Research

Regional Health follows rigorous standards for ethics, quality, and protections for human research.  Regional Health has earned a place among the world’s most respected, trustworthy research organizations by obtaining full accreditation from the Association for the Accreditation of Human Research Protection Program (AAHRPP).  Holding this accreditation earns respect and meets the expectations of our peers, proves our efforts to protect research participants reduces the risk of non-compliance, and highlights our exceptional ability to lead collaborative efforts among our research partners. 

Human Research Protection Program (HRPP)

The HRP is a comprehensive program that affords protections for all human research participants. This website is designed to provide its users with the most up to date information related to conducting research with human participants at Regional Health.
 
Human Research Protection Program (HRPP)
The HRPP was developed to ensure the rights, safety and welfare of all subjects recruited or enrolled in research projects, regardless of funding source. The program also ensures that all personnel involved in research activities understand and comply with the ethical standards of research. The HRPP coordinates oversight by incorporating all aspects of compliance related to human subjects research.
 
Institutional Review Board
The Regional Health Institutional Review Board (RH IRB) is a committee which meets monthly to review research involving human subjects in order to ensure all projects conform to federal and institutional regulations and policies.
 
Investigators and Research Staff
The range of research activities at Regional Health is broad and deep.  There are 3 Regional Health Study Sites which seek to expand human knowledge through analysis, innovation and insight.

Purpose of HRPP and IRB

Human Research Protection Program (HRPP)
The purpose of the Human Research Protection Program (HRPP) and Grants Review Committee will be to assess and monitor the quality, effectiveness, and efficiency of research and grant administration. The purpose of this committee’s assessments is to identify standards of excellence and potential areas for improvement in order to promote a solid foundation for proper grant administration and the conduct of human subject research, to ensure compliance and the safety and protection of research participants.

Regional Health Institutional Review Board (RH IRB) 
The purpose of the RH IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.  The RH IRB is established under the authority of the Food and Drug Administration for the purpose of protecting the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Regional Health. The IRB is intended to protect the rights and welfare of subjects by reviewing clinical investigations regulated by the FDA under sections 505, 507, and 520 of the Federal Food, Drug and Cosmetic Act. In addition, the RH IRB will review all clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use and electronic products.  RH IRB also reviews and approves Community Initiated Research (CIR) such as local physician research, clinic research, and student research.

Contact Information

Regional Health Institutional Review Board
PO Box 6000
Rapid City, SD57709-6000​
Phone: 605-755-9037
Email: rhirb@regionalhealth.com  

RH IRB

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines. Click for more details. 

Download PDF for the 2017 Meeting Schedule and if there are questions to please call the RH IRB Office at (605) 755-9028.

Value of Accreditation
The Value of AAHRPP Accreditation
The primary purpose of AAHRPP accreditation is to strengthen protections for research participants. Each accreditation advances that objective and helps build public trust and confidence in research. The benefits of AAHRPP’s comprehensive approach extend beyond participants to the research enterprise as a whole. Perhaps the greatest value is to those organizations that earn the privilege of displaying the AAHRPP seal. For them, attaining AAHRPP accreditation has proved to be both the right and the smart thing to do. The vast majority find that AAHRPP accreditation provides an excellent return on their investment. Equally important, the value of AAHRPP accreditation endures and is reinforced through reaccreditation.
 
 AAHRPP-accredited organizations:

  • Earn the respect and meet the expectations of their peers. Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process. Increasingly, organizations that have not earned AAHRPP accreditation are being asked, “Why not?”
  • Play a leadership role in collaborative efforts. AAHRPP accreditation instills trust among research partners and, therefore, is becoming a requirement for collaboration. AAHRPP-accredited organizations often insist that accreditation status be a determining factor in decisions on external IRB review.
  • Gain a competitive edge with sponsors and other funders, who recognize that AAHRPP-accredited organizations have more efficient operations, provide more comprehensive protections, and produce high-quality data. Virtually all sponsors require independent IRBs to be AAHRPP accredited. Some sponsors also consider accreditation status when choosing investigative sites.
  • Reduce the risk of non-compliance. AAHRPP accreditation signifies that an organization has built the necessary infrastructure for a quality human research protection program (HRPP). AAHRPP-accredited organizations tend to have more streamlined, effective policies and procedures. These organizations also typically keep better records and are more likely to avoid costly shutdowns and problematic inspections.
  • Enhance their standing with U.S. federal agencies, which are more likely to target non-accredited organizations for inspections. Federal agencies have begun seeking AAHRPP accreditation for their own HRPPs. The central IRB of the National Cancer Institute earned AAHRPP accreditation in December 2012.
  • Benefit from a common commitment to continuous quality improvement. AAHRPP-accredited organizations share innovative practices and collect data to help establish benchmarks and assess quality improvement. AAHRPP compiles and distributes these data to aid organizations, sponsors, government agencies, and participants in identifying and promoting high-quality practices.

Goals, Principles, and Standards
The goals of accreditation are to:

  • Improve the systems that protect the rights and welfare of individuals who participate in research.
  • And communicate to the public the strength of an Organization's commitment to the protection of human research participants.

