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Stacy Hodgkinson and Amy Lewin had the best of intentions when they enrolled the pregnant 15-year-old in their study. The psychologists were evaluating an educational programme for young parents-to-be, and the teenager met all the inclusion criteria: she was 15–32 weeks pregnant with her first child, under 19 years of age, and her partner — who did not live with her — was willing to participate in the study. There was just one problem. Dad was 24 years old, and according to local laws he was guilty of child sexual abuse for sleeping with a minor.

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The couple had apparently lied to each other about their ages, but not to Hodgkinson and Lewin, both then at the Children's National Health System in Washington DC. This presented a dilemma. The scientists had promised the participants that their information would be kept confidential. But did that trump their legal duty to report the crime to the police? And how would that affect the family?

“Here was a young father telling us he'd like to be involved in his child's life in a positive way,” says Lewin, who is now at the University of Maryland in College Park. Telling the authorities, she says, “could potentially do more harm than good”.

In search of moral and legal guidance, Hodgkinson and Lewin contacted Tomas Silber, a paediatrician who also runs a research ethics consultation service, a 'one-stop shop' for advice on thorny research issues.

To Silber, the course of action was clear. “There's only one thing you can do,” he says. “You have to report it.” After explaining their legal obligations to the couple, Lewin and Hodgkinson told the police, who launched an investigation. The teen and her partner broke off contact with the researchers, and Hodgkinson does not know whether the father maintained a positive presence in the child's or the mother's life — which was ultimately the goal of their programme. “Sometimes you do the right thing, but the consequences aren't good,” says Silber.

Ethical dilemmas in research are nothing new; what is new is that scientists can go to formal ethics consultancies such as Silber's to get advice. Unlike the standard way that scientists receive ethical guidance, through institutional review boards (IRBs), these services offer non-binding counsel. And because they do not form part of the regulatory process, they can weigh in on a wider range of issues — from mundane matters of informed consent and study protocol to controversial topics such as the use of experimental Ebola treatments — and offer more creative solutions.

The consulting services are “a really new area”, says Joshua Crites, a research ethicist at the Pennsylvania State College of Medicine in Hershey. “Even some of the most basic questions get complicated really quickly, and it's better to have a group of ethicists working together to sort this out.”

But many scientists either do not know that they exist or fear using them because they could add red tape to an already heavy administrative burden. And this year, the US National Institutes of Health (NIH) scrapped funding for a working group to support ethics-consultation services and to develop best practices for the profession.

Although financial support could return in some form, ethicists are not waiting around for it. Benjamin Wilfond, director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children's Hospital in Washington, has set up the Clinical Research Ethics Consultation Collaborative, a group of around 35 bioethicists who hope to keep improving the consultation service model, even without NIH support. “There's energy behind continuing what we started,” says Holly Taylor, a research ethicist at the Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland, and a member of the group.

Here to help

IRB approval is required for almost all human-subject research in the United States. The foundations for current IRB practices emerged 40 years ago in the wake of numerous ethical lapses in research, including the infamous Tuskegee experiments performed in Alabama between 1932 and 1972, in which doctors allowed syphilis to progress untreated in hundreds of African American men. Today, IRBs are the main channels for policing ethics in academic medical studies. But their primary function is to ensure adherence to regulatory and legal requirements. They do not always include members with bioethics expertise, and discussion of ethics sometimes takes the form of box-ticking rather than careful deliberation.

That is where consultants come in. Unlike IRBs, consultants can provide guidance throughout a study — not just at the point of regulatory review — and do so in a non-confrontational advice-giving capacity. They offer “an open space for talking about research ethics in a way that is not driven by the regulatory environment”, says Marion Danis, chief of the bioethics consultation service at the NIH Clinical Center, a research hospital in Bethesda, Maryland.

You need some independent person to say, 'Well, let's step back and think about this.'

The Clinical Center was the first organization to launch a research ethics consultancy, in 1996, and a handful of academic medical centres followed suit over the next decade. Then, in 2006, the NIH launched the Clinical and Translational Science Award programme to enhance drug development and testing in academic settings, and it led to a rapid expansion of the concept in the United States. According to a survey published last year, by 2010 more than 30 academic institutions had set up research-ethics consultation services. That said, fewer than half of them had fielded calls by researchers seeking advice in the previous year, and just six got more than ten calls1. “In most places, these have not ended up being high-volume activities,” says Steven Joffe, a medical ethicist who led a fairly idle service at Harvard Medical School in Boston, Massachusetts, until moving to the University of Pennsylvania Perelman School of Medicine in Philadelphia in 2013.

Amy Hagopian, a global-health researcher at the University of Washington in Seattle, found herself turning to an ethics consultant for help with a study in Iraq to find out how many people had died as a result of the US-led conflict that began there in 2003. Her team needed to obtain informed consent from participants, but the researchers on the ground in Iraq were concerned that including the University of Washington's name on the consent forms — a requirement for IRB approval — would make it difficult to get the data they needed. “They feared that being associated with American institutions would get them killed”, says Hagopian. “They dug in their heels and refused” to carry the form.

Hagopian wanted to strip the university's name from the consent document, but the IRB insisted that it was an important part of informed consent, which is meant to protect participants, not the investigators. The impasse brought Hagopian and her team to Wilfond. He concluded that it would be ethical to remove mention of the institution, for three main reasons: first, research subjects would also be placed at risk by signing a document linking them to the University of Washington; second, apart from the link to the United States, the research involved minimal risk to the participants; and third, the study would not happen unless the name of the institution was removed.

