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Rights and Responsibilities of Research Participant
Rights and Responsibilities of Research Participant
Rights of Research Participants
- You have the right to voluntarily participate in any research study that you are eligible for and interested in. You can choose to join or not join a study without any pressure or influence from anyone.
- You have the right to know about the Institutional Ethics Committee (IEC) and its role in protecting your rights, safety and well-being as a research participant. The IEC is an independent group of experts that reviews and approves all research studies conducted at pi health cancer hospital.
- You have the right to receive information about any research study that you are invited to join in a language that you understand. The information should include the purpose, procedures, risks, benefits, alternatives, and expected duration of the study. You should also be informed about your rights and responsibilities as a research participant.
- You have the right to give your informed consent before joining any research study. Informed consent means that you agree to participate in the study after you have understood the information and had the opportunity to ask questions. In some cases, you may also be asked to give your consent through audio or video recording.
- You have the right to refuse or withdraw your participation in any research study at any time and for any reason. You do not have to explain your decision to anyone. Your decision will not affect your medical care or relationship with pi health cancer hospital or its staff.
- You have the right to receive quality healthcare in a safe, clean environment without discrimination because of race, age, color, religion, nationality, culture, ethnicity, language, disability, sex or manner of payment. You should also receive the same standard of care that you would receive if you were not in a research study.
- You have the right to be treated with dignity, respect and courtesy in a non-judgmental and non-threatening manner. You should also be able to express your views, feelings and preferences without fear of retaliation or harm.
- You have the right to information regarding the investigational product, if any, that is used in the research study. You should know what the product is, how it works, how it is administered, and what are the possible side effects. You should also know the duration of the study, the treatment options available as per standard of care, the anticipated expenditure, the medical management of any injury, and the compensation in case of any study related injury or death or any compensation provided for participation in the study. All this information should be given to you in a language that you understand.
- You have the right to be informed of the risks, benefits and alternatives of the proposed treatment in the research study. You should know the potential harms and benefits of participating in the study, as well as the other options that you have if you do not join the study. You should also be informed of any new
- information that may affect your decision to continue or withdraw from the study.
- You have the right to privacy and confidentiality. Your personal and medical information should be protected and only shared with authorized persons who are involved in the research study or who have a legal or ethical obligation to access it. You should also be informed of how your data will be stored, used, and disposed of after the study is over.
- You have the right to be informed on how to voice a complaint if you have any concerns, complaints, or grievances about the research study or your rights as a research participant. You should know who to contact and how to reach them. You should also know that you can seek redressal from the IEC or other authorities if you are not satisfied with the response
Responsibilities of Research Participants:
- You are responsible for providing correct and complete information about yourself, such as your full name, age, address, telephone number and e-mail ID (if available), when you join a research study.
- You are responsible for following the study protocol and procedures as instructed by the research doctor and the study team. This may include taking the study medication as prescribed, attending the study visits, completing the study procedures, and reporting any changes in your health or condition.
- You are responsible for providing complete and accurate information about your health, including your previous medical history, and all the records of previous investigations and treatment. You should also inform them of any allergic reactions, especially sensitivity to any drug, that you have experienced in the past or may experience in the future.
- You are responsible for following instructions, advice and restrictions regarding your treatment plan and visit schedules. You should adhere to the dosing schedule, the frequency and duration of the study visits, and the study procedures. You should also follow any dietary, physical, or other restrictions that are required for the study.
- You are responsible for treating the hospital staff and the study team with courtesy. You should respect their time, privacy, and confidentiality. You should also cooperate with them and follow their guidance throughout the study.
- You are responsible for disclosing to your research doctor and the study team if you are currently part of any other clinical trial or had participated in any other clinical trial in the last one year. You should also inform them if you have any history of drug abuse or addiction, or any other medical or psychological conditions that may affect your participation in the study.
- You are responsible for not taking any medications without the knowledge of your research doctor and the study team. This includes any prescription or over-the-counter drugs, vitamins, supplements, or alternative treatments like Ayurveda, Homoeopathy, Unani or herbal medications. You should also inform them of any medications that you are already taking before joining the study.
- You are responsible for informing your research doctor and the study team immediately in case of any injury or development of any new medical conditions during the study. You should also inform them if you have any significant changes in your lifestyle, behavior, or medication that may affect the study results.
- You are responsible for asking questions when you do not understand what the research doctor, the study team, or other healthcare team members tell you about your diagnosis or treatment. You should also ask questions if you have any doubts, concerns, or complaints about the research study or your rights as a research participant.