Informed Consent

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Informed Consent Page 7

by Miller, Melissa F.


  “I really don’t think this is a good idea,” he continued.

  “Look. I’ve been more or less cocooning with Finn and Fiona for months. Don’t get me wrong, it’s cozy. But, I think a little getaway is exactly what I need. What we need. There’s been a dearth of adventure in our lives.”

  He dragged his fingers through his thick, dark hair then gulped his drink. “No adventure,” he said firmly.

  “Fine. Activity. There’s been a dearth of activity. I solemnly swear that while you’re meeting with Wynn, the babies and I will be engaged in safe, non-adventurous tourist activities.”

  The faintest hint of a smile developed on his lips. “Such as?”

  She thought for a moment, trying to come up with suitably staid-sounding options. “Such as browsing antique stores and touring museums. Maybe we’ll go wild and check out a story time at a library or bookstore.” She fixed him with her most dazzling smile and blinked innocently.

  An actual laugh escaped from his throat. “It’s pointless to fight you on this.”

  “It’s pointless to fight me period, end of sentence,” she corrected him.

  He nodded wryly and then leaned in to cover her mouth with a kiss. “Amen to that.”

  Fiona whimpered in her sleep. Sasha rested her wineglass on the side table.

  “I’m so glad you’ve seen the light.” She rested her hands on his warm chest for a moment. “I’m going to take Fiona up to bed to feed and change her. Bring Finn up after you finish your drink?”

  “Okay.”

  “I love you.”

  “I love you more,” he responded.

  She bent and gently moved Finn’s arm then scooped up Fiona and headed for the staircase. As she mounted the first step, she thought she heard Connelly mutter something about, “Not what Hank meant when he said bring your friend.”

  She paused and turned. “I didn’t catch that,” she stage whispered, cradling Fiona against her chest.

  “Nothing important. I’ll be up in a few.”

  She held his gaze for a moment, but he didn’t say anything further, so she continued up the stairs.

  13

  Greta squinted at the test results on the monitor, searching for a pattern in the noise. The soft rap on her office door barely registered. After a moment’s delay, she swiveled her chair toward the entrance and called, “Come in.”

  The door opened. Mikki Yotamora craned her neck and stuck her head into the opening and said apologetically, “Sorry to disturb you, Dr. Allstrom. Director Buxton called the lab and asked to speak to you and, well, none of us knew how to transfer the call.” The graduate student gave a sheepish laugh.

  Greta tried to hide her surprise at the news that the director of the Institutional Review Board was looking for her and searched her memory for the instructions for transferring a telephone call. “Thanks for coming to find me, Mikki. Place the caller on hold, hit star 7, dial my extension, hit the TRF button, wait for the tone, then hit the hold button again.” As she recited the directions, she scribbled them on a post-it note. She handed it to the researcher. “Here, you might want to post this by the phone.”

  Mikki bobbed her head in thanks and snaked her arm into the small space to take the slip of paper. “Thanks, Dr. Allstrom.” She pulled the door shut, and Greta could hear her quick footsteps as she hurried down the hallway back to the lab.

  Greta used the delay to save her work and close the window on her computer so she wouldn’t be distracted during the call. There could really be only one reason Virgil Buxton would be calling her: Golden Village and the visit from the blasted lawyers. She should have known it would get back to him. She closed her eyes and took a centering breath. Last semester, the university had sponsored a mindfulness seminar for the faculty. Although she’d pooh-poohed the notion at the time, she figured it couldn’t hurt now. Any port in a storm and all.

  The phone came to life on her desk. She opened her eyes and lifted the receiver. “Virgil?”

  “Dr. Allstrom,” he responded, all business, “I understand from your student that you’re in the middle of something. I apologize for the interruption, but this is important.”

  “Of course.” She was thrown slightly off-balance by his formal tone. Although Virgil Buxton wielded enormous power, he usually projected an affable, friendly persona. This bureaucratic version of Virgil did nothing to assuage her worry.

  “I received a call from Athena Ray this morning.”

  She groaned inwardly. She’d thought she’d managed to smooth things over with Athena before she’d left Golden Village yesterday afternoon. Apparently, she’d thought wrong.

