Institutional Review Board For Human Participants in Research Utah Valley University

1. What is the IRB? The IRB is the entity with the jurisdiction for reviewing and approving all research involving human subjects carried out by the faculty, staff, or students of UVU. IRB paperwork must be submitted before research can be approved. IRB approval must be obtained before the data collection can begin.

What is a human subject? Living individuals whom an investigator conducting research obtains Data through intervention or interaction Identifiable private information

What is research? "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." 

What is the IRB’s Mission? The IRB furthers the University’s research mission by: Reviewing proposed research involving human participants in order to protect them against potential risks of research participation while promoting high-quality studies; Educating the larger university community about ethical issues in human participants research; Overseeing compliance with federal, state, and university regulatory requirements for human participant research.

Belmont Principles Part of Protection of Human Subjects law Respect for persons – individuals treated as autonomous human beings with right to make own decisions Beneficence – Do no harm, maximize benefits, minimize risk Justice – Study designed for equal treatment of subjects

Classification of IRB Review The IRB Chair, in conjunction with the IRB, determines the level for review. The UVU Investigator’s Handbook for Human Participants includes a detailed description and list of examples. Exempt Review Expedited Review Full Board Review

What is exempt research? Exempt research is reviewed only by IRB chair and administrator Includes research of negligible risk in the following situations: Educational research in commonly accepted settings with normal practices Use of educational tests, surveys, interviews, or observations of public behavior Secondary use of existing data or specimens with no identifiable information Examining public benefit or service programs Research involving taste and food quality/consumer acceptance Not eligible if information recorded is identifiable AND disclosure could place subjects at risk of criminal, civil liability, or harm reputation Not eligible if research involves prisoners and sometimes children

What is an expedited review? Expedited research is reviewed by chair and one other board member. Expedited review covers research that involves minimal risk and falls into Clinical studies of drugs or medical devices Collection of blood samples Prospective collection of biological specimens by noninvasive means Collection of data through noninvasive procedures excluding X-rays Research using data, documents, records, or specimens collected for non-research purposes Collection of data from voice, video, digital, or image recordings made for research purposes Research on characteristics or behaviors (perception, cognition, motivation, cultural beliefs

What is a full review? Research involving moderate to greater risk to the subject requires review by the full IRB. Full review covers all research not falling into the two prior categories.

Students as research subjects Considered a vulnerable population because might perceive that their grades or faculty favor is dependent on their participation. Must be informed in writing that participation is voluntary and have right to withdraw without prejudice If extra credit offered for participation, students must be offered a reasonable alternative to participation that is equal in extra credit value and time/effort Cannot be exempt if: There is risk to the students Identifiable information is recorded

2. How do you prepare? Before starting the paperwork you should have a planned research project. This includes: Research purpose/goals/literature review Methods design/population and sample selection Measures/instrumentation/data collection procedures Description of risks and benefits and a plan for minimizing risks to participants (scientifically valid design to justify risks) Plan to document informed consent and collect/store/analyze data in secure manner All persons associated with the project must complete CITI online training in “The Protection of Human Subjects in Research” at www.citiprogram.org

Informed Consent Federal regulations state “An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that; The research involves no more than minimal risk to the subjects; The waiver of alteration will not adversely affect the rights and welfare of the subjects; The research could not practicably be carried out without the waiver or alteration; Whenever appropriate, the subjects will be provided with additional pertinent information after participation Must at least have an informed consent statement

Implied Informed Consent Must include: Purpose of research Rationale (why important and how to be used) Contact person Statement about confidentiality Time it will take to complete Appreciation for participation Statement that completing survey serves as consent IRB Statement "If you have questions regarding your rights as a research participant, or if problems arise which you do not feel you can discuss with the Investigator, please contact the Institutional Review Board Office at (801) 863-8156."

3. What is the process? What are the IRB paperwork requirements and processes? How long does it take? What if I need help?

3a. What are the IRB paperwork requirements and processes? It is the responsibility of the principal investigator (PI) to submit proposed research for approval. Approval by the IRB does not relieve the PI from the obligation to follow procedures and rules of the University and any other regulatory body involved with the research. For student research, the advisor or faculty member must be either the PI or the Co-PI.

3a. What are the IRB paperwork requirements and processes? Complete IRB application www.uvu.edu/irb  Forms  Application Include informed consent letter/statement Include survey/interview questions/instruments Collect required signatures Submit to IRB office at irb@uvu.edu

3b. How long does it take? The IRB is committed to move packets through the process as quickly as possible. Once the completed packet is submitted to the IRB, the entire process (if the packet needs no revisions) should take approximately: Remember: You CANNOT start your research until you have IRB approval Exempt (1-2 weeks) Expedited (2-3 weeks) Full Review (4-6 weeks)

3c. What if I need HELP? Department Chair Your School’s IRB Member(s) Colleagues who have successfully gone through the process Websites (www.uvu.edu/irb) Cyrill Slezak PhD, Michaela Gazdik Stofer PhD, or Shelly Andrus

IRB School Representatives Education: Mi Ok Kang Emergency Services: Rodger Broome University College: Chitra Duttagupta Humanities: David Connelly, Lars Eggertsen Science: Andrew Creer Unaffiliated: Cameo Johnson, Greg Craner

Utah Valley University QUESTIONS? For further information see the Institutional Review Board website at www.uvu.edu/irb or email irb@uvu.edu Utah Valley University