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Frequently Asked Questions (FAQs)

General Information

Research Study Review Process, IRB & Informed Consent

Your Rights and Risk & Benefits of Participating in a Research Study

Clinical Trials

Questions, Concerns or Complaints


General Information

What is a research study?

Research is defined as “the systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  A research study is designed to answer specific questions that will enhance knowledge and benefit members of society.    

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What are some recent research studies at UA?

Research studies at UA include:

  • surveys (current study - repetitive behaviors in children)
  • studies on insomnia, down-syndrome, and treatments for depression
  • clinical trials

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What is a research participant/subject?

A research participant is a living person who takes part in a research study. Most research studies have certain requirement that you must meet in order to participate in the study. The requirements are designed to protect the safety of the participants as well as ensure the usefulness of the research.

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Who does research at The University of Alabama?

Faculty, professional research staff, and undergraduate and graduate students from just about every field of study on campus do research. (Student researchers are always supervised by faculty.) Also, investigators from other universities, hospitals, professional research firms, or government agencies can request permission from the UA IRB to conduct their research here. 

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What is a Principal Investigator (PI)?

The person who is responsible for the study is called the Principal Investigator (PI). The PI may be a UA faculty member, staff or student. If the research study involves human participants, then the PI is responsible for assuring the safety of the participants.

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Who else is involved in research studies?

The PI often relies on a team to assist him/her in the day-to-day operations of their studies. The research team may include coordinators, statisticians, social workers, educators, students, doctors and other individuals with specialized skills needed for the study.

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Where can I find out more about being in a research study?

Research studies at UA are advertised in many ways, such as local newspapers, TV, radio and are listed on UA’s Research highlight web site and can be accessed at the following link http://research.ua.edu/volunteers.html.

If you are interested in a research study (clinical study/trial) for a specific disease or condition, please contact your physician to discuss which studies you might qualify for participation.

Additional resources about Clinical TrialsHow can I find out about Clinical Trials? 

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Who pays for research studies? 

It costs money to do research.  Research may be paid for by the investigator, scholarships,  private industry like drug companies, non-profit organizations like the March of Dimes, or by university, state, or federal  funds.  The PI will tell you who sponsors their research.

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Will I be paid to be in a research study?

Some studies offer participants a small amount of money or a gift like a store gift card in appreciation of their assistance with the research.  Some studies do not.

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Will it cost me anything to be in a research study?

In most research studies the only cost to you is the time it takes you to participate. Sometimes there may be costs like mileage or parking. In medical studies sometimes you or your insurance company may have to pay for the study drug, especially if it is a drug like aspirin or Tylenol that has already been approved for use. The investigator must explain any costs to you and describe these costs in the informed consent document.

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What is a human research participant protection program?

The Human Research Participant Protection Program (HRPP) is the University of Alabama’s program for protecting human participants in research by educating University faculty, staff and students and the community about ensuring the safety and ethical treatment of our research participants. The IRB is the part of UA’s HRPP concerned with actual research studies. The HRPP also conducts a quality improvement program to evaluate how adequately UA is protecting research participants and identify needed changes.  These are accomplished in many ways, such as providing opportunities for you to ask questions and make suggestions, raise complaints and concerns or complete a Research Participant Survey.

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Research Study Review Process, IRB & Informed Consent

Who reviews a study?

All research that involves human participation conducted at UA is reviewed and approved by UA’s Institutional Review Board (IRB).  UA has two IRBs (medical and non-medical) that review all social science (non-medical) and biomedical (medical) research conducted at UA. 

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What is an IRB?

An Institutional Review Board (IRB) is a committee that consists of 5 or more members with varying expertise and diversity that is responsible for reviewing and approving human participant research activities on behalf of the University of Alabama. The IRB’s primary responsibility is to ensure the protection of human participants.  Anyone performing research studies involving human participants at UA must submit to one of UA’s two IRBs for review and approval prior to initiating their research.

