FREQUENTLY ASKED QUESTIONS

  • The purpose of clinical research studies is to investigate and gather data on a specific research question or hypothesis related to a particular disease, treatment, or medical intervention.

  • If you decide to be in a research study, you should carefully read and discuss the IRB approved Subject Information and Consent Form with the study staff and study doctor before having any procedures done. Any questions you have should be answered. The decision of whether to take part in the study is completely voluntary. You and only you should make this decision. As a research subject, you have a right to information about the study procedures, study drug, risks and benefits of the study, alternative treatment, confidentiality and any payment that may be provided for taking part. If you do not understand why something is being done during the study…ask. If you decide to take part in a study, you also have a right to withdraw from the study at any time. (See FDA)

  • HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. This regulation, also called the Privacy Rule, outlines the standards for privacy of individually identifiable health information. The specific regulations for HIPAA are in Title 45 CFR Parts 160 and 164.

  • The duration of the study can vary depending on the research question, study design, and the outcomes being measured. It may last for a few weeks, months, or even several years. The study protocol will provide an estimate of the study duration.

  • The eligibility criteria for participation will be clearly outlined in the study protocol. It may include factors such as age, gender, medical condition, and other specific requirements. The study team will provide details on who can participate

  • The study team will explain the potential risks and benefits associated with participating in the study. Risks may include side effects of treatments, discomfort, or potential privacy breaches. Benefits can involve access to new treatments, potential improvements in health, or contributing to medical knowledge.

  • The study team will ensure that your personal information remains confidential and is protected according to privacy laws and regulations. They will explain the measures in place, such as using anonymized data or secure data storage systems, to safeguard your privacy.

  • The study team will explain the procedures involved in the study, which may include medical tests, treatments, surveys, or follow-up visits. They will provide clear instructions on what will be expected from participants.

  • Compensation for participation can vary depending on the study. Some studies provide financial compensation to cover expenses such as transportation or offer a stipend for participants’ time and effort. The study team will clarify the details regarding compensation, if applicable.

  • The study team will inform you if you will have access to the study results once it is completed. Some studies may share results with participants individually or through summary reports, while others may publish findings in scientific journals or present them at conferences.

  • Yes, you have the right to withdraw from the study at any time, for any reason, without any negative consequences. The study team will provide information on how to withdraw and clarify any follow-up procedures if applicable.

  • Participant safety is a priority in clinical research. The study team follows strict ethical guidelines and regulations to ensure participant safety. This includes obtaining informed consent, monitoring participants' health, managing adverse events, and providing necessary medical care during the study.

  • The study may be funded by various sources, such as government agencies, academic institutions, pharmaceutical companies, or nonprofit organizations. It is important to disclose any potential conflicts of interest, such as financial relationships between the study investigators and the sponsors. Transparency is crucial to maintaining the integrity of the research.

  • The study team will have procedures in place to monitor and manage any adverse events or side effects that may occur during the study. They will provide appropriate medical care