Mr. Chairman,

I welcome the opportunity to appear before the Committee today in an effort to provide information that may prove useful to the Members and staff as you seek answers to questions about ethical standards in the design and execution of behavioral and bio-medical research with vulnerable human participants.

The central ethical concerns in any research involving people should focus on their informed participation and safety.  The first ethical cornerstone involves an individual’s consent to participate.  Often called “informed consent,” the concept involves providing information by its very definition.  The key elements to consent include:

• Access to all of the information that might reasonably influence one’s willingness to participate;
• Adequate knowledge and understanding of that information,  and
• Voluntariness and freedom from coercion in the decision to participate or withdraw from participation.

Obtaining consent does involve documentation, but is best conceptualized as a process by which the investigator makes certain that potential participants know what will be asked of them, what risks or hazards may be involved, what benefits may result.  In addition, the consent process must inform participants about their right to withdraw at any time, and provide contact information for responsible parties in the event of any problems or complaints.  Those providing this information have the obligation to communicate these details in language the participants can understand.  If the investigator plans changes to a project after obtaining consent, the process must be reinitiated with the new details provided and agreed to by participants.

Many research projects involve studying healthy people.  However, most research populations of interest and available to mental health professionals are restricted or vulnerable in ways that may not allow a full measure of self-determination.  From the standpoint of this Committee’s concerns, such populations may include people at high risk for some possibly preventable outcome, disabled individuals, and those who may face social or economic disadvantage.  Some potential participants may have additional vulnerabilities because of their mental or emotional condition, such as anxiety, depression, or symptoms of post-traumatic stress. Other vulnerabilities may arise from physical illness or issues of confidentiality that bear on social stigma or discrimination.

In addition to adhering to legal regulations, the ethical obligation to protect all research participants rest with the investigators, who stand accountable to professional codes of ethics and a number of regulatory bodies including Institutional Review Boards (IRBs), Data Safety Monitoring Boards (DSMBs), and federal agencies such as the Food and Drug Administration (FDA).  Both IRBs and DSMBs include independent content area experts and representatives of the public.  IRBs and DSMBs typically review research plans, eligibility or exclusion criteria, consent forms, data analysis/management protocols, and adverse events (generally characterized as AEs, adverse events, or SAEs – serious adverse events, as when a death occurs).  Any changes in research protocols that might bear on the safety of participants require advance approval by the institutional IRBs, and DSMBs in the case of multi-site trials.  All of these processes and safeguards generally involve substantial documentation.

In certain exceptional circumstances an IRB may waive obtaining written consent.  For example, suppose an investigator seeks anonymous survey data via the Internet or unobtrusively observes the public behavior of anonymous people in everyday settings (e.g., recording how often many people line up at the “8 items or less” supermarket checkout counter with more than 8 items).   In such circumstances an IRB would typically waive the requirement of individual consent.  Even in such instances, however, the investigator waiver would formally request the waiver and the IRB would document granting it.

As a person who has served as a principal investigator, as an IRB member, as a current DSMB member for the N.I.M.H., and who has studied IRBs and research integrity, I hope that I can provide the Committee with information that will assist you in reviewing the research projects of concern to you.