts of interest to their institutions and to potential participants. Investigators should consult their institutions' IRB to determine how much information should be provided regarding the existence, nature, and management of those conflicts. Institutions should have procedures in place to mitigate the influence that such conflicts have on the study and consent process.
Financial conflicts of interests can be addressed and managed by various means, such as divestiture and wider disclosure (e.g., to scholarly journals). Some professional organizations have made specific recommendations about managing and disclosing possible financial interests. These statements may prove helpful to investigators and institutional review boards. The National Institutes of Health (NIH) has issued guidance clarifying its regulations regarding possible financial conflicts of interest that apply to all NIH-funded research.
To address concerns about both financial and non-financial conflicts of interest, it may be useful to have a person who is not the health provider discuss the research study with the potential participant. A decision-monitoring plan may also be considered. Potential participants should always be told that they are free to participate in the study or not, and that a decision about study participation will not affect their clinical care.
Sample 1 - Non-financial Conflict of Interest
Your physician is a researcher in this study. As a researcher in this study, he/she is interested not only in your health and well being, but also in the results of this study. It is possible that sometimes these two goals may conflict with one another. Researchers protect the rights and interests of participants by carefully following the rules of the study.
You do not have to be in any research study offered to you by your health provider. When you are deciding if you should join the study, you may want to talk with someone not part of the study about your questions and feelings about joining. This could be s a family member, friend, or another health provider.
Sample 2 - Financial Conflict of Interest (adapt for specific circumstances)
The investigator of this study, [name], is an officer in the company that makes the gene transfer agent you will get if you join the study. The investigator also holds stock and options in the company. This means the investigator may make more money if the study shows that the gene transfer agent is helpful. Although the investigator is not supposed to let his/her financial interests affect the study, this may not be always possible.
Sample 3 - Financial Conflict of Interest Disclaimer
This research is sponsored by [name of sponsoring company, agency, or group]. This means that [name of sponsoring company, agency, or group] is paying the research team for the costs of doing the study. The researchers do not have a financial stake in the results of the study.