Informed Consent by Melissa F Miller

yesterday that—”
    “What on earth did you think you were doing? Why would you meet with attorneys without someone from the legal department present, Greta?”
    She winced at the stern tone and sigh of disappointment but allowed herself to feel a smidgeon of relief at the fact that at least he’d used her first name. “Virgil, it wasn’t a planned meeting. I was checking on our subjects when Athena called and asked me to come by her office. I didn’t even know the lawyers were there,” she protested.
    “All the same, this is a problem. You should have referred them to the university counsel’s office.”
    “You’re right. I’m sorry,” she answered meekly. In point of fact, she wasn’t sorry, not in the least. Trying to handle the situation herself was the right call. It was the most efficient, least disruptive option. Having a team of in-house lawyers crawling all over her lab and her records would waste time, prove distracting, and possibly set her behind in her timetable. It had definitely been worth trying to resolve the situation on her own. The memory of the Alpha Fund’s stance on delays made her shiver. But now a setback seemed inevitable, unavoidable.
    Virgil’s tone softened slightly. “Apology accepted. I’m sure you were only trying to protect your project.”
    Or maybe not so unavoidable. Maybe she could convince Virgil to keep the legal folks at bay. “I was,” she hurriedly assured him. “You may not know this, but we’re at a truly critical juncture in the research. Any distraction from our work would be a huge detriment right now. I still should have followed protocol, of course, but I really didn’t see the harm in explaining to the attorneys that Dr. Kayser’s concerns are misplaced.”
    “Are they?”
    “Are they misplaced?” she asked, seeking clarification.
    “Yes.”
    “Of course they are. You reviewed my informed consent forms yourself. They comply with the DHHS regulations. To the letter.”
    “I pulled out my notes this morning after the call from Mrs. Ray. I stand behind the forms as far as they go, but according to the lawyers, your current research exceeds the scope of the consent. Is that true?”
    She pinched the phone between her ear and shoulder and scrubbed her face with her hands before answering. “I would say no.”
    He sighed. “Go on.”
    “Dr. Kayser’s patients—all of the study participants—were advised of the purpose of the study and what we’d be doing with their blood samples. They signed forms consenting to provide regular blood draws.” She paused and searched the tile drop ceiling for inspiration as she considered how to phrase this next part. “Hypothetically, we either could have conducted a re-interview and gotten a new consent form or, at the outset, could have obtained a blanket consent to additional research. But neither option was practical in this case.”
    “Why not?”
    “Well, at the outset, the study design didn’t call for further research beyond the blood samples, so we didn’t include a blanket waiver. Our results were more promising than even we’d expected, so the study evolved. It happens.”
    “It does. It happens all the time. And new informed consent to participate in the new research is generally preferable to a blanket consent, so I likely wouldn’t have approved your original form had it contained a blanket consent. Which leaves the question—why didn’t you go back to the participants and get new consents?”
    “Two reasons. First, the participants are in varying stages of dementia, Virgil. Any consent they could have given would have been open to attack as not being truly informed.”
    He hmmed his agreement to that.
    Heartened, she continued, “And second, the additional research requires the harvesting of brain tissue. That obviously occurs post-mortem. And, unless I’m mistaken, a non-living research subject is exempt from the informed consent requirements.”
    “Ahhhh.” Virgil drew out the