In this section, we will share useful advice and valuable information for patients and other individuals participating in Human-Centered Research (HCR). Our goal is to make participation in such studies more understandable and accessible. Human-Centered Research can be both clinical and non-clinical.
- What are Human-Centered Research (HCR) studies? Human-Centered Research (HCR) studies are essential to test patients' decision-making behavior or outcomes associated with new medications, unapproved treatments, or other medical procedures. These studies involve both patients and sometimes healthy individuals.
- How long does a Human-Centered Research (HCR) study last? The duration of a Human-Centered Research (HCR) study can vary greatly, ranging from a few weeks to several years, depending on the type and scope of the study and the therapy being investigated. You should always be informed about the time commitment at the beginning of the study.
- How am I insured? According to the law, all participants in Human-Centered Research (HCR) studies must be insured against possible risks associated with clinical or non-clinical interventions (e.g., medication or medical products being tested). The insurance costs are covered by the study organizers.
- Who pays for the treatment? Participants typically do not have to pay for participating in Human-Centered Research (HCR) studies. All costs for treatment and examinations are covered by the study sponsor, which could be universities or pharmaceutical companies.
- What do I get from participating in a study? Participants may gain access to or insights about new treatment methods that are not yet available to the public. Close monitoring is part of the process. Even if there is often no direct personal benefit, the purpose and benefit for the general public should always be clearly communicated by the study organizers.
- What are the risks? Risks are minimized as much as possible through thorough pre-study research and ethics committee approvals. The study organizers should always inform you about the ethical approval; if not, it is best to ask directly.
- Can I withdraw from a study at any time? Participants have the right to withdraw from a Human-Centered Research (HCR) study at any time without providing a reason. You should always be informed of this at the beginning of a study. Additionally, there should always be a contact person available to answer any questions about withdrawal and to assist with the process.
- Can anyone participate? Each study has specific inclusion and exclusion criteria to ensure that only suitable candidates participate to avoid unnecessary risks and complications.
- How to find a suitable study? Patients can seek information from support groups, their physicians, or the German Clinical Trials Register. The register provides a comprehensive list of studies and ensures they meet safety and ethical standards.
- What are the potential disadvantages? There is no guarantee that the new therapy will be better than standard treatments. Unforeseen side effects may occur, and participation requires time and effort. The same applies to non-clinical studies, as these can also impact participants' well-being.
- How are my data and privacy protected? Human-Centered Research (HCR) studies adhere to strict data protection regulations. Personal data of participants are anonymized and used solely for research purposes. The study organizers should inform you about the measures taken at the beginning of each study. If you have any questions, contact the study organizers or a data protection officer.
- What rights do I have as a participant? Participants have the right to comprehensive information, informed consent, privacy protection, and the right to withdraw at any time. They also have the right to know all study results.
- How do I recognize a serious study? Look for studies that measure therapeutic success, behavior, or experience with clear metrics and are registered in official databases. Physicians or other study leaders should provide comprehensive information both verbally and in writing.
- Are there financial compensations for participation? Some studies offer financial compensations or reimbursements for travel expenses and other costs. This varies from study to study. It should always be clearly communicated at the beginning of the study whether financial compensation is provided.
- What happens after the study ends? After the study is completed, the data are analyzed, and the results are published. Participants can be informed about the results and learn whether the tested therapy was effective and safe.
If you have any particular questions about Human-Centered Research (HCR) studies, feel free to ask!
