Informed Consent (5 page)

So she was unprepared for what she found when the door to Athena’s office swung open, and the director hustled her inside.

Athena was disheveled and slightly out of breath. The only way to describe her glassy-eyed expression was as one of terror. “Oh, I’m so glad you’re here,” she said. The words poured from her mouth in a rush, and she gripped Greta’s upper arm hard with her bony, be-ringed fingers.

“Are you okay?” she asked, genuinely concerned by Athena’s demeanor.

As Athena searched for an answer, Greta’s eyes drifted over Athena’s shoulder. Two women in business attire were sitting on Athena’s Victorian couch, leather attaché cases at their feet. The African-American woman had short hair, styled back and away from her face to show off high cheekbones and clear skin. She wore a crisply tailored pantsuit with a lavender-colored collared shirt. The white woman was tiny, almost elfin, with wavy dark hair twisted into a high knot and pinned back. She wore a pink sheath dress with black piping and a long pink suit jacket. She was also wearing a pair of impossibly high stilettos—soft black leather, with pink stitching.

Greta sucked in a big whoosh of air.
Lawyers.
They may as well have been wearing flashing ‘Esquire’ signs around their necks. Under ordinary circumstances, she would have toed the university line and immediately called the legal department to ask for representation. Then she would have kept her mouth firmly shut until someone with a legal degree and bar admission card showed up to speak on her behalf.

But these weren’t ordinary circumstances. She answered to two masters, and she was certain the Alpha Fund would not be amused to hear about legal machinations slowing down her work. It was better to see what these women wanted and figure out a way around it. Pronto.

Her eyes flew back to Athena’s face. “What’s going on?”

“These ladies have some questions about your research, Dr. Allstrom. Please, come sit.” Athena seemed to get herself back under control. At least her broad smile was back. And her voice was the usual mix of soothing and lilting.

Greta followed Athena across the office, while the lawyers stood to greet her. Although Greta figured the black one for the senior of the two, the small, white one stepped forward first.

“Dr. Allstrom, it’s nice to meet you. I’m Sasha McCandless-Connelly, and this is my associate, Naya Andrews.” The McCandless-Connelly woman gripped her hand in a surprisingly strong shake, which caught Greta slightly off-guard. She took a closer look at the small woman and noticed that she wasn’t delicate, just sinewy. Scrappy, even.

“Ms. McCandless-Connelly,” she replied in greeting before turning to the taller woman.

“Ms. Andrews,” she said.

“Pleased to meet you, doctor,” Naya Andrews replied, extending her hand for another firm handshake.

With the formalities taken care of, Greta turned back to Athena, who was hovering at the edge of the Persian rug. “So, what’s this about exactly?”

Athena’s hand fluttered nervously toward her neck, but she caught herself and lowered it. “Ms. McCandless-Connelly and Ms. Andrews are attorneys.”

“You don’t say,” Greta deadpanned.

“Yes. They’re here because Dr. Kayser has raised some concerns about our, well,
your
, informed consent procedures.”

Greta blinked. “What kind of concerns?”

“Why don’t we all sit down? I’m sure Ms. McCandless-Connelly can explain it better than I.”

The lawyers returned to their spots on the sofa, and Greta took the nearer of the two chairs. Athena sat down in the other.

“I’d be happy to catch you up on our conversation with Athena,” the little one said. “But, feel free to call me Sasha. McCandless-Connelly’s a mouthful, I know.” She gave a little laugh.

Greta smiled politely.

The lawyer continued. “As we were explaining to Athena, Dr. Kayser contacted us on behalf of several of his patients and their families.” She paused. “Do you know Dr. Kayser?”

“I know of him. We’ve crossed paths here, and elsewhere. But he’s a clinician, and I’m a researcher. So we haven’t had much occasion to interact.”

The attorneys nodded in unison, and Sasha scribbled a note on her legal pad. Greta tried not to let the fact that her words were being recorded throw her off-balance. Despite Athena’s evident case of nerves, she knew she had nothing to worry about. Her research protocols always complied with the letter of the relevant regulations.
Always.

“You may or may not know that Dr. Kayser is a strong proponent of your research—well, all research—into aging-related dementia and cognitive impairments. He actively encourages his patients to enroll in studies like yours.”

She didn’t know that tidbit, but she was glad to hear it. “Good. We need more doctors like him if we want to eradicate dementia.”

Naya jerked her head back sharply, as if some unseen hand had pulled her hair. “Eradicate dementia? That’s a pretty impossible goal, wouldn’t you say?”

“I wouldn’t say that at all. My team is very close to unveiling a drug delivery system that would enable the human brain to repair itself,” Greta told her in a matter-of-fact voice.

