Participant FAQs
About Research and the IRB
What is an IRB, and what is its role in research?
The Institutional Review Board (IRB) reviews and approves human research studies to protect participants’ rights, safety, and welfare.
What is considered research, and who qualifies as a human subject?
Research involves systematic investigation designed to contribute to generalizable knowledge. A human subject is a living individual about whom researchers obtain data through interaction or identifiable information.
What is a research study, and how are clinical trials classified?
A research study is an organized activity designed to answer a question. Clinical trials test the effects of medical, behavioral, or other interventions and are often conducted in phases.
How do individuals verify if a research study has received IRB approval?
Participants can ask the research team for the IRB approval number or contact the IRB office to confirm the study’s approval status.
Deciding Whether to Participate
How can participants decide whether or not to participate in a research study?
Participants should weigh the risks and benefits, ask questions, and make an informed decision before agreeing to participate.
What questions should participants ask before consenting to a study?
Participants should ask about the purpose of the study, procedures, time commitment, risks, benefits, costs, and how their information will be protected.
How do individuals qualify for research studies, and what are the objectives of these studies?
Each study has specific eligibility criteria and goals. The research team will explain these when discussing the study with potential participants.
Are there benefits to participating in research studies?
Participation may or may not provide direct personal benefits, but it may contribute valuable knowledge that helps others in the future.
What are the risks or side effects associated with research participation?
Some procedures may involve discomfort or other risks. Participants are informed of known risks before joining and updated if new information becomes available.
What are the alternative options if someone chooses not to participate?
Individuals may choose not to participate and can pursue other treatments or options without penalty.
How can individuals ensure they are not pressured into participating?
Participation is always voluntary. Individuals should not feel coerced, and declining will not affect their services, care, or standing.
What to Expect During a Study
What types of tests or examinations are involved, and how long do studies last?
Procedures and timelines vary by study. The research team will explain what participants will be asked to do and how long it will take.
How frequently are visits required to clinics, labs, or other locations?
The number and timing of visits depend on the study protocol and will be explained in advance.
What follow-up procedures occur after participation?
Some studies include follow-up visits or assessments to monitor outcomes. These will be described during the consent process.
What happens at the conclusion of a research study?
Participants will be informed about the end of the study and any additional visits or procedures that may be required.
Participant Rights and Protections
What rights do participants have during a research study?
Participants have the right to voluntary participation, confidentiality, informed consent, and the ability to withdraw at any time.
Can individuals decline or withdraw from a study after agreeing to participate?
Yes. Participants may decline or withdraw at any time without penalty. The research team can explain any specific withdrawal procedures.
How is informed consent obtained and maintained?
Consent is obtained after participants receive clear information about the study’s procedures, risks, benefits, and confidentiality. Participants may ask questions at any time.
How is participant confidentiality maintained?
Researchers protect privacy by storing data on secure servers, drives, or in locked locations. Participants can ask for specific details about how their information is protected.
What safeguards are in place to ensure participant safety?
The IRB reviews each study to ensure that appropriate procedures are in place to protect participants throughout the research process.
Costs, Accommodations, and Practical Considerations
Are there any financial costs or compensation associated with participation?
Some studies may involve costs or offer compensation. These details will be explained before participation.
What cultural or linguistic accommodations are provided?
When applicable, research teams provide materials in preferred languages and respect participants’ cultural needs.
Questions, Concerns, and Additional Information
How can individuals address concerns or complaints about a research study?
Participants may contact the IRB office:
- Sandee Aina, Associate Director, HRPP – 801-422-1461 or sandee.aina@byu.edu
- Wayne Larsen, IRB Administrator – 801-422-2153 or WCL@byu.edu
- Stephanie Coyne, HRPP Administrator – 801-422-3608 or sstone@byu.edu
- Emily Gneiting, IRB PM Coordinator – 801-422-3606 or IRB@byu.edu
Where can individuals find additional information about research participation?
Participants can contact the IRB office or visit resources such as the U.S. Department of Health and Human Services Office for Human Research Protections.