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Frequently Asked Questions About Volunteering in Research


What is clinical research?


Clinical research is the study of health and illness in people.  It is the way we learn how to prevent and treat illness.


Why is clinical research done?


Clinical research is done to find out:

·        What new drugs, devices and other treatments work and don’t work

·        What causes disease

·        What prevents disease and improves health.


How is clinical research different from regular medical care?


When you receive medical care from your own doctor, s/he develops a plan of care just for you. 


When you take part in a clinical research study, you and the study doctor must follow a set plan called the “study protocol.”


The study doctor usually can’t adjust the plan for you – but the plan includes steps to follow if you aren’t doing well.



How do I know if I can take part in a research study?



Each study has requirements that describe who can take part. For instance, you may need to have a certain health problem or symptom, or be of a certain sex or age.



How do I decide whether to take part in a research study?


If you are interested and seem to fit the study requirements, the study team will explain the study to you. They will give you a consent form to read.  Then they will go over the consent form with you. They will describe what happens during the study, the possible side effects, and other information you need to know about the study.

 

The study team will give you time to ask questions.  You should ask as many questions as you want.

 

You usually don’t need to decide right away.  You can take the consent form home, read it over, and think about it.  You can also talk to friends, family, and your own doctor about the study.

 

The decision whether to take part is yours.  You can decide not to take part in the study.  Your decision will not affect the care you receive at BWH or MGH.


What happens if I decide to take part in the research study?


You will be asked to sign the consent form. Your signature means that you volunteer to take part and understand what will happen.

 

You will then be asked to do what is required for the study.

 

Remember, you can ask questions or change your mind at any time.


What happens if I don’t want to continue to take part in the research study?


You can change your mind and stop at any time.  Your decision will not affect the care you receive at BWH or MGH.


How are my rights and welfare protected while I am in a research study?


The Human Research Committee approves and watches over all clinical research studies at BWH and MGH.  The Committee follows state and federal laws and codes of ethics to make sure that the rights and welfare of people taking part in research studies are protected.



What kind of research is going on at BWH and MGH?

 

Research studies at BWH and MGH may involve:

·      Taking experimental drugs

·      Taking drugs for new reasons

·      Testing medical devices

·      Having blood drawn

·      Filling out questionnaires

·      Having your body measured and tested

·      Gathering information on your mental health or quality of life

·      Finding the genetic causes of diseases that are passed on from generation to generation