Informed Consent

by Miller, Melissa F.

  They could and, apparently, did. Sasha was silent for a moment, lost in thought.

  “It’s an honest mistake, Mac.”

  Sasha jerked her head up and met Naya’s eyes. “You mean my mom sharing our address? I know. I’m sure it seemed harmless to her.”

  Her mother didn’t fully understand the fact that there were more than a few dangerous people who would love to know where Sasha and Connelly lived. She did understand a community coming together to support new parents, though. It was simply a function of her frame of reference.

  “You could call the church and ask them to delete it.”

  She could and likely would. But the horse had already left the barn. Closing the door wasn’t going to change anything. “Good idea. Thanks for running it down. Did you find out anything about this Wynn character?”

  Naya shook her head forcefully. “Uh-uh. No. That guy is a cipher. Maybe Hank’ll have better luck.”

  “Maybe.”

  They reached the wrought-iron gate that surrounded the manicured lawns of Golden Village and paused to look up at the building.

  “It looks like some kind of fancy New England prep school,” Naya observed.

  It did. The rolling lawns, the elaborate landscaping, and the gracious, if imposing, brick structure combined to create a feeling of understated elegance and old money. If it hadn’t been for the discreet brass sign that read ‘Golden Village Assisted Living Center,’ Sasha would have assumed the building was a private mansion and walked right past it.

  She and Naya skirted the parking lot and circled around to the front of the building. Stairs led to a wide, shaded porch that was dotted with cushioned seating arrangements. Not one of the chairs or gliders was occupied.

  They stopped in front of the leaded glass doors and smoothed their jackets and hair into place.

  “Ready?” Sasha asked, her finger hovering an inch away from the doorbell.

  “Let’s do it,” Naya answered.

  Before they’d finished announcing themselves to the receptionist, Athena Ray, the administrative director of Golden Village, materialized to whisk them along a gleaming hallway.

  “Please, sit.” She ushered them into her office and gestured toward an old-fashioned couch with scrolled legs, a curved back, and a tapestry-like pattern. “Can I offer you a drink? Tea? Water? Coffee?”

  “Nothing for me, thanks,” Sasha said as she lowered herself onto the couch and looked around the office. It was stuffed with antiques—gilded picture frames, blue-and-white ceramic vases, even a bronze statue of a boy and a horse in the corner behind the executive desk.

  “I’m fine, too,” Naya added.

  The director blinked at them from behind her oversized glasses and arranged herself in a Queen Anne chair across from the couch. “Well, do let me know if you change your mind,” she said with a wide smile.

  Sasha smiled back at her. “Thanks for agreeing to talk with us, Ms. Ray—”

  “Please, call me Athena. And it’s my pleasure. We take our guests’ concerns very seriously. So if there’s an issue with any of the research studies we participate in, I certainly want to know.”

  Naya cocked her head. “Your guests?”

  Athena nodded. “Yes, guests. The residents who live in the independent apartments are called, well, residents, but we refer to those who move into our assisted living and nursing care units as guests. Patients sounds so clinical and unpleasant. In any case, I understood from Ms. McCandless-Connelly that there’s some issue as to whether certain guests in our dementia care unit had consented to research that was performed on them posthumously. Do I have that right?”

  Sasha nodded. “You do. Although I believe the, uh, guests in question signed up to participate in Dr. Allstrom’s study when they were living independently—either as residents or possibly before they moved into the facility.”

  “Center,” the director corrected her.

  “Pardon?”

  “We don’t refer to Golden Village as a ‘facility.’ That sounds so cold, doesn’t it?”

  Sasha bit her tongue. She didn’t want to spend her entire morning playing semantic games with this woman, so she just nodded and ignored the quiet muttering of Naya beside her. “Center, then.”

  Athena beamed her approval as if she were an elementary school teacher and Sasha a diligent, if not very bright, student. “Very good. Now, did you say Dr. Allstrom’s running the study that Dr. Kayser is concerned about?”

  “That’s right.”

  “Well, I can assure you that Greta Allstrom is one of the most well-regarded genetic researchers in the city, perhaps the country. I’m certain that she wouldn’t allow anyone on her team to cut corners, particularly not with regard to consent procedures.” The woman’s matronly teacher persona evaporated and she transformed into the consummate bureaucrat. She pitched forward, leaning in toward the couch. “As you no doubt know, grant funding is tied to compliance with federal regulations. Dr. Allstrom would never do anything to jeopardize her funding.”

