- Who can I talk to if I have a question about human participants research?
- When is IRB review required?
- I believe my study is exempt. Why do I need to submit an application?
- What is Private Information?
- What is archival data?
- What information needs to be included on the consent document?
- What does the IRB look for in an application? Are there standard criteria for evaluation?
- Do I need to list all research personnel that might be asked to have access to research participants or their collected data?
- Can researchers be subjects in their own studies? Does self-experimentation require IRB review?
- Can I recruit students for my research from my own class?
- My research takes place at an off-campus site. Are the requirements different for an off-campus study?
- When may I begin data collection for my study?
- Can I use deception in my research?
- What is involved in debriefing participants when deception is used in my research?
- How do I obtain Renewal approval for my research study?
- When should a modification to an approved research study be submitted?
- I received Exempt approval for my study. Do I still need to submit a continuation every year?
- What if I carried out my research without IRB approval?
- Does Waiver of Informed Consent or Waiver of Documentation of Informed Consent mean I don’t have to get a participant’s consent?
- What is the difference between coercion and undue influence?
Who can I talk to if I have a question about human participants research?
The Office of Human Subjects Protections (OHSP) is available to provide assistance to investigators who are engaged in research with human participants. For general questions, please contact our office at HSP@utdallas.edu.
When is IRB review required?
IRB review is required whenever an investigator who is affiliated with the institution conducts research with human participants.
Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
A human participant (or human subject) is defined “as a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
I believe my study is exempt. Why do I need to submit an application?
Exempt Studies are not subject to federal regulations requiring IRB review and approval. However, they must go through an administrative review process to confirm their exemption status. These applications are reviewed and approved internally by the HSP Office. Once a study’s status is confirmed, an exemption category is assigned and approval documents are released. When designated as Exempt, a study is approved for a 3-year period. Failure to submit a Renewal application by the expiration date may cause the study to be administratively closed.
What is Private Information?
Private information has been defined as information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
Private information must be individually identifiable: the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
What is archival data?
Archival (or secondary) data are data that were collected in the past, usually for a purpose other than research. The complete data set must exist prior to the initiation of a research project using the data.
What information needs to be included on the consent document?
The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective participants or their legally authorized representatives adequately understand the research so that they can make informed decisions. Thus, the information must be conveyed in language understandable to those being asked to be a participant in the research. Please see our Forms and Checklists for templates and guides.
What does the IRB look for in an application? Are there standard criteria for evaluation?
The IRB reviews every research protocol according to the ethical principles outlined in the Belmont Report. This means they evaluate the risks and benefits of a study and whether or not the risks are a) recognized by the PI and b) mitigated appropriately. The application should provide adequate information for IRB Reviewers to make this evaluation. Key factors in the evaluation are:
- Recruitment. Recruitment of participants must be appropriate for the study and the participant pool. It should be designed to protect a participant’s privacy and avoid any appearance of undue influence. Copies of all recruitment materials must be provided to the IRB including verbal scripts, email scripts, flyers, advertisements, etc. Language used should be clear and should avoid misleading or unclear statements.
- Inclusion / Exclusion criteria. Selection of participants must be equitable (fair or just) within the confines of the study. Researchers may not exclude individuals based on gender, race, national origin, religion, creed, education or socioeconomic status. The benefits and risks of research must be fairly distributed. If students are being recruited, a justification not based on convenience must be provided.
- Informed consent. The informed consent form should provide a participant with a complete picture of the study including what they will be required to do and what they will experience. Simplified language should be used (avoid scientific jargon) so an average person can understand the study. 6th – 8th grade reading level is recommended. The environment in which informed consent will occur must allow participants to ask questions. Investigators should avoid the appearance of undue influence and have a process for determining a participant’s comprehension of the study.
- Data Security. Investigators must demonstrate they have the appropriate security measures in place to protect participants’ privacy and the confidentiality of the data. The IRB will want to understand where the type of data will be collected, how it will be stored (both paper and electronic), who will access it, and when / how it will be destroyed.
Do I need to list all research personnel that might be asked to have access to research participants or their collected data?
Yes. All research personnel who will be engaged with the research study must be included on the application (including students working on the study). An individual is considered engaged if they perform any of the experimental procedures or have access to data collected from participants. If the research team changes during the course of the study, a modification can be submitted through Cayuse to add or remove study personnel no longer engaged.
Can researchers be subjects in their own studies? Does self-experimentation require IRB review?
Yes, researchers can be subjects in their own studies. However, UTD regards this type of research (investigator self-experimentation) as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects.
Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Submitting an application for review with the Office of Human Subjects Protections allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.