  Virgil seemed to be waiting for her to say something. “Is this about Dr. Kayser’s issue with my informed consent procedures?” she asked, knowing full well that it was. “I explained to his attorneys 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 resear
ch 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 sound, and she could imagine the lightbulb click on over his head as understanding dawned.

  She waited a moment for him to fully consider the situation then said, “So, we’re good. Right?”

  He waffled. “Technically, your program may be compliant.” He hesitated and then said, “But it’s a little too cute.”

  “Too cute?”

  “Please understand, I don’t believe you’ve done anything untoward—”

  “Good. Because I haven’t.”

  “However, surely you can understand that it looks a bit off. You enroll competent seniors into a study to draw their blood, wait until they’re in full-blown dementia, add them to your brain tissue study, and then wait for them to die.”

  “That is assuredly not what I do,” she protested.

  “That’s how it looks, Greta.”

  Her frustration level was rising, threatening to overflow and undo all the gains she’d just made with Virgil. She couldn’t afford to let that happen—he was her lifeline to funding for the drug trials. Completion of the drug trials was her lifeline to the Alpha Fund’s nano-robotics investment. And failure was out of the question. She forced herself to take a long, slow breath before she responded.

  “I’m sorry to hear that it looks that way. I don’t want to upset any patient families or clinicians—that’s the last thing I want. But changing the project design now would be disastrous. All the work to this point would be for nothing. What can I do to ease your mind and keep the study on track?”

  It was Virgil’s turn to take a deep breath. She listened to his loud exhale and prayed he’d tell her to just stay the course.

  He didn’t.

  “It’s not my mind you need to ease, Greta. If I were you, I’d reach out to Dr. Kayser—not through his lawyers, mind you. Contact him directly and walk him through what you’ve just told me. You need to get him on board.”

  The ominous note in his voice wasn’t lost on her. “Or else?”

  “Or else, I’m afraid, I’ll have to freeze your funding until you re-interview all of the patients and obtain new, expanded consent. I’m sorry, Greta.”

  “So am I.” Sorry didn’t begin to cover it. She was terrified.

  “Don’t concede defeat just yet. See if you can’t persuade Dr. Kayser. You can be very convincing, you know.”

  A sliver of hope pushed through her dismay. Convince Dr. Kayser.

  “Thanks. Virgil. I appreciate your candor. Now, if you’ll forgive me, I really do need to get back to my work.”

  “Of course, of course.”

  She ended the call and stared blankly at the whiteboard that hung over her desk, not seeing her scribbled formulae, scrawled reminders, and notes about appointments.

  Convince Kayser—one way or another.

  * * *

  Doug reclined against the stack of pillows piled high in front of his headboard, which he’d carefully arranged just so to prop him up to a half-seated position, and sipped his lukewarm broth. After a moment, he noticed that the answering machine light was blinking. A red numeral 2 flashed on the display to let him know his answering machine had recorded two messages while he’d slept. He leaned over and pressed the play button.

  “Mr. Wynn, this is Marie from Coastal Oncology Specialists, calling to remind you that you have an appointment tomorrow, October 20th, at eleven o’clock. If you can’t keep this appointment, please call the office to reschedule.”

  Could it really already be October 19th? He pushed himself up onto his elbows and squinted at the date on his wristwatch. Yes, it really was. Just three more days and he would know if his son would stand by him. Three more days. He sunk back against the pillows.

  “Doug? It’s Stevey. My errand boy seems to have gone missing. I don’t suppose you know where I might find him, eh?” Stevey’s voice was wry and knowing. Doug shook his head. Apparently Stevey would never learn. If he knew—or even suspected—that his messenger was in a shallow grave, why on earth hint at it aloud, let alone on a recorded message that could theoretically be discoverable evidence some day.

  Stevey’s message continued:

  “Oh. A friend of mine who works for the airlines gave me a head’s up. Leonard Connelly booked a ticket on a flight to Portland. Actually, he booked two tickets. Anyway, it looks like he’s headed your way. I hope it works out for you, old friend.”

