Research - Human Subjects and IRB

The IRB is a group of individuals charged with reviewing proposed research involving human subjects to ensure that the rights and welfare of human subjects are adequately protected in research and are in compliance with federal human subjects regulations. For information on specific IRB issues, Nancy Goldsmith (nancy-goldsmith@uiowa.edu) is available to provide in-house advice. In addition, you may consult the UI Guide to Human Subjects Protections in Research or the UI Human Subjects Office.

Below are a few FAQs regarding the IRB:

I am a student and need someone to sign off on my IRB Assurance form.  Who should I get to sign this?

In lieu of a Department Chair, the Associate Dean for Research or the Associate Dean for Faculty (or their designees) can sign the IRB Assurance Form indicating that they are knowledgeable about the conduct of your research project.

Am I conducting Human Subjects research?

Only the IRB can make a determination whether a project requires IRB approval. PI's who are unsure if their project requires IRB approval should complete a Human Subjects Research Determination Form in HawkIRB. The IRB will use the information you provide in the form to determine if your project meets the definition of human subjects research.

When does the University IRB need to review a project?

A project requires IRB review if any of the following conditions are met:

1. The research is sponsored by this institution
2. The research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities
3. The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
4. The research involves the use of this institution’s non-public information to identify or contact human subjects.”
5. An employee or agent of this institution (including students) meet the criteria for being engaged in research; in other words, they are obtaining:

• Data about the subjects (living individuals) of the research through intervention or interaction with them for research purposes;
• Individually identifiable private information about the subjects of the research for research purposes; or
• The informed consent of human subjects for the research.
• Note: An entity is automatically considered to be “engaged” in human subjects research whenever it receives a direct DHHS award to support such research. In these cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award.

What are some examples of scenarios that would NOT constitute engagement in research and, thus, would not require IRB review?

Institutions whose employees or agents perform commercial or other services for investigators provided that all of the following conditions also are met:

• The services performed do not merit professional recognition or publication privileges;
• The services performed are typically performed by those institutions for non-research purposes; and
• The institution’s employees or agents do not administer any study intervention being tested or evaluated under the protocol.”
• For other examples of being engaged vs. not engaged, see: http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html

What is the proper procedure for dealing with the IRB when a PI or co-PI moves?

According to the Guide to Human Subjects Research, there is no one set way to deal with PIs and Co-PIs who maintain appointments at two different institutions (pp. 65-67). The Guide states, “To avoid duplication of review efforts by IRBs, institutions can choose to conduct joint reviews, rely upon the review of another qualified IRB, or make other arrangements to establish oversight responsibilities.”

When should I close my project with the IRB?

When in doubt, leave your project open. It is much more difficult to initiate a new project and it is impossible to resurrect a project that has been closed prematurely.

I collected data while I was a graduate student at UI. I have since moved and would like to include these data with a new project. What do I need to do to use my dissertation data at my new institution?

The question often arises – what becomes of the data once my dissertation is completed and I take a position at another institution. There are two important points to remember:

1. The University takes the position that it owns any data collected by faculty, staff or students.
2. Any work (e.g., analysis, manuscript preparation) using identifiable data needs to be done under IRB approval – whether at Iowa or another institution.

• Definition of Identifiable Private Information - private information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). This information is considered individually identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the information. If information includes Protected Health Information, identifiable information includes any of the following information for the individual, relative, employer, or household member of the individual:
  
  • Name, street address, city, county, precinct, zip code, geocodes smaller than state
  • Date of birth, ages > 89 years of age; or other dates such as diagnosis dates, procedure dates, admission or discharge dates
  • Telephone numbers, fax numbers, e-mail addresses, social security numbers, medical record number
  • Health plan beneficiary numbers, account numbers, certificate/license numbers
  • Vehicle identifiers and serial numbers or license numbers, device identifiers and serial numbers
  • Web URLs, Internet Protocol (IP) address numbers, biometric identifiers including finger/voice prints
  • Full face photographic images and any comparable images

This means that if you leave the University and have closed out your HawkIRB project (which you must do upon termination of your connection to Iowa), you will:

1. Leave the hard copy data here (usually with your dissertation chair). You can take a copy with you.
2. If your data will continue to be associated with identifiers, you must get IRB approval from your new institution (local IRB) to continuing working with the data.
   
   • Often the new institution wants Iowa to give approval for use of this data. To get that, the individual contacts the relevant department head – in the case of the CON, that would be the Associate Dean for Research – in writing outlining their request to use the data.
   • The approval from Iowa will include the condition that IRB approval be in place at the new institution prior to working with the data.
   • If your data will be de-identified (i.e., if you are able to continue your work with a data set containing only aggregated data and/or data that have no identifiers), you may be able to work with the data at your new institution without formal IRB approval, although it would be wise to review this with the IRB at the new institution.

To download this entire response as a document, click here.

I am conducting community based research. What resources are available to assist me?

Resources on Community Based Research are available through the UI IRB.

To assist you, the CBR program has published a Community-Based Research Program Packet.