Without human subjects there would be no human subjects research. Human subjects expect to be treated fairly, with respect, and in an ethical manner when participating in research. Investigators enter into an agreement with subjects to do so during the consent process and with the IRB when submitting a protocol for review. When deciding whether to participate in research, potential subjects must decide if they trust investigators and believe that they will fulfill their obligations as described in the consent process. Breaking any aspect of this agreement or acting in less than a completely ethical manner will erode the level of trust and respect between subjects and investigators. If subjects are unable to trust investigators, or are skeptical about their motives, they will refuse to participate in research, leaving investigators unable to conduct human subjects research and develop the generalizable knowledge that benefits society. The rise in litigation between human subjects and the research establishment suggests that there is a growing loss of trust between investigators and human subjects. This must be reversed, and to do so it is essential that investigators establish relationships based on trust and respect with their research subjects and maintain the highest ethical standards.
When research is conducted unethically, federal human subjects protection regulations are also often violated. Failure to comply with the federal regulations can lead to sanctions against the investigator and sponsoring institution. Sanctions range from having to develop written corrective action plans and submitting to federal monitoring, to debarment from receipt of federal funds and involvement in future research. The most extreme cases have led to criminal sanctions for fraud or negligence. At Yale University, the human subjects protection regulations have been adopted for all research conducted under the auspices of the University (not just federally funded research). Failure to comply with University policies can lead to termination or expulsion.
The modules that follow in this resource describe the ethical norms and procedures for human subjects research and also provide practical guidance on meeting their requirements in various research settings.