COVID-19 Response


Given the current COVID-19 coronavirus outbreak, and the real or perceived risk of exposure, the risk/benefit ratio for research participation must be reassessed for each protocol. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio.

Study procedures involving in-person contact with participants in risk areas or participant travel for research purposes within risk areas must be paused, effective immediately, or as soon as can be implemented. Procedures such as telephone contact, monitoring, or remote data collection if part of such studies may continue. 

If you have questions or concerns, please contact Dr. Karen Larwin at khlarwin@ysu.edu. 

 

General Guidelines

All research projects conducted under the auspices of Youngstown State University that involve the use of living human subjects, samples, or data obtained from them, directly or indirectly, with or without consent, must receive approval from the Institutional Review Board.

YSU now uses Cayuse Human Ethics (formerly Cayuse IRB), an interactive web application, to streamline the IRB submission and review process. As you answer questions, new sections relevant to the type of research being conducted will appear on the left-hand side. Therefore not all numbered sections may appear. You do not have to finish the application in one sitting. All information can be saved. Throughout the submission, you will be required to provide the following:

  • Research instruments (surveys, questionnaires, or other instruments)
  • Detailed Study Information
  • Informed Consent Forms, if applicable
  • Waiver of Informed Consent Form, if applicable
  • Study Recruitment Information
  • Approval letters from other sites where research will be conducted, if applicable

YSU no longer uses the previous IRB Forms. Previously approved protocols will continue to use the paper forms until their protocol expires.  

 

* Cayuse Human Ethics is supported by Google Chrome and Mozilla Firefox.  

  • Cayuse Human Ethics Quick User Guides 
  • Required Training

    All YSU faculty, students, and staff who are involved with or plan to be involved with human subjects research must complete Human Subjects Research training through the CITI Program prior to engaging in research activities, including starting a new study, when joining an active research project, and accessing and analyzing privately identifiable data. 

    To meet the training requirement, one of the following courses must be completed, depending on the type of research to be conducted:

    1. Social and Behavioral Research: research on individual or group characteristics or behavior, including but not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior. This type of research often employs data collection methods such as surveys, interviews, focus groups, observations, and non-invasive physical measurements. Social-behavioral research also includes epidemiological or outcomes research and health services research.
       
    2. Biomedical Research: research on specific diseases and conditions (mental or physical), including but not limited to the detection, cause, treatment, and rehabilitation; the design and methods, drugs and devices used to diagnose, support, and maintain the patient; cellular and molecular bases or diseases, genetics and immunology. Most biomedical research is patient-oriented and involves clinical trials. 

    A complete set of instructions for registering and completing this training can be found on the Human Subject Protection Required Training webpage. New investigators should consider beginning the online training course up to two weeks prior to the submission of an IRB protocol or grant application. 

    The training is valid for a three-year period. Faculty, student, and staff investigators must renew their training certification before it expires by taking either a refresher course or retaking the full course.

    • Informed Consent

      Informed Consent Overview

      Informed consent refers to both the communication process that allows individuals to make a knowledgeable choice as to whether or not they want to participate in the research study. AND the documentation that is used to ensure that consent is informed.  All prospective participants must be provided with complete information about the study in a way they can understand it so they may make an informed decision as to whether or not they wish to voluntarily participate in the study.  

      As a best practice, written information explaining that the study is considered research or is part of a larger research project and the purpose of that research should be included (verbal or other format is acceptable only if approved by the IRB). Additionally, the following details, if applicable, should also be included, to help potential participants decide if they want to participate in the study: 

      • The risks, side effects, or discomforts that might reasonably be expected
      • The benefits participants might reasonably expect
      • The study's duration and what will happen in the study
      • Whether any procedures, drugs, or devices will be used that are different from those used in standard medical treatment.
      • Appropriate alternative treatments that might be advantageous.
      • Available treatments or compensation, if complications occur during the study.
      • Any risks to participant privacy and confidentiality
      • Contact information for the IRB

      Potential participants are allowed to ask any questions about the study before giving consent and at any time during the course of the study. They must be allowed ample time, without pressure, to decide whether to consent to participate in the study or not.

       

      Tips for Preparing Informed Consent documents

      • Be concise - describe the research in as few words as possible without compromising the meaning
      • Avoid jargon - consider your audience and write for them, not your colleagues
      • Avoid "I" statements- write in the second or third person (you/he/she/they/them) 
      • Use plain language - make it easy for a person with an 8th-grade reading level to understand. For help and examples of plain language, visit https://www.plainlanguage.gov/
      • Have a layperson proofread it -  when possible, have a person unfamiliar with your science proofread it for understanding. If they can't understand it, your participants won't either. 
      • Use a template - when possible, use a pre-approved template. One has been provided for you in the Documents section below.  

       

      Documents

      Informed Consent Template

       

      Reference:
      1. Getz, K., & Borfitz, D. (2002). Informed consent the consumer's guide to the risks and benefits of volunteering for clinical trials. Boston, MA: CenterWatch.

    • Protocol Amendments & Modifications

      Overview

      Sometimes things happen that require an investigator to make changes to his or her protocol. When a change is necessary, an Amendment and Modification Form needs to be completed and submitted to the IRB. All changes to an approved protocol MUST be reviewed and approved by the IRB before the changes can be implemented. Examples of changes that require an amendment include, but are not limited to:

      • number of participants
      • consent document changes
      • funding changes
      • personnel changes
      • recruitment changes
      • site changes
      • title changes
      • protocol changes

      Documents

      Protocol Amendment & Modification Form

    • Event Reporting

      What is a reportable event?

      A reportable event is an unanticipated and unintended adverse event or incident that does or could possibly pose a risk to study participants or others. These events can present in a variety of ways, such as a complaint from a study participant to flooding of the study site.  A reportable event may include a variety of harms, including psychological physical, legal, social, or economic, and therefore must be promptly reported to the IRB.

       

      What if I'm not sure?

      When in doubt, contact the IRB chair for clarification. The key things to ask are:

      1. Is this unexpected?
      2. Is it possibly, probably, or definitely related to the study?
      3. Does it pose a potential risk of any kind?

      If your answers to those three questions are yes, you need to complete an adverse event report as soon as possible. 

       

      Documents

      Adverse Event Report Template

       

    • Continuing Review

      Overview

      If approved, protocols are approved for one year or less, depending on the protocol. In the event that the study or research project will or needs to continue beyond the expiration date, a Continuing Review Request must be submitted. A protocol will usually undergo the same level of review for the continuing review as it was for the original review. There is no grace period for extending the research past the expiration date. Research activities must stop after the expiration date and cannot continue until the Continuing Review is completed and approved by the IRB. 

      Documents

      Continuing Review Request Form 

    • Regulatory Resources

      The Office for Human Research Protections

      The Revised Common Rule

      Protecting Research Volunteers

      21 CFR 50 (FDA Regulations on the Protection of Human Subjects)

      45 CFR 46 (The Common Rule)

      FERPA (Family Educational Rights and Privacy Act)

      HIPAA (Health Insurance Portability and Accountability Act)

      GDPR (General Data Protection Regulation)

      The Belmont Report

      Human Subjects Regulations Decision Charts (HHS)

    • Documents