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, EKG's, chest X-rays 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), EKG's, and chest X-rays 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?WHAT ARE THE TOP TEN THINGS TO REMEMBER IF I AGREE TO PARTICIPATE IN A STUDY PROGRAM?
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.
(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) Virtually all blood work will require that you “fast” for at least 12 hours before the blood is drawn. This means no food or drink (although water and medications are okay).
(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 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.
THE RESEARCH STAFF:
Olivia Fruit RD, LD - Site Manager, Research Coordinator & Research Dietitian
Coury Hobbs RN, BSN - Business Manager / Senior Research Coordinator
Whitney Asher MS, RDN, LD, CN - Recruitment
Specialist/Research Coordinator & Research Dietitian
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
Nikki Nockerts RN, BSN, CCRC - Senior Research Coordinator
Michelle Ritchey RN, MSN, APRN, CCRC -
Subinvestigator / Senior Research Coordinator
Danielle Smith RN, MSN, APRN, Subinvestigator /
Jerry Seadler - Environmental Services
Becky Whitehead RN, BSN, CCRC -
Senior Research Coordinator
Shay Young - FNP, NP-C, DNP - Subinvestigator / Research Coordinator
Harold Bays MD, FTOS, FACC, FACE, FNLA -
Medical Director / Investigator
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 policies detailed below.)
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule gives individuals a fundamental right to be informed of the privacy practices of most all health care providers, as well as to be informed of their privacy rights with respect to their personal health information.
The research staff at L-MARC Research Center are not a "covered entity" under the Health Insurance Portability and Accountability Act (HIPAA), Privacy Rule because in their limited role as researchers at L-MARC Research Center, they do not provide health care within the traditional scope as a medical provider, but rather as outlined by specific research study protocols, and by the obligations towards protecting study volunteer safety. Nonetheless, L-MARC Research Center does have privacy policies and procedures wherein the protected health information (PHI) that is created or obtained during this research study cannot be "used" to conduct the research or "disclosed" (given to anyone) for research purposes without your permission. This permission is called an "Authorization."
Therefore, you may not participate in any study, nor may you have any procedure performed (such as phlebotomy / blood draw) unless you give your permission to use and disclose your PHI by signing this Authorization. By signing, you are agreeing to allow the research staff to use your PHI for determination of potential study eligibility.
In the event that you qualify for, and agree to participate in a clinical trials, by signing this authorization, you are agreeing to allow the research staff to disclose this PHI to all parties who may need it for research purposes:
* Your PHI may be disclosed to the sponsor of any study you may qualify and any agents, representatives or consultants working on behalf of the sponsor to conduct this study (all collectively referred to in this authorization document as "the sponsor"). The term "sponsor" may also include any company that buys the Sponsor, or a company owned by or associated with the sponsor that is involved in the development, regulatory, manufacturing, or marketing of what is being studied in this research trial. Furthermore, the term "sponsor" may include any company that takes over the development, production, marketing or sale of what is being studied, as well as the people or companies working for these parties.
* An Institutional Review Board ("IRB") may have access to your PHI in relation to its responsibilities as an institutional review board.
Unless you specify otherwise, by signing this authorization, you agree that applicable portions of your PHI may be disclosed to your health care provider for treatment purposes.
Other disclosures of protected health information shall be as you have specifically requested and authorized. The use or disclosure of protected health information may also occur as required for compliance with the Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification Rules, to the Department of Health and Human Services (HHS) when disclosure of information is required under the Privacy Rule for enforcement purposes, and as otherwise required by law. These privacy practices may be changed in accordance with applicable law.
* This Authorization will never expire unless and until you revoke (cancel or withdraw) it, or unless these records have been destroyed. You have a right to revoke it at any time. If you revoke the authorization, your PHI will no longer be used for potential study purposes, except to the extent the parties to the research have already taken action based upon your Authorization or need the information to complete analysis and reports for this research.
* To revoke you Authorization, you must send a written notice to L-MARC Research Center, stating that you are revoking your Authorization to Use or Disclose Protected Health Information. If you revoke or decline this Authorization, you will not be allowed to be considered for participation in any potential study.
Any inquiry, requests, or even complaints about protected health information can be directed to any staff member of Louisville Endocrinology PSC, who will then direct any such issues to the appropriate, responsible person for assistance.
* This notice is available to any person who asks for it. In addition, a more complex, not-so-plain language list of examples of what may or may not be listed upon a request of "Accounting of Disclosure" can be found at our L-MARC Research Center web site (found at www.lmarc.com). It is also posted in a clear and prominent location in the waiting room.