Non-medical IRB:  reviews human participant research that involves questionnaires, surveys, interview, focus groups, etc

Medical IRB: reviews human participant research that involves:        

  • scientific study of normal or abnormal physiology and development
  • studies that evaluate the safety, effectiveness, of usefulness of a medical drug, procedure or device
  • studies that involve any invasive procedures (examples: saliva, tissue, urine, or blood samples)

The IRBs are responsible for the initial and continuing review of research studies to ensure that research is conducted ethically and in compliance with all applicable regulations.  The IRB reviews research to determine if: 

  • the research will benefit the research participant and/or study
  • the risks to research participants are minimized
  • the participants are given the opportunity to provide their consent. See additional information at “What is Informed Consent?
  • the participants’ privacy is adequately protected.

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Where can I find out more about the IRB?

The IRB site on the Office for Research Compliance (ORC) is a great source of information for learning about the research process and the IRBs’ responsibilities.  Link to UA’s IRB site:  http://osp.ua.edu/site/irb.html

If you have any questions, concerns or complaints related to human participant research conducted at UA, please contact us via the following methods:

      Phone: 205-348-8461     

      Toll free number:  1-877-820-3066

      Fax: 205-348-8882

      Email: participantoutreach@ua.edu

      Mail: Director, Office for Research Compliance
              Box 870104
              Tuscaloosa, AL 35487

You may also submit comments using our online form, available here.

You may also submit an anonymous complaint using our online complaint form, available here.

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Where can I learn more about human participant protection?

The Office for Human Research Protection has information about research participation on its Public Outreach Page, including pamphlets to download:

Other Resources:

Resources specific to kids:

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Who can participate in a research study?

You must meet the criteria for a study in order to participate.  The criteria for some research studies are very broad (anyone over the age of 18) and others are more specific (research studies looking at a specific disease.)

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 What types of activities are involved in research studies and what can I expect if I choose to participate in a research study?

Research studies involve a variety of activities ranging from filling out surveys and questionnaires to participating in eating a special diet, engaging in an exercise program to using an experimental drug or device.  Some studies last a few minutes, while others may last for years.  The research team will discuss the activities involved in the study before you give permission to participate in the study.

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How do I give permission to participate in research?  

You will be asked to sign a document which is referred to as an informed consent document prior to enrolling in a research study at UA.  Before you give your permission for you or your child to participate, it is important that you read the consent document and ask as many questions as necessary to be sure you understand what you or your child will be asked to do.

If you decided to participate in a study, you will receive a copy of the signed and dated informed consent document. 

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What is Informed Consent? 

Informed Consent is the process of providing people with sufficient information to make informed choices about whether to begin or continue participation in a research study that continues throughout your participation in the study.

Elements of informed consent:

  • Statement that the study involves research and an explanation of the purpose of the research
  • Expected duration of the participant’s participation
  • Description of the procedures to be followed and identification of any procedures which are experimental
  • Description of any foreseeable risks or discomforts to the subject
  • Description of any benefits to the participant
  • Disclosure of appropriate alternative procedures
  • Statement describing the extent to which confidentiality of records identifying  the participant will be maintained
  • For research involving more than minimal risk, an explanation as to whether any compensation whether medical treatment is available in injury occurs
  • An explanation of whom to contact for information about the questions and the participants rights
  • An explanation of whom to contact in the event of a research related injury
  • A statement that participation is voluntary, the refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled and that the participant may discontinue participation at any time

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Do I always have to sign a consent form to be in a study?

Most of the time, yes, but sometimes written informed consent isn’t feasible.  The investigator conducting a mailed survey will send a letter explaining the study and state that “Your return of the completed survey will be taken as evidence of your informed consent to participate.”  Telephone survey interviewers will explain the study and specifically ask you if you wish to continue or if they may ask the first question.

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Your Rights and Risk & Benefits of Participating in a Research Study

What are my rights as a participant in a research study?

If you are asked to be in a research study (to take part, participate, give your consent) or if you have been asked to consent (allow, give permission) for someone else—such as your child or an elderly or very ill relative—you have the right to, but not limited to:

  1. Be told that the study (also called experiment, trial, or survey) is research.
  2. Be told what the study is trying to learn and why this will be useful.
  3. Be told what you will be asked to do in the study and how long it will take in words you can understand.
  4. Be told about any discomforts or risks (harm or danger) that you might be exposed to from the study.
  5. Be told about steps that will be taken to reduce  these risks or dangers  and to care for you if they occur.
  6. Learn about any benefits (good things) that may happen to you from being in the study.
  7. Be told in a medical study if there are other treatments or medicines you could take instead of being in the study—are there alternatives to the study that might help you?
  8. Be told that you can refuse to be in the study or that you can change your mind about being in the study at any time and that no hard feelings or harm will come to you from this.
  9. Ask questions about the study until you feel you understand it.
  10. Receive a copy of the signed and dated consent form.
  11. Feel that your decision is your own and that you were not pressured to take part in the study.
  12. Contact the University of Alabama IRB if you feel you were not treated fairly or that the study did not match what you were told. 

