Institutional Review Board (IRB)

Institutional Review Board (IRB)

Institutional Review Board

The Institutional Review Board (IRB) reviews, approves, and monitors all research involving human participants that qualifies for full or expedited review.

Protecting Human Research Participants

Marywood University is committed to safeguarding the rights and welfare of individuals participating as subjects in research, as well as ensuring compliance with Federal and State regulations, institutional policies, and ethical guidelines. The Office of Planning and Institutional Effectiveness is home to the Institutional Review Board (IRB) and Exempt Review Committee (ERC), both charged with reviewing, approving and monitoring research involving human subjects. The IRB maintains oversight of research which qualifies for full or expedited review, while the ERC maintains oversight of research which qualifies for exemption.

All research involving the use of human subjects, either directly or through the use of records or specimens, and regardless of funding source, requires review and approval prior to the start of the project.

Federalwide Assurance (FWA) Number: FWA00006660

Exempt Review
Committee (ERC)

Announcements

Instructions

All materials must be sent electronically through our online submission system at irbnet.org. If your project is submitted to the wrong board, we will withdraw and forward it for you.

Review Type	Submit To
Exempt	ERC
Expedited	IRB
Full	IRB

PDF Directions

STEP 1: How to Prepare

Read Marywood's IRB policies and procedures below, which explain review types, requirements and definitions.
Complete online training. All principal investigators, co-investigators, research advisors and assistants must register at the CITI website and complete the human research course (Social/Behavioral or Biomedical group, based on activities). Additional courses may be required. Review the Mandatory Training page, including CITI registration and completion report retrieval instructions.
Register on IRBNet at irbnet.org. All principal investigators, co-investigators and research advisors must register. Registration is optional for research assistants. Click on the New User Registration link at the top right of IRBNet's home page and enter requested information. When asked for institutional affiliation, search for and select Marywood University. After clicking the register button, you will be emailed a confirmation message. Click the confirmation link in the email message to finalize registration.
Decide the review type based on activities, population and risk. See our policies, consult with your research advisor or our office, or check OHRP’s decision charts.
Review our checklist of what to submit.
Download forms and templates to create your documents. Find IRB forms on IRBNet.org DO NOT submit class, theses or dissertation proposal documents. DO NOT convert document types (e.g., if original is .DOC format, do not convert to .PDF).
Proofread and run a spell check in your word processing software. Check for errors prior to submission. Editorial services should not be sought from the board and slow down review for everyone.
Review the meeting schedule and submission deadlines. Follow deadlines and allow adequate review time. Student investigators must apply during the semester prior to the one in which they plan to graduate, unless taking a course with an alternate deadline (e.g., end of fall semester for SSW 701, February 1 for PSYCH 422 or other research courses).

STEP 2: How to Submit at IRBNet

Print and carefully review our step-by-step IRBNet Instructions.If you need extra help, view our tutorial videos. Create a new project and upload all necessary materials.
Sign your package. E-signatures are required of the Principal Investigator (PI), the research advisor, and any co-investigators.
Submit your package. The upload to IRBNet itself does not transmit it to a board. Click the submit button in IRBNet's left menu, choose the board and submission type, and click submit. Once submitted, you'll arrive at a confirmation page, and the package's status will change from Work in Progress to Pending Review.

STEP 3: How to Respond

Monitor your e-mail account registered with IRBNet. IRBNet will email you when a decision letter has been uploaded to IRBNet (Reviews button on left, then under Board Documents table at the bottom). Office staff will also send instructions on next steps.
Create a package of requested modifications.

Track your changes. See How to Track Changes for assistance with enabling tracking to show insertions or deletions.
Do not create a new project or ask for the initial package to be unlocked! The original package must remain locked to maintain a history. Create a follow-up package within your existing project (i.e., IRBNet# 12345-1, 12345-2, etc.). Print and review our written IRBNet Instructions for exact steps.
Upload your documents.
Sign your package: The Principal Investigator must e-sign every package.
Submit your package. The upload to IRBNet itself does not transmit it to a board. Click the submit button in IRBNet's left menu, choose the board and submission type, and click submit. You'll arrive at a confirmation page.

Monitor your e-mail account. You'll receive an email, prompting you to log in at IRBNet to retrieve your approval letter and stamped materials. Stamped versions of materials must be used unless otherwise noted in your letter. A check-in report or expiration due date and reporting requirements will be indicated in the letter.

STEP 4: What to Report After Approval

Closure Report Form, Check-In Form or Continuing Review Application: A closure report form must be submitted when you complete your research or separate from MU, unless others from MU will still be engaged in activities. If activities will continue beyond one year, you must submit either a check-in report form annually (ERC and most Expedited IRB approved after 1/21/19) or apply for continuing, annual review, budgeting ample time so that there is no lapse in approval. All research activities must cease as of any expiration dates, until the board approves a renewal. Projects may not be closed until both data collection and analysis have been completed, unless all data are completely de-identified. See the appropriate forms on IRBNet.org.
Deviations, Unanticipated Problems or Serious Adverse Events (All studies): Report these immediately. Please see our Mandatory Reporting policies and procedures, as well as the Deviation and Adverse Event/Unanticipated Problem forms on IRBNet.org.
Revisions to Approved Research (All studies): Researcher initiated changes after approval, however minor, must be reviewed and approved prior to implementation. See our Revisions to IRB Approved Research Request form in the list of compiled forms on IRBNet.org.