The IRB eventually agreed with Wilfond. The researchers went ahead with the study and found that nearly half a million people had died from causes attributable to the Iraq war between 2003 and 2011 — a figure much greater than most previous estimates2. “We couldn't have done this without him,” Hagopian says of Wilfond.

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Worldly advice

Of course, bioethicists have been providing advice about research for years, long before the NIH created a formal service. Outside the United States, ethics consultations mostly happen through the regional equivalent of an IRB or take place in casual conversations or 'kerbside consults'. “All in all, it's pretty ad hoc,” says Mark Sheehan, who studies ethics at the Ethox Centre of the University of Oxford, UK.

At some institutions in Canada, ethics advice about research studies can also be sought through the services that help patients and doctors to settle end-of-life decisions and other moral issues in health care. Unlike in the United States, where training programmes in research ethics and clinical ethics are usually separate, in Canada “we all tend to have both kinds of expertise pretty much”, says Ann Heesters, a bioethicist at the Toronto Rehabilitation Institute in Ontario, one of the only Canadian hospitals that publicizes the availability of ethics consultations for researchers. According to Heesters, around one in every seven of her consultations pertains to research.

In Australia, “it's very difficult for researchers to be able to seek advice before they submit the full application” for official ethics review, says Nikola Stepanov, who studies research ethics and law at the University of Queensland in Brisbane. And if a human-research-ethics committee — the Australian equivalent of an IRB — finds ethical problems in a study's protocol, researchers may have trouble finding a formal channel for further guidance.

“We're obviously in the stage that the United States was at before it brought in these ethics consultations,” says Stepanov. “Something more formalized would be very appropriate.”

But not all ethicists agree that a separate service is needed, even within the United States. “If the IRB has the responsibility for ethics review, why are we pulling in someone else?” asks Susan Kornetsky, director of clinical research compliance at Boston Children's Hospital in Massachusetts. Norman Fost, who studies ethical and legal issues in research at the University of Wisconsin–Madison, would rather see bioethics panels folded into the standard IRB structure. Because IRBs are “a toll gate that everybody has to go through”, Fost says, these panels, which would ideally include qualified ethicists, should “look at every single protocol and identify problems that nobody else has yet identified”. Relying on a separate, optional service means that some problems could be missed. “It's the cases they're not getting called about that worry me,” he says.

Complementary services

Advocates say that the aim of consultancy services is to complement IRBs and other oversight bodies, not to become entwined with them. “For innovative research designs, you need some independent person to say, 'Well, let's step back and think about this not just from the standpoint of do the regulations permit it, but does it fulfil the spirit of what people want done with the public research enterprise?',” says bioethicist Steven Miles at the University of Minnesota in Minneapolis.

Wilfond has been working to increase the visibility and the rigour of ethics consultancies. Last year, for example, he and Taylor launched a biannual series in the American Journal of Bioethics entitled 'Challenging Cases in Research Ethics'. The latest case, from Silber and his colleagues describing the obligation to report statutory rape, was published in September3. Wilfond is also collecting descriptive data about consultations and has expanded the reach of his service at the University of Washington by welcoming external requests — including from pharmaceutical companies, which typically employ armies of lawyers but rarely bioethicists. In such cases, the University of Washington consults on a fee-for-service basis: US$200 an hour for drug companies, less for non-profit organizations.

It's the cases they're not getting called about that worry me.

The Stanford Center for Biomedical Ethics in California also works with drug firms. There, panellists provide their time and advice at no cost, on the condition that they can publish case studies. In 2011, for example, a start-up company approached the centre for guidance on the sale and promotion of a prenatal genetic test that involves analysing fetal DNA circulating in maternal blood (see Nature 478, 440; 2011). The consultation led to an academic paper that called for amendments to informed-consent procedures and restrictions on the sale of direct-to-consumer tests4.

“Many of our consults end up that way,” says Mildred Cho, associate director of the Stanford centre. “We do treat these things as scholarly activity as well as a service.” Cho estimates that around one-quarter of her service's cases come from the drug industry.

Wilfond is currently working to expand the panels to draw in a wider range of views and to broaden the experience of panellists, a move that he considers one of his most innovative for ethics consultancies. In June, he was called into a meeting at Seattle Children's Hospital with Ron Gibson, director of the hospital's cystic fibrosis centre. Gibson had been gathering data from several studies that were using laboratory tests that can be performed only in a research setting or fall outside of recommended guidelines, but he was unsure whether he should incorporate the results into patients' routine clinical care. Seven bioethicists from Wilfond's collaborative telephoned into the meeting, ready to offer their take.

As the consultation began, Wilfond explained that the point of bringing the ethicists into the discussion was twofold. First, it would offer Gibson a wider range of opinions, and second, it would expose the advisers on the phone to a case they might not otherwise have been involved in. “There's a lot of learning that goes on bidirectionally,” Wilfond says. The hour-long meeting was “educational”, says Gibson, who has since implemented a new policy for his research programme, although he declined to discuss specifics. “The spectrum of opinions on various levels of data sharing was reassuring that there is likely not one best way to address the issue.”

Wilfond and his colleagues hope that more scientists and clinicians will start to see the benefits of their services. “There just hasn't been an awareness of how important this is,” says Charles MacKay, a consultant in clinical and research bioethics in Bethesda, Maryland.

But getting scientists to actually buy into such services may require a shift in attitudes. “Researchers generally have become members of a culture of research compliance,” says Christian Simon, a bioethicist at the University of Iowa Carver College of Medicine in Iowa City. They are responsive to what IRBs require, he says, but that sometimes means that they are unwilling to step back and consider the finer ethical details.

“We're not the ethics police,” says Reid Cushman, co-director of the ethics consultation service at the University of Miami in Florida. “We're just another resource to help you stay out of trouble.”