Here is an overview of the concerns associated with research and human subjects. We hope to stimulate your thinking about this important topic. Think about this: The Enron, WorldCom, ImClone, and Adelphia companies sent shock waves throughout our economic fabric. Whether the corporate scandals were individually orchestrated or institutionally ignored, the public trust was shattered yet again. The White House, the intelligence services, and Congress are locked into a war of blame associated with the tragic events of 9/11 and subsequent actions. Public trust is once again being challenged. Martha Stewart, Janet Jackson, Michael Jackson, Jayson Blair, and Jack Kelly all have stirred a variety of emotions among fans and followers. Whether the failing in question is cheating, performing provocative behaviors, or lying, the public is again assailed with trust-breaking behaviors. Trust is one of the critical components of research, and it appears to be in short supply. As researchers, we face increasing difficulties in convincing potential participants to trust us. In 1946, the world learned of even more brutality and indifference to human life during a trial of those who had sworn ” (first do no harm).” Numerous incidents of inhumane experiments and countless cases of euthanasia resulted in the conviction of 16 doctors. Seven were executed. established specific guidelines for the medical profession in conducting research. These included voluntary consent, a requirement that the results cannot be obtained in other ways, and a requirement that subjects can terminate their participation. provided very clear guidelines for biomedical practitioners. It also stipulated that independent committees should review certain research efforts. The was the seminal document in later efforts to establish legal obli
gations for biomedical and behavioral research. The report was in response to tasking by the National Research Act of 1974. The report provided the public and researchers with clear principles and guidelines about ethical behaviors with human subjects. The report also outlined the mechanics of informed consent. The established ethical standards in 1953. Since then, 10 revisions have occurred. The provides practitioners with guidelines covering most (some would argue too many) professional activities. , a result of the Belmont Report, provides very clear and definitive guidance for those performing research with human subjects. The federal regulation addresses the mechanics and process of ethical research. It covers The state of Maryland is one of a number of states that have enacted . Additionally, many professional organizations, like the APA and the , have established ethical codes of conduct that are often more restrictive than federal and state laws. Federal law is clear: If you conduct research associated with federal money or support, you must comply. If you conduct research that is within the scope of the department or agency but is not supported, then the effort must be scrutinized by an IRB. Maryland state law is a bit clearer; if human subjects participate in the research, then compliance with the federal regulations (45 CFR 46) is mandatory. Every year, in compliance with federal law, nonprofit organizations are required to produce a report to members. Part of the APA’s yearly report includes reporting information from the various internal committees and departments. The Ethics Office, within the Executive Office, provides a yearly notice that indicates those APA members who were either expelled or who resigned from the APA because of verified or possible violations of the APA’s .