Read Online Informed Consent by Melissa F Miller - Free Book Online

senior lawyer said, “I trust you waited until they died. But you can’t seriously be claiming an exception to the Common Rule because you enrolled living participants in a study, obtained specific consent, and then just waited for them to die. You could and should have obtained consent for the brain tissue study before they died. You had a duty to do that unless your IRB waived follow-up consent. Did it?”
    Greta exhaled loudly. “That so-called duty is a gray area, at best.”
    “Did the IRB waive follow-up consent?” Sasha pressed.
    “No.”
    “And you knew who the study participants were, right? I mean, you had research assistants coming into their rooms to draw blood on a regular basis. Why not just send them in with an explanation of the brain tissue study and a new consent form? Was it because you thought they’d opt out?”
    She saw the trap a mile away. If she said yes, she believed the patients would decline to participate, she was admitting the research was improper. If she said no, she believed they would have gladly participated, then why hadn’t she simply obtained consent? It was one of those lawyer trick questions she always saw on television.
    “You mean ‘when did I quit beating my wife’? The simple truth is that trying to obtain consent from dementia patients is a risky business. They may have had the capacity to consent at the outset, when they agreed to the blood draws, but once a patient finds himself or herself on a locked dementia ward—well, Athena can tell you, that patient is unlikely to recognize family members or know what year it is, let alone consent to participate in a research study.”
    “And you think that’s a justification to disregard their autonomy?”
    “No, that’s not what I said. I stand behind my work. The Common Rule doesn’t require me to obtain consent from deceased people—it’s as simple as that. And I really don’t have time to argue about it with you. My work is time-sensitive and, frankly, too important to allow myself to get mired down in complying with unnecessary regulations. I complied with the requisite rules. My IRB hasn’t said otherwise.” She stood and turned to Athena. “Now, if you’ll excuse me, I have work to do.”

11
    L eo thanked his mother-in-law and tried to steer her out the front door. She’d had her coat on for at least ten minutes, but she was doing a cooing version of the cha-cha. One step toward the door, two steps back for one last cuddle with Finn and Fiona, who were happy for the interruption to tummy time.
    “Valentina,” he began as she turned away from the door and crouched beside Finn to perform the universal peek-a-boo gesture.
    She looked up at him with large green eyes so like her daughter’s. “Oh, I’m so sorry, I’m sure you’d like to get on with your day. Silly Grandma.” She eased to standing. “Anyway, Leo, call any time you need a hand. I just love spending time with the twins.”
    He considered her for a moment. Then he said, “Actually, I was just wondering if you’d like to stay and join us for dinner. Sasha should be home pretty soon.”
    Her entire face lit up, and she graced him with a smile that stretched from ear to ear. “Oh, Leo, I’d love to. Pat is over at Sean’s helping him rewire his dining room chandelier. I was planning to zip by Panera and get some soup for myself.”
    “Not on my watch,” he told her. He held out his arms, and she deposited her coat into them then kicked off her shoes and joined the babies on the floor.
    He hung her coat and then headed to the kitchen to put the finishing touches on the meal. He’d roasted a large chicken in a pan with autumn vegetables, planning to have leftovers for his lunch for the rest of the week. There’d be more than enough for Valentina.
    As he dressed the salad and set the table, his mobile phone vibrated in his pocket.
    “Connelly,” he said, balancing a stack of plates in his palm and sliding the phone between his shoulder