Human Research Protection Program

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New Studies

Determining if a Proposal Needs IRB Review 

The following definitions and questions are designed to assist the IRB and investigators with deciding if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.  While this guidance is provided to investigators for informational purposes, it is the responsibility of the IRB to make the final determination about when research requires IRB review and oversight.

MCW/FH Other Committees that may need to review a new study

Some new protocols may require review by various administrative or ancillary committees prior to being reviewed by the IRB. Investigators should be aware of these processes when planning to submit a new study to the IRB. The following are examples of ancillary committee which may need to review a submission prior to IRB review:

Decision Charts

The Office for Human Research Protections (OHRP) provides graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. More...

Are you conducting Human Subjects Research? 

 

Human subject means a living individual who is or becomes a participant in research, either as a recipient of the test article or as a control 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 an example of Non-Human Subject Research?

  • A systematic investigation in which
  • Data/samples from living individuals are obtained:
    • To develop or contribute to generalizable knowledge
    • Without intervention or interaction and
    • Include no identifiable private information (e.g. de-identified data/specimens)

Because an incorrect guess by the investigator might have serious consequences, proposals that may not meet criteria for human subject research should be submitted in eIRB for IRB determination. An investigator who fails to submit an IRB application will be found to be in serious non-compliance if later found to be engaged in HSR. If you are unsure, please contact the IRB

Are you conducting research with decedents?

Research with decedents is not governed by the Office of Human Research Protection or the FDA. However, this type of research is governed by HIPAA regulations.  More… 

Who can submit studies?

Refer to IRB SOP: Requirements & Qualifications to Serve as a Principal Investigator regarding who can act as the Principal Investigator for studies at MCW.  More...

Coordinated IRB Review

To learn more about multi-site site projects and established IRB Partnerships with other institutions, click here.

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Page Updated 09/02/2014