Ethical Conduct in the Research Process
It is important to note that the ethical conduct of an intervention research study does not end with the informed consent, but must continue throughout the duration of the study no matter the stage of the pipeline. This means that the protection of the rights, interests, and safety of research participants, regardless of phase along the pipeline, must be considered during the recruitment process, data collection activities, handling of AEs, data storage activities, and data analysis and reporting. Most applications for federal, state, or foundation funding agencies require a dedicated section of a proposal that details the treatment of human subjects as part of the application process. This section of the application is also carefully evaluated within the NIH peer review process. Any infractions will require that the investigator address the issues raised prior for the proposal to be considered for funding.
There are several key reasons why it is important to adhere to ethical protocols in behavioral intervention research. Foremost, of course, is ensuring the protection of the rights, safety, and interests of research participants and the promotion of values such as social responsibility. Other reasons include the promotion of the general aims of research such as knowledge and truth and the avoidance of error; the promotion of values essential to collaborative work such as trust, accountability, and fairness; and the assurance that researchers are accountable to the public, which helps to build public support for research and adherence to regulations and guidelines (Resnik, 2011).
The ethical conduct of behavioral intervention research also encompasses honesty in scientific reporting; striving for objectivity; disclosure of personal or financial interests that may have an impact on a research project; respect for intellectual property such as patents and copyrights; protection of confidential information; responsible publication of research findings; and social responsibility and responsible mentoring (Shamoo & Resnik, 2009). In this regard, the U.S. government defines “fabrication, falsification, or plagiarism” as “misconduct.” It is important to note that misconduct occurs only when a researcher intended to deceive or engage in what is considered to be unethical practice. Other examples of what is generally considered as misconduct within the scientific community include publishing the same paper in, or submitting the same paper to, two different journals without telling the editors; discussing confidential data with colleagues from a paper or grant that one is reviewing for a journal; trimming outliers from a data set without documenting the reasons in a publication; making significant deviations from the research protocol approved by the IRB; or failing to report an AE to the IRB (see Resnik, 2011 for a more complete list).
As noted by Resnik (2011), although codes, policies, and principles exist for the ethical conduct of research, they may not specifically cover every situation that arises. Thus, it is important to learn how to interpret and assess various situations. When in doubt, always consult the appropriate institutional office for assistance in resolving ethical issues. It is also useful to consult a trusted colleague or a more senior researcher who may have experience with the issue at hand.
Ethical Responsibilities of the Principal Investigator
A final comment relates to the responsibilities of a study’s principal investigator (PI). Ultimately, the PI of an intervention study is responsible for assuring compliance with an institution’s IRB policies, federal policies and regulations, oversight of the research, and the informed consent process. Although a PI may delegate tasks to other members of the research team, it is important to remember that the PI has the ultimate responsibility for the conduct of a study and is in charge of, and accountable for, all activities within a research project. Thus, a PI must be closely involved in the trial and directly interact with the research team. As we discuss in Chapter 22, the PI should have regular meetings with the research team to keep abreast of what is occurring within a trial and to discuss any issues or problems that arise.