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Institutional Review Board For The Protection Of Human Subjects (IRB)

What is the IRB? 

The Institutional Review Board (IRB) reviews all research activities that involve human subjects.

An institutional review board, or IRB, is a body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.  IRBs are mandated by, and their general scope/structure defined, under regulations issued by the U.S. Department of Health and Human Services (HHS). The regulation is generally known as “The Common Rule,” and was most recently updated in 2018. In addition, IRB's address the principles of the and other ethical and .
IRBs have the responsibility to review and approve all research activities that involve human subjects under their institutional scope. The IRB is primarily concerned with assuring the welfare, rights, and privacy of those subjects, and that all investigators are taking appropriate precautions to minimize any potential risks or losses of benefit that may be part of participation. The IRB has the authority to exempt, approve, disapprove, monitor, require modifications to, or suspend human subjects’ research (HSR) activities that fall within its scope as specified by both federal regulations and its own home institution’s policy, as well as commonly accepted ethical standards. The IRB conducts analysis of each HSR application to consider these and other issues as they may relate to the research activity, its design and procedures, and all aspects of subject participation.


DOES YOUR PROJECT NEED IRB REVIEW and APPROVAL?

  • Are you conducting research that involves gathering information from, or about, living human beings?
  • Do you or your students plan to publish or present the results of a project involving human subjects research?
  • Do you or your students use human subjects in class research assignments?
  • Do you or your students conduct surveys involving any persons or institutions in or outside of the ÐÓ°ÉÔ­°æ community?
  • Have you been contacted by any persons outside of the ÐÓ°ÉÔ­°æ who wish to use members of the ÐÓ°ÉÔ­°æ community as research subjects?

  If you answered YES to any question above - YOU DO NEED THE IRB!

Click to download the "Do You Need the IRB" Info Sheet
All research projects using human subjects, classroom assignments as well as individual research, must be submitted to the IRB for review. No phase of a project may begin until approval is obtained. Changes to currently approved projects must also be reviewed before they can proceed.

Meeting Schedule


Current Members

IRB Committee Members: Academic Year 2023-2024
Bryan Burnham, Ph.D., Chair Psychology
Sabine Charles, M.D., Dr. PH. Epidemiologist, Lackawanna County (Community Representative)
Carol A. Coté Ph.D., OTR Occupational Therapy
Mary Jane DiMattio, Ph.D. Nursing
Marian Farrell, Ph.D. Nursing
William Miller, Ph.D. Health Administration and Human Resources
Joshua Reynolds, Ph.D. Psychology
Andrew Venezia, Ph.D. Health and Human Performance
Kathryn Yerkes, M.A., M.S. Assistant Provost, Planning & Institutional Effectiveness and IRB Administrator

IRB Forms

IRB applications can be found below or at IRBNet.org. All protocols (including new proposals, revisions, renewals, and departmental review board applications) must be submitted electronically via IRBNet. Applications for Exempt or Expedited review (which includes applications that may meet Federal limited IRB review thresholds) are reviewed on a rolling basis on the timeline described in the IRB Policy. Applications that require Full IRB review must be submitted no later than seven (7) days before each scheduled IRB Committee meeting. See the IRB meeting schedule above for these dates.

It is the role of the IRB, not the researcher, to determine which classification of review is required for a research project. See the ÐÓ°ÉÔ­°æ's IRB Policies and Procedures Manual for further information regarding Exempt, Expedited or Full review categories and processes.

Exempt Research Applications:

Exempt IRB Application (IRB only): Exempt application only applies to research that is (1) minimal risk (no greater risk of harm or discomfort than that encountered during every day life), and (2) anonymous, for which no personally identifiable information about or from participants is included in the study. Exempt research may not include participants from vulnerable populations. Applications for exempt research must comply with other institutional standards as defined in IRB Policy; all of the research procedures fit must fit within one or more of the exemption categories in the federal IRB regulations. Applications that may fulfill federal "limited" review thresholds are reviewed using the Expedited review process.

"Exempt" does not mean that the research project is "exempt" from IRB review. Rather, it means that the project is exempt from selected federal human subjects' research protection regulations. An exempt project still requires review and approval via the processes described in the IRB policy.

  • Under the ÐÓ°ÉÔ­°æ's IRB policy, if your research project includes personally identifiable information about human subjects (such as name, email address) for any portion of the project, the study is not anonymous and therefore will not qualify as Exempt under federal regulation and the ÐÓ°ÉÔ­°æ's IRB policy.  Please use the Expedited or Full application (below).
  • Even if a project is classified as Exempt, any changes to the research process could potentially change the project to a nonexempt classification. Investigators must notify the IRB of any changes to an approved research study.
  • The IRB frequently receives questions about surveys in human subjects research, whether those can be considered anonymous, and what that may mean for the level of IRB review required.  The following guidance discusses surveys in the context of IRB review in more detail.

Expedited or Full Review Applications:

The Expedited or Full application should be used when a research project meets the criteria for either Expedited or Full review as defined in federal regulation and the ÐÓ°ÉÔ­°æ's IRB policy. The ÐÓ°ÉÔ­°æ uses the Expedited review process to consider applications that may meet the Limited review category outlined in federal regulation.

  • Expedited research is that for which there is (1) no more than minimal risk to participants, and (2) the only involvement of participants is in one or more . Expedited research may not include participants from vulnerable populations.
    • Even if a project is classified as Expedited, any changes to the research process could potentially change the project classification. Investigators must notify the IRB of any changes to an approved research study.
  • Full review research is that for which there is more than minimal risk and special precautions need to be taken to protect the rights and welfare of participants. A research project including vulnerable populations will be reviewed via the Full review process.

