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Although many hospitals have long offered a clinical ethics consultation service to their physicians, patients, and allied health professionals, formal ethics consultation in the research setting is a relatively new development.1 This article describes the Research Ethics Consulting Service (RECS) that was launched in March 2005 at the Johns Hopkins Bloomberg School of Public Health (JHSPH). Johns Hopkins University was one of 142 institutions that received funding in fiscal year 2002 to develop programs to “strengthen the oversight of human subject research.”2 After obtaining the capacity development grant, the authors—faculty members at the Bergman Institute of Bioethics (BI) with appointments in the school of public health—conducted a needs assessment to determine what types of continuing education in research ethics would be most useful to school faculty. The universal preference was for a consulting service that would give faculty the opportunity, in real-time, to discuss challenging ethical issues they faced at various stages of their research, with emphasis on issues particular to their work. The authors determined early in discussions with faculty and key senior administrators that the goal of such a consulting service would be to assist investigators (whether faculty, staff, or students) in navigating the ethical challenges that might arise in the design, conduct, or analysis of research projects involving human subjects.
At the end of the six-month pilot period, the JHSPH Office for Research Subjects (ORS) decided to provide salary support for the authors to manage the RECS as a regular component in the school of public health. The focus of this article is to show how the RECS is organized, how it responds to and manages requests for consultations, and what types of consultations the service has provided since its inception.
It is important to note that the RECS is a component of the JHSPH ORS. Thus, the RECS is accountable to the ORS and to the investigator who requests an ethics consultation, and this relationship is described in the service’s written materials. These materials also point out that the RECS is intended to supplement rather than supplant the services and expertise provided by the ORS and the chairs and members of the JHSPH institutional review board (IRB). Investigators are informed that summaries of consultations will be made a part of their JHSPH IRB file if the consultation concerns an active protocol. In addition, the program’s materials clarify that the RECS was designed to provide ethics guidance, whereas regulatory questions are more appropriately addressed to the school of public health’s IRB office. Thus, the service is not designed to “pre-review” submissions to the JHSPH IRB or to review or rewrite consent documents.
The authors manage the RECS and are compensated for 10% effort by the ORS for staffing the service and providing a few other tasks for it, such as organizing a series of research ethics seminars for the school of public health and helping the JHSPH IRB to develop certain new policies. The consulting service is advertised in a variety of ways: at faculty meetings; in memoranda and periodic broadcast e-mails from the ORS to faculty, research staff, and students; at presentations at JHSPH IRB-sponsored brown bag lunch seminars; and through the distribution of a promotional flyer and post-it pads. More recently, the service has initiated a monthly drop-in office hour as an additional means of providing in-person consultations.
A Web-based interface already in use at JHSPH for “help calls” for computer assistance was adapted to provide a way to submit requests for a research ethics consultation.3 Having a Web-based service was important so that investigators located outside the United States could easily submit a consultation request, and most of the faculty, students, and staff at the JHSPH were already familiar with this interface. The RECS interface works only when the person requesting an ethics consultation has a recognizable school of public health e-mail address suffix. Investigators can access the interface from the JHSPH intranet home page, from the JHSPH IRB Web site, and from the Web site for the BI.
When a consultation help call is initiated, the requester is asked to provide certain baseline information. Fields include the requester’s name and contact information, stage of the study (e.g., design, conduct, data analysis), and where the study will be conducted or is being conducted. Specific information about the consultation question and relevant background information can be entered into a dialog box. Requesters can also upload any documents they would like the consultants to review before the consultation takes place.
After the relevant information is submitted, an automated e-mail is sent to the two consultants and their administrative assistant. Because responsiveness is a program priority, one of the consultants tries to respond to the request within 24 hours. The e-mail response confirms that the consultation request was received and, depending on the nature of the request, suggests scheduling an in-person appointment, a phone appointment, or further e-mail exchange in order to resolve the question. When and in what manner a response was made is documented in a text box of the Web-based interface. The consultation is held at a mutually agreeable time; when relevant, the RECS may provide literature, links to relevant JHSPH IRB policy memos, or other resources to the investigator to help address the central issue of concern.
