Rights and Responsibilities of Research Participant
Rights of Research Participant
Right to voluntary participation in research study.
Right to know about Institutional Ethics Committee and its responsibilities towards protecting patients rights, safety and well-being involved in a research project and to provide public assurance of that protection
Right to information about Research Study in an understandable language.
Right to informed consent and if necessary audio-video consenting before participation in any Research Study.
Right to refusal of participation or withdrawal of participation at any point in the study without disclosing any reason.
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.
Right to be treated with dignity, respect and courtesy in a non-judgmental and non-threatening manner.
Right to information regarding investigational product, duration of study, treatment option available as per standard of care, anticipated expenditure, information on medical management of any injury and compensation in case of any study related injury or death or any compensation provided for participation in an understandable language.
Right to be informed of the risks, benefits and alternatives of proposed treatment
Right to privacy and confidentiality.
Right to be informed on how to voice a complaint to express concerns, violation of your rights and/or grievance and seek redressal
Right to participation in research and innovative therapies.
Right to consent for diagnostic and therapeutic procedures.
Right to access clinical records
Right to get 24 hours emergency contact details of Research doctor
Right to get contact details of Chairperson and Member Secretary of Institutional Ethics Committee.
Responsibilities of Research Participant:
To provide correct and complete demographic information including full name, age, address, telephone number and e-mail ID (if available)
To be compliant with research protocol and procedures
To ask question when he/she does not understand what the doctors, research study team, or other healthcare team members tells about diagnosis or treatment
To inform your research study doctor and research study team, immediately in case of any injury or development of any new medical conditions
Not to take any medications without the knowledge of research doctor and research study team
To disclose to doctors and research study team if currently part of any other Clinical Trial or had participated in any other Clinical Trial in last one year
Provide complete and accurate information about your health including your previous medical history, and all the medications that you are presently taking including alternative treatments like Ayurveda, Homoeopathy, Unani or herbal medications, all records of previous investigations and treatment and of allergic reactions, especially sensitivity to any drug
To follow instructions, advice and restrictions regarding treatment plan and visit schedules
To treat hospital staff and study team with courtesy
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