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Nurse researchers work with human subjects to advance health care and improve outcomes.


Can virtual reality alleviate pain? Does yoga help irritable bowel syndrome? How can nursing home staff improve quality of life for older adults?

These are some of the questions researchers at the School of Nursing are exploring with the aid of human research subjects.

Nurse researchers focus their work on optimizing health for everyone, not only those who seek care in a clinical setting. Some of this research relies on data gathered from human subjects, and such research has a fraught ethical history.

Revelations of human subjects’ exploitation in the United States culminated in the 1972 public disclosure of the 30-year Tuskegee Syphilis Study, in which 300 Black men were left untreated for diagnosed syphilis, prompting a report that became the basis for federal regulations. Now, these and other ethical regulations ensure that study participants and researchers are well protected.

UMSON is the only University of Maryland, Baltimore (UMB) school with a staff member dedicated to assisting principal investigators with compliance and quality assurance for human subjects research. The School was ranked 11th nationwide among public schools of nursing in receipt of research funding from the National Institutes of Health during federal fiscal year 2020, and as of late July, UMSON faculty and students were conducting 49 studies using human subjects.

Any research study that gathers information, or data, provided by people is considered human subjects research, explains Erika Friedmann, PhD, professor and associate dean for research. Most UMSON nurse researchers conduct social behavioral research, which examines attitudes, perceptions, feelings, and behaviors, including how they change under different conditions and circumstances. Data gathered from human subjects gives researchers real-time measures, unlike other types of research, such as observational studies that examine large datasets.

UMSON researchers are studying a variety of critical health considerations, including chronic pain (Can placebos and virtual reality reduce the need for opiates?) and sleep (Can sleep education help nurses with work-related sleep loss?), as well as interventions that promote and sustain health across the lifespan. Some nurse researchers bridge laboratory science and clinical human subjects research by examining how genetic or epigenetic characteristics (how your behaviors and environment can cause changes in the way your genes work) are related to disease symptoms and pain.

“A lot of nursing questions can only be answered by doing research with people, but that doesn’t mean everyone is doing something invasive,” Friedmann adds. “Even talking to people or asking people to answer survey questionnaires needs to be conducted ethically to make sure we’re respecting everyone who’s involved in the research.”

The Backbone of Research
Casey Jackson, MS, CCRP, is the research quality manager in the UMSON Office of Research and Scholarship, the only position of its kind at UMB. She assists nurse researchers in navigating the many steps involved in conducting human subjects research, such as quality assurance assessments, regulatory processes, and requirements of the institutional review board (IRB), the UMB committee regulated by the federal Office for Human Research Protections that approves, monitors, and reviews biomedical and behavioral research involving humans.

The School of Nursing is unparalleled in its support of junior researchers, Jackson explains. While there are other research support groups on campus, they don’t share the purpose of Jackson’s position, which is to ensure that researchers fully understand and are compliant with the various regulations. Jackson frequently fields phone calls from junior researchers seeking advice on how to find compliance materials or interpret questions from the IRB. “The School of Nursing’s IRB submissions are so clean because of the thorough vetting and assistance provided by our office, which leads to reduced IRB queries and quicker approvals,” Jackson says.

In addition to providing individualized support for researchers, Jackson also hosts a University-wide monthly seminar series on topics related to human subjects research. “We have high standards for human subjects research ethics, and we take great pride in setting up our researchers for a successful career,” she notes.

Strict policies regarding human subjects research are imperative, not only because of ethical concerns, but to ensure that data are being collected properly. “Now more than ever, we need to have belief in science,” Jackson says. “One of the best ways to strengthen our belief in science is to uphold a positive relationship between researchers and humans volunteering as research subjects.”

That relationship is monitored through a required regulatory binder, a file that contains documents showing proof of compliance and appropriate conduct. For the research conducted at UMSON, nurse researchers must create their own regulatory binders from the ground up. Jackson sought to simplify that process by creating a web-based research toolkit with all the elements and documents necessary to create the binder. “Once this resource became available, everyone was hungry for it,” Jackson says. She spent nearly a year developing the toolkit and binder resources.

Pivoting in a Pandemic
The ongoing COVID-19 pandemic drastically altered human subjects research at UMSON. Many of the School’s active research studies involve interviews and data collection conducted during in-person sessions, including with vulnerable populations in nursing homes and assisted living facilities. During the state’s lockdown phase in spring 2020, all research except that directly related to COVID-19 was paused. As restrictions eased during summer 2020, a University-wide research resumption committee developed new protocols for research projects.