The two women sitting across from her exchanged skeptical looks. Greta hardly noticed. She was accustomed to naysayers doubting her. But Athena reacted.

“It’s true. There’s a team working on nano-robots right now,” she enthused.

“Nano-robots?” Sasha echoed.

“Yes. However, I really can’t get into the details just yet. I’m sure you understand. And, I don’t mean to seem rude, but I am quite busy. Could you just tell me what precisely is troubling Dr. Kayser, so I can put your minds to rest and get back to my work?”

The request had the desired effect. Sasha was visibly chastened.

“Oh, of course. I’m sorry. Multiple patients who were enrolled in your study were given information about your research and signed consent forms agreeing to provide regular blood samples.”

“Ah, yes. The informed consent materials were reviewed by the IRB at the outset of the study and deemed sufficient. And?”

“And, as you are no doubt aware, you never asked for permission to harvest their brain tissue, but you did it anyway.” Sasha settled back against the couch and gave her a look that said, ‘let’s see you weasel your way out of this one.’

A wave of relief washed over Greta. If that was the extent of Kayser’s concern, she could explain it easily. She took her time forming her answer, though, because she wanted to make sure the two lawyers would get the clear message that they were on a wild goose chase and back off. She couldn’t afford to be distracted with legal wrangling, not at this critical point in the project.

“I assume you familiarized yourself with the Common Rule that the Department of Health and Human Services promulgated?”

Sasha answered instantly. “I have. DHHS requires that researchers obtain informed consent for federally funded research that involves the collection of data from living people with whom the researcher interacts directly. I’m paraphrasing, of course, but that’s the gist.”

“Right. And you said it yourself. Consent is required from
living
people. The Common Rule doesn’t apply to tissue obtained postmortem. You don’t think I took brain tissue from living people, do you?” She laughed at the notion.

Naya cocked her head and narrowed her eyes. Sasha sat up straighter and stiffened her spine.

“No,” the 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.”

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 and neck.

“It’s Hank.”

“What’s going on?” He glanced at the time display on the oven.
5:45.
Since adopting the six Bennett children, Hank rarely worked past four o’clock. He did, however, make exceptions for national security emergencies. “Is something going down?”

“What? Oh, no. The kids are over at the neighbors on a scavenger hunt. I checked my messages and already had the results on that search we talked about, so I figured I’d give you a call while I can hear myself think.”

“Already? That was fast.”

Hank chuckled. “I may have put a rush on it. Anyhow, he’s clean.”

Leo knew better than to say Wynn’s name on an unsecured line. “No flags?”

Hank huffed out a breath. “No flags. But it’s a slim file. He’s got a year of birth of 1948, but from birth until mid-1975, your guy was a ghost.”

“Meaning?”

“For the first twenty-eight years of his life, he may as well not have existed. No school records, no driver’s license, no draft registration. Nothing.”

“You think he’s a spook?”

“It crossed my mind. He could be one of us.”

Leo pondered the possibility. If another federal agent had information about his father, why wouldn’t he just go through official channels? Unless the information could cast a shadow on Leo and endanger his own standing. Even though he was a contractor now, he’d been a federal marshal for several years—this could be an effort to protect him.

Valentina poked her head into the kitchen. “Leo? Do you need any help in here?” She noticed the phone to his ear and mouthed ‘sorry’ before retreating to the living room.

He waited until he heard her resume her high-pitched stream of chatter directed at the twins then lowered his voice a notch and said, “You think it’s safe to meet with this guy?”

Hank answered instantly, as though he’d been waiting for the question. “Ah, heck, Leo, I don’t know. It’s a risk. How big of one? No telling. All I can say, is this guy doesn’t have a record or anything approaching a flag. He’s allegedly a retired fisherman, apparently did well enough to buy that house in Maine with cash.”

Cash home sales were yet another tell that suggested Wynn was, or at least had been, undercover at one point in his career.

“Hmm. Nothing on the prints?”

“Oh, we got some hits on the prints. All yours. Do you need a refresher?”

Leo ignored the jab. “Thanks for the intel.”

“Don’t mention it.”

He knew Hank intended for his words to serve as a literal admonition. They’d both have some explaining to do if Hank’s database queries traced back to Leo’s personal life. The government tended to frown on using their resources for personal purposes.

“Understood.” He eased the roasting pan out of the oven and rested it on the stovetop.

“Have a good night.”

“You, too.”

“And Leo?”

“Yeah?”

“If you go up to Maine to meet this guy, take a friend.”

“Right.” Leo had no plans to travel to Great Cranberry Island without his Glock.