Study Enrollment


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Augusta University is committed to the safety and protection of research participants

What You Need to Know

At its most basic, research is an investigation. Researchers search and gather information, usually to answer a particular question or problem. Research can be medical, social or behavioral, and it almost always involves people like you.

Volunteers participate in medical research that provides better ways to diagnose, treat and prevent different diseases and conditions. Social and behavioral research explores how and why people behave certain ways in a given situation and how this may impact human health.

If you’ve ever taken medication or been treated for an illness, then you’ve received the benefits of medical research. Medical research helps people enjoy better health and lifestyles. Some studies may not benefit you as an individual, but taking part can help others in the future. With your help, researchers may be able to improve the health of a community or help a group with a particular disease or condition.

HOW AM I PROTECTED?

There are ethical guidelines that protect research participants and the integrity of science.

  • A review board, Institutional Review Board (IRB), must review studies to ensure rights, welfare and safety of research participants are protected.
  • IRB must approve a research study before an Investigator (the person responsible for conducting the study) is allowed to begin a clinical research study.
  • A Research Informed Consent Document describes the research study to participants who may decide to enroll in a clinical research study.
  • Participation is voluntary, which means you can decide whether you want to be in a study.

WHAT ARE MY RIGHTS?

As a research participant, you have the right:

  • To know the purpose of the research study
  • To know the research study procedures
  • To know the risks and benefits of the research study
  • To ask any questions about the research study
  • To withdraw from the research study at any time
  • To receive a copy of the consent document form
  • Not to feel forced, obligated, or coerced to participate in the research study

Before enrolling in a research study, it is a good idea to learn as much as possible about the study and your role as a participant.

Ask questions, use resources, such as the Internet, to search for information, and seek advice from family, trusted doctors, clergymen or friends. Speak to the research study team about what will be done and what your rights are as a participant. If you need help understanding what you were told about the research study, ask the investigators and research study team to explain it to you.

Your participation in a research study is completely voluntary, and you may drop out at any time.

When deciding whether to participate in a research study, you may want to ask the investigators and research study team some of the following questions:

  • What You Should Know About Research
  • What is the purpose of the research study?
  • Who is participating in the research study?
  • Will I know which treatment I am getting?
  • What has been learned about the study treatment so far?
  • What will I be asked to do?
  • How long is the study going to last?
  • Will I have to pay for any part of the research study?
  • Will my insurance cover the costs?
  • Will I be reimbursed for travel or childcare costs associated with the research study?
  • How will I know if the treatment is working?
  • If the treatment works, can I keep using it after the research study ends?
  • What will happen to me if the treatment does not work?
  • Will anyone else know about my participation?
  • Will this study help my family or my community?

What to do if you have concerns about research non-compliance

Allegations of research noncompliance with federal and state laws, rules and regulations and institutional policies and procedures are referred to the Office of Human Research Protection (OHRP). The Chairman of the Human Assurance Committee (HAC) may refer a study for review to OHRP. Should OHRP determine that the alleged practices appear to (1) cause injury or any other anticipated problems involving risks including but not limited to, physical, social, psychological, confidentiality, financial or emotional, to subjects or others or (2) constitute serious or continuing noncompliance with HAC Policies or Procedures, then the OHRP may recommend further action to the HAC Chairman.

The HAC Chairman may suspend the study pending a timely investigation and review. The Chairperson may recommend to the full HAC that the study should be terminated. The HAC has the authority to suspend or terminate protocols that are found to be non-compliant with federal and state laws, rules and regulations and institutional policies and procedures. Other sanctions imposed by the HAC and/or OHRP may include, but are not limited to, routine compliance audits, letters of reprimand and restrictions on serving as an investigator on human subjects protocols. Suspensions or terminations are reported to the appropriate institutional officials responsible for the federal wide assurance (FWA) and the human research protections program (HRPP)Serious or continuing noncompliance will require reporting to both sponsor and/or federal agencies.

RESEARCH. INNOVATION. DISCOVERY.