Institutional Review Board
Federal-wide Assurance (FWA) for the Protection of Human Subjects
Additional information on the Federalwide Assurance (FWA) for the Protection of Human Subjects is available from the U.S. Department of Health and Human Services – Office for Human Research Protections.
Institutional Review Board Registration
Institutional Review Board (IRB) Name: Oakland City University IRB #1 IRB Identification and Registration #IRB00012529.
IRB Committee History
Oakland City University has a five-member committee that is comprise of faculty and staff that oversee and review IRB compliance. For more information on the committee, Contact Dr. JC Campbell, Chair of the IRB committee at email@example.com.
Nuremberg Code (1946): A U.S. military tribunal of German physicians conducted experiments on captives during WWII. Because of this, we created requirements for voluntary participation, documented consent, and proof that benefits outweigh risks to subjects.
Information on the Nuremberg Code is available at https://research.unc.edu/human-research-ethics/resources/ccm3_019064/.
Thalidomide Tragedy (1950s): An unapproved drug taken by pregnant women to help with nausea and sleep led to deformed babies. This led to strict FDA regulations on drugs and testing on humans that are still in place today.
Information on the Thalidomide Tragedy is available at https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation
Declaration of Helsinki (1964): International standards were set to protect human subjects so that the risks did not exceed “the benefits to humanity.” These standards led to the requirement of an independent review board for research, which became the IRB.
Information on the Declaration of Helsinki is available at https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/.
Tuskegee Experiment (1932-72): Low-income African-American males infected with syphilis were observed by the U.S. Public Health Service in a longitudinal study to document the progression of the disease. Subjects were not given the known cure for the disease (penicillin) even after it became available in the 1950s. Risks were increased and vulnerable publics were used for research that benefits a larger general population.
Information about the USPHSA Syphilis Study is available at https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study.
Development of the Law: Lessons learned from the tragic case in Tuskegee (and other cases) led to some of our distinctions and protections of special populations as outlined in the Belmont Report and in the National Research Act (1974).
Information on the National Research Act is available at https://www.imarcresearch.com/blog/the-national-research-act-1974.
The Belmont Report established three basic ethical principles: respect for persons, beneficence, and justice. These principles serve as the foundation for regulations involving human subjects.
The Belmont Report is available at https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html.
What to Consider Before Doing Research
What to consider…
Determine whether your activities are focused on research or continuous improvement
Determining if an activity is Research or focused on Quality Improvement (QI) can be challenging. Federal regulations require human subject research to be reviewed and approved by an Institutional Review Board (IRB), while strictly QI activities do not require IRB oversight.
Determine whether activities are human subjects research
In some cases, an activity that involves human subjects may not meet the federal guidelines for IRB review of human subjects research. For example, a project such as a quality improvement survey or oral history documentary may involve human subjects, but is not considered “research.” Alternatively, a project may be considered research, but the existing data being analyzed has no identifiers or codes linking to identifiers and therefore the research does not involve human subjects.
Many investigators choose to wait until they hear that a project will likely be funded before submitting an IRB protocol. This saves time for both the primary investigator or the student researcher and the IRB since many grant applications do not get funded the first time. Most grant applications will allow you to indicate that human subjects review is “pending” or “in process.”
Exempt vs. non-exempt research
Please check first to see if your study fits under an exemption. Certain categories of human subjects research are low-risk and exempt from IRB criteria for review. For example, projects involving benign or anonymous surveys or normal classroom activities may be exempt. OCU IRB reviews exempt requests to determine whether your study meets the criteria for exemption. Once a study is determined exempt, the study is valid for the duration of the described research as written without having to be renewed.
Researchers conducting exempt research are exempt from the regulations but must adhere to the ethical principles in the Belmont Report: Respect for persons (e.g., informing subjects they are in an OCU research study, describe what they are being asked to do, provide contact information, and tell them they can choose to participate or not, or refuse to answer any questions), Beneficence (minimize any harms including breach of confidentiality), and Justice (equitable selection of subjects).
External research involving OCU students as subjects
External researchers who are not collaborating with OCU researchers and who plan to conduct research involving OCU students are asked to notify the OCU IRB and provide their respective institution’s IRB approval as a courtesy. Please contact firstname.lastname@example.org.
Determining if an activity is Research or focused on Quality Improvement (QI) can be challenging.
Federal regulations require human subject research to reviewed and approved by an Institutional
Review Board (IRB), while strictly QI activities do not require IRB oversight. However, some QI activities
may also be research and therefore need IRB approval.
The Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services provides a useful website, About Research Participation, with resources that are designed to help potential research subjects better understand research and ask for the information they need to decide whether or not to participate. The resources include a series of short videos about participating in research and a printable list of questions potential volunteers can ask researchers.
Current and potential research participants are encouraged to check out the links on About Research Participation to watch videos, view questions to ask researchers and find additional resources related to research participation.
How to Proceed
No human subjects research can begin until an IRB decision is reported to the primary investigator(s), co-investigator(s), student researcher(s), and faculty sponsor(s).
OCU requires that human subjects research training is mandatory for all researchers working with human subjects whose research protocol is subject to review by OCU’s IRB. This requirement includes students conducting research that is subject to IRB review.
All researchers must prepare a New Research Project Request and any supplemental documentation that describes the proposed research project. All IRB forms are provided as MS Word documents and checklists and guides associated with the IRB forms are available to assist researchers in the preparation of the IRB application packet.
If you have any questions prior to preparing any of the IRB forms, please feel free to correspond to the IRB through the following email account: email@example.com.
After submitting your OCU IRB form(s) in the submission drop box in this Moodle shell, the IRB administrator/coordinator will conduct an initial screening to determine if your research fulfills the criteria for exemption from IRB review, and if it does your request will be reviewed so that you may proceed with your study.
If your protocol does not qualify for exempt status, you will be sent and electronic message will be sent describing what actions you can take regarding your research project.
The IRB may request additional information in order to complete its deliberation.
IRB Quiz & Certification
All investigators and research personnel listed on a New Research Project Request (human subjects research application) submitted to Oakland City University’s Institutional Review Board (IRB) are required to complete a training course prior to protocol approval. Successfully passing the training course quiz will result in the issuance of a Certificate of Achievement by OCU’s Office of Assessment and Institutional Effectiveness.
This online training module is designed to provide a general overview of the policies and procedures for applying for the necessary IRB approval for all research activities involving human subjects and animals. In addition to a general overview of the policies and procedures, this training module will provide the online researcher with an understanding of these policies and procedures.