To help promote these goals, AAHRPP has adopted nine overarching principles for protecting human research participants, which serve as the foundation for the AAHRPP Accreditation Standards for Human Research Protection Programs. The AAHRPP Accreditation Standards themselves describe what Organizations can do to consistently act on these principles by applying them to the diverse organizational and cultural contexts in which research is conducted and reviewed.
 

Ethical Guidance

Codes and Policies for Research Ethics
Given the importance of ethics for the conduct of research, it should be no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics.

Many government agencies, such as the National Institutes of Health (NIH), the National Science Foundation (NSF), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the US Department of Agriculture (USDA) have ethics rules for funded researchers.

Other influential research ethics policies include the American Chemical Society, The Chemist Professional’s Code of Conduct, Code of Ethics (American Society for Clinical Laboratory Science)  American Psychological Association, Ethical Principles of Psychologists and Code of Conduct, Statements on Ethics and Professional Responsibility (American Anthropological Association), Statement on Professional Ethics (American Association of University Professors), The Belmont Report, the Nuremberg Code and the World Medical Association's Declaration of Helsinki.
 
The following is a rough and general summary of some ethical principles that various codes address:

Honesty
Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity
Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Integrity
Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness
Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Openness
Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Respect for Intellectual Property
Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality
Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication
Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring
Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for colleagues
Respect your colleagues and treat them fairly.

Social Responsibility
Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination
Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Competence
Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Legality
Know and obey relevant laws and institutional and governmental policies.

Human Subjects Protection
When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

Participants Rights 

Research Participant’s Bill of Rights
It is important that the purpose and procedures of the research study are fully understood and that consent is offered willingly. A subject in a research study, or someone who is asked to give consent on behalf of another person for such participation, has the right to:

1. Be informed of the nature and purpose of the research.
2. Be given an explanation of all procedures to be followed and of any drug or device that will be used.
3. Be given a description of any risks or discomforts, which can be associated with the research study.
4. Be given an explanation of any benefits, which can be associated with the research study.
5. Be informed of any risks and benefits of the appropriate alternative procedures, drugs, or devices in the research study.
6. Be informed of any medical treatment, which will be made available to the participant, if complications should arise from the research study.
7. Be given an opportunity and encouraged to ask questions concerning the research study or procedures involved.
8. Be made aware that participants can quit the research study at any time.
9. Be given a copy of the signed and dated written consent form, if requested.
10. Not be subjected to an element of force, fraud, deceit, duress, coercion, or any influences in reaching the decision to consent or to not consent to participate in the research.

 
To discuss problems, concerns, questions, offer information, or provide suggestions to input to someone who is not involved with these research studies, you may call Customer Service and Patient Relations at 605-755-8134. 

Guidances & Templates

Education

Before a Principle Investigator can submit a protocol for IRB Review and Approval the PI must have demonstrated and submitted documentation of training – Collaborative Institutional Training Initiative (CITI) or National Institutes of Health (NIH).  If the PI does not have training documented contact the RH IRB Office for the sign-on information for CITI Training.

Information on CITI Training

HIPAA

18 IDENTIFIERS OF PHI
HIPAA recognizes that health-related information is often so rich in content that it can never be made truly anonymous, but that the risk of re-identification of an individual is greatly decreased by removing certain elements from data. Health information lacking these elements is said to be de-identified and may be used or disclosed without restriction under the HIPAA Privacy Rule (the health information is no longer PHI).

To de-identify PHI, remove the following list of 18 identifiers of the individual and of the individual’s relatives, employers, or household members:

  1. Names
  2. All geographic subdivisions smaller than state
  3. All elements of dates except year – e.g. date of birth, date of death, admission date, discharge date, all ages over age 89.
  4. Telephone numbers
  5. Fax numbers
  6. E-mail addresses
  7. Social security numbers
  8. Medical Record numbers
  9. Health plan beneficiary numbers
  10. Account numbers
  11. Certificate/license numbers
  12. Vehicle identification, serial, or license plate numbers
  13. Device identifiers and serial numbers
  14. Web Universal Resources (URLs)
  15. Internet Protocol (IP) address numbers
  16. Biometric identifiers, including finger and voice prints
  17. Full face photographic images any comparable images
  18. All other unique identifying number, characteristic, or code

HIPAA allows for the use of a Limited Data Set for Research and Public Health
A “limited data set” is a limited set of identifiable patient information as defined in the Privacy Regulations issued under the Health Insurance Portability and Accountability Act”. A “limited data set” of information may be disclosed to an outside party without a patient’s authorization if certain conditions are met.

  • First, the purpose of the disclosure may only be for research, public health or health care operations.
  • Second, the person receiving the information must sign a Data Use Agreement (DUA).