IRB Policy

Purpose

The purpose is to outline the policies and procedures for review of human research.

Definitions

An agent is an individual who: (1) acts on behalf of the institution; (2) exercises institutional authority or responsibility; or (3) performs institutionally designated activities. Agents can include employees such as faculty or staff, or students, contractors, and volunteers, among others, regardless of whether the individual receives compensation.

Auto-ethnography is a qualitative research approach which uses self-reflection and writing to analyze an investigator’s personal experience in order to explore and understand one’s culture.

To be engaged in research activities, an institution’s employees or agents, for the purposes of research must obtain: (1) Data about the subjects through intervention or interaction with them; (2) identifiable private information about the subjects; or (3) The informed consent of human subjects for the research.

Policy

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of Marywood University. Marywood University seeks to comply with all federal, state and local laws and regulations requiring the establishment and operation of such a board (See "Code of Federal Regulations," 45 CFR 46, 21 CFR 50 and 21 CFR 56). The IRB is charged with the responsibility of reviewing, prior to its initiation, all research involving human subjects, whether or not funding is sought. Where research qualifies for exemption, the Exempt Review Committee (ERC) performs review.

The IRB or ERC reviews research which:

is sponsored by or through Marywood University
engages Marywood University's employees or agents in research
is conducted by or under the direction of any employees or other agents of Marywood University in connection with their institutional responsibilities, regardless of location
is conducted by or under the direction of any employees or other agents of Marywood University using any property or facility of the institution
even if approved by another IRB:
- is conducted under the auspices of another institution on the premises of Marywood University
- involves the use of Marywood University’s non-public information to identify or contact potential human subjects or use data about them

IMPORTANT

No human research activities, including subject recruitment, enrollment, the consent process, data collection or data analysis, may begin until official IRB or ERC approval has been granted.

Members of the research team may not enroll in their own projects as subjects, except where auto-ethnography is proposed.

Institutional Policy and Review

Marywood University's Policies and Procedures Manual contains its Institutional Review of Research Involving Human Participants policy under Academic Affairs. Research which receives the approval of the IRB or ERC may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by the IRB or ERC [45 CFR 46.112].

History

06/08/2017 - Updated ERC link and corrected office name
06/12/2017 - Adjusted regulatory reference
07/18/2017 - Correction to punctuation
06/12/2018 - Added information and links to the Institutional Policy pages
09/21/2018 - Updated regulatory links
06/25/2019 - Updated as a result of the Revised Common Rule
12/16/2021 - Added a definition and clarified what is reviewed

IRB/ERC Forms & Templates

Forms and templates are available on IRBNet.org

IRB Policies & Procedures

University Policies

Resources

IRB Members

Institutional Review Board Committee Policy

Annual Reports

Committee Roster

Position	Member	Non-Scientist	Term(s)
Physician/PA/Medical Professional Representative	Brian Piatak, DC		2022-2025
Representative of the Insalaco College of Arts & Sciences	Eun Sil Suh, Ph.D., KCMT, MT-BC		2022-2024 (PT)
Representative of the Insalaco College of Arts & Sciences	Patrick M. Seffrin, Ph.D.		Chair 2023-2024 (PT)
Representative of the College of Health & Human Services	Gretchen Welby, PharmD		2023-2025 (PT)
Representative of the College of Health & Human Services	Lindsay Morton, Ph.D.		2023-2026
Representative of the the Reap College of Professional Studies	Liyang Ding, Ph.D., LEED GA	✓	2023-2026
Unaffiliated	David G. Schappert, M.L.S., M.A.T.S.	✓	2019-2021 (PT) 2021-2024
Director of Human Participants Protection and Research Compliance	Courene M. Loftus, MPA, CIP	✓	Ex-Officio (Voting)
Prisoner Representative	Sr. Susan Hadzima, IHM, M.S.		2010-2013 2013-2016 2016-2019 2019-2022 2022-2025
Alternate - Insalaco College of Arts & Sciences	Joan McCusker I.H.M., Ph.D.	✓	2023-2024 (PT)
Alternate - College of Health & Human Services	Kaitlyn Eck, Ph.D., RDN, LDN		2023-2024 (PT)
Alternate - Reap College of Professional Studies	Miguel A. Calvo-Salve, Ph.D.	✓	2018-2021 2021-2024

PT = Partial Term

Schedules & Deadlines

The below schedules are contingent upon your submission being complete, and they will aid you in the submission process. Please refer to our Application Process and Deadlines policy for full details.