For a copy of UA’s brochure on “RESEARCH AND YOU: KNOW YOUR RIGHTS”, please click on the following links:

If you have any questions or concerns about your rights, please contact the Office for Research Compliance via the following methods:

      Phone: 205-348-8461     

      Toll free number:  1-877-820-3066

      Fax: 205-348-8882

      Email: participantoutreach@ua.edu

      Mail: Director, Office for Research Compliance
              Box 870104
              Tuscaloosa, AL 35487

You may also submit suggestions using our online form, available here.

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Are there any risks to being in a research study?

Research studies may involve risk, which varies greatly depending on the type of study.  Studies asking you to complete a survey may involve minimal risk such as some uneasiness when answering questions.  Studies asking you to participate in an exercise regimen may involve some muscular discomfort.   Studies using an experimental drug or device can involve more risk, as you could experience a bad reaction.  The researcher will clearly explain to you the possible risks of the study before you decide whether or not to participate.  These risks will also be identified in the inform consent form that you will be asked to sign before enrolling in the research study.

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Are there any benefits to being in a research study?

Some research studies directly benefit the individuals who participate.  For example, a diet or exercise study may offer certain health benefit where other studies are designed to offer greater benefit to society.  If you join a study that compares treatments, you may or may not benefit directly.

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Are there any special rules to protect certain participants?

Yes.  Per federal regulations, UA has policies and procedures in place to protect “vulnerable populations” who participate in research studies.  Vulnerable populations include:

  • children
  • pregnant women & fetuses
  • prisoners
  • cognizantly impaired persons

See Brief History of the events that contributed to the development of research regulations and ethics rules.

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What questions should you ask about the study? 

  • Why are you doing the study?
  • Who is sponsoring the study?
  • Who can be in the study?
  • What possible risks or benefits are there to being in this study?
  • If I am upset because of questions asked in the study, how will I get help?
  • What happens at the end of the study?
  • Will the results of the study be given to me?
  • Can I stop being a part of the study at any time?
  • What kinds of tests or exams will I have to take while I am in the study?
  • How much time do these take?
  • What is involved in each?

For clinical trials:

  • Will I be hospitalized, and if I am, how often and for how long?
  • What are the costs to me?
  • Will my health insurance pay for any of the costs?
  • What are my other treatment choices?
  • How do they compare with the study treatment?
  • What are the possible risks and benefits to being in the study?
  • How do they compare with side effects of the usual treatment?
  • How long will they last?

For a copy of UA’s brochure on “RESEARCH AND YOU: KNOW YOUR RIGHTS”, please click on the following links:

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Clinical Trials

What is a clinical trial?

A clinical trial is the scientific term for a test or study of a drug, procedure or Biomedical device in people.  These tests are done to see if the drug, procedure or device is safe and effective for people to use.  Doctors, health professionals and other researchers run the test according to strict rules set by the Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA). 

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What are the Phases of a Clinical Trial?

Clinical trials are conducted in a series of steps, called phases.  Each phase is designed to answer separate questions.

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range and identify side effects

Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety

Phase III:  The drug or treatment is given to a larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.

Phase IV:  Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

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How can I find out about Clinical Trials?

For information on research studies that are currently enrolling participants at:

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Questions, Concerns or Complaints

What if I have questions, concerns or complaints about a research study?

If you have questions, concerns or complaints, please contact the Director for the Office for Research Compliance via the following methods:

      Phone: 205-348-8461

      Toll free number:  1-877-820-3066

      Fax: 205-348-8882

      Email: participantoutreach@ua.edu

      Mail: Director, Office for Research Compliance
              Box 870104
              Tuscaloosa, AL 35487

You may also submit comments using our online form, available here.

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