DUAs are contractual documents used for the transfer of nonpublic data that is subject to some restriction on its use. DUAs serve to outline the terms and conditions of the transfer. Specifically, DUAs address important issues such as limitations on use of the data, obligations to safeguard the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data.  The understanding established by a DUA can help avoid later issues by clearly setting forth the expectations of the parties (provider and recipient). Having a signed DUA in place may be a required precondition to transfers of certain data, or it may simply be a good idea. Determining whether a DUA is required is necessarily context dependent. When a DUA is required, it must be study specific – i.e. data cannot be transferred pursuant to “master” or blanket sharing agreements.
The agreement needs to be reviewed and approved by the RH Legal Department through the normal contract control process.

Helpful Links

Association for the Accreditation of Human Research Protection Program, Inc. (AAHRP): http://www.aahrpp.org/
 
Food and Drug Administration: http://www.fda.gov/
 
Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/
OHRP Educational Videos: http://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/index.html
OHRP YouTube Videos: https://www.youtube.com/playlist?list=PL5965CB14C2506914
 
Collaborative Institutional Training Initiative (CITI): https://www.citiprogram.org/
National Institutes of Health (NIH): https://crt.nihtraining.com
 

REGIONAL HEALTH INSTITUTIONAL REVIEW BOARD (IRB)

RH IRB

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.

 
What is an IRB and its purpose?

An IRB is charged with protecting the rights and welfare of people involved in research.  The IRB reviews plans for research involving human subjects.  Institutions that accept research funding from the federal government must have an IRB to review all research involving human subjects (even if a given research project does not involve federal funds).  The Food and Drug Administration and the Office for Human Research Protections (OHRP) (part of the National Institutes of Health) set the guidelines and regulations governing human subjects research and IRBs.

 

The definition of research involving human subjects is broad.  The IRB must review research that involves the following areas, among others:

  • Medical and administrative record data
  • Research that uses leftover tissues.
  • Health services research.
  • Survey research.
  • Behavioral research.
  • Biomedical and other clinical research.

 
Purpose of the IRB:

The Regional Health (RH) Institutional Review Board (IRB) is established under the authority of the Food and Drug Administration for the purpose of protecting the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Regional Health. The IRB is intended to protect the rights and welfare of subjects by reviewing clinical investigations regulated by the FDA under sections 505, 507, and 520 of the Federal Food, Drug and Cosmetic Act. In addition, the IRB will review all clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use and electronic products.  RH IRB also reviews and approves Community research such as local physician research, clinic research, and student research.

 
Why Does an IRB Review and Approve Research?

Review of research involving human subjects is required by federal law.  Federal laws and regulations regarding research on human subjects have specific requirements for IRB and study administration.

The federal requirement for review of research by human subjects committee stems directly from previously conducted unethical research experiences like the Tuskegee Study.  The Tuskegee Study was a federally funded study.  In it, a large number of poor African-American men with syphilis were studied for several decades to determine the natural history of untreated syphilis.  The diagnosis of syphilis was made before treatments for syphilis were available.  But the men were not offered treatment with penicillin even after it became available.  Worse, the men were not told they were subjects in a research study.  Many men in the study died of the complications of syphilis.

When this breach of ethics became publicly known in the middle of the 1970s, the federal government decided to put in place legal requirements for an external process for review and approval of research done using federal funds.  The federal government also decided to require that all institutions accepting federal research funds review all research done in that institution by the same procedures.

 
Responsibilities of the IRB:

The RH IRB operates under the principles of The Belmont Report. The Belmont Report exists because of the unfortunate history of unethical research conducted on human subjects. It clearly explains the three principals that are the main tools that all IRB members should use to evaluate the ethics of specific research proposals. Respect for Persons is the first principle which mandates that subjects voluntarily consent to participate in research, that they are adequately and thoroughly informed about the research and what is required, and that their privacy and confidentiality are protected. Beneficence is the second principle which mandates the risks of research are justified by potential benefits to the individual or society and that those risks are minimized.  Justice is the third and final principle which mandates the equitable distribution of risks and benefits among those who may benefit from the research, meaning that one subset of a population should not take on all the burden of risk and reap all of the rewards; risks and rewards should be applicable and available to all subsets of a community.

IRB FAQs

Meeting Dates

Download PDF for the 2017 Meeting Schedule and if there are questions to please call the RH IRB Office at (605) 755-9028.

 

Contact Information

Regional Health Institutional Review Board

PO Box 6000

Rapid City, SD57709-6000​

Phone: 605-755-9037

Email: rhirb@regionalhealth.com  

CLINICAL TRIALS

Clinical Trials
Current/Active Trials

Cardiovascular

 

  • CANTOS
  • CONFIDENCE
  • CSL112_2001
  • dal-GENE
  • DURABILITY PAS
  • EBBINGHAUS
  • ENABLE MRI
  • EUCLID
  • EXSCEL
  • FOURIER
  • FOURIER-OLE
  • GLORIA-AF
  • Graftmaster
  • HARMONY Outcomes
  • LSR ACUITY
  • LSS of 4-SITE
  • NAVIGATE X4
  • NODE-1
  • ODYSSEY
  • OSLER
  • PARADIGM-HF
  • PARADISE
  • PARAGON-HF
  • PIONEER HF
  • PRE-DETERMINE
  • PROMUS
  • REDUCE
  • REDUCE-IT
  • REVEAL
  • SCAFFOLD
  • SILVER-AMI
  • SPIRE-1
  • SPIRE-2
  • STRENGTH
  • THEMIS
  • TWILIGHT
  • VOYAGER
  • WED-HED

