PARTICIPANT - genesisresearchllc.com

Thank you for your valuable contribution to the discovery of new therapies. We would like to share with you some important information about Biomedical Research:

What is Biomedical Research?

Biomedical Research exams the effects of drugs and techniques on the biological systems of living creatures by means of collecting and analyzing data that is done to answer a question. Some other words for research are clinical trial, protocol, survey, or experiment.

The Subject of the Research can be animals or Humans.

What is a human subject?

A subject is someone who volunteers to participate in research.

Who can be a subject in a research study?

Most research studies have certain requirements that must be met in order for a subject to participate, these requirements are called Inclusion and Exclusion criteria and are designed to ensure the safety of the subjects and the usefulness of the research, for instance having certain diseases or age.

Do I have to participate?

NO Participating in a research study is voluntary.

Even if the Investigator who is conducting the Study is your Primary Care Physician your participation in the Study is completely voluntary and if you decide to participate you can drop out of a study at any time. Refusing to participate in a study will not result in a penalty or loss of any benefits to which you are entitled.

What are the risks to being in a research study?

Biomedical research in Human Subjects that involves more than taking a Survey or answer questions, such as taking an experimental drug, involves greater risks (e.g. having a bad reaction to the drug). The research team is required to explain to you the foreseeable risks of being in the study before you decide whether or not to participate.

Are there benefits to being in a research study?

Not everyone who participates in a research study will benefit personally. Sometimes, your participation in the research study will be of benefit to society by helping researchers to learn more about a certain disease or condition or the way a particular medicine works, however, you may personally benefit from medication that aids in your medical condition.

Who are involved in a research study?

The Principal Investigator (PI) leads the research study, (e.g. qualified physician).

The PI is responsible for the overall conduct of the research study. The PI is also responsible for assuring the safety of the subjects. The Principal Investigators rely on a research team to assist them in their study. The research team is made up of other physicians called Sub Investigators, research nurses, Study Coordinators and other people with special skills needed for the study.

Who will see my records?

Like your medical record, the information in your research record will be confidential. Information will be given only to the researchers who carry out the study or to those who make sure the study is safe and carried out the way it was planned such the Monitor, FDA and IRB (Institutional Review Board)

Who is responsible in reviews a study?

At Genesis Research Center a Central IRB.

What is an IRB?

IRB is a committee of scientists and non-scientists who review projects submitted by researchers. The IRB’s purpose is to protect the rights and welfare of the research subjects in a study. Subjects can contact the IRB at any time and the telephone Number and contact information of the IRB is in the Informed Consent.

What is informed consent?

Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your decision to volunteer should be based upon a clear understanding of what will take place in the study and how it might affect you. The consent process begins when the research staff explains the facts about the research study to you. The research staff will assist you with the informed consent form, that goes over these facts so you can decide whether or not you want to take part in the study.

These facts include details about the study, tests, or procedures, the benefits and risks that could result, alternatives available treatments. Before signing the Consent Form, you can bring it home to consult with your family or advocate if you wish, therefore is called a process because may be take you few days before you sign it in the presence of the research staff, during the Trial may be the Informed Consent is updated with more information that you should know and you will be consented again, so the process is dynamic, ongoing.

Are there any special rules to help protect certain subjects?

Yes, for instance Children, pregnant women, prisoners, etc. are considered potentially “vulnerable populations.” There are special rules to protect participants who fall into one of these groups.

What questions should I ask before I agree to participate in a research study?

Before you decide to volunteer for a research study, you need to know as much as possible about it. Below are some questions you should ask:
Will I benefit from this study?
Who is doing this study?
Will this research help me to understand my condition? If so, how? What tests or procedures will be done?
What are the risks involved in this Study?
What alternatives are available if I decide not to participate in the study?
Is it possible that I will receive only a placebo (inactive substance)?
What could happen to me, good or bad, if I take part in the study?
How long will the study last? What will happen to specimens I give?
What IRB has reviewed/approved this study?
Can my medical condition get worse during the study?
Will I be charged anything or paid anything to be in this study?
If I decide to participate in this study, how will it affect my daily life? What will happen to me at the end of the study?
Will I be told the results of the study?
Who will find out that I am taking part in this study?
If I change my mind after signing Informed Consent to whom I have to communicate my decision?
Do I receive care after withdrawal of my consent to be “sure I’m OK”?