Can I recruit students for my research from my own class?
The recruitment of students from a course taught by the PI of a study is not recommended as this creates the appearance of undue influence due to the power dynamic between student / professor. However, if a PI would like to recruit their students, this risk can be mitigated by having a someone other than the PI/Professor conduct the recruitment / informed consent process and by having the PI / Professor out of the room when it occurs. Other ways to mitigate the risk of undue influence that can be discussed by contacting the Office of Human Subjects Protections (OHSP).
My research takes place at an off-campus site. Are the requirements different for an off-campus study?
Regardless of the study location, all UTD affiliated research studies must go through the same IRB submission process. When the study is conducted on private property (schools, hospitals, community agencies, etc.), additional documentation is needed to confirm the off-campus site’s approval (a letter of support). The letter must confirm the off-campus site’s approval as serving as a study site and must be signed by (or submitted from if an email) the institutional official with appropriate authority.
When may I begin data collection for my study?
No human subjects research activities can be conducted until after IRB approval is obtained. This includes recruitment, data collection and data analysis. Prior approval is required.
Can I use deception in my research?
In some instances, being told the true nature of the study can cause participants to change how they would normally respond, challenging the scientific validity of the study. Deception is acceptable when revealing the true nature of the study will influence participants and bias their responses. Participants should be debriefed at the end of the experiment.
Deception or incomplete disclosure in research cannot be approved if:
- Non-deceptive alternatives are available;
- The deception is intended as a ploy to get people to participate in a study they would not otherwise want to; and/or
- It introduces unmitigated financial, physical, legal, psychological, or social risk to participants.
What is involved in debriefing participants when deception is used in my research?
When deception or incomplete disclosure is used, the participant is not able to consider all elements of the study and prospectively provide fully informed consent. Therefore, investigators should employ the following items to preserve the autonomy of research participants.
- Acknowledge the Deception. Including a statement in the consent document to inform participants the study involves deception or incomplete disclosure allows participants to determine whether or not they are comfortable enrolling in the study on these terms.
- Debrief Participants. After study procedures are complete, participants are provided with information about the use of deception or incomplete disclosure, called a debrief. Debriefing sessions can mitigate any harm of deception by explaining the scientific need to use the technique. Participants should be given simple, clear and informative explanation and should have the opportunity to ask questions. The IRB may require investigators allow participants to sign the debriefing form and also have the option to exclude their data from analysis.
How do I obtain Renewal approval for my research study?
A Renewal application can be submitted through Cayuse. It is the responsibility of the Principal Investigator (PI) to ensure continued approval of their human participant research study. As a courtesy, automatic reminders are sent to the PI approximately 30 days prior to the study’s expiration date. If no action is taken, the Office of Human Subjects Protections will administratively close the study 30 days after the expiration date. Once closed, the PI must submit a new initial study application before any research activity can resume (including data analysis).
When should a modification to an approved research study be submitted?
A modification request must be submitted prior to any change taking place in study procedures or study measures. This includes recruitment documents, consent form language, changes in personnel, changes in study methods, etc. All changes must be submitted and approved prior to implementation.
I received Exempt approval for my study. Do I still need to submit a continuation every year?
No. A continuing review must be submitted three years after the initial study approval. Failure to submit a continuation in a timely manner will result in your study being in a Completion status. The study will be kept in Completion status for 30 days after which it will be “inactive.” Once a study has a status of “inactive,” it will be closed and a new initial study application must be submitted to and approved by the Office of Human Subjects Protections (OHSP) before study activities can resume.
What if I carried out my research without IRB approval?
If you are conducting human subject research without IRB approval, you are in violation of Federal Regulations and subject to non-compliance reporting both to University officials as well as OHRP (Office of Human Research Protections) in Washington, D.C. You also put the University at risk of having its research privileges shut down. If the research is being done for a Master’s Thesis or a Doctoral Dissertation, the Graduate School will require that you submit proof of IRB approval with your paper. If you didn’t receive approval from the IRB prior to starting your project, you will not receive approval once it is completed.
Does Waiver of Informed Consent or Waiver of Documentation of Informed Consent mean I don’t have to get a participant’s consent?
No. A waiver of documentation of informed consent simply means the informed consent process is not documented by the participant’s physical signature. An investigator must always obtain consent from a participant before engaging in human subjects research. Consent can be obtained in different ways (verbal, online, etc.), however the process must be outlined in the IRB application and prospectively approved by the IRB.
What is the difference between coercion and undue influence?
Coercion is defined as the practice of persuading someone to do something by using force or threats.
Undue influence is influence by which a person is induced to act otherwise than by their own free will or without adequate attention to the consequences.