     

Specialty

  • Merck T2D Sitagliptin
  • NovoEllipse
  • Reflections
  • T1DExchange
  • AMGEN OSLER 2
  • AMGEN PSA       
  • ANSWER
  • AZT2D 
  • CDiffense
  • Edition Jr
  • Grifols 
  • GSKMMR                                                 
  • Lexicon

Cancer Care Institute 

 

Past Trials

Cardiovascular

Specialty

Cancer Care Institute

 

 

ABOUT RESEARCH/CONTACT INFORMATION

About Regional Health Clinical Research

                  Mission: The mission of Regional Health Clinical Research (RHCR) is to support innovative clinical research and provide quality clinical research services to the physicians and citizens of our local communities.

                  Clinical research is an essential key to healthcare. Patient volunteers help doctors and scientists discover opportunities to improve patient care, advance treatments, diagnostics, medications and devices.

 

                  Trials: The Clinical Research Department, a department of Regional Health, participates in multiple research studies providing research coordination and study management services for physicians conducting clinical research studies. Regional Health Research Clinical Research incorporates over 43 providers (Insert Link to Researchers bio box #5) representing more than 16 specialty areas:

 

  • Radiation Oncology
  • Medical Oncology
  • Gynecological Oncology
  • Cardiology
  • Cardiac Electrophysiology
  • Interventional Cardiology
  • Vascular Medicine
  • Nuclear Cardiology
  • Endovascular Medicine
  • Family Medicine
  • Pediatric Medicine
  • Pediatric Endocrinology
  • Endocrinology
  • Immunology
  • Rheumatology
  • Infectious Disease
  • Nephrology




 
Learn More About Clinical Studies (Insert link to https://clinicaltrials.gov/ct2/about-studies/learn)

The types of studies conducted at Regional Health Research include:

  1. Treatment studies to improve the standard of care
  2. Prevention studies to look for better ways to prevent disease
  3. Diagnostic and screening studies designed to find better ways to detect diseases
  4. Pharmaceutical trials to advance medical treatment
  5. Cardiac device trials
  6. Symptom management trials to treat and reduce side effects from cancer treatments

 
Phases

Clinical research trials are conducted in phases, or steps to answer multiple research questions. According to www.nlm.nih.gov/services/ctphases.html, phases are individually defined as:
Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

 

 
Contact Us:
Regional Health Institutional Review Board

PO Box 6000

Rapid City, SD 57709-6000

Phone: (605) 755-9037

Email: rhirb@regionalhealth.com

Or
Regional Health Clinical Research

Contact: Crystal Gruetzmacher

Phone: (605) 755-3982

Email: research@regionalhealth.com

Or
Cancer Care Institute Research

Contact: Angie Dunbar

Phone: (605)755-2370

Email: adunbar@regionalhealth.com

 

 
Clinical Research FAQs

RESEARCHERS

Dr. Michael T. Avery, DO, has been working with Regional Health Clinical Research since 2014. He completed his rheumatology fellowship in 2014 from University of Nebraska Medical Center in Omaha, NE. Outside of medicine, he enjoys beekeeping.

                 
Principle Investigator Trials:
  • Reflections
Sub Investigator Trials:
  • AMGEN PSA

 
Dr. Rachel Edelen, MD, has been working with Regional Health Clinical Research since 2003. She completed her pediatric endocrinology fellowship in 2006 from Baylor College of Medicine in Houston, TX. Outside of medicine, she enjoys spending time with her family and skiing.

                 

Principle Investigator Trials:

 

  • NovoEllipse
  • T1DExchange
  • AMGEN OSLER 2
  • ANSWER
  • AZT2D
  • Edition Jr
  • Grifols
  • KIGS
  • IGFD Registry
  • TEENS
  • T1D Older Adults
 
Dr. Gregory A. English, DO, has been working with Regional Health Clinical Research since 2013. He completed his internal medicine residency in 2009 from Hennepin County Medical Center in Minneapolis, MN. Outside of medicine, he enjoys hunting and playing soccer.

                 
Principle Investigator Trials:
  • ART-123

 

 
Dr. Stephen Tamang, MD, has been working with Regional Health Clinical Research since 2012. He completed his family medicine residency in 2014 from Southern Illinois University in Carbondale, IL. Outside of practicing medicine, he enjoys woodworking.

                  Principle Investigator Trials:

  • Merck T2D Sitagliptin

 
Dr. Kurt Stone, MD, has been working with Regional Health Clinical Research since 2002. He completed his family medicine residency in 1980 from Malcolm Grow Medical Center, Andrews AFB, MD. Outside of practicing medicine, he enjoys rock climbing.

                  Principle Investigator Trials:

  • CDiffense

 
Dr. Thomas B. Repas, DO, has been working with regional Health Clinical Research since 2006. He completed his endocrinology and metabolism fellowship in 2007 from University of Wisconsin in Madison, WI. Outside of practicing medicine, he enjoys beekeeping and running ultramarathons of up to 100 miles.

