On July 23, Molly Klote, M.D., heard news she’d been hoping for since early April: Yes, HHS made a mistake when it laid her off from her job as director of the Office for Human Research Protections (OHRP).
“You’re still a government employee. You’re still being paid. I’m waiting to find out how to bring you back,” the human resources (HR) official told her as he read from the personnel system that her termination was “processed erroneously.” That entry was dated July 14—the same day that a letter she’d gotten in the mail identified as her final day of federal service, one of tens of thousands who were part of a governmentwide reduction-in-force (RIF).[i]
On administrative leave since April 1 from a job she’d held for only six months—and that had been vacant the two previous years—Klote was eager to move forward with the more than half-dozen major initiatives she’d quickly undertaken to improve oversight and operation of federally funded clinical trials. These included obtaining funding from another agency for a new staff member to study various provisions in the 2018 revised Common Rule that she believes are not “evidence-based.”[ii]
“And I said, ‘Okay. Well, I’m leaving for Africa on August 20th.’ He said, ‘I’m sure we’ll have an answer before that,’” Klote said, recalling the discussion with the HR official.
That turned out not to be the case, and on Sept. 5, one day back from her photo safari that took her to South Africa, Zambia and Botswana, Klote found herself in the surreal position of resigning from a job she’d been told had ended weeks earlier. “I was just done with the seesaw,” she told RRC. “Done with the ‘You’re in, you’re out, you’re in, you’re out.’ I just decided I was going to come home [from Africa], talk to my husband….but I had pretty much made the decision to get control of my life. As much as it pained me to leave OHRP and the mission, I just got tired of the uncertainty.” For a detailed timeline, see story, p. X.[iii]
OHRP is the lead agency that develops policy and guidance and investigates alleged violations of federal human subject research regulations, also known as the Common Rule, which apply to the billions of dollars of clinical research supported by HHS.
RRC was first to report Klote’s termination, which occurred in tandem with HHS’ dissolution of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Klote’s termination was to have gone into effect June 2, after 60 days of paid administrative leave. She appealed the RIF action, believing that it resulted from an error in the personnel system that placed her in an HHS office that had reportedly seen universal terminations.
“Deciding to leave the federal service after a dedicated 36-year government career is a profoundly difficult decision,” Klote wrote in her three-sentence resignation letter to Dorothy Fink, HHS acting assistant secretary for health. “I wish HHS and OHRP success in their crucial public safety work.”
Klote’s most recent post before OHRP was as deputy director of the Office of Research and Development for the Department of Veterans Affairs (VA); she had been with VA for six years. From 2015 to 2018, Klote was director of the Army’s Human Research Protections Office, and retired from the Army as a colonel in 2018.
Klote told RRC that when she joined OHRP in October, she’d expected to spend six-to-seven years leading the agency.
“It probably would have been my last job in government,” Klote said. “I like to stay in jobs until I feel like I’ve accomplished the changes that need to be made. I like being part of the change solution. I don’t really like babysitting offices that are functioning. My goal always was to go in, get the funding, get the staffing, get the evidence-based work underway and get some changes made to policy, and then I would’ve looked at leaving.”
When terminations first began, HHS Secretary Robert F. Kennedy Jr. acknowledged the speed with which RIFs were done resulted in some mistakes and that some employees would be brought back. Klote had expected to be in that group, but then the letter came on July 18, finalizing her termination.
About a week later, she got the surprising call from the HR official who said it was all a mistake, and promised that the paperwork to bring her back would be ready before her long-planned trip, which she took with her 24-year-old son.
Trip Provided Needed Break
Klote said she kept her possible return a secret from OHRP staff, with the exception of Acting Director Natalie Klein, “because I didn’t want to get anyone’s hopes up. I told her not to tell people until it was official. I started making plans to go back because I believe so strongly in what I went there to do in the first place.”
Klote knew that OHRP had dropped to nine employees from a peak several years ago of 20, the result of the loss of probationary employees, earlier retirements, her RIF and a hiring freeze. Although the situation recently reached a more dire point, OHRP has been chronically underfunded and resourced. For example, a study conducted when OHRP was first created 25 years ago found that it should have 42 employees.
OHRP has not issued any determination letters—which close out investigations or evaluations—since May, but that work continues, she said. OHRP has been able to bring in additional staff from the HHS Commissioned Corp, whose offices were abolished but who were exempt from the RIF, bringing staff to 12. The agency has “at least four people” who are investigating complaints and handling reports of adverse events, according to Klote.
For her part, there Klote was on Aug. 22 in Botswana, still not knowing anything, so she contacted HR from a rare Wi-Fi hotspot for an update. This time, the word was not encouraging: reinstatement letters were on “indefinite pause,” she learned. That’s all the message said.
“And you know what? I had just gotten to Africa, and I basically just said, ‘Thanks for letting me know.’ I just wasn’t interested in following up on it at the moment, because I just needed a break from it,” she recalled.
Klote called taking photos her “feel-good hobby.”
“I don’t do anything professionally with them but post them on Facebook. About 10 years ago, I picked up a camera to be more intentional with my kids,” said Klote, a mother of three. “It forced me to show up to school events. You can get busy in your career. I decided I was going to be the family photographer. Family photos then turned into National Geographic and natural habitat trips all over the world.”
