Institutional Review Board (IRB)

The U.S. Department of Health and Human Services requires that all research projects involving human participants be screened to confirm that the participant's rights, privacy, welfare, and civil liberties are protected. The Institutional Review Board (IRB) is responsible for reviewing all research projects involving human participants affiliated with Harper College.

Contact Us
Office of Institutional Research
847.925.6950
oir@harpercollege.edu

Manual

Policy for conducting research at Harper College; Institutional Review Board (IRB) Manual

Forms

Committee Information

Frequently Asked Questions

Graduate work (thesis or dissertation) which involves research on human subjects requires IRB review.

Student projects or assignments involving collection of data from human subjects may or may not meet the definition of research. Course instructors are responsible for making the decision whether the activities meet the definition of research. Course instructors are encouraged to call the IRB if they have any questions.

A student project is a study in which a student investigator (individually or as part of a group) gathers or analyzes information in a systematic manner, primarily for pedagogical purposes. It is not intended to contribute to generalizable knowledge and is not to be presented outside the class in which the research is being done or published/disseminated (including publication on the Internet) in any way, presented, archived, or compiled with similar research for later publishing or presentation.

Research conducted for a seminar project, masters thesis, or dissertation does not fall under the definition of student project, and therefore, would require IRB review.

The consent form must be signed by the parent, guardian, or other responsible party if the study involves minors or others who are unable to sign suitable consent. Special provisions are to be made for soliciting the assent of children, when in the judgment of the IRB the children are capable of providing assent. Factors in this judgment include age, maturity, and psychological state of the children. This judgment can be made for all children involved in the study or individual child, as the IRB deems appropriate.

Yes. All changes (including study personnel changes) to a study must be approved by the IRB. Please complete and submit the attached Research Amendment Form .doc

If the IRB has not approved continuing review past the expiration date, new subjects should not be enrolled until the IRB approves the project for another year. The renewal must be submitted at least 30 days before the expiration date. Renewals can be sent directly to the Office of Institutional Research in Building A, Room 317 for review by the IRB chair.

Studies that have expired due to submissions past the expiration date are subject to full review with a new application to the IRB.

The continuation of research after the expiration date is a violation of the regulations [21 CFR 56.103(al)]. Therefore, all research activities pertinent to the study should stop and no new enrollment should occur. You may submit a new application for the continuation of the project which will go through full IRB review. The IRB Chair will be pleased to provide necessary assistance to secure approval for this project with minimum delays.

All IRB protocols are approved for one year or less depending upon the level of risk. Continuing reviews are required at a frequency determined by the IRB at the time of approval to ensure the rights and welfare of research subjects.

IRB policy requires investigators to maintain their research records (includes data collection form(s) including source documents and case report form(s) for five years after completion of the study. For research, which falls under authority of other agencies or statues with longer research record retention requirements, the longer retention period applies.

Research conducted at Harper College that has been reviewed and approved by another qualified IRB may qualify for an Expedited IRB Review. The Principal Investigator must complete the Secondary Research Proposal IRB Application and submit this with:

  1. the application materials from their home institution, and
  2. a copy of their project approval from their home institution's IRB.

The items should be submitted to the IRB in Building A, Room 317 or electronically to oir@harpercollege.edu

Follow the directions for completing an IRB application. If the data involve documents or records that are publically available or if the information is recorded so that subjects cannot be identified, the research will probably qualify for an expedited review.

If Harper College is the only IRB to review the research, then use the primary application.

If another institution of higher education IRB will first review the research, then use the secondary application.

Existing data with personally identifying information (e.g., SSN, name, etc.) requires an approved Data Sharing agreement.

(Taken from the Code of Federal Regulations, Title 45, Part 46, Subpart A)

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human participant means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Vulnerable populations are groups of individuals who require additional measures to ensure that rights, privacy, welfare, and civil liberties are protected. These groups include children, prisoners, pregnant women, and people with mental, physical, and/or intellectual disability. People with intellectual disability are not officially considered a vulnerable population in the current code of federal regulations as there is no subpart devoted to this group. They are included here as their inclusion appears to be consistent with the spirit of the regulations. Refer to the current code of federal regulations for additional information concerning vulnerable populations.