Student Project Timelines | Modifications or Revisions Timelines

All ReviewsPlan ahead, especially during holidays, summer or other breaks. Review times are affected by your package's condition and current volume. Since all research is equally important, we review on a first-come, first-served basis in as timely a fashion as possible. Also:

Incomplete submissions are held until complete, which may place them in a future review cycle.
Submissions made after a deadline's business hours are subject to the next meeting or review cycle.
Prisoner research requires inclusion of our Prisoner Advocate, which may add review time.
Certain activities may require expert consultation (e.g., IT, attorney, physician specialist, etc.), which may add review time.

Full Review

Deadlines are two weeks prior to scheduled meetings. Initial decisions are communicated in about 2-7 business days after the meeting. We recommend applying about 3 months prior to the start of your project. Due to Federal quorum requirements, meeting dates and times are subject to change.

Meeting Dates	Application Deadline by 5:00pm	Meeting Time	Location
June 10	May 27	10:00 a.m.	Online
August 22	August 8	1:00 p.m.	Online
September 20	September 6	12:00 p.m.	Online
October 18	October 4	1:00 p.m.	Online
November 22	November 8	1:00 p.m.	Online

Expedited Review

Deadlines are each Monday by 5:00pm, but you do not need to wait until a Monday to submit. Initial decisions are communicated in about 2-3 weeks after the deadline, depending on volume and staffing. We recommend applying about 2 months prior to the start of your project.

Applications due MONDAY by 5:00pm on:	IRB should render an official, initial decision on or before:
May 27	June 17
June 3	June 24
June 10	July 8
June 17	July 15
June 24	July 15
July 1	July 22
July 8	July 29
July 15	August 5
July 22	August 12
July 29	August 19
August 5	August 26
August 12	September 2
August 19	September 9

Exempt Review

There are no deadlines, except for students planning to graduate or students taking two-semester research courses (see Student Project Timelines). We recommend that you apply at least 4 weeks prior to the start of your project if you are not a student subject to special deadlines.

Always submit as early as possible, especially during our high volume times, which are late fall into mid-spring.

Decisions are communicated roughly one week after the submission of a complete package during normal volume times.

Regulations

General Data Protection Regulation - Europe

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Office of Human Research Protections (OHRP)

OHRP Homepage

Current Revised Common Rule - 45 CFR 46 (2018 Requirements) - Fully Effective 1/21/2019
Previous Common Rule - 45 CFR 46 (Pre-2018 Requirements)Studies reviewed and approved prior to 1/21/2019 will be subject to these requirements unless an IRB/ERC takes action to move them to the new requirements upon annual renewal review.
Decision Charts
- Decision Charts - Current, Revised Common Rule (2018 Requirements)
- Decision Charts - Old Common Rule (Pre-2018 Requirements)
Current Exempt Review Categories - §46.104
Previous Exempt Review Categories - §46.101(b)
Expedited Review Categories - §46.110
Federalwide Assurance - Search for Assurance, IORG or IRB Numbers
International Research
- 2021 International Compilation of Human Research Standards
- 2021 Region Specific Compilations (PDFs at the bottom)
Informed Consent Tips
OHRP Guidance Documents

US Department of Education

US Food and Drug Administration (FDA)

List of Regulations (FDA 21 CFR 50 and 21 CFR 56)
Running Clinical Trials - Good Clinical Practice Program

Other Resources

Qualtrics

Qualtrics, the official survey software of Marywood University (MU), is free to all MU students, faculty and staff. It offers practical drag-and-drop functionality for designing surveys, complex branching logic, and the ability to collaborate on surveys, along with instructor oversight. Qualtrics uses the TLS method of encryption (HTTPS) and survey security options for transmitted data, such as password protection and HTTP reference checking.

Location

Visit MU’s official Qualtrics account at https://marywood.co1.qualtrics.com/login. Enter your MU username and password, and you will be added to MU’s license automatically.

Support and Training

Visit Qualtrics Basecamp at https://basecamp.qualtrics.com/, which provides a variety of self-paced training courses, webinars, and certification opportunities. To log in:

Click Log In in the upper right corner of the Basecamp page.
For sign in method, click the Qualtrics Credentials button.
Ignore the user name/password fields. Instead, click the blue Sign in with SSO link, which appears below the sign in boxes.
For Organization ID, type Marywood and click Continue.
Log in with your MU user name and password.
Use the top menu to navigate to courses or webinars.

Survey Creation – Basic

Visit Survey Overview to learn how to create a basic survey.

Survey Creation – Data Anonymization

To create an anonymous URL to your survey, see Anonymous Link.
To create an anonymized raffle, even when you must capture email addresses or other potentially identifying data, see Anonymized Raffle.

Survey Creation – Completion Codes

Visit Assigning Randomized IDs to Respondents to generate completion codes for MTurk or other survey platforms

Survey Design and Requirements - MU Guidance

For information about required survey settings as they relate to research involving human subjects, please refer to our Guidance on Data Collection via Online Survey document.

Troubleshooting

For issues concerning access to Qualtrics or information about workshops, contact the IT Help Desk.

Helpful Tools and Guides

Miller-Scandle, Dr. Tabbi L

Assistant Vice President for Research & Sponsored Programs
tlmillerscandle@marywood.edu
570-961-4502

Bio

IRB & ERC Help
irbhelp@marywood.edu
570-348-6211, x. 2418