Patients involved in clinical research trials generally assume someone somewhere is watching out for their safety. But who and where has become a matter of controversy.

Since the 1970s, all clinical research involving human subjects has needed the approval of an institutional review board (IRB), a committee responsible for ensuring that appropriate patient protections are in place. IRBs were traditionally made up of scientists and doctors working in the hospitals or universities conducting the research. Nowadays, most IRB duties are outsourced to for-profit organizations, a trend some fear compromises the quality of the reviews.

A recent announcement by the National Institutes of Health is likely to boost the outsourcing trend even further: Beginning in May 2017, federally funded clinical trials conducted at multiple research centers must begin using a single IRB. Because few research institutions have the resources to review protocols across multiple research centers, the new ruling—meant to “streamline” the review process—is likely to force even more universities and hospitals to hire private IRBs.

Outsourcing became popular over the years as the number of clinical trials exploded and institutions found their review boards stretched thin. Commercial IRBs now oversee 70 percent of U.S. clinical trials for drugs and medical devices. Since for-profit IRBs oversee the same institutions that write their paychecks, critics say there’s an inherent conflict of interest.

But neither are nonprofit IRBs free from conflicts of interest, according to Ezekiel Emanuel, head of the medical ethics and health policy department at the University of Pennsylvania. Scientists who sit on academic boards may have a bias toward approving the research protocols of their colleagues. And academic medical centers “get money—as well as access to new drugs and prestige—for conducting the research,” Emanuel wrote in an op-ed for the journal PLOS Medicine. Also, many academics view IRB service as an uncompensated burden, which is not conducive to careful review work, he said.

On the other hand, David Borasky, a vice president at WIRB-Copernicus Group, a popular commercial IRB, believes companies like his can provide faster evaluation of clinical trials and can better oversee multiple-site trials because of their more advanced technology. “In this day and age you don’t have to be sitting in the same building as somebody to have good monitoring,” he told the news website STAT.

But whether profit or nonprofit, Emanuel wrote, “the crucial question is whether an IRB, regardless of its tax status, is performing at a high level of quality.”

Immunity proficiency

In an age when some wish to reduce maleness and femaleness to a matter of self-identity, science continues to reveal distinctions between the sexes. One study, presented recently at a microbiology meeting in Boston, supports research that indicates women tend to have a faster and more robust immune response than men.

In the study, an Australian researcher found that a tuberculosis vaccine given to infants suppressed an anti-inflammatory protein in girls, without the same effect in boys. According to a report in Nature, this boosted the girls’ immune response and possibly made the vaccine more effective for them than for boys.

Marcus Altfeld, a German immunologist, believes women’s stronger immune response may serve to protect developing fetuses and newborn babies.

But the phenomenon may be a doubled-edged sword: The immune system can overreact and attack the body. That may explain why more women than men develop autoimmune diseases such as multiple sclerosis and lupus, Altfeld told Nature. —J.B.