*In any request of "Accounting of Disclosures," Louisville Endocrinology PSC is not required to list:
- Uses and disclosures made to carry out treatment, payment and health care operations;
- Uses and disclosures made to the individual that is the subject of the PHI;
- Uses and disclosures made pursuant to a valid authorization;
- Uses and disclosures made for the facility’s directory or to persons involved in the individual’s care or other notification purposes;
- Uses and disclosures made for national security or intelligence purposes;
- Uses and disclosures made to correctional institutions or law enforcement officials;
- Disclosures that are part of a "limited data set" and the information does not contain any information that directly identifies the individual;
- Disclosures that occurred prior to the compliance date for the covered entity; and
- Disclosures that are merely incidental to another permissible use/disclosure, e.g. using waiting room sign-in sheets. * In any request of "Accounting of Disclosures," the following are examples of what health care providers (including Louisville Endocrinology PSC) may list, depending upon applicability and lawfulness:
(1) Example of the types of uses and disclosures for public health activities and required by law.
Reports of child abuse.
- Registration of births with local registrar pursuant.
- Reporting of death.
- Disclosure of vital statistics records (i.e. – birth, death, marriage and divorce) to the Cabinet for Health Services or its designee.
- Reports made to the state regarding specific diagnosed diseases.
- Reports made to the state for investigation and control of communicable diseases.
- Disclosures to the Cabinet for Health Services of blood tests of pregnant women who tested positive for syphilis.
- Disclosures to the Cabinet for Health Services of a diagnosis of communicable diseases.
- Disclosures to the Cabinet for Health Services of positive newborn screens for PKU and other inborn errors of metabolism and other inherited diseases.
- Disclosure to the state of any person found or suspected to have high levels of lead in the blood.
- Disclosure to the Kentucky Birth Surveillance Registry of data on the incidence, prevalence and trends of congenital anomalies, stillbirths and disabling conditions.
- Disclosure of names and chest X-rays to the local health department of a person who tests positive for tuberculosis.
- Disclosure to the Cabinet for Health Services regarding prevalence of drug and alcohol abuse during pregnancy. [Note: the statute requires that any such reporting be kept confidential, but should still be listed]
- Reports made by licensed health facilities of each case of cancer to the Kentucky Cancer Registry.
- Reports made regarding HIV infection.
- Reports made regarding HIV infection of inmates.
- Reports to the Cabinet for Health Services of positive HIV tests a using unique identifier.
- Reports to the Commission for Children with Special Health Needs of potential hearing loss in infants.
- Disclosures made to the Cabinet for Health Services of data on cost, quality and outcomes of health care services.
- Disclosures made to the Cabinet for Health Services for release of public data sets for health care discharge data.
- Disclosures to the Cabinet for Health Services of HIV testing of persons convicted of prostitution.
(2) Examples of disclosures about victims of abuse, neglect or domestic violence
- Reports to Cabinet for Families & Children of domestic violence, elder abuse or neglect.
- Reports of dependency, neglect or abuse of a child.
(3) Examples of uses and disclosures for health oversight activities.
- A "health oversight agency" is a government agency or someone acting under a grant of authority with a government agency. Oversight activities involve those related to the receipt of health care; a claim for public benefits related to health; or qualification for public benefits when a patient’s health is integral to the claim. Examples of health oversight agencies are listed below.
- AdminaStar Federal
- Kentucky Board of Medical Licensure
- Kentucky Board of Nursing
- Kentucky Department of Insurance
- Department for Medicaid Services
- Centers for Medicare and Medicaid Services
(4) Examples of disclosures for judicial and administrative proceedings
- Disclosures made pursuant to a subpoena [as long as certain guidelines are met] or court order.
- Disclosures made during testimony given at a judicial or administrative proceeding [i.e. – a deposition] unless they are made after the individual patient authorizes the disclosure pursuant to a valid HIPAA authorization.
- Disclosures to the Cabinet for Health Services of HIV testing for defendants of certain sexual offenses.
- Disclosures to Court Appointed Special Advocate Volunteers.
5. Examples of disclosures for law enforcement purposes
- Disclosures made pursuant to a valid warrant.
- Disclosures made to identify or locate a suspect, fugitive, material witness or missing person [Note: Only certain information may be disclosed]
- Disclosures to law enforcement to alert them that someone has died under certain circumstances.
- Disclosures regarding evidence of a crime that occurs on the premises of the covered entity.
6. Examples of uses and disclosures about decedents
- Disclosures to a coroner and/or funeral director to report a deceased or determine the cause of death.
7. Examples of uses and disclosures for research purposes
- Waiver of authorization
- Protocol preparation
8. Examples of uses and disclosures to avert a serious threat to health or safety
- Mental health professional’s duty to warn
- Uses and disclosures for cadaveric organ, eye or tissue donation purposes
- Disclosures to organ procurement organizations or other entities engaged in procurement, banking or transplantation of cadaveric organs, eyes or tissue.
9. Unlawful or unauthorized disclosures
- Disclosures in violation of the HIPAA statute [i.e. – medical records stolen or accessed by unauthorized personnel].
10. Uses and disclosures for workers’ compensation
- Disclosures of protected health information in workers’ compensation cases may be made "as authorized by law." In Kentucky, disclosures may be made after the patient executes a waiver and consent of any physician-patient privilege with respect to any condition or complaint related to the condition for which the patient seeks workers’ compensation.
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