After the consultation is completed, brief notes summarizing its nature and describing additional issues raised and/or suggestions for resolution are entered in another text box on that consultation’s specific Web-based interface. The interface is then “closed,” which results in an automatic e-mail to the requester explaining that the consultation has been closed and asking the requester to complete a short, anonymous Web-based evaluation of the service (consisting of six multiple choice questions and one open-ended question). Most consultations are resolved through one meeting and/or phone call, though occasionally some e-mail follow up is necessary. In a few cases more than one phone call or meeting is needed to complete the consultation.
Students are welcome to use the RECS. However, in order to encourage students to seek advice regarding the ethics of human subjects research from their academic advisor and to ensure that the advisor is aware of and engaged in the student’s research decisions, students may only use the service when accompanied by their advisor, who is officially listed as the Principal Investigator (PI) on student-initiated research projects. When students conduct research with a faculty member who is not their academic advisor, the faculty member is asked to join the student on the consultation.
Investigators are informed that all consultations are confidential with four exceptions. First, the two consultants who staff the service are permitted to discuss consultations with each other. Second, as long as no personal or protocol details that would easily identify the investigator are revealed, the consultants may discuss the generalities of a case with colleagues who are members of the Program in Research Ethics. This program consists of faculty members in the BI who are members of one of the seven IRBs that serve the medical school and school of public health or who are engaged significantly in the teaching of research ethics at JHU. Third, notes that briefly describe the consultation and the major issues discussed are sent to the JHSPH IRB office to be included in the files for any active studies. Finally, the consultants will notify the JHSPH IRB of regulatory violations or ethical transgressions that may come to light during the consultation.
When the RECS was established, both of the consultants were members of the two IRBs at the JHSPH. This raised questions about whether there would be any real or perceived conflict of interest if a protocol for which they provided a consultation came to the IRBs. Of concern was whether the consultants would be so invested in the outcome of the consultation that they might not be objective about the protocol when reviewing it as an IRB member. The ORS recommended that the consultants remain on the JHSPH IRBs as voting members for such protocols, that the IRBs be provided with a history of any consultation regarding the protocol, and that the consultants not serve as primary reviewers of protocols submitted to the IRBs that they were involved with through the RECS. Of note, JHSPH IRB members were informed about the RECS in advance of its launch date and, if they had concerns, encouraged to challenge research procedures for protocols that were involved in an ethics consultation.
At a presentation to colleagues in the BI that outlined the initial plans for the RECS, it was suggested that a legal disclaimer should be developed regarding any advice the consultants provided to investigators requesting consultations. The following language was approved by the general counsel of Johns Hopkins University:
An ethics consultation is an advisory service to assist Johns Hopkins University Bloomberg School of Public Health faculty, staff, and students in considering ethical challenges that arise in the design and conduct of human subjects research. The information provided is intended to be educational and helpful in decision-making processes. However, the ethics consultants will not make decisions for the investigators. Investigators remain responsible for their choices. Even after an ethics consultation, faculty and student researchers must obtain formal JHSPH IRB approval before initiating contact with human subjects in any research project. The JHSPH IRB is not bound by the options presented by the consultants, nor are the alternatives presented by the consultants institutionally or legally binding.
To avoid conflicts of interest, consultants will inform the JHSPH IRB if they are asked to review a protocol on which they have consulted. Further, JHSPH IRB members, including consultants themselves, may conclude that a consultant should recuse herself from a JHSPH IRB vote to avoid a conflict of interest.
Staff members in the Information Systems department responsible for the database management of the consultation service provided raw data in Excel format for 76 consultation requests placed between April 2005 and December 2007. Relevant, close-ended data were reviewed, abstracted, coded, and imported into Stata4 for univariate analysis. The narrative data on the nature and resolution of the consultation were reviewed and coded as either ethics or regulatory in nature, by the mode of interaction (e.g., in-person or by phone), and then labeled with up to three content codes to facilitate descriptive analysis. HT conducted qualitative coding (i.e., classified a consultation as related to the informed consent process, to the study population, or to some other feature), and NK confirmed the qualitative code. Discrepancies were discussed and resolved. To review and summarize points of interest regarding a consultation’s time line (the time from submission of the consultation request to first contact to the time the consultation was resolved), a report was generated by the Web-based interface and confirmed by a review of the narrative data regarding the resolution of the consultation. The JHSPH IRB determined that analysis of data for this manuscript was exempt from IRB review.
