ADC
Alzheimer's Disease Center
Clinical Research Study Opportunities...
STUDY OPPORTUNITIES:
Overview
UK ADC Affiliated Studies
UK ADCS Trials
UK Aging Studies
Lexington Clinic Studies
Neuroimaging Studies of Depression in Parkinson's Disease
Research Participation Opportunities (pdf)
UK ADC Affiliated Studies Flyer (pdf)
We offer a variety of research opportunities for interested persons that wish to help us promote normal healthy brain aging for all, cure diseases such as Alzheimer's disease and related disorders, and improve the general medical health and well being of the aging population today.
Why Participate?
Participation in clinical trials and research is the only way we can hope to find cures for diseases such as Alzheimer's disease, and promote normal healthy brain and body aging for all!
Ongoing research opportunities exist for those:
- Currently enrolled or planning enrollment in our Clinical Core activities, including normal or impaired persons
- Interested in clinical trials for Alzheimer's disease and related disorders through our participation in the Alzheimer's Disease Cooperative Study (ADCS) group trials
- Interested in helping us understand memory and thinking in aged populations
- Interested in affiliated studies in gerontology and noncognitive aspects of the aging process
- Individuals of all genders, racial backgrounds, and ethnicities. Minority participants are encouraged to enroll.
Links to Websites for Further Information
- UK Clinical Research organization:
http://www.mc.uky.edu/ukcro/contact_us_page.htm - UK Office of Research Integrity:
http://www.research.uky.edu/ori/ - HIPAA Guidelines for research at UK:
http://www.research.uky.edu/ori/HIPAA/main%20page.htm - NIH Bioethics:
http://bioethics.od.nih.gov/ - National Office of Research Integrity, Department of Health and Human
Services:
http://ori.dhhs.gov/ - Clinical trials supported by government funding mechanisms:
http://www.clinicaltrials.gov/ - National Institutes of Health:
http://www.nih.gov/ - US Food and Drug Administration:
http://www.fda.gov/ - US Department of Health and Human Services Outreach for clinical trial
participation:
http://www.hhs.gov/ohrp/outreach/ - National database on funded research projects:
http://crisp.cit.nih.gov/ - Alzheimer's Disease Cooperative Study Group home page:
http://adcs.ucsd.edu/Home.htm - The National Alzheimer's Disease Education and Referral Center:
http://www.nia.nih.gov/Alzheimers/ - The National Alzheimer's Association:
http://www.alz.org/ - Federal Office of Health and Research Protection:
http://www.hhs.gov/ohrp/outreach/documents/Brochure.htm - FDA Human Subject Protection - Know your rights & understand the
researcher's responsibilities (FDA-CDER):
http://www.fda.gov/cder/Offices/DSI/humanSubjectProtection.htm
Is Research Participation Safe?
Yes, current research guidelines require that the benefits are always greater than the risks associated with participation. Current research practices are regulated by protective committees and agencies at the university, local, state, and federal levels. At the University of Kentucky (UK) Alzheimer's Disease Center (ADC) and the Sanders-Brown Center on Aging, we stay focused on safety and ensure that you and your loved one's best interest always come first. We do not engage in "risky" research or activities that may place your health and well being at risk.
In the past, research participation was at times conducted without participant knowledge or even against the wishes of the research participant. From prehistoric trephining (cutting holes in the skull to release evil demons), to the harmful medical research conducted by the Nazis in the mid 20th century, to the Tuskegee Syphilis Study in the US in the early 1900s, research atrocities have been carried out in the name of "medical research." These practices have led to many unfortunate outcomes in research participants.
The realization that research could potentially be distorted and endanger, rather than help research participants, has led to the development of many protective agencies at the local, state, and federal levels. The misconception that such atrocities could occur today hampers research and slows our progress in reaching our goals. These goals include curing Alzheimer's disease and related disorders and promoting normal, healthy brain aging for all.
An extensive system of research oversight has been developed to protect individual human rights and ensure that research benefits always outweigh the risks.. The historic declaration of Helsinki, adopted in 1964 by the World Medical Association (WMA) http://www.wma.net/e/policy/b3.htm, most recently clarified at the WMA Assembly in Tokyo 2004, sets forth guidelines for the protection of human research subjects that are strictly adhered to by the UK ADC and the Sanders-Brown Center on Aging and at the university, local, state, and federal levels for all research programs. All of our personnel involved in human research activities have completed extensive training in the ethics, principles, and practices of conducting human clinical research http://www.citiprogram.org/.
The research projects we are currently participating in are regulated from the university to the federal level to ensure that we are meeting or exceeding the guidelines set forth by the Declaration of Helsinki. UK has an independent Office of Research Integrity http://www.research.uky.edu/ori/ that mandates all research conducted at UK be reviewed by the IRB (Institutional Review Board) to ensure safe and ethical medical research practices. In addition, the vast majority of our research studies have been reviewed and are overseen by IRBs at the National Institute of Health (NIH) and its centers, ensuring multiple levels of oversight and protection for our participants. At the UK ADC and the Sanders-Brown Center on Aging, we follow the strictest ethical guidelines to ensure the safety of you and your loved ones who might be participants, or consider participating in our ongoing research efforts!