                  Principle Investigator Trials:

  • Lexicon

 
Dr. Brian P. Bowers, DO, has been working with regional health clinical research since 2012. He completed his fellowship in rheumatology in 2008 from Stony Brook University Medical Center in Stony Brook, NY. Outside of practicing medicine, he enjoys fly fishing.

                  Principle Investigator Trials:

  • AMGEN PSA

Sub Investigator Trials:

  • Reflections

 
Dr. Bobbie Schneller, MD, has been working with Regional Health Clinical Research since 2014. She completed her residency in family medicine in 2009 from Rapid City Regional Hospital Family Medicine Residency in Rapid City, SD. Outside of practicing medicine, she enjoys   .

                  Sub Investigator Trials:

  • CDiffense

 

 
Dr. Jennifer K. May, MD, has been working with Regional Health Clinical Research since 2008. She completed her fellowship in rheumatology in 2005 at Mayo Clinic in Rochester, MN. Outside of practicing medicine, she enjoys   .

                  Sub Investigator Trials:

  • Reflections
  • AMGEN PSA

 
Dr. Louis C. Raymond, MD, has been working with Regional Health Research since 2011. He completed his fellowship in nephrology in 1994 at Hahnemann University Hospital in Philadelphia, PA. Outside of practicing medicine, he enjoys bike riding and spending time with his family.

                  Principle Investigator Trials:

  • OVERTURE 156-10-291

                  Sub Investigator Trials:

  • WED-HED

 
Dr. Fredric M. Birch, MD, has been working with Regional Health Research since 2016. He completed his fellowship in nephrology in 1987 at University of Utah Hospital in Salt Lake City, UT. Outside of practicing medicine, he enjoys hunting and spending time with his family.

                  Principle Investigator Trials:

  • WED-HED

 
L. Michelle Wasson, Chapa-C, has been working with Regional Health Research since 2008. She earned her master’s degree from University of Colorado Health Sciences Center in Denver, CO in 2000. Outside of medicine, she enjoys taking care of all of her animals.

                  Sub Investigator Trials:

 

  • Merck T2D Sitagliptin
  • NovoEllipse
  • T1DExchange
  • AMGEN OSLER 2
  • ANSWER
  • AZT2D
  • Edition Jr
  • Grifols
  • GSKMMR
  • Lexicon

 

 

 
Emily Huntley, PA, has been working with Regional Health Clinical Research since 2008. She earned her master’s degree at Des Moines University Osteopathic Medical Center in Des Moines, IA in 2004. Outside of practicing medicine, she enjoys spending time with her family.

                  Sub Investigator Trials:
  • Reflections
  • AMGEN PSA

 
Shari A. Fechner, CNP, has been working with Regional Health Clinical Research since 2010. She earned her Master’s Degree in Nursing at South Dakota State University in Brookings, SD in 1997. Outside of medicine, she enjoys golfing.

                  Sub Investigator Trials:

  • Reflections
  • AMGEN PSA

 
Dr. David B. Whitney, MD, has been working with Regional Health Clinical Research since 2012. He completed his pediatric residency in 1994 from University of Arizona Health Sciences Center in Tucson, AZ. Outside of medicine, he enjoys hunting, and fishing.

                  Principle Investigator Trials:

  • GSKMMR

 
Dr. Cara Hamilton, MD, has been working with Regional Health Research since 2012.

                  Sub Investigator Trials:

  • GSKMMR

 
Dr. Lori Strong, MD, has been working with Regional Health Research since 2012.

                  Sub Investigator Trials:

  • GSKMMR

 
Dr. David Mueller, MD, has been working with Regional Health Research since 2012.

                  Sub Investigator Trials:

  • GSKMMR

 
Dr. Kelly J. Airey, MD, has been working with Regional Health Clinical Research since 2014. She completed her cardiac electrophysiology fellowship in 2009 from the University of Utah in Salt Lake City, UT. Outside of practicing medicine, she enjoys hiking and biking.

                  Principle Investigator Trials:

  • ENSURE
  • PARAGON-HF

                  Sub Investigator Trials:

  • PIONEER HF
  • NAVIGATE X4
  • NODE-1

 
Dr. Samuel J. Durr, MD, has been working with Regional Health Clinical Research since 1998. He completed his cardiology fellowship in 1988 from Creighton University in Omaha, NE. Outside of practicing medicine, he enjoys the outdoors and cheering on the Chicago Cubs.

                  Principle Investigator Trials:

 

  • ACCELERATE
  • ACCENTUATE
  • CATCH
  • EVENT
  • LUNAR
  • PRE-DETERMINE
  • REDUCE-IT
  • STRENGTH
  • TRA-PCI
  • TWILIGHT

 

                  Sub Investigator Trials:
  • AddHoc PCI 2

 
Dr. Michael P. D’Urso, MD, has been working with Regional Health Clinical Research since 1999. He completed his interventional cardiology fellowship in 1997 from Iowa Heart Center in DesMoines, IA. Outside of practicing medicine, he enjoys traveling and spending time with his children.

