For Sharon Shriver, it’s a simple equation. “Poorly designed research is inherently unethical,” says the director of programs for PRIM&R.
Part of the remedy, Shriver says, is to incorporate ethical considerations into study design. “It’s not a focus for institutional review boards [IRBs], but it should be,” she notes.
A study can contain the best informed consent documents in the world, but if the research is designed poorly and you are exposing more subjects than you need to risk, or you don’t have enough subjects to attain statistical validity, then you are essentially harming the patient population without benefit, Shriver adds.
“It’s been shown that physicians tend to underestimate the risk of pain to their patients, so we find that people who design the studies sometimes are looking at it differently than someone without that vested interest and deep scientific background,” Shriver explains.
Shriver advocates examining what she calls the “pivotal points” of research design and the ethical questions that should be addressed along the way. A few examples: statistical analysis plans and sample size considerations.
At ACRP’s 2016 Meeting & Expo, Shriver and Boston University School of Public Health Professor and PRIM&R Board of Directors member Susan Fish presented a session addressing ethical considerations in study design and were “flooded with questions” from trial practitioners who see this as a critical issue and want to do the right thing. The problem? “They don’t feel prepared to do it,” Shriver explains.
There’s another aspect of the challenge: the human factor. For example, if a study goes to the IRB and the IRB members feel that the study design doesn’t shield subjects appropriately, what’s the best way to take that concern back to the investigator?
It’s trickier than other conversations, Shriver says, such as those surrounding informed consent document review. She adds that investigators are used to a certain amount of give and take in getting studies started; however, it can become an “awkward conversation” if the IRB attempts to question enrollment criteria. “Investigators feel that this is their territory,” she explains. “They feel that scientific decisions are their territory and the decisions are solely theirs.”
The IRB members might feel tentative, yet they must ask tough questions in this scenario, Shriver stresses. However, there are ways to use language and the very structure of the questions being raised to make the process run more smoothly, she says.
This year, Fish and Shriver’s session has been expanded into a half-day workshop (Practicing Good Science Through Ethical Study Design) at the ACRP 2017 Meeting & Expo in Seattle due to popular demand.
PRIM&R offers short-course programming on ethical study design and other integrity in research topics.