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Information for study volunteers and participants

What is Clinical Trial?

A clinical trial involves research study on human volunteers that is designed to add medical knowledge to improve health and also helps to determine the safety and efficacy of the proposed new treatment. Medical knowledge is related to new treatment, diagnostics techniques, medical devices etc.

Who conducts clinical trials?

Clinical trial is led by Principal investigator.

Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, government programs

Where are Clinical studies conducted?

Hospitals, universities, doctors' offices, and community clinics

Who Can Participate in a Clinical Research Study?

Clinical studies have standards inclusion criteria who can participate according to respected study protocol. Some research studies need the participants with the illnesses or condition; whereas some other studies need healthy participants. Participating in a clinical trial is personal decision.

Participants have the right to withdraw from the study at any time without losing any of the benefits that are due as a hospital patient.

Are you eligible to participate?

That depends upon a variety of factors, such as the nature of the study and whether you meet the screening requirements. You will know more about the study and whether you qualify when you receive the informed consent form, which will provide you with a thorough description of the project and any risks to participants.

If you decide that you would like to volunteer for a study, the study staff will determine if you meet the study’s requirements. Those requirements may involve your age, physical condition, race or gender.

Rights of study volunteers

Informed consent

Before enrolment into the study, participants should know the all information of clinical study. This formational documents called an inform consent form which is intended to protect participants and should provide study related information (potential risks, benefits etc)The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study.

Protecting rights and safety

An Ethics Committee of Aditya Jyot Eye Hospital supervises clinical studies that involve people; ensuring research is conducted safely and ethically.

What should you consider before deciding to be a participant?

Even if you are eligible to participate in a study, you should give it careful thought before deciding to become a participant. While you may benefit in a host of ways from participation, you should also be aware that participating could impact your life in many ways, as well.

It’s important for you to make an informed decision. So, you will probably want to consult with your personal physician and members of your family before making a commitment. If you have any concerns about the project, you should also discuss them with the research team working on the project. Here are some questions you’ll want to obtain answers to before making a decision:

• What are the goals of the study?
• What will I be required to do as a participant?
• Are there any risks? How likely they to occur and what are is done to reduce the likelihood of their occurring?
• What role will I play in the study?
• Am I likely to benefit directly from participating in the study?
• What are the study’s potential benefits to other people and to society as a whole?
• How long will my participation in the study be required?
• What discomforts, inconveniences or costs will I experience as a participant?

What are your responsibilities as a participant?

All volunteers in the clinical studies are expected to comply with the specific requirements of the study. Also, study participants are expected to stick to a general set of necessities which includes:

1. Arrive for all scheduled appointments or call in advance if you are not able to keep an appointment.
2. Listen and follow all the directions of the principal investigator or co-investigator.
3. Provide your updated contact details and accurate medical history.
4. Seeking healthcare for any medical conditions unrelated to the study.
5. Inform the research staff of any adverse reaction you may have while participating in the study.

What are the benefits and risks of participating in a clinical trial?

The benefits include:

1. Gaining access to new treatment, diagnostic tool which is not yet available to the public
2. Acquiring expert medical care
3. Helping others by contributing to medical research

The risks include:

1. Unpleasant, serious, or even life-threatening side effects from treatment
2. Treatment may not be effective for some individuals