Participating in a Study - Office of Research and Innovation

The University of Texas at Dallas (UTD) Office of Research and Innovation is responsible for ensuring the protection of the rights, welfare, and well-being of participants involved in research studies conducted by UTD faculty, staff and students – per federal law and regulations.

One way this is accomplished is by having all research studies reviewed by an Institutional Review Board (IRB). The IRB carefully reviews and monitors research to ensure that it is carried out legally and ethically. Research studies involving human subjects cannot be started until the IRB has approved the study.

What Is Research?

When most people are asked about research, they think of scientific or medical research –and with good reason. But research takes other forms, too. Some studies use questionnaires, interviews, or other types of surveys to gather information about habits, opinions, and beliefs. Other studies observe the way people interact with one another or react to certain situations, providing new insights into human behavior. Many of these studies would not be possible without human participants.

Benefits and Risks

One way or another, all of us have benefited from research. The vaccines that help prevent diseases and the medications that help manage symptoms are just a few examples of scientific discoveries that resulted from research. Many of the psychological and social support services that we routinely provide to victims of trauma and disaster also were developed in response to research findings.

It’s important to note, however, that research is experimental, and that means it involves risk. The federal government requires researchers to inform participants about the risks involved – and to do everything possible to minimize those risks. Even so, risk can never be completely avoided.

Deciding to Participate

The decision to participate in a research study is a personal one. Certainly, it is helpful to discuss your options with researchers and your family, but ultimately the choice is yours. There are a number of reasons why people choose to participate in research, but no matter what the reason, it is important that your decision not be made lightly.

Every Research Participant has the following rights:

To be treated with respect, including respect for your decision whether or not you wish to enroll in, continue in, or stop being in a study.
To choose to stop being in a study at any time.
To be given time to read the consent form and have the research study explained to you.
To be given time to ask questions, and to be told whom you can contact if you have any more questions.
To be given a copy of the consent form after you have signed it.

Responsibilities

Participant

Read the consent form and ask the PI any questions you may have. You should understand what procedures will occur before you agree to participate.
Contact the Principal Investigator (PI) if you desire to terminate involvement in a study.
Know the start and end dates of your participation.
Contact the PI or the Office of Research Integrity and Outreach with complaints or concerns about study participation.
Report any and all unanticipated problems to the PI immediately.
Comply with responsibilities of participation as enumerated on the consent forms unless discontinuing participation in the study.
Confirm receipt of extra-credit points or monetary compensation.
Maintain copy of consent form for your records.
The integrity of research depends upon honest and ethical subject participation.
Request study results if so desired.
Carefully weigh the potential benefits of participation (if any) against actual risk of participating.

Principal Investigator

Conduct the IRB approved research protocol
Obtain informed Consent
Effectively train and mentor student researchers in the ethical conduct of human subjects research
Obtain approval for any changes, additions, or deletions to the study from the IRB prior to implementation
Retain research records for 3 years after study completion date
Promptly report all unanticipated problems or injury to the IRB
Follow all University of Texas at Dallas procedures for the ethical conduct of human subjects research
Respond promptly to all participant concerns and questions.
Maintain subject confidentiality.
Inform subjects if risks or benefits of study change.
Maintain cultural sensitivity
Design research methodology appropriate to your desired research setting.
Obtain permission to use intellectual property and/or private data.
Different sites have different rules and expectations. Know your site and follow appropriate guidelines.

Questions to Ask

Before you participate in a study

Why is the research being done?
What will be done to me as part of the research?
How will I benefit from the research?
Could the research hurt me?
What will the researcher do with my personal information or other data obtained through my participation in the study?
Will the research cost me anything?
How long will the study last?
What happens if I decide to leave the study early?
What interests me in this study?
Why would I want to or need to participate in the study?
When does this study take place?
Where does the study take place?
Is this study safe?
Do I feel that I can trust the researchers?
Who gains from my participation?
Does this study have IRB approval?
Am I feeling pressure or obligation to participate in the study?
How do I contact the PI if I have questions or concerns?
Who can I contact with questions or concerns that is not involved in the research study?
If I really wanted to quit would I be able to?
Am I learning anything from participating?
How will I be notified if risks or benefits to the study change?
How is my privacy being protected?
Is this study confidential or anonymous?

After you participate in a study

What results did the study produce?
Will the study be published?
Can I have a copy of the article?
Am I willing to do this again?
What have I learned that I would do differently next time?
What benefits did I receive?
Would I recommend being a human research participant to others?

Additional Information and Resources

The Office of Human Subjects Protections (OHSP) at the University of Texas at Dallas is dedicated to addressing any concerns or complaints about the rights, safety, and welfare of participants in research studies reviewed by UTD’s Institutional Review Board. Individuals can report concerns or complaints using the Research Participant Report Form. As an alternative method of contact, individuals can contact the OHSP at 972-883-4575, via email to HSP@utdallas.edu, or a letter sent to IRB Administrator, The University of Texas at Dallas, 800 W. Campbell Road, AD15, Richardson, TX 75080.