六九色堂

Research investigators, department heads, and thesis/dissertation or faculty advisors are responsible for insuring that ALL research involving human subjects is submitted to the IRB for review. Definitions from the federal rules for human subject research :

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalize knowledge

The following activities are deemed not to be research:

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority.
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

All research involving human subjects will be reviewed if:

• The research is sponsored by the University.
• The research is conducted by or under the direction of any employee, student or agent of the University in connection with his or her institutional responsibilities.
• The research is conducted by or under the direction of any employee, student or agent of the University using any property or facility of the University.
• The research involves the use of the University's nonpublic information to identify or contact human research subjects or prospective subjects.

Projects that entail quality improvement or program evaluation may not need IRB review. These studies focus on a particular group or setting and are not intended to result in generalizable findings. In these cases, investigators should request a determination memo from their study site and attach it to their Cayuse IRB submission.

Most projects with minimal risk will be reviewed by the chair alone, and whether or not a full board review will be necessary can usually be ascertained by contacting Elizabeth Hill, interim chair of the IRB.

Project proposals being submitted for IRB review should be sent to the Chair and must include:

1. A completed IRB Application Form
2. A copy of the exact Informed Consent Form or Research Information Sheet that will be used with the study volunteers along with the advertisements for study volunteers. See guidelines for these advertisements. Consent forms must include all items identified in the model and must be readily understandable by the average lay person. If the volunteers are children, see #7 below. Consent forms provided by a funding agency must be amended to conform to the above referenced policy statements or will be returned for amendments prior to IRB review.
3. A copy of the complete research proposal or grant proposal, including questionnaires and interviews when applicable.
4. A copy of your CITI training completion certificate.  CITI provides an on line course on human subjects protection in research. If you have been certified in the past two years, please complete the Revised Common Rule module.  If your certification is older than that, please complete the new modules appropriate to your learner group.  Click here for further instructions. 
5. A copy of the Investigators Brochure (supplied by the Drug Company), when applicable.
6. A letter of approval authorizing the use of their site, signed by an appropriate official, if research volunteers are to be used at sites other than Detroit Mercy or Detroit Mercy affiliated hospitals (i.e., schools, shelters, social agencies, nursing homes).
7. Research with children or adolescents requires a Parental Consent Form (which can be adapted from the Consent Form above) and a Child Assent Form. The assent form must be written to be understandable by the age group of your participants. (Assent forms for children 7-13 are written at the third grade level, forms for adolescents 13-17 are written at the fifth grade level.) If the research is minimal risk, only one parent must consent. If the research is more than minimal risk, both parents must consent.  Researchers should be aware that any studies involving minors that are more than minimal risk may be subject to additional requirements.  Please see the for additional information.  

All documents to be reviewed by the IRB must be submitted to the IRB chair.  Most projects will qualify for expedited review, which is determined by the Chair within 10 days of the receipt of the application.  If the project requires review by the full board, documents must be received at least three weeks prior to the next regularly scheduled board meeting.  Please see the schedule below for IRB meeting dates. 

The IRB shall notify the research investigator in writing of the IRB's decisions, conditions and requirements and provide the research investigator reasons for the IRB's decision to disapprove a research project and an opportunity for the research investigator to respond. Reasons for disapproval shall also be transmitted to the Academic Affairs Office by the IRB. Upon approval, the investigator will be sent an approval letter signed by the IRB chairperson. The letter will state whether a continuing annual review is needed.

If your expedited project requires annual Continuing Review, please submit the Continuing Review Application at least 10 days prior to the expiration date.

If your project required full board review, please submit the Continuing Review Application to the Chair three weeks prior to the next regularly scheduled board meeting closest to the expiration of your project.

If you have significant changes in your research protocol, please submit a Modification Form to amend your application.

If your project requires Continuing Review, please submit the IRB Continuing Review Application as directed above.

If your project does not require continuing review, please submit an annual Status Report to the Detroit Mercy OSPRA.

Please report any adverse events immediately using the Incident Form.

Please submit a Project Closure form at the end of the study.

The Institutional Review Board generally meets on a regular basis six times a year. Documents to be reviewed by the IRB must be submitted to the chair, IRB, at least three weeks prior to the next regularly scheduled board meeting. Location of the meetings is in a Student Union conference room.

Researchers who are certain that they will need to have their protocols reviewed by the full board must submit the application at least three weeks ahead of the meeting date and also contact the interim chair, Elizabeth Hill

Voice: 313-578-0405
Email: hillelm@udmercy.edu

Board members

James Tubbs, Jr., PhD
Harold Greene, PhD
Julia Stocker Schneider, PhD, RN, CNL
Cristine Smoczer, MD, PhD
Curtis Smith, MURP
James Windell, MA
Elizabeth Hill, PhD (Interim Chair)

Revised 10/22