All researchers had to pivot and redesign their studies to comply with new safety measures outlined by the research resumption committee, including altering interview techniques and data collection methods. Those redesigned studies were then submitted to the IRB for review. Despite these challenges, most studies were able to continue in a revised capacity by this past June. As of late July, in-person research at UMSON had resumed, and some researchers are allowed to visit off-campus research sites.

COVID-19 has inexorably altered society as well as the design of future research studies. Even post-pandemic, “we’ll still be thinking about how to do research with as little in-person contact as possible,” Friedmann predicts, indicating that transitioning to digital processes facilitates the work and keeps researchers and subjects safer. Secure software makes it feasible for research subjects to give informed consent digitally and to participate in remote meetings and interviews.

Researchers conducting studies with vulnerable populations may continue to face recruiting challenges. “Moving forward in terms of community-based settings, we’re going to have to be prepared for future outbreaks,” says Elizabeth Galik, PhD ’07, CRNP, FAAN, FAANP, professor and chair, Department of Organizational Systems and Adult Health, who has conducted human subjects research with older adults and advises doctoral students. “Unfortunately, we’re likely to see less research done with vulnerable populations and less well-designed studies with those populations because of access issues to sites.”

The School’s dedicated researchers are forging ahead despite the ongoing pandemic and the possibility of future outbreaks. During the pandemic, Joan Carpenter, PhD, CRNP, ACHPN, FPCN, assistant professor, has had to redesign a clinical trial testing a palliative care intervention for nursing home residents receiving post-acute care. As part of the intervention, nurse practitioners assess and manage symptoms, conduct goals of care discussions, and assist with decision-making, to measure the effectiveness of the intervention on residents’ quality of life. The nurse practitioners then communicate the findings and care recommendations to nursing home staff and primary care providers. Carpenter’s team now conducts all study procedures (e.g., screening, enrollment, data collection) virtually.

“COVID-19 has changed everything with our study,” she explains. “There were 12 nursing homes we were conducting the study in prior to the pandemic, but we’ve only been able to start back up in one. Because we changed so many procedures, we wanted to make sure we were setting nursing home staff, research participants, and research team staff up for success.”

Studies focused on the well-being of nurses, especially those affected by COVID-19, are also a priority among some UMSON researchers. They’re asking how COVID-19 has changed the work environment by gathering data on nurses’ quality of life before and during the pandemic and exploring the impact of stress on their mental health. “We’ve seen all over the news how much we appreciate our front-line workers,” Jackson says. “Saying that is one thing, but to create change and provide more resources you need data.”

The School’s researchers are committed to improving health care locally, nationally, and globally. Rigorous education behind the research bench and at the bedside uniquely positions nurse researchers as leaders in the advancement of nursing science and patient care.

“Nurses are the front line, they see things through a much more engaged lens than other clinicians,” Jackson says. “At UMSON, a great deal of social-behavioral research is being conducted – we could all use more of that to understand the impacts of a whole array of clinical outcomes.”


MPOWERING FUTURE RESEARCHERS
This past summer, four undergraduate students from the University of Maryland, College Park (UMCP) were selected as UM Scholars to serve as interns for UMSON faculty conducting human subjects research. The UM Scholars program is part of a collaboration between UMB and UMCP, the state’s two most powerful public research engines, dubbed the University of Maryland Strategic Partnership: MPowering the State (or MPower).

“The program exposes students to research and to faculty at UMB – it gives them an understanding of things that are going on at our different institutions,” explains Adrianne Arthur, executive director and assistant vice provost for MPower initiatives at UMB.

This year’s UMSON UM Scholars (the program also provides opportunities for UMCP undergraduates at the University of Maryland School of Medicine) assisted researchers studying Alzheimer’s disease and related dementias, pain, and palliative care with human subjects. Luana Colloca, MD, PhD, MS, professor, hosted two students who assisted with monitoring patient compliance, data collection and analyses, and literature reading for pain modulation induced by virtual reality and placebo effects, examining the perception and mechanisms of pain and pain reduction. “The goal is to let them become familiar with basic aspects of human research conduct in pain and pain-related fields,” Colloca says.

Early exposure to nursing research is not only an enriching educational experience but can open students’ eyes to various career paths, Arthur adds. Fifteen out of the 16 students who have participated as UM Scholars at UMSON since 2016, when the School began participating, have matriculated into UMSON’s Bachelor of Science in Nursing program or are planning to do so.

“The earlier we can expose students to research careers and what the work of a doctoral-prepared nurse scientist entails, the better off we are going to be in making sure our profession has highly qualified nurse researchers,” Carpenter says.


 

Fall 2021 Magazine CoverTHIS ARTICLE FIRST APPEARED IN THE FALL 2021 ISSUE OF MAGAZINE.

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 Graphic by: BRIAN STAUFFER

 

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