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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
    *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).

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

If you are uncertain if your project needs IRB review, complete and submit the "Determining Human Research" form in the Forms section below.

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.
 
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.
 
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 human research protection training. For research involving multiple investigators, each researcher must provide proof of training. Proof of training is acceptable for five years from the date of training completion.

Completion of the online tutorial, “Protecting Human Research Participants” at the NIH Office of Extramural Research fulfills the requirement for training.

https://phrp.nihtraining.com/#!/login 

At this website, complete the registration form. You will 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”. This will show you a webpage with your certificate of completion. To provide documentation of completion of the training to the IRB, please take a screen capture of your certificate; then paste it into an appendix to your IRB form.

For faculty supervising students, when you email the student’s submission to the IRB, please also submit a copy of your NIH certificate of training in your email unless alternative evidence of human research protection training is 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.

Ungrouped
Collecting data in the classroom (.pdf, 164K)
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.
Informed Consent with Minors (.pdf, 203K)
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.
Research involving physically taxing activities (.pdf, 107K)
Even if participants are healthy, there are protections that must be in place if the protocol involves them engaging in physically taxing activity.
IRB requirements for selected special circumstances (.pdf, 123K)
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
Adobe Acrobat Reader is required to view and print PDF files.
Ungrouped
IRB Submission Form (.docx, 49K)

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 (chrissy.may@msj.edu).

Determining Human Research (.docx, 46K)

Complete and submit this form when you are uncertain if the project you are conducting qualifies as human subjects research. PLEASE NOTE that if you believe your project is not research, you need to provide enough detail in the description of the project to enable the IRB to determine that (for example, stating that your results will not be submitted publicly and are not going to be offered for generalizable knowledge). Please indicate the purpose of conducting the project as well as how the results will be used.

Email Determining Human Research Forms to the Administrative Assistant in the Office of the Provost (chrissy.may@msj.edu).

Adobe Acrobat Reader is required to view and print PDF files.