  Doug’s emotions cycled through excitement that his son was coming; irritation that Stevey had overstepped—he hadn’t asked the man to monitor flights; anxiety about the fact that his son was apparently not coming alone; and, strangest of all, comfort from the genuine concern he detected in Stevey’s voice. The news that Leonard was bringing someone with him resonated most strongly. Doug knew that his son had, at one time, been employed by the U.S. Marshal’s Service. Although records showed him to be retired, Doug believed the maxim ‘once law enforcement, always law enforcement.’ A cold finger of uneasiness trailed along his lungs.

  He considered calling Stevey to get more details about his son’s traveling companion but decided against it. He didn’t want to involve Stevey any more than necessary in his personal business. If the meeting with his son went poorly, the less Stevey knew, the better. No, the prudent course would be to prepare for his visit as completely as he could in the next three days. Two days, he corrected himself. Tomorrow would be taken up entirely by the long trip to the oncologist’s office.

  He gulped down the remainder of his soup, grimacing at the taste of the now-cold liquid. But he needed nourishment to keep his strength up. There was much to do before Leonard arrived. Much to do.

  He swung his legs over the edge of the bed and pushed himself to standing. He was tough, he reminded himself. And unafraid—he added mentally—rolling up the sleeve of his pajama top and gazing for a moment at his faded tattoo.

  14

  Sasha appraised the diminutive woman who struggled down the aisle, wrestling with her suitcase as she bumped against the seats that edge the narrow pathway. She was smaller than Sasha—which was rare in itself—but looked friendly, if harried. Late middle-aged, maybe older. So even if she didn’t have children of her own, surely she’d been exposed to them in some capacity—as an aunt, a godmother, a neighbor? Please let her have the seat across the aisle, she willed silently.

  Better her than the sour-looking businessman who interrupted his haranguing cell phone call long enough to roll his eyes at her as she juggled both babies while Connelly engaged in whatever top-secret machinations allowed him to conceal carry his weapon on a commercial flight. And definitely better her than the gaggle of bridesmaids and already tipsy bride-to-be who’d stumbled past on their way to the back, tiaras and sashes crookedly in place. Maine in late October seemed like an odd destination for a bachelorette party, but she wasn’t one to judge.

  She simply wanted to survive the plane trip with a minimum of nasty looks and muttered comments. It seemed that merely appearing in public with infant twins was enough to ruin some adults’ days.

  The woman stopped, checked her ticket, and scooted into the seat across the aisle from Sasha. Yes, Sasha celebrated silently. The woman tried in vain to hoist her suitcase above her shoulders to jam it into the overhead compartment. She rested it on the seat and then tried again. Another miss. Ah, the
travails of the petite.

  The woman’s seat mate, a thin man in his twenties with a soul patch and a sketchbook lolled his head against the window, sleeping. He wasn’t going to come to her aid. Sasha sensed the opportunity to buy some good will.

  “Excuse me, ma’am?” she said.

  The frazzled woman turned. “Yes?” Her eyes were enormous, magnified behind her glasses.

  “If you’ll hold my babies for a moment, I can get that up there for you.” She nodded toward the suitcase.

  “Oh … I can call the flight attendant.” She trailed off and looked at the stream of passengers making their way along the aisle. It would be quite some time before a flight attendant would reach her. In the meantime, Sasha was sitting right there.

  “It’s okay, they don’t bite. No teeth,” she assured the woman with a smile.

  The woman gave a little laugh and held out her arms. “Thank you. That’s very kind. I must warn you, though, it’s been a long time since I’ve held a little one.”

  Sasha eased Fiona into the woman’s open arms first. Fiona immediately curled a tiny fist around the woman’s shoulder-length hair and gave it a tug. Then she placed Finn in the crook of the woman’s free arm. He batted his eyelashes and cooed up at her as if he were taking stage directions. She hurriedly grabbed the suitcase and hefted it overhead. It landed with a thud in the compartment, and she retrieved the twins, gently prying Fiona’s fingers off the woman’s hair in the process.

  “Thank you so much,” the woman breathed. She held onto Finn a split-second longer than absolutely necessary, and Sasha concealed her smile.

  Mission accomplished.

 

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