Of the 76 requests for an ethics consultation, 72 are included in this summary. Two separate consultations appear twice in the data set, so one of each was deleted from the analysis. In addition, two consultation requests were deleted based on the content of the issues raised. One involved a question about how to secure a password for the electronic JHSPH IRB application system, and the other concerned a nonresearch ethics consultation (i.e., involving a question about the ethics of public health practice). Table 1 provides information about who requested a consultation and the academic departments the requesters were affiliated with. The majority of investigators who requested consultations did so only once. However, a small subset of faculty requested multiple consultations: five faculty members requested two consultations; one faculty member requested five consultations; and one faculty member requested nine consultation. Almost 70% (48) of consultation requests were from faculty members, with most requests coming from the Department of International Health. An investigator who requested a consultation typically did so only once within the time period during which we collected data.
One of the consultants responded to nearly all of the consultation requests (91%) within 24 hours of receiving the initial request. Eight of the consultations were conducted by telephone (11%), 31 were resolved by e-mail (43%), and 33 involved in-person meetings (46%). The median time from a consultant opening a consultation request to the resolution of the consultation was one day. The mean time from open to close was five days. Almost all e-mail consultations (90%) were completed within one day of submission. Seventy percent of in-person consultations took more than one day; these had a median resolution time of seven days and a mean resolution time of 10 days. In-person consultations require identifying a mutually convenient time to meet, not only for the consultant and the researcher who placed the request, but sometimes also for other members of the study team the requester would like to include in the meeting. One consultation took 49 days from open to close because the Web-based system failed to generate the e-mail notifying RECS staff that a consultation request had been submitted, and because the timing of the request also spanned the winter holidays.
A monthly office hour for the RECS was initiated in April 2007. Between April 2007 and January 2008, the consultants handled 18 in-person consultations for a total of 10 office hour sessions. A brief tally was kept of the status and affiliation, topic, and summary of each consultation conducted during the office hour sessions. These data were not included in the summary of the Web-based consultations detailed above. In general, the content of the consultation requests that originated from office hour sessions is very similar to the content of those submitted through the Web-based system. However, students were more likely to use the office-hour session than the Web-based system to request a consultation. On average, the consultants fielded two consultations per hour during office hour sessions, ranging from no consultations in June 2007 to six in January 2008.
Almost one-third of the consultation requests involved a community/clinical trial, and one-quarter were in reference to a survey or a study involving interviews. One-third of the requests were in reference to a study conducted in an international setting, and just over half (52%) concerned a study in development (Table 2).
The nature of each consultation was first categorized as a question primarily related to ethics or primarily related to regulatory compliance. The vast majority of consultations (58/81%) primarily concerned a question of research ethics. Consultations that related significantly to regulatory compliance were answered more quickly, often by e-mail, with the caveat that our answers did not represent regulatory authority, and that the requester should also contact the JHSPH IRB office. The 14 regulatory consultations were categorized with one or two of 18 different codes. The two most common codes were regulatory requirements for use of secondary data (four) and regulatory requirements for local ethics review in an international setting (five) (Table 3). For example, in one consultation an investigator wanted guidance about how to obtain local ethics review of a protocol in a setting where no ethics review board had ever been established.
