IRB Guidelines and Forms

IRB Guidelines

Process, Exemption, Approval

The following Guidelines are excerpts from the IRB Guidebook and other material online at the Office of Human Research Protections (http://www.hhs.gov/ohrp/). No human research may be initiated or conducted without the written approval or determination of exemption by the IRB. A link to the submission form can be found at the bottom of this page.

Under no circumstances should human research data be collected prior to written approval or exemption by the IRB. Collecting data without IRB review may result in serious consequences, including (a) the researcher being asked to destroy any data collected, (b) large federal fines levied against the researcher, (c) large federal fines levied against the institution, and (d) a federally-imposed ban on research at the institution. The IRB chairperson will investigate any reports of noncompliance, and will consult with the other IRB members about the appropriate course of action. The decision reached by the IRB will be communicated to the researcher, the supervising faculty member (if applicable), and the department chairperson.

What is reviewed by the IRB?

The IRB process is mandated by the Federal Government for research involving human subjects,and the process is explained in Title 45 Part 46 of the Code of Federal Regulations.

  • What is "research?"- a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. NOTE: Developing or contributing to generalizable knowledge means that the intent or purpose of the systematic investigation is to produce knowledge from which conclusions will be drawn that can be applied to populations outside of the specific study population. Studies conducted to gather information for a course project (and to be shared only with the instructor and/or other students) or for internal use by an organization do not usually contribute to generalizable knowledge.
    *Mount St. Joseph University considers all human studies that contribute to generalizable knowledge, whether conducted by students or faculty, as research.
  • What are "human subjects?"— living individual(s) 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.
  • What is "identifiable private information?" - information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record).
  • PLEASE NOTE: If your project does not meet this definition of "research," you may not have to submit your project to the IRB.  If you are not sure whether your project meets the definition of "research," you can ask the IRB Chairperson via email at Michael.bindis@msj.edu.  In your email, please describe the purpose and procedures of your study as well as how the results will be used (i.e., will your results will be shared publicly, or are they for use mainly for a class project or for internal use in an organization?). 

The purpose of IRB review is to determine whether:

  • procedures of the research will minimize risks to subjects
  • risks to subjects are reasonable in relation to expected benefits (Risk/Benefit Analysis)
  • selection of subjects is equitable
  • informed consent is sought
  • research plan makes adequate provision for monitoring data collected to ensure safety of subjects, the protection of privacy, and the confidentiality of data
  • appropriate safeguards are included to protect the rights and welfare of subjects

Types of Review

Exempt — e.g., research on effectiveness of instructional techniques; research involving public observation of behavior, anonymous surveys, or existing records/specimens (if publicly available or the researcher records the information in such a manner that subjects cannot be identified). Visit http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 for more exempt categories and additional detail. Exempt review is performed on a continual basis by the IRB chair or another IRB member. This review is typically performed within 7 working days.  NOTE: During the summer months, review times could be longer if the IRB chairperson or administrative assistant are on vacation during the time an IRB form is submitted; please plan for longer review times during the summer.  
 
Expedited — nonexempt research involving minimal risk (i.e., “the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”). An expedited study must be reviewed for approval by the IRB chair or designated member of the IRB. Visit http://www.hhs.gov/ohrp/policy/expedited98.html for more information on expedited review. Expedited review is performed on a continual basis and is typically performed within 7 working days. NOTE: During the summer months, review times could be longer if the IRB chairperson or administrative assistant are on vacation during the time an IRB form is submitted; please plan for longer review times during the summer.  
 
Full Review — research involving more than minimal risk. A full review study must be approved at a meeting of the IRB. The full IRB meets as needed and during Final Exam week in the following months: May and December. Proposals must be submitted at least 10 days prior to these weeks. You should receive the IRB’s decision within 10 working days of their meeting.

Note: Special considerations must be given for vulnerable populations, for example: fetuses, children, prisoners, and individuals with impaired decision-making ability.

Researcher Decision Charts

Decision charts are available online at http://www.hhs.gov/ohrp/regulations-and-policy/decision-trees/index.html to help you determine whether a project needs to be submitted to the IRB and, if so, whether it falls into the exempt or expedited category.
 

Suspension or termination of IRB approval of research or removal of exempt status

An IRB shall have authority to suspend or terminate approval or remove exempt status for any study that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval or exemption shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Department or Agency head.

Training in Protecting Research Participants

All faculty, staff, and students who submit research protocols to the IRB, or supervise students who make submissions to the IRB, must provide proof of current training in the protection of human subjects in research. For research involving multiple investigators, each researcher must provide proof of training. 

Completion of the online tutorial, “Human Subjects Research Online Training” through Protecting Human Research Participants (PHRP) fulfills the requirement for training, and the university has a contract with PHRP. This training does have a fee associated with it, and the University will be covering the cost of MSJ researchers who need the training. HOWEVER, please know that MSJ will not be covering the additional CME cost, so please do not choose that option. Prior to starting your training, contact IRB administrative assistant Sarah McGowan (Sarah.McGowan@msj.edu) for a code to enter that will cover the cost. Please only request a code when you are ready to do the training, as codes are only good for 1 year. 

https://phrptraining.com/#!/login

At this website, complete the registration form to create an account and password. Be sure to remember your password. Once you have registered, you can login to the training course. The course has seven sections, four of which have quizzes. You may do the course at one setting or several settings. Estimates to complete all of the seven sections range from two to three hours.

When you have completed the course, click on “Get Certificate”. To provide documentation of completion of the training to the IRB, please take a screen capture or save a copy of your certificate; then paste it into an appendix to your IRB form.
 
PHRP certificates are accepted as well as alternative training programs (ex., CITI); however, certificates must be dated within 5 years of IRB protocol submission.

For faculty supervising students, when you email the student’s submission to the IRB, please also submit a copy of your human research protection training certificate in your email unless documentation of your human research protection training is already on file with the IRB.

Further information

Further information and guidance may be obtained from the Office for Human Research Protections of the U.S. Department of Health and Human Services.

Guidance Documents

Handouts list view Handouts card view

Ungrouped

Title Description File type
Collecting data in the classroom
Here is a guidance document for researchers (faculty, staff and students) who want to collect data in the classroom. It also includes guidance for instructors when they want to offer course credit in exchange for research participation.
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Informed Consent with Minors
Research with minors involves obtaining both informed consent from parents as well as assent from the children. Here are some guidelines for how to obtain consent/assent in those circumstances.
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Research involving physically taxing activities
Even if participants are healthy, there are protections that must be in place if the protocol involves them engaging in physically taxing activity.
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IRB requirements for selected special circumstances
The attached document is by no means exhaustive, but it does provide some guidance on the following circumstances:
  • Research (questionnaires) inquiring about intimate or potentially upsetting issues
  • Procedure to follow when requesting a waiver of informed consent
  • Conducting online surveys
  • Research (questionnaires) inquiring about illegal activities
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Educational Research: When are Teachers Investigators?

If you are conducting research in an educational setting and using teachers to help you conduct the research, this document provides guidance on when those teachers might be considered investigators by the IRB.  Teachers who are investigators would need to provide proof of ethics training (e.g., PHRP certificate).

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IRB Forms

Handouts list view Handouts card view

Ungrouped

Title Description File type
IRB Submission Form

Complete and submit this form when you know that the project you are conducting qualifies as human subject research and requires IRB review.

Email IRB Submission Forms to the Administrative Assistant in the Office of the Provost (sarah.mcgowan@msj.edu).

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