IRB Policies and Procedures

Application Process and Deadlines


Purpose

The purpose is to outline the policies and procedures for the application process to the Institutional Review Board (IRB) or Exempt Review Committee (ERC) and appropriate deadlines for each.

Policies

All research involving human subjects (participants) must be submitted for review and approval via a web-based submission and management system, IRBNet, at www.irbnet.org. In the system, three boards exist, each with its own forms and templates.

  • Institutional Review Board (full or expedited human research review)
  • Exempt Review Committee (exempt human research review)
  • Institutional Animal Care and Use Committee (animal research review)

Investigators must submit to the correct board. No hard copy or emailed materials will be accepted.

In determining the human research review type, investigators should first read our policies for exempt, expedited, and full review of research. If an investigator has difficulty in selecting the appropriate review level, he/she should refer to the Office of Human Research Protections’ Decision Charts. If there is still a question, he/she may consult with the Director of Human Participants Protection and Research Compliance. The Director will make the final determination about review type, with consultation of the IRB chairperson, appropriate members of the IRB, or Assistant Provost, as needed.

Submission instructions and a Checklist of what to submit for each board may be found on our IRB Forms and Instructions web page.

Student Research Projects

Student investigators must name a research advisor from Marywood University. Students who plan to graduate in a given semester must apply during the semester prior to the one in which they plan to graduate, in order to allow ample time for the review process and study execution. The exception would be research courses which have a built in submission deadline of February 1st (e.g. PSY 421/422), or a deadline of the end of fall semester (e.g. SSW 701). Also see our Student Research policy.

Deadlines and Review Timing

Since all research projects are equally important, review takes place on a first-come, first-served basis. Deadlines and turnaround times are shown in the table below. Submissions must be complete at the time of receipt in order to meet a deadline. Submissions received after the close of business on the day of any deadline are subject to the next meeting or review cycle.

Review Type

Submission Deadline

Decision Usually Within

Recommend Applying Ahead by

Full

2 Weeks before Meeting

2-7 Business Days after Meeting

3 Months

Expedited

Every Monday by 4:30pm

2-3 Weeks from Deadline

2 Months

Exempt

N/A

1 Week after Receipt

1 Month

Certain types of research may require the IRB to consult with an expert in a particular field (e.g., medical specialist, pharmacist, etc.). Research involving prisoners requires activation of our Prisoner Advocate, a voting IRB member. These situations often involve additional review time.

Modifications

Turnaround times for review of any requested modifications depend on the original type of review performed and decision rendered by the IRB or ERC. In most cases, a study which was granted a decision of "modifications required" will have a turnaround time of roughly one week or less, depending on completeness of the package and current submission volume. Turnaround times for studies with a decision of "deferred" take more time. For instance, a full study with a decision of "deferred" must have its modifications reviewed at a convened meeting of the IRB.

Investigators must submit any requested modifications within six months, otherwise the project will be administratively withdrawn by the IRB or ERC. Investigators must then reapply if they plan to continue with the application process.

Revisions or Continuing Review in Approved Research

Turnaround times for revisions to approved research or annual continuing reviews are subject to the same schedule as an initial review. There are a few exceptions allowed in the regulations, such as where certain minor changes or renewals may be reviewed as expedited if they were originally reviewed as full. These instances will be determined by the Director.

Please see our meeting schedule and submission deadlines for specific deadlines.

Procedures

  1. The investigator and any research advisor, co-investigator and/or research assistant completes mandatory online training at www.citiprogram.org.
  2. The investigator reviews policies concerning human research, a submission checklist, and instructions on how to submit (menu of four steps or downloadable PDF).
  3. The investigator registers at www.irbnet.org, affiliates with Marywood University, and confirms the registration via e-mail. If applicable, co-investigators or advisors do the same (RA registration optional).
  4. The investigator downloads and completes necessary forms and templates, which are located on the IRB or ERC's websites or in IRBNet's forms library.
  5. The investigator proofreads and runs a spellcheck on all completed documents.
  6. Following the written and/or video instructions for IRBNet, the investigator creates a new project, shares it with research team members (if applicable), applies an e-signature, has the advisor and/or co-investigators sign, and then submits it to the IRB or ERC.
  7. The investigator monitors his/her e-mail account for a notice, which informs of the decision letter’s location for download by the investigator.
  8. The IRB or ERC's decision letter describes requested actions, how to track changes, and how to submit a response via IRBNet.
  9. Once approved, the IRB or ERC emails an approval notice, prompting the investigator to download the approval letter and all stamped materials (documents part of the consent process) in IRBNet. Stamped versions of documents must be used in the research unless the IRB or ERC states otherwise.
  10. The investigator submits via IRBNet any requests for revisions after approval, deviations from the approved research, unanticipated problems or serious adverse events, should they occur. See appropriate policies and procedures about these topics.
  11. The investigator submits a completed closure report form upon study conclusion, at or by the one-year approval anniversary. If activities will continue, the investigator submits either a continuing review (annual renewal) or an annual check-in report form. See Mandatory Reporting policy for report requirements.

Related Policies

  • Approval of Research
  • Expedited Review of Research
  • Exempt Review of Research
  • Full Review of Research
  • Mandatory Training
  • Revisions to Approved Research

 


History

07/11/2014 - Updated to remove pregnant women exclusive IRB requirement and add statement about research involving children
06/12/2017 - Consolidated Submission and Application Procedures policy pages; adjusted format; pregnant women/children removed (already in other policies)
05/24/2018 - Updated checklist links
06/25/2019 - Updated as a result of the Revised Common Rule
10/01/2019 - Corrected checklist link and updated student deadline due to SSW's policy change