                  Principle Investigator Trials:

 

  • ARCHIPELAGO
  • EARLY-ACS
  • IMPROVE-IT
  • KILO
  • LANCELOT
  • ODYSSEY
  • PEGASUS
  • STEEPLE
  • SYNERGY
  • THEMIS
  • TRA2P
  • TRA2P-OCULAR
  • TRACER

 

                  Sub Investigator Trials:

 
Dr. L. Norman Ferrier, MD, has been working with Regional Health Clinical Research since 2003. He completed his cardiology fellowship in 1985 from Dalhousie University in Halifax, Nova Scotia. Outside of medicine, he enjoys playing tennis.

                  Principle Investigator Trials:

 

  • ACCLAIM
  • ACUITY
  • ARTEMIS
  • AXIOM-ACS
  • BALANCE
  • CHAMPION
  • CHAMPION-PCI
  • DEScover
  • ELEVATE TIMI-56
  • EXSCEL
  • LATITUDE-TIMI 60
  • MEND-CABG
  • NAPA CS
  • PHOENIX
  • PHOENIX Econ
  • PLASMA
  • VISTA-16

 

                  Sub Investigator Trials:

 

  • GEMINI ACS
  • PIONEER
  • SAVOR TIMI 53
  • SILVER AMI
  • SPIRE 1
  • SPIRE 2

 

 

 

 
Dr. K. John Heilman II, MD, has been working with Regional Health Clinical Research since 2006. He completed his cardiology fellowship in 1986 from the University of Colorado Health Sciences Center in Aurora, CO. Outside of practicing medicine, he enjoys fishing.

                  Principle Investigator Trials:

 

  • ASCEND-HF
  • ASTRONAUT
  • CUPID
  • ENCYSIVE
  • PARADIGM
  • PARADIGM HF
  • PIONEER HF
  • RELAX
  • ROCKET-AF
  • X-VERT

 

                  Sub Investigator Trials:

 

  • BI 1160.128
  • BOREALIS
  • ENABLE MRI
  • ENSURE
  • GLORIA
  • GLORIA AF
  • LSR ACUITY
  • LSS 4-SITE
  • MK 4448-006
  • NAVIGATE X4
  • NODE 1
  • PALLAS
  • PARAGON HF

 

 

 

 
Dr. Rajesh Pradhan, MD, has been working with Regional Health Clinical Research since 2013. He completed his cardiology fellowship in 2013 from Thomas Jefferson University Hospital in Philadelphia, PA. Outside of practicing medicine, he enjoys playing soccer and running.

                  Principle Investigator Trials:
  • AEGIS-1
  • CSL 112-2001

                  Sub Investigator Trials:

  • dalGENE
  • TWILIGHT

 
Dr. Drew A. Purdy, MD, has been working with Regional Health Clinical Research since 1998. He completed his cardiology fellowship in 1987 from Creighton University in Omaha, NE. Outside of practicing medicine, he enjoys photography and collecting wine.

                  Principle Investigator Trials:

 

  • APEX-AMI
  • CARIN
  • dal-ACUTE
  • dalGENE
  • dalOUTCOMES
  • dalOUTCOMES-2
  • EBBINHAUS
  • EIAF
  • EQUATOR
  • ERASE-MI
  • Espirion ETC
  • FOURIER
  • FOURIER OLE
  • GRAVITAS
  • INNOVATE-PCI
  • JUMBO TIMI-26
  • LAPLACE TIMI-57
  • LAPLACE-2
  • OASIS-5
  • OFFSET
  • OSLER
  • PEACE
  • PLATO
  • PolyMedix
  • PRIMO-CABG II
  • PRINCIPLE TIMI-44
  • RADAR
  • REGULATE-PCI
  • REVERSAL-PCI
  • SPIRE 1
  • SPIRE 2
  • SWAP
  • SWAP 2
  • TRIGGER-PCI
  • TRIPLET
  • TIRTON TIMI-38
  • TRITON-LTFU
  • VALIANT
  • WIZARD

 

                  Sub Investigator Trials:

 

  • AddHoc PCI
  • CSL 112-2001
  • EXSCEL
  • IMPROVE-IT
  • POZEN
  • SOLID
  • CUPID

 

 

 

 

 
Dr. Bhaskar Purushottam, MD, has been working with Regional Health Clinical Research since 2015. He completed his interventional cardiology fellowship in 2014 from William Beaumont Hospital in Royal Oak, MI and his endovascular and structural interventional fellowship in 2015 from Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, NY. Outside of practicing medicine, he enjoys reading and traveling.

                  Principle Investigator Trials:
  • LEADERS FREE II

                  Sub Investigator Trials:

  • CONFIDENCE
  • Espirion ETC
  • CSL 112_2001

 
Dr. Alex Schabauer, MD, has been working with Regional Health Clinical Research since 1998. He completed his fellowship in cardiology and vascular medicine in 1996 at Mayo Graduate School of Medicine in Rochester, MN. Outside of medicine, he enjoys hiking.

                  Principle Investigator Trials:

  • ELIXA
  • EUCLID
  • HARMONY
  • PROVIDENCE

                  Sub Investigator Trials:

  • VOYAGER

 

 

 

 

 

 

 

 

 
Dr. Jose M. Teixeira, MD, has been working with Regional Health Clinical Research since 1998. He completed his fellowship in cardiology in 1988 and his fellowship in electrophysiology in 1989, both at the University of Medicine and Dentistry of New Jersey in Browns Mills, NJ. Outside of practicing medicine, he enjoys running.

                  Principle Investigator Trials:

 

  • ALPHEE
  • ATHENA
  • BI 1160.128
  • BOREALIS
  • ENABLE MRI
  • ENGAGE
  • EXPLORE-Xa
  • GLORIA
  • GLORIA AF
  • HESTIA
  • ICARIOS
  • INTRINSIC
  • LSR ACUITY
  • LSS 4-SITE
  • MAIA
  • MK 4448-0006
  • NAVIGATE X4
  • NODE 1
  • PALLAS
  • RELY
  • SHEILD 2
  • ULTRA

 

                  Sub Investigator Trials:
  • ASTRONAUT
  • PARADIGM
  • PARAGON HF
  • RELAX

 
Dr. Joseph L. Tuma, MD, has been working with Regional Health Clinical Research since 2006. He completed his fellowship in cardiology in 2005 from the Cardiac Center at Creighton University Medical Center in Omaha, NE. He completed his fellowship in interventional cardiology/endovascular medicine in 2006 from the Cardiac Center at Creighton University Medical Center in Omaha, NE. Outside of practicing medicine, he enjoys spending time with his kids at the lake.

                  Principle Investigator Trials:

 

  • CANOPY
  • CHOICE
  • CONFIDENCE
  • CREATE-PAS
  • CREATE-SUV
  • DAPT
  • DURABILITY-PAS
  • ENDOMAX
  • FREEDOM
  • PROMUS
  • REDUCE
  • SCAFFOLD
  • SuperNOVA
  • TAXUS
  • TRILOGY
  • VOYAGER

 

                  Sub Investigator Trials:
  • EMINENCE

 

 

Dr. Amad M. Zineldine, MD, has been working with Regional Health Clinical Research since 2009. He completed his fellowship in cardiology in 2002 from The Brooklyn Hospital Center in Brooklyn, NY. Outside of practicing medicine, he enjoys to travel.

                  Principle Investigator Trials:
  • CANTOS
  • REVEAL
  • REVEAL TIMI-55

                  Sub Investigator Trials:

  • HARMONY

 
Roger E. DeRaad, MN, CNP, CNS, has been working with Regional Health Clinical Research since 1998. He earned his master’s degree in nursing in 1994 from the University of Washington in Seattle, WA. Outside of practicing medicine, he enjoys woodworking and traveling.

                  Principle Investigator Trials:

  • PALM Registry

                  Sub Investigator Trials:

 

  • ARTEMIS
  • LAPLACE-2
  • PARADIGM HF
  • SCAFFOLD
  • ACCELERATE
  • ACCENTUATE
  • ACCLAIM
  • ACUITY
  • AddHoc PCI
  • AddHoc PCI 2
  • AEGIS 1
  • ALPHEE
  • AMGEN PSA
  • APEX-AMI
  • APPRAISE-2
  • AQCLAIM
  • ASCEND-HF
  • ASTRONAUT
  • ATHENA
  • AXIOM-ACS
  • BI 1160.128
  • BOREALIS
  • CANTOS
  • CARIN
  • CATCH
  • CDiffense
  • CHAMPION
  • CHAMPION PCI
  • CHARISMA
  • CHOICE
  • CONFIDENCE
  • CREATE-PAS
  • CREATE-SUV
  • CSL 112-2001
  • CSL 2a
  • CUPID
  • dalACUTE
  • dalGENE
  • dalOUTCOMES
  • DAPT
  • DEScover
  • DURABILITY PAS
  • EARLY ACS
  • EBBINHAUS
  • EIAF
  • ELEVATE TIMI 56
  • ELIXA
  • EMINENCE
  • ENABLE MRI
  • ENCYSIVE
  • ENODMAX
  • ENGAGE
  • ENSURE
  • EQUATOR
  • ERASE-MI
  • Espirion ETC
  • EUCLID
  • EVENT
  • EXPLORE-Xa
  • EXSCEL
  • FOURIER
  • FOURIER OLE
  • FREEDOM
  • GEMINI ACS
  • GLORIA
  • GLORIA AF
  • HARMONY
  • HESTIA
  • ICARIOS
  • IMPROVE IT
  • INNOVATE PCI
  • INTRINSIC
  • JUMBO TIMI 26
  • KILO
  • LANCELOT
  • LAPLACE TIMI 57
  • LATITUDE TIMI 60
  • LSR ACUITY
  • LSS 4SITE
  • LUNAR
  • MAIA
  • MAINTIAN
  • MEND-CABG
  • Merck T2D Sitagliptin
  • MK4448-006
  • NAPA CS
  • NODE 1
  • OASIS-5
  • ODYSSEY
  • OFFSET
  • OSLER
  • PALLAS
  • PARADIGM
  • PARAGON HF
  • PEACE
  • PEGASUS
  • PHOENIX
  • PIONEER
  • PIONEER HF
  • PLASMA
  • PLATO
  • PolyMedix
  • POZEN
  • PRE-DETERMINE
  • PRIMO-CABGII
  • PRINCIPLE TIMI 44
  • PROVIDENCE
  • RADAR
  • REDUCE
  • REDUCE IT
  • REGODO
  • REGULATE PCI
  • RELATE
  • RELAX
  • RELY
  • REVEAL
  • REVEAL TIMI 55
  • REVERSAL PCI
  • ROCKET AF
  • SAVOR TIMI 53
  • SCAFFOLD
  • SHIELD 2
  • SILVER AMI
  • SOLID
  • SOLSTICE
  • SPIRE 1
  • SPIRE 2
  • STABILITY
  • STEEPLE
  • STRENGTH
  • SWAP
  • SWAP 2
  • SYNERGY
  • TADS
  • THEMIS
  • TRA2P
  • TRA2P-OCULAR
  • TRACER
  • TRA-PCI
  • TRIGGER PCI
  • TRILOGY
  • TRIPLET
  • TRITON TIMI 38
  • TRITON LTFU
  • TWILIGHT
  • ULTRA
  • VALIANT
  • VISTA 16
  • VOYAGER
  • WIZARD
  • X-VERT




 

 
Dr. Eric S. Eastmo, MD, has been working with Regional Health Clinical Research since . He completed his fellowship in radiation oncology in   from the Medical College of Wisconsin in   , WI.

 
Dr. Helen Frederickson, MD, has been working with Regional Health Clinical Research since 1987. She completed her fellowship in    

 
Dr. Joshua C. Lukenbill, DO, has been working with Regional Health Clinical Research since 2014. He completed his medical oncology/hematology fellowship in 2014 from Taussig Cancer Institute, Cleveland Clinic in Cleveland, OH.

 
Dr. Daniel G. Petereit, MD, has been working with Regional Health Clinical Research since 1992. He completed his fellowship in radiation oncology in   from the University of Wisconsin Hospital/clinics in   , WI.

 
Dr. Michael O. Robinson, MD, has been working with Regional Health Clinical Research since 1993. He completed his fellowship in medical oncology in   from the University of Kansas in Kansas City, KS.

 
Dr. M. Behnan Sahin, MD, has been working with Regional Health Clinical Research since 2000. He completed his fellowship in medical oncology, hematology in    from the University of Wisconsin in Madison, WI and the University of Minnesota in Minneapolis, MN.

 
Dr. Mark Schroeder, MD, has been working with Regional Health Clinical Research since 1995. He completed his fellowship in medical oncology, hematology in   from   .

 
Dr. Michael J. Swartz, MD, has been working with Regional Health Clinical Research since 2003. He completed his fellowship in radiation oncology in   from Johns Hopkins University School of Medicine in Baltimore, MD.

 
Diane Coon, CNP, has been working with Regional Health Clinical Research since 2000. She earned her master’s degree in nursing in   from South Dakota State University in Rapid City, SD.

 
Heidi Glood, CNP, has been working with Regional Health Clinical Research since    . She earned her master’s degree in nursing in 2010 from South Dakota State University in Rapid City, SD.

 
Cherise Hunter, MSN, CRNP, has been working with Regional Health Clinical Research since 2004. She earned her master’s degree in nursing in    from University of Pennsylvania in Philadelphia, PA.

 

PATIENTS/RESEARCH PARTICIPANTS

Interested in participating in clinical research?

  • Contact Cancer Care Institute Research if interested in participating in any of these research areas:
  • Radiation oncology
  • Medical oncology
  • Hematology
  • Gynecologic oncology
  • Contact Regional Health Clinical Research if interested in participating in any of these research areas:
  • Cardiology
  • Cardiac electrophysiology
  • Interventional cardiology
  • Vascular medicine
  • Nuclear Cardiology
  • Endovascular medicine
  • Family medicine
  • Pediatric medicine
  • Pediatric endocrinology
  • Endocrinology
  • Rheumatology
  • Infectious disease
  • Nephrology
  • diabetes
  • dialysis
  • vaccines
  • heart failure
  • cardiac stents
  • cardiac monitoring devices

Contact Regional Health Institutional Review Board if interested in IRB information

Regional Health Institutional Review Board

PO Box 6000

Rapid City, SD 57709-6000

Phone: (605) 755-9037

Email: rhirb@regionalhealth.com

 
Regional Health Clinical Research

Contact: Crystal Gruetzmacher

Phone: (605) 755-4326

Email: research@regionalhealth.com

 
Cancer Care Institute Research

Contact: Angie Dunbar

Phone: (605)755-2370

Email: adunbar@regionalhealth.com

 

 

RESEARCH STUDY SITES

Current Research/Study Sites

  • Cancer Care Institute
  • Black Hills Cardiovascular Research
  • Specialty Research