Medical Research Officers at the Clinical Research Centers
Who are MROs?
- A medical research officer (MRO), available at each of the four Harvard Catalyst Clinical Research Centers (CRCs)—Massachusetts General Hospital (MGH), Brigham and Women's Hospital (BWH), Boston Children's Hospital (BCH), and Beth Israel Deaconess Medical Center (BIDMC)— assists with planning and implementing research at their CRC and provides medical oversight for tests and procedures.
What are CRCs?
- Harvard CRCs provide Harvard-wide investigators with dedicated outpatient, inpatient, and laboratory facilities, services, and staff to perform clinical research. This includes research coordination and support, nursing care for research participants, metabolism and nutrition services, and specialized physiological monitoring such as EEG/sleep testing.
Who is this program for?
- Non-MD investigators at an institution where they would like to conduct clinical research (includes basic scientists, RNs, and NPs)
- Non-credentialed MD investigators at an institution where they would like to conduct clinical research
- Institutionally credentialed investigators who require coverage for travel and other needs.
Jody Dushay, MD, MMSc, Medical Research Officer
The MRO Program at each of the four Clinical Research Centers (CRCs) provides medical oversight for studies conducted by non-MD and MD investigators. MROs also assist both new and experienced investigators with developing grants and research protocols, as well as implementing multisite studies via the centers. "CRCs are equipped with specialized research equipment and staffed by experienced research staff," Stavroula Osganian, MD, the MRO at BCH, says. For example, all of the CRCs have metabolism and nutrition research units with staff expertise in assessing resting metabolic rate and body composition, and most have facilities for bone density testing. BWH has an intensive physiological monitoring unit, including EEG/sleep recording.
In the past year alone, more than 500 studies have been conducted at the CRCs by about 300 investigators. Approximately 51 percent of the investigators are junior level and 49 percent are senior level. Currently, about 50 studies use MRO services.
Help with Oversight and Connections
"We are available to help with grant and protocol development, optimal study design, and budgeting by offering CRC resources," points out Madhu Misra, MD, MPH, who is the MRO at the MGH CRC. "An MRO can also take on the role of the physician responsible for medical oversight for a study at their CRC on behalf of a principal investigator who is not an MD or is an MD who doesn't have medical credentials at that institution."
Madhu Misra, MD, MPH,
Medical Research Officer
Depending on the study, MROs may be able to admit and discharge study participants, take histories and perform physical examinations, and provide medical oversight for visits involving blood draws and simple questionnaires, or sometimes for more complex visits. Sometimes an MD collaborator is necessary to do study-related medical procedures and provide medical oversight, Misra points out, and MROs can help identify people with the appropriate credentials at their institution to serve as collaborators or as the site-specific principal investigator.
For example, suppose you are a non-MD scientist working at MGH, and your laboratory findings in animals suggest the need for a human application. In this case, you will require a physician collaborator at MGH for medical oversight of your study participants. In many instances, the MRO at MGH can meet this need, or if not, she could help you identify a potential MD collaborator at MGH. Perhaps you are an investigator at BIDMC, and your research requires sleep studies for which you would like to use the BWH Clinical Research Center sleep lab. For such a study, you will need a researcher with medical credentials at BWH to provide medical oversight, and the MRO at BWH could fill this role, or find an MD collaborator for you at BWH to do so.
Gail Adler, MD, PhD, the medical research officer at the BWH CRC, uses her own research as an example. She was investigating in an animal model a drug that blocked the deleterious effects of aldosterone, which includes damage to small blood vessels. She wondered if the drug eplerenone could also improve coronary microvascular disease in people with diabetes. There is poor cardiac mortality if small vessels are impaired and a blocker may have benefits, she explains.
"Here was an observation in animals and I wanted to know how to translate it into humans," she says. "As both a clinical and basic scientist researcher, I needed many collaborators, including cardiologists, diabetologists, biostatisticians, and so on. MROs can help make all these connections for investigators. I couldn't have done this study without Harvard Catalyst."
User Experiences with MROs
Dara Manoach, PhD, a neuropsychologist in the MGH Department of Psychiatry, has been using CRCs for her clinical studies over the past eight years. She is currently studying the role of sleep and cognition function in patients with schizophrenia. "I started with very little funding, but was able to use the CRC and its resources for sleep studies to get the data I needed before the NIH would fund it, which it now does," she says.
Monika Haack, PhD, conducts all her studies at BIDMC's CRC, researching the mechanisms related to insufficient sleep and insomnia, and the regulation of mood and pain. Her research involves both outpatient visits and inpatient stays of five days, during which sleep disruption is induced. "Before the CRC offered the MRO services, we had a single-study physician who did all the medical screens, admissions, and daily check-ins, and was basically on-call all the time," says Haack. "This doctor wasn't always available, so we had to scramble for a replacement. Now with the MRO services, we schedule our study participants and the CRC takes care of the rest. This saves us a lot of time and stress."
The mission of Harvard Catalyst is to improve human health by enabling collaboration and providing researchers with the resources necessary to further discoveries, translating results from the bench to bedside. Inter-institutional research is an important way to do that. And as Jody Dushay, MD, MMSc, the MRO at BIDMC, says: "MRO services make it much easier to do inter-institutional research."