Knapp appoints committee to investigate research ethics

University Provost Steven Knapp recently announced the formation of a Committee on Participation Policies for Human Subjects made up of members of each of the University's four major divisions. In the wake of last summer's incident involving the death of a research subject, Ellen Roche, at Johns Hopkins Hospital, policies and procedures of research involving human subjects have come under review.

"We've been taking a look at a lot of areas of research since then," said Knapp, and the need to protect participants in research has become a priority, especially when the participants are students or employees of the University.

Knapp appointed this committee to study the issues specifically related to participation of employees and students as subjects in research. Dr. Ruth Faden, Director of the Johns Hopkins Bioethics Institute, is chairing the committee. The other three members are Dr. Gary Gerstenblith, a professor of medicine at the School of Medicine, Dr. Karen Haller, vice-president for Nursing and Patient Care Services at Johns Hopkins Hospital, and Dr. Michael McCloskey, a professor of Cognitive Science at the Krieger School of Arts and Sciences.

"The purpose of the committee is to look carefully at practices... involving employees' and students' participation in research," said McCloskey. The goal is "to avoid any possibility of [employees or students] feeling pressured to participate" in a study.

Employees and students affiliated with the University present a special situation when considering the ethical guidelines of research. For example, said McCloskey, a situation could arise where an employee of the School of Medicine is recruited to participate in a study being conducted by their supervisor, and they might feel compelled to accept for fear of losing their job. The committee is working to ensure that "any subtle pressures would be avoided," said McCloskey.

Knapp shared the same concerns: "The question is raised- does someone in that situation participate of their own free will?" Students could also potentially be pressured to volunteer as a subject in a research study. In many undergraduate psychology classes at Hopkins, especially at the introductory level, students who sign up to participate in experiments receive extra credit. Generally, taking part in three experiments will raise a student's grade a few points.

Participation in such experiments "still has to be completely voluntary," said McCloskey, which is questionable if there is no alternative.

"There needs to be another option available" for students to earn extra credit, such as writing a paper, and it "should be a real option that requires the same amount of work," McCloskey added.

Dr. Howard Egeth, a Professor of Psychology and at the University, does not feel that Hopkins students are being compelled to participate in experiments when they would rather not. "I don't think 'pressure' is the right word," said Egeth, who studies human perception and attention. "At many schools it's sort of a requirement."

The death of Roche last summer brought national attention to the University and in particular the ethics of recruiting students and employees. Roche was a 24-year old technician employed at Hopkins' Asthma and Allegy Center who was taking part in an asthma research protocol titled "Mechanisms of Deep Inspiration-Induced Airway Relaxation." As part of the study, she inhaled the chemical hexamethonium, and researchers were to monitor how her lungs responded to the irritant.

She soon developed a cough, and on May 9, five days after inhaling the chemical, she was admitted to intensive care. Roche died on June 2.

Her "death... made us aware of some issues we hadn't been thinking about," said McCloskey. Immediately following the tragedy, an external review board was sent in to examine all aspects of University-affiliated research practices. On July 19, the U.S. Office for Human Research Protections (OHRP) suspended all federally funded research involving human subjects at all Hopkins divisions except for the School of Public Health and the Homewood campus.

Approximately 2,400 protocols were suspended. The suspensions were partially removed after five days with the understanding that a rigorous review of all research protocol was to take place.

The committee, which held its first meeting in January, is first taking steps to "pin down exactly what the procedures are for recruiting [subjects]" said McCloskey, who served on the Internal Review Board (IRB) at Hopkins in the past.

In addition, they are using of policies and procedures at other research institutions to guide them. "Different institutions have different policies," said Knapp, and the committee wants to find out more specifically how they operate. They are currently "making a review of the policies at other institutions," said McCloskey. They are also taking into account the guidelines of organizations like the American Medical Association and the American Psychological Association.

Knapp said that he appointed Faden to chair the committee because she is "a national expert on the ethics of research" and the "ideal person" for the job.

While acknowledging that "all institutions that are involved in research have responsibility to protect [their subjects]," Knapp noted that Hopkins has a particular responsibility. Hopkins is "the largest recipient of NIH (National Institute of Health) funds," said Knapp, and is also known for having a "tradition of providing leadership in this area."

McCloskey added that the research done at Hopkins may be scrutinized more than most. "It's important for Hopkins to take the lead because we are so prominent in medical research," said McCloskey.

Solving the problem of protecting research participants without compromising or constraining the actual studies will require "a delicate balance," said Knapp. "You don't want to be too restrictive but you want to make sure you're protecting people's safety."

It is not as if Hopkins has not worked to look out for the interests of research participants before the incident, said McCloskey. "Hopkins has always tried very hard to protect the rights of subjects."

Another question that has been raised in the aftermath of the investigation is whether the medical school human subjects review committee is overworked. According to Knapp, Hopkins has increased the number of IRBs as well as the number of people reviewing research.

In terms of how research taking place on the Homewood Campus has been affected by the incident, "basically we're just more careful about things like consent forms and following procedures," said Egeth.

The committee will eventually produce a report for the Provost after concluding their research "giving recommendations if any policy changes need to be made," said McCloskey.

There are no strict timelines in place at the moment. "We did not impose a deadline" for when this report is to be completed, said Knapp.

The members of the committee hope to have finished the report within the next few months. "We're looking toward late in the spring [or] early summer" said McCloskey.

Whatever recommendations the committee makes, Knapp knows that "there isn't any clear-cut answer" to the ethical questions being raised.