The 58 consultations that primarily involved a research ethics issue were coded with 90 different codes corresponding to the substance of the consultation question(s). These consultations often raised questions at the interface of two separately coded ethics issues. For example, a consultation might have involved a question about informed consent in the context of research with a vulnerable population. As such, 23 consultations were coded with one content code, 36 received two content codes, and 14 were given three content codes. The five most common codes applied to ethics consultations were consent process (20), population (20), risk/benefit assessment (17), study design (13) and distinguishing human subjects research from other activities (seven) (Table 3). The term “population” was used to code a consultation that included a question about the involvement of a vulnerable population (e.g., individuals with low literacy or those with terminal illnesses). “Risk/benefit assessment” was used to code consultations that included a question about the assessment of risks and/or benefits or the balance of the two. This might include whether it was acceptable to use a placebo control in a large trial when very small trials had shown positive results; whether a study should be terminated when one study endpoint had been reached, but other study endpoints had not; or how best to ask questions related to suicide in adolescent populations. Several brief examples of consultations and accompanying codes ascribed to them are described below (codes listed in alphabetical order):
Women enrolled in a cancer screening study in a rural area in South Asia refused to accept the standard therapy and requested a riskier, clinically nonindicated procedure. (Codes assigned: Population, Risk/Benefit, Subject Request for “Unnecessary” Treatment)
Investigators working with a local health department to evaluate the effect of an intervention to reduce youth violence wanted to survey youth who had or had not been exposed to the intervention and needed guidance related to confidentiality, child assent, and parental consent. (Codes assigned: Consent Process, Distinguishing Human Subject Research from Other Activities, Population)
Investigators planning to conduct a mineral supplementation trial in a resource-limited setting knew there was some, albeit limited, evidence from another resource-limited setting on another continent indicating that supplementation was beneficial. The investigator requesting the consultation wanted help in thinking through whether clinical equipoise existed and whether it would be ethical to conduct the planned trial. (Codes assigned: Risk/Benefit Assessment, Study Design)
Investigators planning to conduct in-depth interviews with immigrant parents of young adolescents wanted advice on how to maximize confidentiality given that some parents might be undocumented immigrants. (Codes assigned: Population, Risk/Benefit Assessment, Study Procedures)
Issues related to the informed consent process, study design, the population under study, and research risks and benefits were the most common ethics-related (rather than regulatory-related) consultations the RECS handled over the last 34 months. A consultant routinely responded to the person requesting a consultation within 24 hours after the consultation request was submitted via the Web-based interface. In-person consultations took relatively longer than those conducted via e-mail, but almost all were resolved within a week from the submission of the consultation request.
One limitation of this report is that due to confidentiality concerns, we were only able to provide general descriptions of the 72 consultations processed to date. This general description belies the sophistication of the questions raised by the consultation requests. Indeed, the vast majority of consultations have involved ethically complex and challenging study contexts. For example, consultations involved research with hidden populations in conflict ridden regions of the globe; research with minority adolescents at risk of suicide; or studies where the state of evidence was both in flux and contested.
A number of challenges were encountered in providing a research ethics consultation service to investigators in the JHSPH. First, few of the investigators who used the service submitted an evaluation through the evaluation component of the Web-based interface. Several reasons may explain the limited response to the automatically generated e-mail requesting completion of the evaluation. An evaluation component was added to the system after the consultation service was initiated, and a number of technological problems were encountered that may have resulted in the evaluation request not being sent to the first set of users of the service. Yet even after the e-mail evaluation system was in place, few evaluations were submitted. Since researchers are inundated with what appear to be automatic e-mail messages daily, it’s likely that after requesting an ethics consultation, they simply deleted e-mails they did not quickly recognize. Thus, we may consider developing a more robust evaluation process in order to obtain feedback that can help us improve the RECS, especially since the consultation service will be expanded to meet the needs of the new Institution for Clinical and Translational Research funded through the NIH’s Center for Translational Science Award (CTSA) program.5
Another challenge is ensuring that all faculty, staff, and students are aware of the existence of the consultation service, especially since there is continual turnover of faculty, staff, and especially students at a large academic institution such as ours. Periodic outreach efforts through additional faculty meetings, flyers, and broadcast e-mails are generally met with a new flurry of use of the service, but we also acknowledge that such outreach can only happen intermittently.
Finally, we will soon face the challenge of expanding the consultation service beyond the JHSPH. With funding from the CTSA program, the RECS will be made available to all faculty, staff, trainees, and students affiliated with the Johns Hopkins Schools of Medicine, Nursing and Engineering, and the Kennedy Krieger Institute. Up to now the RECS has addressed ethics issues related only to public health research, and the consultants have interacted only with JHSPH investigators, many of whom they know and whose work covers familiar subject areas. The RECS will likely face a new set of challenges as the consultants manage a potential increase in requests for consultations and respond to ethics concerns raised by areas of research with which they are less familiar.
We would like to thank Jennifer Lohse and Emily Oster for their research assistance.
The RECS was initially funded by NIH grant 1S07RR018230-01 (Theodore Poehler, PI) and subsequently funded by the Office for Research Subjects, Johns Hopkins Bloomberg School of Public Health.
Holly A. Taylor, Assistant Professor, Department of Health Policy and Management, Bloomberg School of Public Health and Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD;
Nancy E. Kass, Phoebe R. Berman Professor of Bioethics and Public Health, Bloomberg School of Public Health and Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD.