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Questions?

  • Call 502.214.3977 for the study recruitment phone line
  • Call 502.515.5672 to talk with an L-MARC Staff Member

WHAT IS L-MARC RESEARCH CENTER? (Click here to view movie clip about L-MARC Research Center)

The Louisville Metabolic and Atherosclerosis Research Center (L-MARC) is a metabolic research center that investigates treatments for cholesterol disorders, diabetes mellitus, hypertension, osteoporosis, obesity, arthritis, and other metabolic disorders. Our research center began in 1986, where it first focused on research in cholesterol disorders (lipids).  It was then known as “The Lipid Center.”  Since then, we have continued to expand our research efforts to many other metabolic disease areas.   To reflect the increased diversity, the center was renamed “L-MARC” (Louisville Metabolic and Atherosclerosis Research Center) in 1998.   Our research team consists of research coordinators,  on-site dietitians,  research phlebotomists, affiliated research physicians as well as other important research personnel.  Finally, Dr. Harold Bays has been, and continues to be our Medical Director.  In fact, he has been the only Medical Director since the center began conducting research.  As such, he  has been the Principal Investigator of numerous clinical research trials.  He has given national and international presentations at scientific meetings and conferences, is published in the medical literature, and serves as a research consultant for pharmaceutical companies. However, Dr. Bays is not the only physician who conducts research at L-MARC Research Center.  For example, other physicians often utilize the resources of L-MARC to conduct their research.

WHY DO PEOPLE PARTICIPATE IN STUDY PROGRAMS? (Click here to learn more about research study programs)

Volunteers who participate in study programs may receive study-related procedures such as medical evaluations, physical exams, laboratory/blood testing, dietitian visits, electrocardiograms, and study drug - all without charge.  Sometimes, study volunteers may receive reimbursement for time and travel.  But our experience suggests that these are typically not the major reasons why volunteers participate in study programs.  Most of our study volunteers participate because they appreciate the one-on-one chance to discuss their health issues with a trained health professional.  Other study volunteers enjoy the social atmosphere of being part of the research family.  But perhaps the most important reason that our study volunteers participate in study programs is to assist us in the research and development of investigational medications/drugs for an assortment of medical conditions.   They recognize that their efforts may potentially result in the development of safer and more effective treatments for future generations to come.  And in this way, they find participation in study programs an enjoyable and rewarding experience.

HOW DO I BENEFIT FROM PARTICIPATION IN A STUDY PROGRAM? (Click here to learn more about L-MARC Research Center)

It should be made clear that L-MARC is not a free treatment center.  Our primary focus is investigational research.  Therefore, most of our study programs involve the use of drugs that have yet to be proven effective or safe.  Furthermore, many of our study programs compare study drug to placebo (or “dummy” pills).  As such, in some studies, volunteers may not be guaranteed that they will be on active treatment, sometimes throughout the entire study program.  

Nevertheless, for the reasons previously discussed,  our study volunteers often feel they benefit from participation in study programs.  The safety monitoring procedures such as study-related medical evaluations, physical exams, laboratory/blood testing, dietitian visits (with personalized review of diet history, and personalized dietary recommendations), and electrocardiograms often represents a battery of testing to a degree that exceeds what their insurance might approve, or what they might receive by simply going to their doctor.  As a result, many (if not most) of the abnormalities found on physical exams, or found on laboratory testing are unrelated to the study program medication/drug.  In other words, because we evaluate our study volunteers to a degree that is specified by a study protocol, we often discover medical issues that would have otherwise gone undetected.  And once these previously undetected abnormalities are found, the study volunteer, and the study volunteer’s doctor is notified for further evaluation and treatment.

WHAT STUDY PROGRAMS ARE AVAILABLE? (Click here for L-MARC Clinical Trial Ad Page)

We typically have several metabolic study programs ongoing at any point in time. Therefore, if you have a metabolic condition that you feel might make you eligible for participation, then simply call us and speak with one of our staff.  You also can leave a message on the phone, and we will get back with you.  (If you do not hear back within a few days, please call back!)  Also, if you are not eligible for a current study program, keep in touch.  We may very well have a different study program available for you in the future.

HOW DO I QUALIFY FOR A STUDY PROGRAM? (Click here to contact us)

First of all, you must qualify by having a medical condition that requires a treatment that we are studying.  Secondly, you must meet inclusion criteria, while avoiding exclusion criteria.  Thirdly, you must carefully evaluate the consent form to see if this is something you really want to do, and are really committed to do.  Finally, if you agree to participate by signing the consent form, you will likely receive an extensive evaluation including laboratory and clinical exams.  Afterwards, if you continue to qualify, then you may receive study drug treatment. (Please remember, you cannot change any aspect of your medical care, nor can you undergo any study related procedures, including blood testing, until you understand, and sign a consent form.)

WHAT HAPPENS ONCE THE STUDY PROGRAM IS OVER?

Once the study program is over, you will receive an “exit letter” that will briefly describe the study again, and will list conditions or medical issues that were found, or that occurred during your participation in the study program.  Although the vast majority of these conditions and medical issues will likely be unrelated to the study drug, we feel it is important that you be provided this letter, with a copy sent to your primary care doctor for your medical records.

WHAT ARE THE TOP TEN THINGS TO REMEMBER IF I AGREE TO PARTICIPATE IN A STUDY PROGRAM?

(1)  Always notify your research coordinator of all medications, including over-the-counter medications, vitamins, herbs, birth control pills, and hormones.

(2)  Many medications may interact with study drugs, or may alter blood tests.  Therefore, if you are developing a condition that you feel might require medication treatment (even if over-the-counter), please contact your research coordinator as soon as possible.  For example, if you are developing an illness on Friday, please call your research coordinator on Friday.  Please do not try to “tough it out” over the weekend.

(3)  Strenuous physical activity can alter muscle blood tests.  Alcohol can alter liver blood tests.  Therefore, during participation in a study program, please try to avoid unusually strenuous exercise and excessive alcohol within two days of having your blood drawn.

(4)  Many (but not all) study programs require that your diet and exercise remain constant throughout the duration of the program.  Therefore, you may need to maintain the same level of diet and exercise at the beginning of the study, as at the end of the study.

(5)  Laboratory has to be performed at precise time periods.  You will need to plan these visits into your schedule.  If you are unable to keep an appointment, please contact your research coordinator as soon as possible.

(6)  Notify your research coordinator of any illnesses or injury that occurred during the study program - particularly if it required a doctor’s office visit or hospitalization.  This is regardless of whether or not the illness, condition, or injury had anything to do with the study.

(7)  If you are on study drug, always bring study medications and empty bottles and/or boxes with you at each visit.

(8) It is our standard medical practice that patients fast at least 12 hours before their blood is drawn.  This means no food or drink (although water and medications are okay).  However, if you have not yet signed an informed consent document, then we cannot require you to fast before your visit, because fasting is a procedure.  Fasting will be your choice

(9)  You are entitled to discontinue the study at any time of your choosing.  However, a great deal of time and expense is involved in entering volunteers into study programs.  Furthermore, each study volunteer dropped from the study decreases the overall quality of the study.  Therefore, if you feel it is possible you may not have the commitment of time or effort to adhere to study guidelines throughout the duration of the study, please notify the research coordinator before you agree to sign consent.

(10)  At the end of each study, it is necessary for you to have an exit visit.  Therefore, even if you drop from the study early, you will be asked to keep the exit visit so that we can ensure safety issues.

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THE RESEARCH STAFF:

Olivia Kelly RD, LD - Site Manager, Research Coordinator & Research Dietitian

Coury Hobbs RN, BSN - Business Manager, Senior Research Coordinator

Noreen Behl - Research Assistant

Debbie Conliffe BS - Research Assistant

Tammy Jackson MA - Research Laboratory & Phlebotomist

Sarah Keiran RN, BSN, CCRC - Senior Research Coordinator

Susie Lucas MA - Research Assistant, Data Entry, Research Laboratory & Phlebotomist

Jean Micklewright  RD, LD - Director of Nutritional Programs / Research Dietitian

Melanie Moore RN, MSN, APRN, CCRC - Sub-investigator / Senior Research Coordinator

Nikki Nockerts RN, BSN, CCRC - Senior Research Coordinator

Michelle Ritchey RN, MSN, APRN, CCRC - Subinvestigator / Senior Research Coordinator

Danielle Smith RN, MSN, APRN, Subinvestigator/ Research Coordinator

Jerry Seadler - Environmental Services

Samantha Thomas  -  Research assistant / Recruitment specialist

Tabitha Wilson BS  -  Kinesiology, Recruitment Specialist

Shay Young  - FNP, NP-C, DNP  - Subinvestigator / Research Coordinator

Harold Bays MD, FTOS,  FACC, FACE, FNLA, Medical Director / Investigator

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NOTICE OF L-MARC RESEARCH CENTER’S PRIVACY POLICIES

(If a study subject / volunteer undergoes the informed consent process and signs a consent form for a specific study program that contains privacy policies, it is the signed agreement that applies, which may vary from the below.)

Health Insurance Portability and Accountability Act (HIPAA) and Protected Health Information

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION.
We understand the importance of privacy and are committed to maintaining the confidentiality of your medical information, sometimes termed “protected health information.” We make a record of the medical care we provide and may receive such records from others. We may use these records:

  • To provide or enable other health care providers to provide quality medical care
  • To obtain payment for services provided to you as allowed by your health plan (in the event our services are, or become covered by health plans)
  • To enable us to meet our professional and legal obligations.

We are required by law to maintain the privacy of protected health information, to provide individuals with notice of our legal duties and privacy practices with respect to protected health information, and to notify affected individuals following a breach of unsecured protected health information. This notice describes how we may use and disclose your medical information. It also describes your rights and our legal obligations with respect to your medical information. If you have any questions about this, please contact a staff member.
How might this medical practice use or disclose your health information?
This medical practice collects health information about you and stores it in a chart, on a computer, and in electronic health records/personal health records. The medical record is the property of this medical practice, but the information in the medical record belongs to you. The law permits us to use or disclose your health information for the following purposes:
1. Treatment. We use medical information about you to provide your medical care. We disclose medical information to our employees and others who are involved in providing the care you need, such as your other treating clinicians.  We may share your medical information with other physicians or other health care providers who will provide services we do not provide. We may share this information with your insurance company to obtain your medical history and retrieve your medication history.  We may share this information with a pharmacy to retrieve a record of your medications, or a pharmacist who needs it to dispense a prescription to you.  We may share this information to a laboratory that performs a test. We may also disclose medical information to members of your family or others who can help you when you are sick or injured, or in the event of your death.
2. Payment.  In the event our services are, or become covered by your health insurance, then we will use and disclose medical information about you to obtain payment for the services we provide. We may also disclose information to other health care providers to assist them in obtaining payment for services they have provided to you.
3. Health Care Operations. We may use and disclose medical information about you to operate this medical practice. For example, we may use and disclose this information to review and improve the quality of care we provide, or the competence and qualifications of our professional staff. Or we may use and disclose this information to work with your health plan to authorize services or referrals. We may also use and disclose this information as necessary for medical reviews, legal services and audits, including fraud and abuse detection and compliance programs and business planning and management. We may also share your medical information with our "business associates," such as our billing service, that perform administrative services for us. We have a written contract with each of these business associates that contains terms requiring them and their subcontractors to protect the confidentiality and security of your protected health information. We may also share your information with other health care providers, health care clearinghouses or health plans that have a relationship with you, when they request this information to help them with their quality assessment and improvement activities, their patient-safety activities, their population-based efforts to improve health or reduce health care costs, their protocol development, case management or care-coordination activities, their review of competence, qualifications and performance of health care professionals, their training programs, their accreditation, certification or licensing activities, or their health care fraud and abuse detection and compliance efforts.
4. Appointment Reminders. We will use and disclose medical information to contact and remind you about appointments or need to reschedule through email, phone and/or text messages. If you are not home, we may leave a voice mail about your appointment on your answering machine or with the person answering the phone.
5. Sign In Sheet. We may use and disclose medical information about you by having you sign in when you arrive at our office. We may also call out your name when we are ready to see you.
6. Notification and Communication With Family. We may disclose your health information to notify or assist in notifying a family member, your personal representative or another person responsible for your care about your location, your general condition or, unless you had instructed us otherwise, in the event of your death. In the event of a disaster, we may disclose information to a relief organization so that they may coordinate these notification efforts. We may also disclose information to someone who is involved with your care or helps pay for your care. If you are able and available to agree or object, we will give you the opportunity to object prior to making these disclosures, although we may disclose this information in a disaster even over your objection if we believe it is necessary to respond to the emergency circumstances. If you are unable or unavailable to agree or object, our health professionals will use their best judgment in communication with your family and others.
7. Marketing. Provided we do not receive any payment for making these communications, we may contact you to give you information about products or services related to your treatment, case management or care coordination, or to direct or recommend other treatments, therapies, health care providers or settings of care that may be of interest to you. We may similarly describe products or services provided by this practice and tell you which health plans this practice participates. We may also encourage you to maintain a healthy lifestyle and get recommended tests, participate in a disease management program, provide you with small gifts, tell you about government sponsored health programs or encourage you to purchase a product or service when we see you, for which we may be paid. Finally, we may receive compensation which covers our cost of reminding you to take and refill your medication, or otherwise communicate about a drug or biologic that is currently prescribed for you. We will not otherwise use or disclose your medical information for marketing purposes or accept any payment for other marketing communications without your prior written authorization. The authorization will disclose whether we receive any compensation for any marketing activity you authorize, and we will stop any future marketing activity to the extent you revoke that authorization.
8. Sale of Health Information. We will not sell your health information without your prior written authorization.
9. Required by Law. As required by law, we will use and disclose your health information, but we will limit our use or disclosure to the relevant requirements of the law. When the law requires us to report abuse, neglect or domestic violence, or respond to judicial or administrative proceedings, or to law enforcement officials, we will further comply with the requirement set forth below concerning those activities.
10. Public Health. We may, and are sometimes required by law, to disclose your health information to public health authorities for purposes related to: preventing or controlling disease, injury or disability; reporting child, elder or dependent adult abuse or neglect; reporting domestic violence; reporting to the Food and Drug Administration problems with products and reactions to medications; and reporting disease or infection exposure. When we report suspected elder or dependent adult abuse or domestic violence for which you are a potential victim, we will inform you or your personal representative promptly unless in our best professional judgment, we believe the notification would place you at risk of serious harm or would require informing a personal representative we a believe is responsible for the abuse or harm.
11. Health Oversight Activities. We may, and are sometimes required by law, to disclose your health information to health oversight agencies during the course of audits, investigations, inspections, licensure and other proceedings, subject to the limitations imposed by law.
12. Judicial and Administrative Proceedings. We may, and are sometimes required by law, to disclose your health information in the course of any administrative or judicial proceeding to the extent expressly authorized by a court or administrative order. We may also disclose information about you in response to a subpoena, discovery request or other lawful process if reasonable efforts have been made to notify you of the request and you have not objected, or if your objections have been resolved by a court or administrative order.
13. Law Enforcement. We may, and are sometimes required by law, to disclose your health information to a law enforcement official for purposes such as identifying or locating a suspect, fugitive, material witness or missing person, complying with a court order, warrant, grand jury subpoena and other law enforcement purposes.
14. Coroners. We may, and are often required by law, to disclose your health information to coroners in connection with their investigations of deaths.
15. Organ or Tissue Donation. We may disclose your health information to organizations involved in procuring, banking or transplanting organs and tissues.
16. Public Safety. We may, and are sometimes required by law, to disclose your health information to appropriate persons in order to prevent or lessen a serious and imminent threat to the health or safety of a particular person or the general public.
17. Specialized Government Functions. We may disclose your health information for military or national security purposes or to correctional institutions or law enforcement officers that have you in their lawful custody.
18. Workers’ Compensation. We may disclose your health information as necessary to comply with workers’ compensation laws. For example, to the extent your care is covered by workers' compensation, we will make periodic reports to your employer about your condition. We are also required by law to report cases of occupational injury or occupational illness to the employer or workers' compensation insurer.
19. Change of Ownership. In the event that this medical practice is sold or merged with another organization, your health information/record will become the property of the new owner, although you will maintain the right to request that copies of your health information be transferred to another physician or medical group.
20. Breach Notification. In the case of a breach of protected health information, we will notify you as required by law. If you have provided us with a current e-mail address, we may use e-mail to communicate information related to the breach. In some circumstances our business associate may provide the notification. We may also provide notification by other methods as appropriate.
21. Psychological Notes. We will not use or disclose psychological notes without your prior written authorization except for the following: 1) use by the originator of the notes for your treatment, 2) for training our staff, students and other trainees, 3) to defend ourselves in the case of a legal proceeding, 4) if the law requires us to disclose the information to you or the Secretary of HHS or for some other reason, 5) in response to health oversight activities concerning your psychological evaluation, 6) to avert a serious and imminent threat to health or safety, or 7) to the coroner or medical examiner in the event of your death.  To the extent you revoke an authorization to use or disclose your psychological notes, we will stop using or disclosing these notes.
22. Research. By signing this document, you agree to allow us to use protected health information data we collect for research purposes.  We may disclose your health information to researchers conducting research without your written authorization, as approved by an Institutional Review Board or privacy board, in compliance with governing law.  If your protected health information is used for research purposes, such as for the analysis of data we collected from you (and others) before the research started, the research report will be “de-identified.”  This means any data collected will not identify you as an individual.  Nothing about you as an individual will be included in any research publication, without your separate authorization, allowing us to do so.
Can you revoke your authorization to disclose your health information? 
Yes.  If you authorize this medical practice to use or disclose your health information, then you may revoke your authorization in writing at any time – which will apply to the items listed above not otherwise required by law.
What are some of your health information rights?
1. Right to Request Special Privacy Protections. You have the right to request restrictions on certain uses and disclosures of your health information by a written request specifying what information you want to limit, and what limitations on our use or disclosure of that information you wish to have imposed. If you tell us not to disclose information to your commercial health plan concerning health care items or services for which you paid for in full out-of-pocket, we will abide by your request, unless we must disclose the information for treatment or legal reasons. We reserve the right to accept or reject any other request, and will notify you of our decision.
2. Right to Request Confidential Communications. You have the right to request that you receive your health information in a specific way or at a specific location. For example, you may ask we send information to a particular e-mail account or to your work address. We will comply with all reasonable requests submitted in writing which specify how or where you wish to receive these communications.
3. Right to Inspect and Copy. You have the right to inspect and copy your health information, with limited exceptions. To access your medical information, you can use the patient portal function of the practice electronic health records.  If you do not to access your medical information electronically, then you must submit a written request detailing what information you want access to, whether you want to inspect it or get a copy of it, and if you want a copy, your preferred form and format. We will provide copies in your requested form and format if it is readily producible, or we will provide you with an alternative format you find acceptable, or if we can’t agree and we maintain the record in an electronic format, your choice of a readable electronic or hardcopy format. We will also send a copy to any other person you designate in writing. We will charge a reasonable fee which covers our costs for labor, supplies, postage, and if requested and agreed to in advance, the cost of preparing an explanation or summary. We may deny your request under limited circumstances. If we deny your request to access your child's records or the records of an incapacitated adult you are representing because we believe allowing access would be reasonably likely to cause substantial harm to the patient, you will have a right to appeal our decision.
4. Right to Amend or Supplement. You have a right to request that we amend your health information that you believe is incorrect or incomplete. You must make a request to amend in writing, and include the reasons you believe the information is inaccurate or incomplete. We are not required to change your health information, and will provide you with information about this medical practice's denial and how you can disagree with the denial. We may deny your request if we do not have the information, if we did not create the information (unless the person or entity that created the information is no longer available to make the amendment), if you would not be permitted to inspect or copy the information at issue, or if the information is accurate and complete as is. If we deny your request, you may submit a written statement of your disagreement with that decision, and we may, in turn, prepare a written rebuttal. All information related to any request to amend will be maintained and disclosed in conjunction with any subsequent disclosure of the disputed information.
5. Right to an Accounting of Disclosures. You have a right to receive an accounting of disclosures of your health information made by this medical practice, except that this medical practice does not have to account for the disclosures provided to you or pursuant to your written authorization, or as described in paragraphs 1 (treatment), 2 (payment), 3 (health care operations), 6 (notification and communication with family) and 17 (specialized government functions) of Section A of this Notice of Privacy Practices or disclosures for purposes of research or public health which exclude direct patient identifiers, or which are incident to a use or disclosure otherwise permitted or authorized by law, or the disclosures to a health oversight agency or law enforcement official to the extent this medical practice has received notice from that agency or official that providing this accounting would be reasonably likely to impede their activities.
6. Right to a Paper or Electronic Copy of this Notice. You have a right to notice of our legal duties and privacy practices with respect to your health information, including a right to a paper copy of this Notice of Privacy Practices, even if you have previously requested its receipt by e-mail.  If you would like to have a more detailed explanation of these rights or if you would like to exercise one or more of these rights, contact our Privacy Officer by asking any staff member. 
What changes might we make to this Notice?
We reserve the right to amend this Notice of Privacy Practices at any time in the future. Until such amendment is made, we are required by law to comply with the terms of this Notice currently in effect. After an amendment is made, the revised Notice of Privacy Protections will apply to all protected health information that we maintain, regardless of when it was created or received. We will keep a copy of the current notice posted in our reception area, and a copy will be available at each appointment.
Where can you send complaints about Protected Health Information?
Complaints about this Notice of Privacy Practices or how this medical practice handles your health information should be directed to our Privacy Officer, who can best be contacted by asking any staff member.
If you are not satisfied with the manner in which this office handles a complaint, a complaint form may be found at www.hhs.gov/ocr/privacy/hipaa/complaints/hipcomplaint.pdf. You will not be penalized in any way for filing a complaint.

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