Institutions that conduct human research generally have a reputation for strict fact-finding, going where the research leads while maintaining firm rules to protect the people who are studied.
If those rules are violated, the consequences can be serious. It’s worse when workers and others are afraid to report violations.
When a study does not follow procedures, patient safety is jeopardized, public confidence in the research institution and the government agency funding the work suffers, sometimes for decades, with the mistrust passing through generations.
Consider the impact of the Public Health Service’s scandalous “Tuskegee Study of Untreated Syphilis in the Negro Male.” Patients were denied needed treatment in the name of science. Launched in 1932, it lasted 40 years and is an example of perverted research with lingering negative consequences.
Now comes an investigative report about deterrents in reporting problems with human research. The Department of Health and Human Services (HHS) Office of Inspector General found evidence of a fear of retaliation among whistleblowers in research institutions.
The human studies are funded by the federal government, but generally done by non-federal institutions, such as universities and hospitals.
The Department’s Office for Human Research Protections (OHRP) does not provide adequate information on whistleblower protections for research employees and others, according to the report. That’s a problem because “fear of reprisals may prevent potential complainants from reporting suspected” violations of “protections for human subjects” in research projects, the report said.
Whistleblowers have been transferred or put in fear of losing benefits.
“Information from whistleblowers is important because it can be insider information,” said Joyce Greenleaf, a regional inspector general. “It can bring to light problems with critical research that puts volunteering human subjects at risk. So, to sustain the public’s confidence in this research, we need people to be willing to bring these concerns to light.”
Pressed for instances, the inspector general’s office offered four cases that were not included in the report:
- A nurse who assisted with neurosurgeries at a medical center told investigators a surgeon delayed operations on patients for weeks to obtain equipment needed for a research study, but not needed to treat patients. “Nurse believes this is not in the best interest of the patients. Other nurses have voiced concerns but were reassigned.”
- An ophthalmology resident in a large hospital said children and adults were enrolled in research that does not have appropriate approvals. Research involves chemotherapy to treat retinoblastoma, a cancer that begins in the retina, the black part of the eyeball. “There have been adverse events. Many research participants do not speak English, informed consent is inadequate and consent forms are not provided in the participant’s native language.” The whistleblower was “not comfortable complaining and does not want retaliation.”
- A student athlete on a university scholarship “alleges that students do not have a choice but to participate in athletic testing research. The coach is in the room during the informed consent process, and the student alleges that the research has blanket IRB (Institutional Review Board) approval meaning that additional testing can be included without additional consent. The researchers are coaches as well as teachers so students feel like refusing to participate may result in poor grades as well as a loss of scholarship.” The student feels a need “to be cautious because this could affect his situation and career.”
- A whistleblower provided “several examples of noncompliance particularly with cancer research trials, such as research not reviewed by the IRB, researchers not following IRB procedures/paperwork submissions, IRB having no protocols for the reporting of adverse events.”
The report had no information on disciplinary actions, if any, against those who violated procedures or retaliated against whistleblowers. Inspector general recommendations for the Office for Human Research Protections included instituting efforts to better inform people on available whistleblower protections against adverse personnel actions such as terminations and transfers.
Existing protections might not be enough.
“Our work raises questions about the adequacy of current whistleblower protections …” the report said. “Elevating this issue would prompt HHS to consider whether a broad review of whistleblower protections is appropriate. Furthermore, it could help HHS determine whether it should seek a legislative change that enables OHRP and other HHS entities that are not responsible for contract or grant oversight management to receive protected disclosures.”
Don Wright, the acting HHS assistant secretary for health, agreed with the recommendations. In a letter to the inspector general’s office, he said information on whistleblower protections will be posted on the agency’s website.
“We agree that elevating this issue could help HHS determine whether it should seek legislative change,” he added.
Meanwhile, “the industry has made a lot of strides in getting human subject protections established and they matter,” Greenleaf said. “And they need to be upheld, and we need to know that individuals working in these environments that see something happening that shouldn’t be happening would be willing to come forward without fear.”