  Sasha felt her eyebrow arching toward her hairline and smoothed her expression. Interesting that the faux-personalized luxury resort schtick went out the window so quickly. Forget about any ethical responsibility to the guests, the researchers were worried about their funding.

  Beside her, Naya shifted on the couch, as if she, too, were uncomfortable with the woman’s sudden change in demeanor.

  Sasha held up a hand, palm facing the administrator. “Be that as it may, Athena, Dr. Kayser knows of at least four pat—er, guests—who enrolled in Dr. Allstrom’s study and consented to regular blood draws but who did not consent to donate brain tissue after their deaths. All four individuals were housed in Golden Village’s dementia care unit when they passed away. All four individuals were autopsied; in all four cases, brain tissue was removed and forwarded to Dr. Allstrom. And before you ask, no, in none of the cases was the next of kin either asked or informed about the brain tissue removal.” She nestled herself against the back of the couch and waited.

  Athena blinked rapidly and the color drained from her face. She shook her head. “That’s not possible.”

  “And yet, here we are,” Sasha responded. Naya coughed into her fist to cover a laugh.

  “No. This can’t be right.” The woman seemed to be speaking more to herself than to Sasha and Naya.

  She continued shaking her head as she stood and walked over to her desk to pick up the telephone. “Charles, is Dr. Allstrom in the building this morning?” she asked. After a pause, she said, “Yes, please. Tell her it’s urgent.” She replaced the receiver and looked over at Sasha. “Dr. Allstrom happens to be here today. I’m sure she can clear up this misunderstanding.”

  It seemed to Sasha that the woman was anything but sure, but she just smiled back at her. “Great.”

  Athena returned to her conversation area, and the three of them sat in awkward silence for several minutes. Sasha glanced down at her watch and then surveyed the oil paintings on the walls.

  Finally, Naya cleared her throat. “How many people live here?” she asked.

  Athena brightened, obviously relieved to be back on familiar footing. “We have forty individuals living in one-bedroom apartments and seven married couples, who live in suites in the carriage houses. Collectively, we call those residences the cottages. Our stepped-up care unit is housed in this building and serves up to thirty guests at any given time. The dementia care unit is also in the building. At the moment, I believe we have eight guests in that unit, although there are twelve beds.”

  “The apartments and carriage houses are on the grounds, too?” Sasha asked. She craned her neck toward the window. She hadn’t spotted any other structures, but the property looked like it extended as far she could see.

  “Yes. We own three acres, which, as you can appreciate, is quite an expansive footprint for an urban location.”

  “Three acres?” Naya repeated as if she must have misheard.

  “Yes,” Athena said, an u
nmistakable note of pride in her voice. “We own the entire block. The original property contained this main house, separate servants’ quarters, and two carriage houses. In between, there are magnificent English gardens. We restored the buildings, taking care to keep period-appropriate touches, and then renovated the buildings to serve our residents’ and guests’ unique needs. Golden Village prides itself on blending modern medical technology with elegant, old-world charm.” She finished her spiel with an expansive gesture toward the window.

  Naya raised her eyebrows and asked, “So what’s that cost for your guests and residents? I mean, ballpark.”

  “Costs vary depending on the individual’s situation, but we view aging in place in comfort and dignity as an investment in oneself.”

  In other words, if you have to ask, you can’t afford it.

  Sasha was about to ask about the staff-to-resident ratio when a muffled knock sounded on the office door.

  “Ah, that’ll be Dr. Allstrom,” Athena said as she practically ran to open the door.

  * * *

  Greta couldn’t imagine why she’d been summoned to Athena Ray’s office, but then again, she wasn’t overly concerned. Her relationship with the director of Golden Village was good, had always been good. In part, because Athena was more of a cruise director than a penny-pinching facilities manager. Her focus was on the residents’ comfort and happiness and not on whether the research teams used too many paper towels or remembered to turn off the lights when they left a patient’s room—which made Athena an anomaly in Greta’s experience.

  Her researchers were always glad to be assigned to Golden Village, and not simply because it was so close to the university. Golden Village was a genuinely pleasant place. Greta wouldn’t mind ending up here herself when the time came.

  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 d
id 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?”