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VOLUNTEER

Volunteers are of two distinct types – Clinical Research volunteer and Patient volunteer

Clinical Research Volunteer

A Clinical Research Volunteer is one with no noteworthy health problems and who takes part in research to test an intervention. Such a volunteer could possibly be a family member of a patient or any member of the community. The application of intervention with these volun¬teers is to develop unique knowledge, not to provide direct benefit to study participants. They play a very vital role in medical research. Healthy volunteers are exposed to such research for several reasons: They help define the limits of “normal.” These volunteers are recruited to serve as controls for patient groups. They are often matched to patients on such characteristics as age, gender, or family relationship. They are then given the same intervention as the patient group receives. Investigators learn about the disease process by com¬paring the patient group to the clinical research volunteers.

A major commitment in time and effort on the part of the volun¬teer is needed, and may involve some discom¬fort. The research procedure may also be accompanied by some risk. The consent process involves a detailed discussion of all the study’s pro¬cedures and tests, followed by a consent document to read. It is to be read careful¬ly and signed only when the volunteer understands what is involved and is prepared to accept the potential risk, discomforts, and inconven¬ience involved.

Patient Volunteer

Patient volunteers are volunteer subjects with a known health problem, who partic¬ipates in research to better understand, diagnose, treat, or cure a particular dis¬ease or condition. There is no guarantee that the new approach will be effective for all study participants. However, it can give an opportunity to those who have no other treatment alternative to opt for. Though the patient may not receive any direct benefit, as a result of participating in research, the knowledge may help others.

Enrollment

There are various phases of the study that the volunteer can volunteer can enroll into:
The phase 1 study is used to learn the maximum tolerated dose of an intervention that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the intervention affects their disease. The first few volunteer subjects receive low doses of the intervention to see how it is toler¬ated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the vol¬unteer subjects.

The phase 2 study involves intervention whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is utilized in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study.

The phase 3 study compares the new intervention as against a commonly used intervention. Some volun¬teer subjects will be given the new intervention and some the commonly used intervention. The trial is designed to find where the new regimen fits in managing a particular condition.

Informed Consent

Any volunteer’s participation in any Clinical Research is voluntary. Every volunteer will receive a “CONSENT FORM” that explains the study in basic language, that the volunteer can understand. A member from TRICell will discuss the protocol, explain its details, and answer queries. The volunteer is free to discuss the proto¬col with family and relations.

At any time after signing the consent document, the candidate is free to change his / her mind and decide not to participate further.

To enroll in any of our trials, kindly go through the ongoing and pipeline trials link of this website. If interested, kindly get in touch with our clinical trial representative or mail us at info@tricell.in

Benefits

The benefits that ensue to the volunteers depend on the trial that they are enrolled into and other factors like economic status, which will be discussed at the time of enrollment. Some of the benefits include:

	Waiver of Kit costs.
	Waiver of the Operation Theatre and Pharmacy charges.
	Waiver of Surgeon’s professional fees.
	Waivers of Hospital stay charges.

There are certain circumstances under which, the volunteer will be monetarily compensated in appreciation of his/her participation.