On Sept. 1, Klote was nearing the end of her trip, having just arrived at the Gomoti Plains campsite for what would be a fulfilling couple of days photographing predators—leopards, lions, hyenas and wild dogs. “The only thing we didn’t see was a cheetah.”
She decided to query HR again. Was there an update? Nope, came the answer.
Wait Began to Feel Pointless
Klote then accepted that she had to resign. “I thought, ‘Really? How long am I going to do this?’ I just didn’t know how much longer it was going to go on. The fact that they got around at all to acknowledging that my RIF was an administrative error, I think, shows that they were trying to get through the backlog. [But] we’re getting near to the end of the fiscal year and I started to wonder if there really was an intention to bring anyone back, or if they were just kind of running out the clock on this fiscal year.”
Unlike several former members of OHRP—notably Deputy Director Julie Kaneshiro, Lisa Buchanan, former director of the Division of Compliance Oversight and Yvonne Lau, who led the Division of Education and Development—Klote wasn’t eligible to retire. She had six-and-a-half years of the required 10 years of federal service.
Since April, RRC has repeatedly asked HHS to comment on Klote’s situation, as well as the agency’s decision to abolish SACHRP; no response was received until Sept. 18.
However, the agency did not answer any questions, so many unknowns remain. RRC asked why Klote was terminated and why HHS had not completed the process to bring her back after acknowledging the RIF was an error. RRC also asked if OHRP was still moving to a new Assistant Secretary for Enforcement as had been previously announced under a proposed HHS reorganization. Regarding staffing, RRC asked why HHS had allowed OHRP to drop to nine employees and whether it intended to hire a new director.
“HHS does not comment on personnel matters,” the agency’s Sept. 18 email said. OHRP, it said, “remains committed to its mission to protect the rights, welfare, and safety of people who participate in HHS-conducted or supported studies.”
Klote wrote a “number of versions” of her resignation letter. “In the end, I decided just keep it very short because I’m not interested in pointing fingers,” she said. “I’m not interested in burning bridges. I just want to try to be part of the solution, and I think the best way for me to do that right now is from outside of government.”
She purposely referenced “public safety” rather than subject or participant protections, Klote told RRC, because “public safety was one of the topics, essentially, that were supposed to be protected from cuts. In fact, before I left OHRP, I had changed many of our presentations to talk about our mission as public safety instead of human subjects protection.”
‘I’ll Always Be Sad’
After sending the resignation email, Klote felt disappointed and will “always be sad about how” the OHRP job ended. Yet with that came the end of the “emotional stress” caused by six months of limbo. “I don’t like uncertainty. I like to make decisions and move forward. That’s part of the reason I became a doctor. I like to diagnose and create a treatment plan,” she said.
Klote added that she has “full faith in Natalie Klein to do everything she can to move the office forward and make progress. I wouldn’t be opposed, someday, to returning to government service if the climate permitted. But I, for now, am going to do everything I can from outside of government to advance what I was trying to do in OHRP.”
People have told Klote they share her disappointment. “They’re happy for me personally that the whole kerfuffle is over. But they’re sad that I didn’t get to finish what I started there. They just think it’s a lost opportunity.”
Her termination “was an administrative error, as I said all along, which is good news for OHRP. We weren’t being targeted,” she said. Asked if she thinks HHS will hire a new director, Klote said, “if they ever lift the hiring freeze, I imagine they would.”
Looking back over her truncated tenure, Klote said OHRP “had laid a lot of good groundwork, made a lot of good connections and partnerships. There’s so much to be done. I hope Natalie can keep up some of it. With her reduced staff, it’s going to be difficult. I hope that some of the ideas of what needs to get fixed, at least, will live on.”
Klote: Still Doing ‘All I Can’
Klote certainly hasn’t been sitting still herself.
She authored a 100-plus page book for a trade publisher on how pharmaceutical companies can adapt to changing federal policies and has written six (at last count) opinion pieces and policy white papers she posted on LinkedIn, including one advocating that institutional review boards and investigators consider following her example by enrolling in a clinical trial. “I did not write all these papers overnight; I have been working on them all summer long. I am hoping that the arguments can be used to move policy decisions inside the government,” she wrote in a note accompanying a six-pager on exempting scientific research from the Paperwork Reduction Act.
She also was working on a proposal for work evaluating the human research protections program at a “large” academic institution, the type of work she relishes.
“One of my favorite things is to help research offices get more efficient,” Klote told RRC. “There’s so much local overregulation typically, or complex administrative burdens they’ve put on themselves that they don’t need. Everybody modifies their policies based on that one bad researcher to try to prevent that same mistake from happening again. Then you get all these policies that are conflicting and overlapping. Streamlining programs is what I did in the Army and for the VA as well. I visited many VA medical centers and talked through their process and policies. I love to go into offices and help them try to untangle and get back to basics, but also to ask the goal of a policy. A lot of offices are very focused on the forms they’ve created and the process, and they forget about why they’re doing something.”
Klote is working on a presentation she will deliver on complex innovative trial design at the annual meeting of Public Responsibility in Medicine & Research in November. She hopes to participate in the efforts of the National Committee on Human Research Protections, she said, a panel formed by SACHRP members to continue offering guidance and recommendations to their peers.[iv]
Plus, there are 13,000 photos from Africa to edit.
