Human Subjects Core

Our clinical research office is located just steps away from UnityPoint Health-Meriter hospital and a short drive from University of Wisconsin Hospital, which provides staff with easy access to the inpatient, general and ambulatory clinics. This ideal location has facilitated the development of well-established, research-focused partnerships between clinical and research staff as well as the ability to connect easily and promptly with a diverse, research-receptive cohort of potential subjects. The clinical research office itself is well equipped with dedicated, limited access storage for physical records, private meeting rooms and technology to support web conferences.

Regulatory Services

• IRB submission of new protocols and amendments to local and central IRBs
• Preparation of research authorization and informed consent documents
• Assembly of regulatory binders
• Support for Investigational New Drug/Investigational Device Exemption applications

Study Administration

• Initial study feasibility analysis
• Development of electronic case report forms (eCRFs)
• Participation in site initiation visits and investigator meetings

Subject Recruitment

• Development of recruitment plans materials
• Pre-screening potential participants via multiple electronic medical record systems

Study Coordination

• Obtains and documents informed consent
• Conducts study visits according to protocol
• Collects and enters data into CRF
• Participation in study monitor visits

Financial Support

• Develops and negotiates budget based on study protocol
• Monitors clinical expenditures against approved budget
• Works with the Sponosed Projects and Finance core to ensure financial compliance on projects

The goal of the Gynecologic Oncology Clinical Research Program is to advance treatment through research. To accomplish this, our dedicated team of professionals works to offer the latest cancer clinical trials, where patients volunteer to participate in clinical research and receive novel cancer treatments. The clinical trials program is robust, with dozens of cancer research trials currently open. In addition, at the UW Carbone Cancer Center, women with metastatic disease can get a no-cost genetic analysis of their cancer that may reveal mutations that can be targeted with new drugs. Other ongoing research is as simple as donating extra tissue from surgery, or participating in a research database to track treatment response.

• Learn more about gynecologic oncology clinical trials at the UW Carbone Cancer Center
• Take a look at these resources on gynecologic cancer clinical trials from the Society of Gynecologic Oncology

Advancing Chronic Hypertension and Pregnancy (CHAP Maternal)

Principal Investigator: Kara Hoppe, DO

UW IRB #2016-1184

Funding: National Institute of Health (NIH)

Purpose:

Advancing postpartum care for Black women in Wisconsin by engaging community partners with a home telehealth service for hypertension– a feasibility project (Telehealth for Black Women)

Principal Investigator: Kara Hoppe, DO

UPH IRB #2020-017

Funding: Wisconsin Partnership Program

Purpose: The immediate primary goal of this proposal is to align efforts of healthcare and community providers throughout the postpartum period to address current gaps in postpartum care for Black women in Dane County. This program will incorporate new elements to specifically address social, mental health and lactation needs to the current postpartum telehealth program. This effort will be a collaboration between the UW Department of Obstetrics & Gynecology, UnityPoint-Meriter Hospital, Harambee Village Doulas, and Anesis Therapy Center. Our long-term goal is to promote telehealth services (beyond hypertension) as a novel way to increase access to a wider breadth of services for all postpartum women.

The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial

Principal Investigator: Kara Hoppe, DO

UW IRB #2017-0372

Funding: National Institute of Health (NIH)

Purpose:

Pre-labor rupture of membranes managed with oral misoprostol versus intravenous oxytocin (PROMMO)

Principal Investigator: Jacquelyn Adams, MD

UPH IRB #2020-003

Funding: Meriter Foundation

Purpose: To compare two medications, Misoprostol and Pitocin, used for inducing labor when a woman has broken her water but is not yet in labor, to see which medication will make labor go faster and determine if there are any additional benefits to the mother. Both medications are used regularly in the hospital and are considered standard of care.

Postpartum Ultrasound Evaluation of the Inferior Vena Cava, Aorta, and Brachial Artery as Predictors for Persistent Postpartum Hypertension (IVC-Ao)

Principal Investigator: Igor Iruretagoyena, MD; Jenna Racine, MD

UPH IRB #2020-005

Funding: Meriter Foundation

Purpose: to study IVC collapsibility, IVC-aortic index, and brachial artery reactivity in postpartum women with and without hypertension. We will study these ultrasound parameters as markers for persistent postpartum hypertension. We will be performing the ultrasounds every day the patient remains in the hospital postpartum, starting on PPD1 up until PPD3. There will be 62 patients in each group for a total of 124 patients.

Personalized Reproductive Medicine in PCOS (PCOS-IVF)

Principal Investigators: Laura Cooney, MD; Aleks Stanic-Kostic, MD, PhD
IRB # 2018-1247
Funding: American Society for Reproductive Medicine and department support

Purpose: to analyze the immune profile of women with and without PCOS undergoing in vitro fertilization treatment. The study aim to identify key profiles in women with PCOS can help determine a course of treatment that can improve the chances of conceiving in women with PCOS.

Randomized controlled trial of Combined Letrozole and Clomid (CLC II) versus Letrozole alone for women with anovulationoductive (Iowa study)

Principal Investigators: Laura Cooney, MD
IRB # 2021-0489
Funding: University of Iowa

Purpose:

Angiotensin 2 receptor expression/activation in endothelial cells in preeclampsia (“AT2R”)

Principal Investigators: Dinesh Shah, MD; Sathish Kumar, DVM, PhD
UPH IRB #2018-008
Funding: National Institute of Health (NIH)

Purpose: To determine if the expression and activation of the Angiotensin 2 receptors is different in the blood vessels of women with preeclampsia compared to women with an uncomplicated pregnancy. Study includes placenta donation and/or an omental biopsy during caesarean section.

Systems Biology of Immunity in Pregnancy Complications (“Preterm Birth Study”)

Principal Investigator: Aleks Stanic-Kostic, MD, PhD
UPH IRB # 2018-010
Funding: Burroughs Wellcome Fund

Purpose: To analyze the immune profile of women with preterm delivery and term delivery. The goal is to identify key differences in the immune profile (if any) than can later be used to predict the risk of preterm delivery or develop a treatment.