Some Expedited and Full applications may be reviewed by approved departmental review boards (DRBs). Consult the ÐÓ°ÉÔ­°æ's IRB policy for details.

Note that current, ÐÓ°ÉÔ­°æ approved IRB training must be documented for all individuals involved in the research protocol as part of any application.

Other Forms

  • Does your project include a researcher from another institution with their own IRB? If yes, and you intend to use the ÐÓ°ÉÔ­°æ's IRB as the IRB of record, you will need to submit this form: IRB of Record Form.
  • Does your project include a researcher from an agency or entity without an IRB? If yes, they will need to submit an Individual Investigator Agreement Form.
  • Are you translating research materials to any language other than English? If yes, submit the Certification of Translation form along with your IRB application.

IRBNet

The ÐÓ°ÉÔ­°æ uses the IRBNet platform to gather and process IRB applications of all types. All applications for human subjects' research must be submitted via IRBNet. Click below to learn more about how to navigate the IRBNet system.

Getting Started training:  

  • IRBNet Training Energizers to help you get started can currently be found at the following link:  .   When prompted, please enter the institutional login -- Username: scranton and Password: training.  You may log in to the training system at any time to begin training.

Submitting revisions:

CITI Training

All investigators (i.e., Principal Investigators (PI), faculty advisors, and other persons including student researchers) actively engaged in human subject research are required to complete and maintain human subjects research training requirements. Engagement in the project typically means they are interacting directly with human subjects, or have access to data about/from those subjects.

Training must be completed no less than three (3) years prior to submission of the IRB application, and must remain current through the research project. Members of the ÐÓ°ÉÔ­°æ's IRB Committee, and members of Departmental Review Boards (DRBs), are also required to maintain current training requirements.

Training is available for members of the ÐÓ°ÉÔ­°æ community through a contract with the CITI (Collaborative IRB Training Initiative) program. ÐÓ°ÉÔ­°æ personnel and students have unlimited access, so we encourage faculty members to use this online training for Research Methods Classes.  Please note, if a research project is grant funded, those involved in the project may need to complete additional CITI Responsible Conduct of Research (RCR) training modules. 

Instructions for Renewing Training for Previously Completed Courses


Required IRB Training Program (CITI)

Policies & Regulations

ÐÓ°ÉÔ­°æ IRB Policy:

Federal Regulations:

  • , DHHS Comprehensive site for all federal regulations and guidance
  • , DHHS Health records privacy regulations and information
  •  
  • Please note that other federal, state and topical regulations may also apply to certain research activities, populations, and/or settings. Investigators are responsible for identifying and addressing such regulation, as well as site-specific requirements.

IRB Guidance and Resources

IRB Review Process Flowchart

ÐÓ°ÉÔ­°æ IRB Education Requirements

Surveys in Human Subjects Research

About the IRB: Information and Guidance for Student Researchers

"Do You Need the IRB?" Info Sheet

External Guidance

  • U.S. OHSS, Office for Human Research Protections:

About Informed Consent


Informed Consent From HHS: "The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at  and  describe the informed consent requirements."

The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Consent may only be sought after IRB approval is obtained.

Informed consent language must be organized and presented in a way that facilitates comprehension, is in clear and non-technical language  appropriate to the subject, and is at an appropriate reading level. Informed consent materials should provide sufficient information that a “reasonable person” would want to have in order to make a choice about whether or not to take part in the research activity.

Investigators have the responsibility to seek informed consent "only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence." (34 CFR 46.116). 

Informed consent materials, where printed or verbal, must address the following elements:

  • That consent is being sought for research
  • The purposes of the research, duration of participation, and study procedures
  • That participation is voluntary, subjects may end participation at any time, and there is no penalty or loss of benefit not taking part
  • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  • Any potential foreseeable risks or discomforts (remember - there is never "no risk" to participating, though risk may be no more than that encountered during every day activities)
  • Potential benefits to subjects or others, if any
  • Alternatives to participation, if any, and
  • Other elements that may apply based upon the nature of the research

Review by other Research Committees and ÐÓ°ÉÔ­°æ Personnel

As described in the IRB Policy,

  • In addition to IRB review, review by other research committees may be necessary depending upon the type of research to be undertaken. These committees include but are not limited to the Institutional Biosafety Committee (IBC), and Institutional Animal Care and Use Committee (IACUC). Researchers are responsible for consulting the Chairpersons of committees to determine if additional review and approval is required.
  • IRB approval for a research activity does not constitute approval to utilize ÐÓ°ÉÔ­°æ programs, facilities, or services for research purposes. Researchers should consult with relevant ÐÓ°ÉÔ­°æ administrators to secure any other approval or permission required.
  • IRB approval is separate from approvals or requests to use ÐÓ°ÉÔ­°æ data, such as student or employee email addresses, for research purposes. IRB approval does not constitute approval for these activities or access to such data.

Contact

General questions about IRB, and questions related to a specific IRB protocol may be directed to Kate Yerkes, IRB Administrator, at kathryn.yerkes@scranton.edu, or to the IRB Committee Chair, Dr. Bryan Burnham, at bryan.burnham@scranton.edu.

Other Research Resources

Research Compliance Home: IRB, IACUC, IBC, and RSC Committees

Office of Research and Grants Support

Internal Grants and Research Funding, Office of the Provost

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