What is the IRB and why do we have one?
The IRB, or Institutional Review Board, exists to protect human participants involved in research conducted by University members (faculty, staff, and students). For this reason we ensure that correct procedures, such as clearly stated release and consent prior to participation, are followed when human subjects are involved in research. Providing the University with supporting documentation helps to safeguard the University as well as the researcher(s) from potential liability.
When do I need to apply for IRB approval?
IRB approval is needed when human subjects are involved in a research project. The Federal Policy for the Protection of Human Subjects defines human subjects as “…a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” Notice that the definition of human subject focuses on what information or material is obtained from people. If either of the following applies, your research activity involves human subjects: (1) Data about living individuals through intervention or interaction, and/or (2) Identifiable information about living individuals.
What information will I need to apply for IRB approval?
The application form asks for information about the individuals involved in the research, what methods, materials, and apparati you are using for collecting data, how you will protect participants from harm, and how information is safeguarded. You will need to submit a curriculum vitae for principal investigators to ensure they are qualified to conduct the research. You also need to submit a PHRP certificate that the principal investigators have engaged in human subjects training..
What is PHRP certification and how do I obtain it?
The National Institutes of Health requires University IRBs to ensure that researchers obtain PHRP (Protecting Human Research Participants) certification to ensure that human subjects are treated ethically and provided the appropriate protections for privacy and safety. PHRP certification can be obtained through the CITI Program website. PHRP certification lasts for five years from the date the certification is obtained.
To register and create an account, go to the CITI Program website and select REGISTER. Select your Organization Affiliation by entering Southern Arkansas University. In this section, you must also (1) Agree to the terms of service, and (2) Affirm affiliation with Southern Arkansas University. Next, select Create a CITI Program Account and fill in the blanks with your contact information. You will then set up a username and password following the instructions provided. Continuing Education Unit (CEU) credit is not required for SAU IRB application submissions but is available here if needed in your respective discipline. To select your course, choose Social Behavioral Education (SBE) Comprehensive. Lastly, select Finalize Registration to complete the registration process.
I want to collect data from students in my class. Should I submit my study to the IRB?
It depends. If you are using the data for your own use and participants cannot be individually identified, then you should be okay without review. For example, if you wanted to survey your class to evaluate your teaching, and you are not collecting names or other identifying information, then no, you do not need to submit your protocol for IRB review. If, on the other hand, you are collecting data on the effectiveness of a teaching method and plan to present or publish that data as a generalizable result, then it would very likely be considered research with human subjects and should be submitted for review. In any event, if you are not sure, you can submit the proposal to the IRB on the Request for Exempt Certification Form, and if it qualifies for exempt certification, you’ll receive an acknowledgement that the IRB has evaluated it and it is exempt from review.
What is Expedited Review and Full Review?
Expedited or full review is used when a research protocol does not qualify for exempt review. Expedited review means that two IRB members will review the proposal (the IRB chair and an IRB committee member from the researcher’s college if possible). It is done when there is no more than minimal risk, and where the identification of participants would put them at risk of legal liability, damage to reputation or stigma unless their confidentiality is reasonably protected. If the proposal does not qualify for expedited review, or if the committee’s concerns about the research cannot be resolved with the researcher, the proposal is referred for full review. Full review involves the review of the proposal by a convened meeting of the full IRB committee. For more details, see the IRB Policy Procedure Manual, section titled “Categories of Research that may be reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure.”
What is the threshold of “minimal risk?”
Minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Anything beyond this may be considered greater than minimal risk.
What if I want to make a change to the protocol following approval by the IRB?
There is a form for this: the Request for Change in Protocol/Consent Form(s). After the IRB chair reviews this form, you’ll be notified that the changes are acceptable or if the changes require expedited or full review.
What if something unexpected happens after I begin research and I suspect my participants might have been injured or harmed or they complain about the research?
You will need to use your judgment to determine whether the incident needs to be reported. Generally, if the participant is physically or psychologically harmed to a degree that medical or psychiatric intervention is required, you need to report it. If the participant believes that the research presented risks greater than those specified in their signed informed consent, you should report it. In these cases, you will need to report the incident to the IRB and your department chair and your college’s dean. To report the incident, use the Report of Injury/Unanticipated Events Form. If you are unsure, just email the IRB chair for advice and counsel.
Will the IRB hold up my research if I submit a proposal?
No. The IRB committee has streamlined its processes and is usually able to provide a response within three to five business days.
Does the IRB evaluate my research on its scientific, social, or other forms of worth?
No! The IRB is not a censorship body. We evaluate the safety of research protocols and ensure that participants are protected from foreseeable harm, physical, social, and psychological, that is not outweighed by the benefits of the research. However, in order to help researchers, the IRB might consider the design of the experiment and suggest changes that may improve the study’s value to the scientific enterprise. This is a rare occurrence though.
Are there special populations I might study that need special protections?
Yes. Vulnerable populations are those who may be at risk of coercion or violation of rights as a product of their physical, mental, or social conditions. These populations include children, prisoners, pregnant women, or persons with mental and/or physical disabilities. Studies with these populations will be reviewed for sufficient safeguards to protect the rights and welfare of these vulnerable populations, and to ensure there is not undue influence or coercion involved with the research or consent procedures.
Are researchers allowed to offer financial rewards for study participants?
Various disciplines/fields have differing opinions on this matter. For this reason the IRB Committee does not make a determination, leaving it up to the Principal Investigator(s) to decide on the appropriateness of such offerings. However, to comply with Arkansas state disclosure laws, a list of all award recipients must be submitted to the Office of Financial Services at Southern Arkansas University. In this case only names are requested, keeping participants’ responses confidential. Respondents must be informed of this legal requirement in the Release and Consent documentation for the study. Suggested language for a Release and Consent form is included in the section titled Other Forms.
What is the Common Rule and what does it mean for informed consent?
The Common Rule is a 2019 Federal regulation requiring that informed consent begin with a concise and focused summary of “key information” to facilitate a prospective participant’s understanding of the reasons one might or might not choose to participate in research.
For more information on the Common Rule, please visit the following links:
For general information and definitions https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html
For examples and templates https://primr.org/resources/aereo-project-on-key-information
Additional information on (Revised) Common Rule – https://www.research.psu.edu/node/2955
Is there a way to provide PHRP training and certification to students?
Yes. A Student IRB Course has been created for that purpose. This course can be found in the Virtual Student Center (VSC) in Blackboard at https://blackboard.saumag.edu/ultra/organizations/_41202_1/outline. After logging in to Blackboard, click the Organizations tab and look for the Virtual Student Center. After clicking on the VSC link, click academics from the left menu, and open the Student IRB Course folder. There are six modules with quizzes included. Upon completion of the IRB course, the student is provided a certificate of completion.
