More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R

Today’s episode of More Than Meets the IRB includes segments from a panel discussion entitled “Increasing the Public’s Understanding of Clinical Research” and focuses on the question of why minority groups are less likely to participate in research.

The answer revolves around the issue of trust. Distrust of research among African Americans stems from a history of racial discrimination, exploitation and ethical misconduct in this country. This distrust extends all the way back to the history of enslavement, including medical and surgical experimentation on slaves and robbery of black graves for cadavers.

African Americans are more likely to believe that doctors would ask them to participate in harmful research, expose them to unnecessary risks, not explain research, or include them in experiments without their consent.

The research community can approach and address these issues of distrust in a couple of different way.

1. Thinking About Benefit

Researchers can attempt to better convey the following benefits of research study participation to minorities:

Direct Benefit: The possibility of pulling the random card and getting the best treatment in a clinical trial

Collateral Benefits: Access to medical care during the study

Societal Benefits: How the results of the study can accrue benefit to others in the greater society

2. Consider the Role of Public Education and the IRB in Building Trust

Another approach is for the medical community not to focus on making minorities more trusting, but rather on being more trustworthy.

To illustrate this point, consider that minorities with cancer are less likely to be offered the opportunity to participate in a study. When cancer researchers were asked what they look for in an optimal subject, they replied that good candidates were compliant, spoke English, and wouldn’t be too challenging to work with. This brings up the question of who is being overlooked for these studies.

The conventional wisdom in the research community is that education is critical in enhancing the public’s trust and getting more patients interested in participating. But we really need to be thinking of education coupled with action, because passive education alone isn’t going to get it done.

To that end, the IRB needs to start asking the following questions:

How can we make sure that every eligible patient is offered the opportunity to participate and can make an informed decision?

How can we make sure every patient has the confidence to ask “Is a trial right for me?”

How can we activate the constant of community engagement in our institution’s research in a meaningful fashion?

Dr. Susan Lederer is the chair of the Department of Medical History and Bioethics at the University of Wisconsin, and the author of "Flesh and Blood and Subjected To Science". During this panel from the 2014 Advancing Ethical Research Conference, Dr. Lederer discusses the significant and compelling role Henry K. Beecher played in the world of clinical research ethics with his paper Ethics and Clinical Research - http://www.nejm.org/doi/full/10.1056/NEJM196606162742405.

Today we’re talking to Karen Masterson, the scientific journalist who wrote The Malaria Project, a book detailing the history of the US government’s attempts to find a cure for malaria during World War II. Karen discusses the role journalism plays in research ethics and how the scientific community’s treatment of human research participants has shifted dramatically since the 1940s.

In this panel session from the 2013 PRIM&R Advancing Ethical Research Conference, we continue to look at the shifts and trends in social media use that impact the way we culturally perceive privacy and risk. The speaker is Dr. Joseph Konstan, a professor in the department of computer science and engineering at University of Minnesota who has conducted research in the field and also advises the IRB on data security and IT issues related to internet research.

With the proliferation of social media in our daily lives, the way we communicate has been completely transformed. Our guest is Jeff Hancock, formerly a professor of information science and communication at Cornell and currently a communications professor at Stanford, who is well known for his research and TED Talk on how people use deception with technology.

In this podcast, Dr. Ochsner looks at the complicated nature of consent in neuroscience and behavioral research, acknowledging that the risks and benefits of this type of research can be hard to define, making it difficult for IRBs to review.

During this podcast, we talked to Nicolle Strand and Elizabeth Fenton of the Presidential Commission for the Study of Bioethical Issues (PCSBI), which is an incredible but surprisingly underutilized resource when it comes to reviewing human subjects research. We are going to specifically discuss the PCSBI's report Gray Matters: Integrative Approaches for Neuroscience, Ethics and Society, which looks at the ethical issues associated with neurological research.

Today we’re learning from John Wilbanks, chief commons officer at Sage Bionetworks, who has authored numerous publications about data sharing. On this panel, The Evolving Nature of Privacy and Confidentiality from the 2014 AER Conference, he discusses the evolving nature of privacy, confidentiality and anonymity when it comes to collecting and analyzing “big data.”

Camille Nebeker: Goals for Improving the Informed Consent Process in Behavioral Research by Washington University in St. Louis and PRIM&R

The issues surrounding human subject protections and the participant-researcher relationship do not lie in technical non-compliance. The problem lies with the human ability to be trusted and to be counted as trustworthy. The words ‘trust’ and ’trustworthiness’ are not found in guidance provided by federal agencies. These words are much more associated with human relationships and friendship.