Institutional Review Board

PURPOSE AND COMMITMENT

Hiram College is committed to safeguarding the rights and welfare of both human participants and animal subjects involved in the conduct of research by Hiram College faculty, students, and staff. Hiram College supports responsible research which promises to increase knowledge and understanding, and encourages the highest ethical standards among Hiram College researchers. To ensure these safeguards and standards are met, Hiram College has an Institutional Review Board (IRB), that is responsible for working with investigators to maintain the protection of human participants and/or animal subjects.

EDUCATION

The IRB views the education of the Hiram College community, with regard to the ethical conduct of research, among its primary responsibility. To that end, instructors of courses that engage students in the research process are strongly encouraged to contact Dr. Michael Rebold (chair of the IRB committee) at reboldmj@hiram.edu, in addition, instructors are also encouraged to schedule classroom informational sessions which allows students to learn the research process. Likewise, primary investigators should contact the IRB chair in order to obtain information regarding college guidelines or advice regarding the preparation of their application for approval of research involving human participants and/or animal subjects.

COMPLIANCE

The IRB is required to ensure that any research activity remains in compliance with Federal Wide Assurance (FWA) (i.e., the common rule) regarding the protection of human participants in research. Further, the IRB is required to report the following: 1) serious or continuing non-compliant research activity, 2) the suspension or termination of previously approved research, and/or 3) any unexpected serious harm to participants associated with a research investigation.

Investigators are responsible for conducting human participant’s research in accordance with all applicable federal and state regulations. Once the IRB has reviewed and approved a research protocol and the various forms (e.g., consent, assent, data collection, etc.), no changes may be implemented without review and approval by the IRB. The only exception to this rule involves emergency action by an investigator to protect participants from apparent immediate hazards.

To report researcher misconduct or non-compliant research activity, please complete an IRB Noncompliance form and submit it to the IRB chair at reboldmj@hiram.edu. Your identity will not be shared with anyone outside of the IRB and all information is confidential.

INSTITUTIONAL REVIEW BOARD

The IRB is a committee mandated by federal law to protect the rights and welfare of human participants engaging in research activities. 

According to federal regulations, the IRB shall consist of at least five members with distinctive backgrounds in order to ensure adequate review of the breadth of research projects conducted at the institution. The members of the IRB should be diverse in terms of race, gender, cultural backgrounds, and sensitivity to community attitudes. No IRB may consist entirely of one gender or profession. Each IRB must include a nonscientist and a person not otherwise affiliated with the institution. At its discretion, an IRB may invite individuals with expertise to assist in the review of proposed research, although these invited experts may not vote with the IRB.

DOES YOUR INVESTIGATION NEED IRB APPROVAL?

IRB approval is required if your human participant research consist of any of the following criteria:

• The research is conducted by College faculty, staff, or students
• The procedures are performed on the premises of the College
• The procedures are performed with or involve the use of facilities or equipment belonging to the College
• The research involves College students, staff, or faculty participants
• The research project satisfies a requirement imposed by the College as the condition for the award of a degree or for completion of a course of study in the College
• The research project satisfies an obligation of the faculty appointment at the College, as consistent with departmental research goals and objectives, including “clinical or adjunct” appointments

The following types of investigations typically DO NOT require IRB review/approval:

• Institutional investigations (i.e., polls intended for “internal” use)
  • College services opinion polls, department or program outcome surveys, employee satisfaction surveys, campus climate surveys, and marketing investigations
• Class projects
  • Designed specifically for educational/teaching purposes; not intended for use outside of the classroom
• Contracted services
  • Journalistic or Political polls, College partner/customer projects; contracted services could be considered research in instances where there is a clear intent to contribute to generalizable knowledge and therefore would need IRB review/approval

TYPES OF IRB REVIEWS

Exempt, Expedited, and Full Review descriptions can be found by clicking on category descriptions.

IRB APPLICATION SUBMISSION PROCEDURES

Step 1:

• Complete the Assurance Training by reading through each Module (Modules 1-3) and reading through the additional resources/links that are provided.
• Sign the certificate of completion for this training.
• Complete the Human Research Protection Foundational Training by completing the 5 lesson training.

Step 2:

• Complete the IRB Application for all new, revised, or amended investigations.
• Revision Applications MUST include strike-through as opposed to deletions of original material. In addition, all new and/or changed material MUST be highlighted.

Step 3:

• Complete Informed Consent documentation.
  • What documents do I need?
    • If you requested a waiver of Informed Consent (and justified this) in your IRB Application, proceed to step 4 below.
    • If participants are 18-years or older and capable of offering informed consent, complete the Informed Consent form.
    • If participants are less than 18 years old, complete the Parental Consent and (when necessary) Child Assent forms.

Step 4:

• Gather supporting materials.
  • Recruitment or informational materials (e.g., recruitment scripts, e-mail scripts, fliers, debriefing statements, etc.).
  • Data instruments (e.g., copies of surveys, interview questions, tests, web-surveys, etc.).
  • Intervention instruments (e.g., any video clips, music clips, photos that participants will be exposed to as part of your investigation).
  • Grant description, if study is funded.
  • Copy of investigator(s) Ethics and Human Subject Protection certificate of completion.

Step 5:

• Collate all materials.
  • All materials should be collated into a single Word document for submission.
• Submit application to Dr. Michael Rebold (chair of the IRB committee) reboldmj@hiram.edu.
• If the primary investigator is a student, the faculty mentor overseeing the project must be cc’d on the submission e-mail.

CONTINUING APPLICATION

Investigations are approved for 12-months. To continue your research beyond 12-months, please complete the IRB Continuation Application and submit to reboldmj@hiram.edu.

IRB FORMS

• IRB Noncompliance form
• IRB Application
• Informed Consent form
• Parental Consent form
• Child Assent form
• IRB Continuing Application
• Decision Tree for Human Subjects Research During COVID
• Procedures for In-Person Human Subjects Research During COVID
• FORM to Request to Conduct In-Person Human Subjects Research During COVID

IRB RESOURCES

• The Office for Human Research Protections (OHRP)
• Electronic Code of Federal Regulations (eCFR)
• Hiram College IRB Policies
• Hiram College IRB Basics PowerPoint Presentation