Increasing Research Transparency

There also needs to be greater transparency in research practices, with a wider variety of research requiring mandatory registration, the panel’s report states.

“Shining a light on research makes it difficult to ignore the ethics,” Grady said. “It’s not the fact that we lack standards and rules, it’s that we don’t have enough enforcement of them. Investigators and institutions can only be held accountable for things that they know about.”

In the last decade, there have been a number of efforts to have clinical trials registered around the world. Current U.S. law requires advance registration in a public database (clinicaltrials.gov) of all interventional clinical trials. However, that does not include Phase 1, observational or epidemiological trials.

“By current definitions of what goes onto clinicaltrials.gov, most of the studies done in Guatemala, if they were done today, would not be registered,” Grady noted.

The commission should consider expanding the requirements for registration to include more trials or discuss other options for encouraging or enforcing accountability, Grady said. “Governments should consider requiring all greater-than-minimal risk research to be registered and results reported to enhance transparency and accountability.”

Another way to promote transparency would be to create a more open dialogue with human research subjects and their communities, explained panel member Nelson Michael, MD, PhD. “Researchers must demonstrate respect for human subjects and their communities in all phases of clinical trial design and implementation.”

That means creating community advisory boards, having open meetings to discuss research activities and inviting community representation on study teams.

Nelson admitted that such a close dialogue with the community could result in the discontinuing of a trial. “This process may very well expose information that would lead research teams not to do science at that place at that particular time,” he said.

He also said that researchers should realize when regulations are not enough and always favor human protection over simple compliance with regulations. “I think the system needs a little more sanity, so that we can concentrate on what might be well and good in an international norm,” he said. “We need to be reflective of how U.S. standards may not truly be enhancing research protections.”

Ethics Training

Funders of human research should support ethics training for investigators, including institutional review board (IRB) members, according to the report. While such training is usually mandatory, it is not always wholeheartedly embraced by those requiring it or those receiving it.

“Training in bioethics isn’t just a box-checking exercise,” Nelson said. “It’s something that truly needs to be embraced. It can’t be seen as a hurdle to get over before science can be done. Experienced investigators will understand that even a single episode in their careers in lapses of ethics in science can have very dire consequences for their careers and institutions and for the entire field they’re involved in.”

Whatever training occurs needs to be performed with the culture of the research subjects in mind — something especially important when conducting international research. “This research needs to be done in context,” Nelson said. “Ethic training can’t just be an onerous online series of exercises that are pro-forma.”

At the same time, ethical training needs to be strengthened. Having undergone such training himself, Nelson admitted that he found it to contain very little that helped him to be an international researcher.

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