Participant Frequently Asked Questions
- What is an IRB?
- What does the IRB do for participants?
- How can I find a study at Emory?
- How do I enroll in a research study?
- What are "phases" of clinical research?
- What are the types of clinical trials?
- What will it cost me?
- Will I be paid to participate?
- What if I change my mind after the start of the study?
- How do I withdraw from a study?
- What if I don't like something about the study?
- What if something bad happens to me while I am a research participant?
- Will I be told the results of the study?
- What if something with my health changes while participating in a study?
- What if I can't get in touch with my study doctor?
- What if I have questions, comments, or concerns after the study is completed?
An Institutional Review Board (IRB) is a group of people who review research to make sure it will be done safely and that the benefits of the research outweigh the risks to the participants. Members of the IRB are usually physician scientists, pharmacists, and other experts. IRBs also include nonscientists and members of the community. IRBs follow the rules mandated from the federal government, the Department of Health and Human Services and the Food and Drug Administration.
The Emory University IRB's sole function is to protect human subjects by ensuring safeguards are in place for each study. The IRB does this by reviewing all research activities affiliated with the University (even international trials). Research activities can not begin at Emory until the IRB has given full approval. The IRB also serves as a place for participants, along with research staff and employees, to report any complaints or suspicious activities related to the research study.
You can search for a trial at Emory on www.clinicaltrials.gov.
If you find a study on the internet that you would like to participate in, you can contact the study staff directly. Otherwise, your healthcare provider may refer you for a particular study.
Clinical research done for submission to the U.S. Food and Drug Administration is done in phases. Phase I trials test an experimental drug or treatment in a small group of people for the first time. The purpose of phase I studies is to determine how the treatment can be given, its safety, and identify side effects. Phase II trials are administered to a larger group of people to determine the effectiveness and to further evaluate safety. Phase III trials test the experimental treatment in a larger group of people to confirm its effectiveness, monitor side effects, compare it with the standard current therapy, and continue to collect safety information. Phase IV trials are carried out after a drug has been approved by the FDA or the treatment is launched. Researchers track its safety, risks, benefits, and optimal use.
Treatment trials test new treatments, drugs, or therapies. Prevention trials look for better ways to prevent diseases in people who have never had the disease or to prevent the disease from returning. Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition. Screening trials test the best way to detect certain diseases or health conditions. Quality of life trials measure ways to improve the comfort and quality of life of people with chronic illness.
Your participation in research studies will usually not cost anything. Most research is funded by the government (NIH is the largest contributor), pharmaceutical or device companies, or philanthropists. Talk to your research team to find out whether they will reimburse you for travel expenses, what will be billed to your insurance company (e.g. a standard test you will receive anyway), who will pay for injury that may arise as a result of the study, and what will happen to your care at the end of the study.
All studies are different. Some studies pay participants and others do not. You will be told whether or not you will be paid, how you will be paid, and how much you will be paid before you are asked to decide if you want to participate. The amount of money you may receive should not be so large to influence your decision to participate. The reason some studies pay you is not to persuade you, but instead is to reimburse you for the time spent to participate and the out of pocket costs you may incur (e.g. travel expenses or missed work).
If you agree to participate in a study, you have the right to withdraw from the study at any time without penalty. You also have the right to ask that your study data or biological specimens not be used in the analysis of the study.
It is important that you contact your study doctor or coordinator right away if you would like to withdraw from a study. In some studies, you will be asked to fill out a revocation letter for documentation purposes.
You can contact the IRB anonymously at 404-712-0720 or 1-877-503-9797 to report complaints or research misconduct. You can also contact the study doctor or coordinator.
In case of an emergency, call 911 immediately. If it is not an emergency, please contact the study doctor as soon as possible. If you visit another healthcare provider, or in urgent medical circumstances, please tell your provider that you are participating in a research study. Your study doctor has the right to stop your participation at any time if he/she believes it is in your best interest not to continue.
The Informed Consent Document should tell you if you will be informed of the study results at completion of the study. Some studies will notify you of results at the end of the entire study, which may be a long time depending on the study and data analysis.
Notify your study doctor right away if there is a change to your health in any way while participating in research.
The Informed Consent Document should provide you with contact information of your study doctor. If you can't reach your study doctor, or if you are not satisfied with his/her response time, you may contact the Emory IRB at 404-712-0720 or 1-877-503-9797.
You may contact your study doctor or coordinator at any time. You may also contact the Emory IRB any time before, during, or after your participation.