A public health researcher was unclear on the ethical implications of a “secret shopper” concept — in this case, to see how many local stores failed to ask children under 18 for identification before selling them cigarettes. Another researcher wanted to recruit adolescents with chronic illness for a study through social media but was unclear how to go about ethically obtaining parental consent.

These are two recent issues handled by the research ethics consultation (REC) service at Johns Hopkins. The REC serves as a resource to help answer investigators’ ethical questions. “We have created a place to come talk about research ethics that’s different from the IRB. It is an educational opportunity,” says Holly Taylor, PhD, MPH, PhD program director and core faculty at the Johns Hopkins Berman Institute of Bioethics in Baltimore.

Taylor is lead author of a recent paper on a national REC collaborative.1 Based on data collected on more than 350 consultations, the authors concluded that REC can assist investigators:

• before and after regulatory review;

• when facing challenging or novel ethical issues;

• navigating informed consent and risk/benefit analysis;

• overcoming study hurdles;

• mediating conflicts within a team;

• directly engaging with research participants.

“What researchers really want is the opportunity to talk to a person about their work,” says Taylor. “That’s really the reason we were created — to meet the investigator where they are.”

The REC works independently from the institution’s IRBs, although the IRBs occasionally reach out for help with challenging cases. Researchers typically seek help early in the process when thinking about recruitment or what populations to include. “The vast majority of consults we get are long before it gets to the IRB,” says Taylor.

Most questions are about study design or informed consent. Sometimes, investigators are recruiting in a region with low literacy levels and need to determine how to obtain informed consent in this population, for instance.

Consultants at Johns Hopkins assess the satisfaction of participants by asking, “Did you get the information you wanted? Would you recommend it?”

“We would like to do a more robust evaluation in the future,” says Taylor. “Perhaps it would be even more powerful if we as a group identified key outcome measures that consultants could collect across institutions.”

The REC service emphasizes education, as opposed to helping investigators gain IRB approval or grant money. “My goal is to help them realize they already know the answer and I’m helping them get there. I’m interested in helping them build their ethics capacity,” says Taylor.

Any and All Areas

Zubin Master, PhD, a consultant at the Mayo Clinic’s biomedical ethics research program, authored a recent paper arguing that the scope of REC services should be expanded.2 “There is a need for it. It’s a necessary role. It can help solve issues that arise and prevent issues from escalating,” says Master.

At the Mayo Clinic, the REC service handles a wide range of issues. These include authorship, mentorship, and conflicts of interests. At Albany (NY) Medical College, where Master was an associate professor at the Alden March Bioethics Institute, a REC was created by the bioethics department. “We did have people coming to us with these sorts of questions,” says Master. “It could be a small chat around an issue, or something that took several days with lots of back and forth.”

Scientists may primarily perform animal research but are now working with human embryos. They may find that their research integrity office lacks ethics expertise specific to this area. “They can call people like us,” says Master. “We handle any and all areas surrounding research ethics.”

Sometimes, the IRB turns to the REC service for assistance. “It might be over a consent form, unfamiliar research, or a vulnerable population is involved and they just want somebody to double-check something,” says Master.

One issue is that struggling investigators do not always know REC exists at their institutions. Generally speaking, clinical ethics services are “much better embedded institutionally,” says Master. “This is just anecdotal, but people we’ve asked are not necessarily even aware that research ethics consultation services exist.”

Accessible to All

Not every institution offers an in-house REC — but that does not mean REC services aren’t accessible to researchers. The national collaborative hosts a monthly call where a member of the group presents a case and how it was resolved. Any institution can participate in these calls.

“We offer consults to individuals at institutions that don’t have a consult service,” says Taylor. “Not every institution is going to have the expertise in-house, whether in the IRB or elsewhere.”

However, the service doesn’t need to be resource-intensive. Smaller institutions could conceivably start it up on their own. “If you can find a champion in the institution with research ethics expertise, and there always is, certainly, those people could start a research ethics consultation service,” says Master.


1. Porter KM, Danis M, Taylor HA. The emergence of clinical research ethics consultation: Insights from a national collaborative. Am J Bioeth 2018; 18:39-45.

2. Master Z, Martinson BC, Resnik DB. Expanding the scope of research ethics consultation services in safeguarding research integrity: Moving beyond the ethics of human subjects research. Am J Bioeth 2018; 18:55-57.