Case study

Dan did not have an advocate when he signed the ten-page-long consent form.

The investigator told the ethics committee that each participant would have an advocate, but a social worker was assigned to Dan only three days after he signed the consent form. Dan’s mother, Mary, was not involved even though she would have been an appropriate advocate.

At the time of his recruitment, Dan was in very vulnerable circumstances as he was under a court order to cooperate with the treatment plan devised by his psychiatrist (also the principle investigator of the trial). Failure to cooperate would lead to his admission into a psychiatric inpatient unit. Without an advocate, Dan could have been easily threatened into consenting for the trial, although he was under no obligation to do so (because research is not treatment).

Dan’s ability to provide informed consent was evaluated by research staff who was under pressure to recruit.

Dan was deemed to be competent after evaluation by two research staff who were also responsible for taking his consent. One of the staff was the study’s coordinator. At the time, she was facing difficulties reaching her recruitment goals because several patients’ parents had already ‘put the pressure on and said, “NO.”’

Mary’s concerns were not taken seriously nor followed up promptly.

Dan signed a release that allowed the research team to disclose his medical information to his mother. Mary took great efforts to contact the research team,making phone calls and writing letters to the research coordinator, Dan’s psychiatrist and the head of the department when she noticed that her son was getting out of control,. Many of these attempts were not responded to, or only documented and followed up after several days or weeks.

The review from the Office of Legislative Auditor (OLA, 2015, pg. 18) stated that:

‘When a family member takes the time to compose a letter (...), common courtesy requires an acknowledgement that the letter was received and a response, even if brief’

‘The study team should have built a more open and collaborative relationship with Mary Weiss. (...) Even if the team ultimately ruled out her concerns, it should have explained the reasons why so that she knew that those caring for her son had heard her and considered her observations.’

Mary was never told that the university has a research ethics committee, and no one ever offered to help her lodge her complaints.

The consent form that Dan signed provided information on where family members could direct their questions or concerns. Dan’s mother never saw the consent document and was ultimately left to feel hopeless in getting help for his son.