Submission to the Institutional Review Board
All research activities involving human subjects must be reviewed and approved by an Institutional Review Board (IRB) unless the Office of Responsible Research Practices (ORRP) prospectively determines that the research falls into a category of exemption established by federal regulation. In accordance with the Office for Human Research Protections (OHRP) guidelines and the Food and Drug Administration (FDA) regulations, the IRB reviews human subjects research proposals to ensure risks have been minimized and assessed against the potential for benefit before human subjects participate in the research. The IRB also ensures, when required, that human subjects only volunteer to participate in research after providing legally effective informed consent. Investigators may not solicit subject participation or begin data collection until they have received approval from the appropriate IRB or written concurrence that research has been determined to be exempt from IRB review. The Ohio State University (OSU) has three internal IRBs to review, approve the initiation of, and to conduct periodic reviews of research involving human subjects or materials obtained from human subjects: 1. The Behavioral and Social Sciences IRB, 2. The Biomedical Sciences IRB, and 3. The Cancer Biomedical Sciences IRB. The Western IRB (WIRB), a contract Board, reviews clinical trials that are industry-sponsored and industry-initiated.
The Office of Responsible Research Practices supports the OSU Institutional Review Boards. ORRP assists OSU faculty, staff and students seeking required research reviews, helps OSU review boards apply clear and transparent processes, ensures compliance while minimizing administrative burdens, fosters and provides education on the responsible conduct of research, and supports OSU’s efforts in securing and maintaining accreditation for human subjects research programs. ORRP offers guidance on meeting regulatory and sponsor requirements, collaborative consultation on identifying flexibility within the regulations, educational programs focusing on ethical and responsible human research practices, and a protocol courier service for researchers submitting materials for IRB review.
Office of Responsible Research Practices (ORRP) Resources
- OSU Human Research Protection Program Policies
- IRB Information Session Held Quarterly (check for schedule on ORRP IRB workshops page)
- Investigator Guide
- Human Participants in Research Video
Completing the IRB forms
- IRB Forms Help Sessions
- Exempt Application
- Initial IRB Application
- Amendment (Changes to Research) Form
- Continuing Review Form
- Event Reporting Policy
- Event Reporting
- Office for Human Research Protections videocast, Reviewing and Reporting Unanticipated Problems and Adverse Events
- Closing out IRB Study (Final Study Report)
- Western IRB for Industry-Sponsored Clinical Trials
Informed Consent and Assent
Federal regulations require investigators to: ensure that potential participants clearly understand the risks and benefits associated with the research before enrollment, provide potential participants with all information necessary to decide whether or not to participate in the research, and most importantly, protect the rights, safety, and welfare of all research participants under their care. One of the three ethical principles outlined in the Belmont Report is “Respect for Persons” and this principle is applied to research with human participants in the form of informed consent. Informed consent is the process of information exchange between the participant and the investigator (or designee), beginning with initial contact and continuing throughout the study, to ensure that the participant can freely decide whether or not to participate in research.
Informed consent is an essential part of ethical research involving human participants. Institutional Review Boards (IRB) and investigators are responsible for ensuring that research involving participants provide informed consent prior to participating in research, unless the requirement for informed consent is waived or altered (in non-exempt research) by the IRB.
OSU consent templates contain the basic elements of informed consent and are recommended for use to streamline IRB review and assure that regulatory requirements are met. Investigators, co-investigators, and key personnel who recruit or consent participants or who collect study data are to be included on the OSU initial review of human subjects application.
Assent and parental (or guardian) permission must be obtained as required by federal regulations and IRB determinations for research involving children. Assent is generally required for children based on their ages, maturity, condition, and the nature of the research, unless assent can be appropriately waived or some or all of the children are not capable of providing assent.
Assent may also be appropriate for adults with diminished decision-making capacity and other adults unable to consent for themselves, for whom a legally authorized representative will provide informed consent.
Basic Elements of Informed Consent (45 CFR 46.116(a)(b) and 21 CFR 50.25(a)(b))
The consent process must include the following basic elements:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the participant’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the participant;
- A description of any benefits to the participant or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
- A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained, and when applicable, that notes the possibility that the Food and Drug Administration may inspect the records;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant; and
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
When appropriate, one or more of the following elements will also be provided to potential participants during the consent process:
- A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;
- Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent;
- Any additional costs to the participant that may result from participation in the research;
- The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant;
- A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant; and
- The approximate number of participants involved in the study.
NOTE: Any informed consent, whether written or oral, must not include exculpatory language such that the participant is made to waive, or appear to waive, any of his or her legal rights or to release the institution or its agents, the investigators, or sponsor from liability for negligence.
Waiver of Documentation of Informed Consent
An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if it finds either:
- That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern; or
- That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.
Waiver or Alteration of Consent Process
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
- The research involves no more than minimal risk to the participants;
- The waiver or alteration will not adversely affect the rights and welfare of the participants;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the participants will be provided with additional pertinent information after participation.
- Informed Consent, Parental Permission, and Assent Templates and Waiver Appendices
- Glossary of Medical Terms
- Glossary of Lay Language for Use in Informed Consent Forms
- Informed Consent Self-Assessment Tool
- NIH Guidelines for Writing Informed Consent Documents
- Human Research Protection Program (HRPP) Policy on Informed Consent Process and the Elements of Informed Consent
- HRPP Policy on Documentation of the Informed Consent Process
- HRPP Policy on Assent and Parental Permission
- HRPP Policy on Short Form Informed Consent