Emergency research is essential to improving healthcare, but following regulatory human research protection rules can be challenging — particularly with informed consent.
Researchers studied the use of a two-page, full consent form, given by paramedics to patients who suffered a traumatic injury. Investigators conducted a randomized controlled trial that compared prehospital fentanyl/intranasal ketamine to fentanyl/placebo in patients with traumatic injuries. Paramedics provided patients informed consent before administering pain medication and transporting them to the hospital.1
“The study is being done in the field with EMTs, and it did not qualify for waiver or alteration of consent,” says Michael Linke, PhD, CIP, IRB chair and volunteer associate professor of medicine at the University of Cincinnati.
“We developed a two-page consent form that contained all required elements for FDA studies and had a signature line,” he says.
The IC form includes straightforward, condensed language, and doesn’t require HIPAA authorization, he adds. (See sample from two-page consent form in this issue.)
Initially, the IRB and research team discussed wanting brief consent forms of eight pages, says Jason McMullan, MD, FAEMS, principal investigator of the study, ED physician, and associate professor of emergency medicine at the University of Cincinnati College of Medicine.
“We worked together as a team to make sure the document was true to the spirit of informed consent, had the required elements, and was written at a level that would be easily understandable so that we could get informed consent in this atypical environment,” McMullan says.
“For this study, the primary objective is initial pain control side effects, collected directly from subjects, and so we don’t have to access medical records for that,” Linke adds.
Any patients that normally would receive a pain medication and who qualify for the study could be enrolled in the study and eligible for the add-on drug, says Emily Werff, senior regulatory coordinator at the University of Cincinnati’s department of emergency medicine.
“The mechanism of injury doesn’t matter,” Werff says. “Some victims have had gunshot wounds; one had a broken femur.”
EMTs ask patients if they’re interested in the study and, if the answer is “yes,” patients receive the consent form. More than 150 paramedics were trained in the consent process, the study, and human research protection, and the training is continuing, Linke says.
“Patients have to be conscious and able to provide consent,” he explains. “One potential subject was too inebriated to provide consent.”
Studies of patients in pain are not new, but a study beginning outside of the hospital setting was novel and challenging, McMullan notes.
“We have five people enrolled in it, right now,” he says. “One person had both arms broken and still signed the informed consent.”
The medic’s training was so thorough that one person caught a potential problem prior to enrolling a patient, McMullan says.
“We had one very nice case where the person met all inclusion criteria,” he says. “They screened the patient and started to get consent, when the medic realized that the person had a concussion.”
The medic was not convinced that the patient knew what was happening with the study, so the patient was not enrolled.
The FDA required the study to apply for an investigational new drug (IND) because the ketamine solution would be administered intranasal, and the solution was approved for intravenous and intramuscular use, but not intranasal.1
Researchers initially thought the study would not involve more than minimal risk or require an IND, but the IRB that reviewed the protocol disagreed. “The IRB felt it was more than likely greater than minimal risk and that it might need an IND from the FDA, so we asked Dr. McMullan to consult with the FDA,” Linke says.
If the FDA had said the study was no more than minimal risk, then full consent would not be necessary, he says.
“We could have had an altered consent process with a script read to patients,” Linke explains. “But the FDA reviewed it, and they felt similar to the IRB, and they required full informed consent.”
1. Linke M, McMullan J, Werf E. FDA and IRB approval of a novel prehospital consent process for emergency research. Presented at PRIM&R 2017 Advancing Ethical Research Conference, Nov. 5-8, 2017, San Antonio. Poster 27.