Institutional Review Board

• What is and is not Considered Human Subject Research?

  
  What is Considered Human Subjects Research?

  Research is considered to involve human subjects when a researcher (1) obtains information or biospecimens through intervention or interaction with a living individual and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (45 CFR part 46).

  1. Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

  Research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether the research is published or not.

  Systematic Investigation: is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

  2. Intervention: physical procedures by which information or biospecimens are gathered (for example, venipuncture) or manipulations of the subject or the subject’s environment are performed for research purposes.
  3. Interaction: communication or interpersonal contact between the researcher and the subject.
  4. Identifiable: for which the identity of the subject is or may readily be ascertained by the researcher or associated with the information or biospecimen.
  5. Identifiable Private Information: private information for which the identity of the subject is or may readily be ascertained by the researcher or associated with the information.
  6. Identifiable Biospecimen: specimen for which the identity of the subject is or may readily be ascertained by the researcher or associated with the information.

   

  What is Not Typically Considered Human Subject Research?

  1. Scholarly and journalistic activities: including the collection and use of information that has already been published and is being examined, and information is collected. Examples include: journalism, biography, and literary criticism.
  2. Public health surveillance activities: limited to those activities 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 criminal justice or investigative purposes: for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. This does not include social and behavioral studies of the causes of criminal behavior.
  4. Authorized operational activities for national security purposes: authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.

   

  *Please also review the Campus Survey Policy, as some research or training projects may need more coordination with the Office of Institutional Effectiveness (OIE) first before completing the IRB submission form.

  *Other University of Mount Union Policies that may need to be reviewed pending the research or training project include, but are not limited to: Bloodborne Pathogen Policy, Minors on Campus Policy, Animals on Campus

  IRB Approval is required for ALL human subject research activities designed to develop or contribute to generalizable knowledge (e.g., publication, presentation, dissertation, or surveying). This includes student dissertations and thesis projects. This applies regardless of the funding source.

• IRB Application Process for Submission and Revisions

  
  Step 1

  • First, complete the required Assurance Training by reading each Module (1-3) and reading additional resources/links that are provided by the U.S. Department of Health and Human Services. Once completed, download (at the bottom of the page) and sign the certificate of completion for this training.
  • Next, complete the appropriate CITI Training that pertains to your area of research, prior to application submission, using this link for the CITI Log In
    • If you are a new user, please use this CITI Registration Information Sheet for our institution.
    • Please note that some research may require more than one training course to be completed.

  *Please keep in mind that the Collaborative Institutional Training Initiative (CITI) Program includes an "Integrity Assurance Statement" that must be completed by all learners before they can access course modules. This statement ensures that each learner completes the training for themselves and is a prerequisite for accessing the course content.

   

  Step 2

  Complete the Informed Consent Documentation

  • What documents do I need?
  • If subjects are 18 years or older and fully capable of providing informed consent, complete the Informed Consent Form.
  • If subjects are less than 18 years old, complete the Parental Consent Form and (when necessary) Child Assent Forms.
    • The HHS regulations do not require documentation of assent. The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent. Based on such considerations as the child's age, maturity, and degree of literacy, the IRB should decide what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent's assent. If young children are involved who are yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place. The IRB may also decide that documentation of assent is not warranted. Please address any questions to the IRB chair.

  Step 3

  • Complete the Debriefing Documentation
  • This documentation is required by the University of Mount Union on all human research studies conducted.
  • Please use the provided Debriefing Documentation Form.
  • As a reminder, this is something all research participants should receive and be able to keep at the conclusion of the human subject’s participation.

  Step 4

  • Gather Supporting Materials
  • Recruitment or Informational materials (recruitment scripts, e-mail scripts, fliers, etc.)
  • Data Collection Instruments (copies of surveys, interview questions, tests, etc.)
    • Researchers are required to contact the Mount Union Office of Institutional Effectiveness to have any data collection instruments that are noted to fall within this University Survey Policy reviewed.
  • Instrumentations used within the methods (video clips, photos, etc., that the subjects will be exposed to as part of the study)
  • Copy of investigator(s) CITI training verification
  • Working Word Document for IRB application, to use to ensure all areas of the online application are addressed prior to starting the application process
    • IRB recommends that the researcher use this document as their guide and may copy and paste their work into the online application from it. Only online applications are accepted.

   

  Step 5

  • Complete the IRB application using the Human Subjects Application Link.
  • Applicants should be aware that once an application is started, researchers do not have the option of saving and returning. This is why we encourage using the working document above to make the application process smoother.

   

  Step 6

  • Once the application is received and reviewed, the listed principal investigator will be sent communication via the provided email address within the application regarding the IRB Committee's decision.

  • Should any identified revisions need to be made, researchers are asked to use the provided IRB Application Revisions Link.

• IRB Approved Research Continuation Application

  • For approved research at the University of Mount Union, to continue research beyond the approved 12 months, please use the Continuation Application Link.
  • Researchers who are looking to apply for continuation yearly must meet with the Chair of the IRB to discuss.

FAQs

• Do I need IRB approval for my project?

  If your project involves systematic investigation designed to contribute to generalizable knowledge and includes living human subjects or identifiable private information, IRB review is required. Quality improvement, program evaluation, or class projects may not require IRB review, but should still be submitted for determination.

• When may I begin my research?

  Investigator(s) may begin work on a study/project upon receipt of the Full Approval Letter and Study Number assigned. Please be advised there are different letters sent to applicants. Each letter informs the applicant of the review status assigned to the application. Any work begun beforehand violates federal law and puts all research and data obtained in jeopardy.

  All applications are reviewed by IRB as they are received on a rolling basis. For full consideration, the committee requires 3-4 weeks to review materials prior to the monthly meeting. Additional time may be required if an OIE collaboration is needed.

  *Any study/project that received IRB full approval that extends beyond 1 year (12 months) from the date approved, requires a renewal to be completed.

• Do quality improvement (QI) or program evaluation projects need IRB review?

  Not always. If the goal is internal improvement only, it may not require IRB review. If the results will be generalized, published, or presented, IRB review is typically required. Submit an inquiry to the IRB chair for determination.

• Can I begin recruiting or collecting data before I have IRB approval?

  No. Research activities involving human subjects may not begin until IRB approval (or exemption determination) is granted.

• What happens if I make changes to my study after approval?

  You must submit a modification request form to the IRB and receive approval before implementing any changes, unless necessary to eliminate an immediate risk to participants.

• Do student research projects need IRB approval?

  Yes, if the project meets the federal definition of human subjects research. Faculty supervisors should guide students in preparing and submitting protocols.

• What counts as “informed consent”?

   

  Informed consent is a process, not just a form. It requires explaining the purpose of the study, procedures, risks, benefits, confidentiality, voluntary nature, and the right to withdraw. Consent forms must be written at a level participants can understand.

   

• What if my study involves vulnerable populations?

   

  Special protections apply for children, prisoners, pregnant women, and individuals with impaired decision-making capacity. These studies often require full board review and additional safeguards (e.g., parental consent, assent, guardian involvement).

   

• Can I use data from publicly available sources without IRB approval?

   

  If the dataset is truly public (e.g., census data, publicly available government data) and contains no identifiers, it is usually not considered human subjects research. If there are identifiers or restricted access, IRB review is likely required.

   

• What happens if I conduct research without IRB approval?

  This is considered noncompliance and may result in:

  • Data not permissible to being used for publication/presentation.
  • Institutional sanctions.
  • Loss of funding or inability to conduct future research.
  • The IRB cannot grant “retroactive” approval.