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Informed consent is a process of educating and legally protecting people who participate in research. At the UW ADRC, this process begins with a research nurse explaining the basics of our research over the phone. Before arriving for a visit at the ADRC, participants receive documents known as consent forms; these forms thoroughly describe the procedures, tests, data collection, and privacy protection of the study. When participants arrive for their first appointment, we will begin by reviewing these forms and fully answering any questions about study participation.
We want our participants to feel informed from the very beginning of the research process, and informed consent is great way of achieving this.
Informed consent is also meant to ensure participant safety and to prevent unethical research on vulnerable populations. Our researchers take very seriously the declining memory and cognitive ability of people with memory loss. We evaluate each participant's ability to understand the research process, and if participants are unable to provide informed consent because of problems with memory or confusion, authorized legal representatives may be able to give permission in their place. In instances where authorized legal representatives provide informed consent for participants, we will only enroll and perform procedures with participants if they assent to the research; that is, they must be active and willing participants.
At any point during their participation in ADRC research, people can decide to discontinue with no loss of benefits. All of the research at our center is voluntary, which means that the level of involvement is determined by participants and not ADRC staff. Participants occasionally discontinue research at the UW ADRC because they decide it requires too much of a time commitment or involves a level of risk with which they are uncomfortable, but whatever the reason (or for no reason at all), discontinuing research is completely fine. Participants may also discuss their involvement with family, friends, and primary care physicians before making this kind of decision.
The research registry is a once-yearly commitment. These yearly appointments usually include a two-and-a-half-hour visit at the ADRC followed by a forty-five-minute phone call with the participant's study companion. The appointments are slightly longer (approximately three hours) if participants are accompanied by a study companion.
Clinical trials generally require a more substantial time commitment than registry participation. However, the precise appointment length or overall duration of a trial varies depending on the specific study. More information about the length of our different clinical trials can be found here.
Eligibility requirements play two roles in clinical trials: (1) they help keep participants safe and (2) they create a group of volunteers who are specifically suited for the research questions being investigated.
Participant safety is one of the most important parts of research at the ADRC. This is one of the reasons we work with the study sponsors and regulatory groups to implement comprehensive eligibility requirements. Our goal is to ensure that getting involved in research is in the best interest of participant personal health and well-being.
Another reason for eligibility requirements is to create a group of research participants who have similar characteristics, such as age, level of memory loss, medical history, and health status. Enrolling participants with comparable characteristics helps to ensure that the results of the trials will be from the medication or treatment being studied and not other factors. In this way, eligibility criteria help researchers achieve accurate and meaningful results.
Why is there a chance study volunteers will be on placebo and not the active, experimental treatment?
The gold standard for testing new treatments and medications in people is the randomized, placebo-controlled clinical trial. In this type of research, volunteers are randomly assigned – that is, selected by chance – to be in either a test group receiving the experimental medication or a control group receiving a placebo, an inactive substance that looks like the active treatment. Comparing the results from these two groups can indicate whether changes in the test group are a result of the treatment. In many trials, no one – not even the research team – knows who is receiving the treatment and who is receiving the placebo. If participants, family members, and staff are all "blind" to whether participants are receiving the treatment or placebo, the study is called a double-blind, placebo-controlled clinical trial.
Someone must know who is on the placebo and the experimental treatments, otherwise, how will there be a comparison of the results to other participants? What about complications during a study?
The research center keeps a sealed list that outlines who is on the experimental treatment and who is on the placebo. This list is kept for safety purposes and can be referenced if it is clinically important to know what substance a research participant is on. After a double-blind placebo-controlled research study is completed the list may be opened and participants may be notified of what substance they were taking. However, this may only happen after all participants have completed the study and the study data has been analyzed.
If a research participant has normal memory, why does someone else need to be involved with them in research?
Memory can be a tricky thing to test. At our research appointments, we ask participants to complete several different memory tests, but we also rely on the input of research study companions to provide another perspective on the participants’ memory. A study companion can be anyone who knows the research participant well and is able to answer potentially sensitive questions about the participant’s daily functioning and behavior. For most people, this is a spouse or a child, but the study companion can also be a close friend or a neighbor. Clinical trials may have more extensive requirements for study companions, and these requirements can vary from trial to trial.
Many people take herbal supplements, but some of them are exclusionary in clinical trials because they may not be monitored or regulated by the Food and Drug Administration (FDA). Additionally, many herbal supplements have not been tested for their effectiveness and reliability; thus, the effects of the supplements are unknown. Given the lack of research and FDA regulation for these supplements, there may be irregularities in their effectiveness and levels of potency, and so people may be excluded from certain clinical trials if they are taking certain supplements. Although this is the case with some over-the-counter herbal supplements, others are allowed, so it is best to check with one of our research nurses just to make sure.
After a clinical trial is completed, the researchers look carefully at the data collected during the trial. They thoroughly analyze these data to sort out the meaning of the findings, their medical importance, and the potential need for further testing of research participants. The results of clinical trials are often published in peer-reviewed, scientific journals. Peer-reviewed journals use a process by which fellow experts in the field review all reports before they are published to make sure the analyses and conclusions are sound. If the results are particularly important, they may be featured by the media, discussed at scientific meetings, and used by patient advocacy groups. After a research study has ended, the review process may take several years to complete. Once a new approach has proven safe and effective in a clinical trial, it may become standard practice. We try to contact people who have participated in our past research to let them know the findings and how the findings are affecting changes in the way we treat and prevent Alzheimer's disease. Many of the research updates can be found in our Dimensions newsletter. Also, after the blinded portion of the study is completed, some ADRC clinical trials inform participants whether they were taking a placebo or the experimental medication.
What happens to the information after it is collected at a research appointment and how is this information kept private?
The information collected at ADRC appointments is turned into de-identified data, which means the data is given a study number and all identifiable information (such as initials, areas of residence, and full birthdates) is omitted from the data. This de-identified data is then combined with other ADRC data from across the country. Combining this information allows researchers to ask questions about Alzheimer's disease from a larger data source and to examine trends throughout the United States.
There are several different ways that data are kept private at the ADRC. All of the information we have at our center is kept in locked cabinets that are in locked rooms, and it can only be accessed by research doctors and staff who are trained in privacy protection. Additionally, identifiable medical information is only released to individuals or organizations when a research participant gives their explicit permission to release such information. These privacy measures are regulated and enforced by both the Department of Veterans Affairs and the UW.
If someone is already participating in a research project, can they still become involved in the ADRC?
Ordinarily, a person can only be involved in one clinical trial at a time, particularly if they are taking an experimental medication. This helps to ensure that the changes the person is experiencing are caused by the research study they are involved in, whereas if someone is enrolled in two studies, there could be confusion about which study is causing which effect. However, because the ADRC research registry does not involve experimental medications, people can be involved in both the registry and an outside research study or clinical trial at the same time. Participation in multiple studies at once can sometimes be a confusing issue, so if you have any confusion, please feel free to ask one of our staff members for more clarification.
Ordinarily, geriatric check-ups and dementia work-ups can be quite costly. How is participating in the ADRC registry and clinical trials free?
Participants in ADRC research receive yearly memory evaluations, investigational medications, and consultations with dementia experts, and they receive each of these benefits for free. It may seem too good to be true, but thanks to generous grants from the National Institute of Health, the Department of Veterans Affairs, and the pharmaceutical companies that sponsor clinical trials, we can provide these services as part of our research at no cost to participants. This funding allows us to provide services to our participants for free in exchange for the valuable information we collect, information we hope will lead to preventions, better treatments, and a cure.