Institutional Review Board (IRB) FAQs

The scope of the Institutional Review Board's (IRB) charge is broad. Generally, any University research that uses humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.

IRB review and approval is required for any research involving human subjects that:

• Is conducted by University faculty, staff, students
• Is performed on the premises of the University,
• Is performed with or involves the use of facilities or equipment belonging to the University;
• Involves University students, staff, or faculty;
• Involves Davenport University data
• Satisfies a requirement imposed by the University for a degree program or for completion of a course of study; or
• Is certified by an institutional official to satisfy an obligation of a faculty appointment at the University, including clinical or adjunct appointments.

Submit the completed Human Subjects Review (HRS-1) with  certificate(s) of completion of  Human Subjects training to irb@davenport.edu.

Investigators requesting full or expedited review of a protocol should submit the Human Subjects Review Form (HRS-1) and all relevant attachments to the IRB office no later than the 1st of the month preceding the IRB meeting at which it will be reviewed. For example, submit by May 1 for the May IRB meeting.

The IRB meets monthly.

Applications for Human Subjects Review Form (HRS-1) that meet the criteria for Exemption are accepted throughout the month, and reviewed on a rolling basis. There is no disruption of the exemption review process in the summer. 

An Adverse/Unexpected Event is defined as:

•  any medical, psychological, or behavioral event that is undesirable and unintended, although not necessarily unexpected
•  an event in which the outcome is fatal or life-threatening causes permanent disability, causes hospitalization, or prolongation of hospitalization
• an overdose
• a complaint by a research subject or family member of a research subject concerning the research or the protocol

If an adverse or unexpected event occurs on an approved protocol, the investigator is required to submit an Adverse/Unexpected Event Report to the IRB. The form and specific instructions may be downloaded from the IRB website. The investigators must notify the IRB in a timely manner (within 48 hours of the event).

When reviewing a protocol, the IRB must make the following determinations:

1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.
5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

There are three levels of IRB review: exemption, expedited review, and full review.

• Exemption: Protocols that present extremely low levels of risk to participants and include only procedures described in six specific categories of research may qualify for exemption. The investigator must complete a Human Subjects Review Form (HRS-1), attach a copy of the research protocol and all relevant documents, and submit the packet electronically to the IRB for review. After the administrative review is completed, the investigator is notified of the outcome by email.
• Expedited Review: Protocols that present no more than minimal risk to subjects and include only procedures described in nine specific categories of research may qualify for expedited review. The investigator must complete a Human Subjects Review Form (HRS-1), attach a copy of the research protocol and all relevant documents, and submit of the entire packet to the IRB for review. After review by the assigned IRB members, the investigator is advised of the outcome by email.
• Full Review: Protocols that do not meet the criteria for either exemption or expedited review must be reviewed by the convened IRB. The investigator must complete a Human Subjects Review Form (HRS-1), attach a copy of the research protocol and all relevant documents, and submit the entire packet to the IRB for review. After preliminary review by two IRB members, the protocol is presented and discussed at a convened meeting of the full IRB. The investigator is notified of the outcome shortly after the meeting by email.