In general, research is defined by the Department of Health and Human Services as a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)).
Per Federal regulations (45CFR46.102(f)), a human subject is defined 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.
Any research project that will be conducted at Mercy Medical Center and its clinics or at St. Luke’s Hospital is subject to the review of the Mercy & St. Luke’s Joint Institutional Review Board.
All projects must be reviewed and approved before they can begin.
Research applications are reviewed at one of three levels, depending on the level of risk to the human participants and on the federal regulations that define the categories of review.
The levels of review are exempt, expedited and full board review. The final determination of what level of review is required is determined by the IRB staff, NOT the researcher.
Please note that the designation given to your project by the IRB at your educational institution may be different than the IRB designation given by the Mercy & St. Luke’s Joint IRB Committee.
On occasion, an application initially submitted as exempt may be reviewed and returned with a response that the study requires full review.
A study may be considered exempt if the project involves human subjects in entirely non-invasive activities, such as:
- Conducted in established or commonly accepted educational settings.
- Involving the use of educational tests, survey procedures or observation of public behavior.
- Involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens.
- Studying, evaluating or explaining public benefit or service programs.
- Involving taste and food quality evaluation or consumer acceptance studies.
Studies will undergo a full review if the investigator conducting research obtains: 1.) Data through intervention or interaction with the individual, or 2.) Identifiable private information.
In some cases, a project deemed to be of minimal risk can be granted approval via an expedited review. The chair may elect to approve the study and will determine if it needs to be placed on the agenda of the next regularly scheduled IRB meeting.
Amendments to existing studies may also be approved in an expedited manner.
Exempt applications are reviewed and approved by the chair of the IRB and will generally be reviewed within one week of submission.
Full applications must be submitted at least two weeks prior to the regularly scheduled IRB Committee meeting in order to give committee members adequate time to review the submission.
The Joint IRB meets quarterly. The dates for 2023 and 2024 are as follows:
2023 Dates:
2024 Dates:
- January 26, 2024
- April 25, 2024
- July 25, 2024
- October 24, 2024
EXEMPT STUDIES
FULL STUDIES:
Additional materials you should submit:
- Advertising materials used to promote the study.
- Materials to be given to research subjects.
- Data collection tools that will be used.
- Confirmation of Human Research Protection Training
You will also be invited to attend the IRB meeting where your study is reviewed in order to speak to your study and to answer any questions the committee may have.
Questions and completed application materials can be directed to
Shannon Rieniets:
srieniets@mercycare.org
319-369-4466
Any study that is approved by the full IRB requires annual renewals submitted to the full board. Additionally, when the study is complete, the IRB should be contacted with notification that the study is closed.
Renewal and/or Closure Form (PDF)
