General Information

General Information

General Information

Informed Consent
For some studies, if you agree to participate, someone from the study will ask for your "informed consent." To give that consent, you may be asked to sign a form, but remember: Informed consent is a process, not a form.

If you have a question or concern about your participation at any time during the study, ask about it. After all, you need to be informed before you can give your consent.

Your Rights & Responsibilities
The ultimate goal of research at the UAB Medical Center is to improve health care. However, to study possible improvements, our researchers need to compare different treatments, drugs, or procedures to see how they work.

Regardless of the nature of the study or the participant group you might be placed in, you have the same rights.

Your general rights are outlined below. The researchers may give you more information on these rights during the informed consent process. They will also tell you what is expected of you (your responsibilities) while you are in the study.

Adverse Events
For the research to be complete, you may be asked to tell the study staff about any unusual symptoms or problems with your health while you are on the study. The researchers will explain this to you during the informed consent process.

Children in Research
You may be asked if you are willing to allow your child to participate in a research study. Special efforts are made to protect children who participate in research. Most studies involve no more than minimal risk to children, or they offer some possibility of direct benefit. No undue risks are taken with children who participate in research.

As a parent, you play an important role in this process. Make sure you understand the risks as well as any possible benefits of your child participating in the study. Ask questions of anyone involved in the study, and feel free to discuss the study with your child's regular pediatrician as well. Children also have the right to an age-appropriate explanation of the research.

We want both you and your child to be comfortable.
 
Research Participant's Bill of Rights
If you are asked to participate in a research study, you have the right to
  1. Be told what kind of study it is and why it is being done.
  2. Be given an explanation of the procedures to be used, as well as a description of any drug or device to be used.
  3. Be given a description of any discomforts and risks to be expected, as well as whether there will be any financial costs to you or your insurance company.
  4. Be given an explanation of benefits to be expected, if any.
  5. Be told of procedures, drugs, or devices that might help you if you do not participate in the study, as well as how the risks and benefits of such options compare with those of participating.
  6. Be told of any treatment or alternative treatment, if any, available to you during and after the study.
  7. Be given an opportunity to ask any questions about the study or the procedures involved.
  8. Be told of new findings that could change your willingness to consent and be informed that you may withdraw your consent to participate at any time, without penalty to you.
  9. Be given a copy of any consent form used in relation to the study.
  10. Be given the time and opportunity to decide freely whether to consent or not consent to participate in the study.
If you have a question, please ask!
You will be given a person's name and telephone number as a contact for the study. If not, ask anyone working on the study! Wondering about benefits and risks of the study? Ask. Wondering whether you'll be paid? Ask.
 
If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact the UAB Office of the IRB (OIRB) at 205-934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday. You may also call this number in the event the research staff cannot be reached or you wish to talk to someone else.
 
You can also use the web to learn about research with humans at any of these sites:

Office for Human Research Protections (OHRP)
Operated by the US Department of Health and Human Services, OHRP oversees many aspects of federally funded research.

Click here for the OHRP brochure "Becomming a Research Volunteer: It's Your Decision".

National Center for Bioethics
Operated by Tuskegee University, the center is devoted to engaging the sciences, humanities, law and religious faiths in the exploration of the core moral issues which underlie research and medical treatment of African Americans and other underserved people.

NIH Bioethics Resources on the Web
Listed resources provide background information and various positions on issues in bioethics