Ethics and consent in research
Case text (Anonymised)
A letter was sent to the chief editor of our journal in response to a recently published article in our journal. The author had serious concerns about the ethics and consent obtained as a result of this study and the follow-up by the researchers.
The author explained that he was the physician of two of the “volunteers” who participated in this study and was concerned about informed consent procedures in the trial. Specifically, workers never provided informed consent that their tests, mandated by a company medical monitoring program, be used in any “research” study. His concerns were in four areas.
(1) The researchers failed to inform both the company and the injured workers that they should have been removed from further exposures when their test results showed severe impairment.
(2) The researchers failed to report abnormal findings to the workers in a timely and appropriate manner, a failure that placed these workers’ health in jeopardy.
(3) The researchers failed to fully inform the workers of the known risks of exposure.
(4) The timing and location that the researchers used to obtain signatures on the informed consent forms did not permit the workers to adequately question the researchers and become informed.
One of the author’s patients who was studied was a previously (pre-employment) healthy 40-year-old woman who was found after a period of time at work to have abnormal results. However, no doctor contacted her to explain the results and written communication did not describe them as serious, and so she did not seek further medical attention. Her tests were repeated again one and two years later. The two year test indicated more severe disease. These findings were reported to her 10 months later by one of the researchers who failed to mention their significance in his cover letter to the radiologist’s report. Given the patient’s history, she should have been removed from work immediately, and the researchers should have reported this case of occupational disease to the state authorities. The following year, she sought care from a non-corporate physician and was removed from work the same day.
Another patient of the author’s had abnormal test results in 2005, which were markedly worse on repeat tests conducted in the same year. The researchers wrote to her in September of 2005 and advised her to have a CT scan and repeat testing. A year later, a member of the researcher’s group ordered a CAT scan. In November 2006, the CAT scan revealed moderately severe disease. The patient requested that these results be forwarded to her personal physician. At the time of the author’s first visit with her in late August 2008, she had never seen the results, and neither the company nor the researchers had communicated with her about her condition or continued occupational risk. The author requested that the researchers send him her complete medical records, including communications with the company and the research protocol. However, only incomplete records were sent, omitting the research protocol and including none of the communications with the company.
In October 2008, the author wrote to the IRB Director and filed a formal complaint concerning these matters informing them that one of the researchers was both a paid consultant advising on occupational health procedures while simultaneously conducting the research/monitoring program. This researcher based his published paper on a mandated monitoring program in which the “volunteer” workers had to participate as a “condition of work” in order to keep their jobs. The “research” was based on test results for which full consent had not been obtained. The Director of the Office of Research Compliance and Regulatory Affairs responded in February of 2009, stating that although the committee’s investigation determined that “no misconduct occurred” with respect to any violation of IRB policies, their findings prompted them to institute “modifications to our processes that will help us to continue to raise that bar.” The author concluded that “IRB protocol modifications” were based on an acknowledgment that the researcher’s study violated patient rights, even if the study did not violate IRB rules. The author believes that journal editors have a responsibility to investigate allegations like these.
All agreed that this was a very serious matter and possibly of criminal concern and were surprised that the complainant had not taken any more action or taken the matter up with the medical authorities or the police. If medical staff are aware of abnormal test results and they do not tell their patients, the staff should be reported to the GMC in the UK or to a similar authority in the country where the research took place. The editor should contact the authors and ask for a detailed copy of the ethics approval. The editor should explain that he has had a complaint about the paper but he should not divulge the name of the whistleblower. The editor should also ask for copies of the consent forms.
It was suggested that the editor might want to consult the flowchart on “What to do if you suspect an ethical problem with a submitted manuscript”. All agreed that this case has wider implications than ethics or patient consent and that the whistleblower should pursue other avenues. There is little that the editor can do other than to contact the authors and request an explanation. All agreed that the journal cannot offer due process to investigate the concerns itself but must leave this to the institution involved or the committee that gave ethical approval for the research.
Following the advice from COPE, the chief editors wrote to the authors of the paper to mention that we had received a complaint regarding the ethics of the paper. The chief editors asked for proof of approval of the study from the authors’ university and also the patient consent forms. These were both received from the authors and the chief editors were happy with the documents provided and have therefore taken no further action.