How Do I Know What the Risks and Benefits of the Study Are?
Risks and benefits of participating in any study are described in the detailed consent form for each study. They are explained in easily understandable language designed for persons with a greater than 5th grade education. Consent forms designed for persons with cognitive impairment or educational levels below the 5th grade level are available for many of the studies we offer.
Do I have to Participate?
Research participation is voluntary in all our activities. If you decide not to participate, it will in no way affect your planned or ongoing clinical care by our trained professional staff.
Can My Participation End Early?
If you enroll in one of our research activities and decide that you would like to end your participation in the study, you may do so without explanation. Your ongoing or planned clinical care with our staff will continue regardless of your research participation.
Who Will See My Information?
All research at the UK ADC and the Sanders-Brown Center on Aging is kept strictly confidential. Participants are assigned a study number (i.e. #812074) to protect confidentiality. Health care information released or obtained as part of your research participation is de-identified and not accessible to future employers or insurance agencies. Your private health information is protected by the UK ADC and the Sanders-Brown Center on Aging according to the Health Insurance Portability and Accountability Act (HIPAA regulations) http://www.research.uky.edu/ori/HIPAA/main%20page.htm.
Other agencies or institutions may see your information depending on the research study you enroll in. These agencies and institutions may include any affiliated centers, universities, private corporations or facilities participating in the research activities, the Food and Drug Administration (FDA), the NIH, or other funding mechanisms. Release of your health information to any of these organizations is also protected by HIPAA regulations to further ensure your privacy.
What Happens if You Get Sick or Hurt During a Research Study?
If you accidentally get sick or hurt while participating in a research study, you should immediately notify the study staff. They will ensure that you receive the proper care and will will evaluate how it will affect your research participation. If you have any questions about your safety or rights as a volunteer in this research, you can also contact the staff in the Office of Research Integrity at the University of Kentucky at 859-257-9428 or toll free at 1-866-400-9428.
It is important for you to understand that the University of Kentucky does not have funds set aside to pay for the cost of any care or treatment that might be necessary if you get hurt or sick while taking part in most research studies. Also, the University of Kentucky will not pay for any wages you may lose if you get sick or hurt.
Medical costs that result if you get sick or hurt cannot be included as regular study related costs. Therefore, the medical costs related to your care and treatment if you should get sick or hurt, will be your responsibility; or
will be paid by the sponsor (if research is industry sponsored); or
your insurer may agree to pay those costs (you should ask your insurer if you have any questions regarding your insurer's willingness to pay under these circumstances); or
Medicare or Medicaid will pay medically necessary costs (if you have any questions regarding Medicare/Medicaid coverage you should contact Medicare by calling 1-800-Medicare (1-800-633-4227) or Medicaid 1-800-635-2570.
A co-payment/deductible from you may be required by your insurer or Medicare/Medicaid even if your insurer or Medicare/Medicaid has agreed to pay the costs).
If you are eligible for Veterans Affairs (VA) medical benefits, the VA provides medical care if you get hurt or get sick as a result of taking part in this study. The necessary care must be provided in a VA medical facility unless an exception is granted. In cases of exceptions, the VAMC Director may contract for such care. Exceptions include: situations where a VA facility is not capable of furnishing economical care, situations where a VA facility is not capable of furnishing the care or services required, and situations involving a non-veteran research subject. The VA does not provide medical treatment for a research-related injury in cases where injuries result from noncompliance by a research subject with study procedures.
A co-payment from you may be required for medical care and services provided by the VA.
Will You Recieve Any Awards for Taking Part in a Research Study?
Each study is different in regard to direct benefit including monetary rewards for participation. You should address these issues directly with the study staff who are enrolling you in their individual research opportunities.
What if You have Questions, Suggestions, Concerns or Complaints?
If you have any questions, suggestions, concerns or complaints about enrolling in or during participation in a clinical study conducted by or affiliated with the UK ADC or Sanders-Brown Center on Aging, you should first contact the study principal investigator. If you have additional concerns or issues, you should contact Dr. Greg Jicha at the UK ADC and Sanders-Brown Center on Aging at (859) 257-1412 ext.255. You can also contact the staff in the Office of Research Integrity at the University of Kentucky at 859-257-9428 or toll free at 1-866-400-9428.
We hope this information is helpful and makes you feel comfortable with your decision to participate in our clinical research opportunities at the UK ADC and Sanders-Brown Center on Aging. Your involvement is critical if we ever hope to cure diseases such as Alzheimer's disease and promote normal, healthy brain aging for all!