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Human Subjects Participating in Research Studies

What is clinical research?
Clinical research includes identification of effective ways to diagnose, treat, prevent or understand human diseases or disorders. It aims at finding new ways to improve quality of health care.

What is a Clinical trial?
The term “clinical trial” refers to a research study using human subjects to answer specific health related questions about biomedical or behavioral interventions (drugs, devices, treatments, or new ways of using known drugs or treatments). A clinical trial is the most definitive method to determine whether a treatment is safe and effective. Clinical trials are required before any national regulatory body (e.g., the FDA) approves marketing of the drug or device.

Who can volunteer to take part in the clinical study?
Every clinical trial has its own unique criteria for eligibility in the research. The criteria include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Why should you volunteer to participate in the study?
By taking part in a research study, you are making a great contribution towards the improvement of healthcare. The outcomes of the study will help society in the future.

What information you will be given about the study?
The principal investigator will provide you information such as the purpose of the study, benefits and risks and exactly what is expected of you during the study.

Who will conduct the study?
Every study has a Principal Investigator (PI) who is the person in charge of the study. The PI is a healthcare professional.

What is the Informed Consent process?
Information must be presented to enable persons to decide whether or not to voluntarily participate as a research subject. The informed consent procedure is fundamental to the entire research process. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that the subjects can easily understand. If you agree to participate in a study and sign the Informed Consent Document, you may still change your mind for any reason and at any time during the study. It is important that you contact the study doctor or study staff to let them know that you changed your mind. Depending on what kind of study you are in, they may need to perform some tests or ask you some questions to make sure that you withdraw from the study safely.

What are your rights and responsibilities as subject?

  • You must be treated with respect.
  • You must be made aware of the risks of your participation in the study.
  • You need to be made aware of what alternatives to your participation in the study are available.
  • You many withdraw from the study at any time without penalty.
  • You should make your decision without feeling any pressure from the research staff.
  • You should know the name, credentials and contact information of the study’s principal investigator.
  • You should know the purpose of the study.
  • You should know who will have access to your personal health information.
  • You should know what study procedures may be performed on you and what drugs or medicines you may be asked to take.
  • Remember to seek additional help or clarification during the informed consent process or at any time during the study. This includes asking questions of the study staff at any time and/or taking the informed consent form home to discuss with your family, friends, or primary care physician.

List of questions you might ask before making a decision on participation.

  1. What is the duration of the clinical trial?
  2. Where will the clinical trial take place?
  3. What procedures will be involved during the study?
  4. How is the confidentiality of your personal health information going to be protected?
  5. What are the costs of participating in the clinical trial?
  6. What alternative treatments are available to your participation in the clinical trial?
  7. What procedures will be involved in monitoring your safety during the clinical trial?

If you have additional questions regarding your participation and rights as a subject in a research study, please contact Asentral, Inc. IRB at 978-462-6415.