Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- University Policy on Human Research
- Whistleblower Policy
Application Process and Deadlines
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.
All research projects involving human participants (subjects) must be submitted for review via our submission and management system, IRBNet, at www.irbnet.org. There are three boards in the system: (1) the Institutional Review Board (for full or expedited review), (2) the Exempt Review Committee (for exempt review), and (3) the Institutional Animal Care and Use Committee (for animal research review). Each board has its own forms and templates which must be utilized. Investigators are asked to submit to the correct board, or delays may result. No hard copy or emailed materials will be accepted.
To help determine the review type required, investigators should first read our policies for full, expedited, and exempt review of research, and then consult the decision charts provided by Office of Human Research Protections (OHRP). If an investigator continues to have difficulty in selecting the appropriate level of review, s/he should 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 Associate Vice-President for Planning & Institutional Effectiveness or members of the IRB, as needed.
Students who plan to graduate in a given semester must apply during the semester prior to the one in which they plan to graduate. This is to allow ample time for the entire review process, including any modifications and follow-up review needed, as well as implementation and completion prior to graduation. The only exception to this is courses which have their own built in a deadline of February 1st (e.g., certain School of Social Work and Psychology two-semester research courses; consult with course instructor).
As all research projects are equally important, review takes place on a first-come, first-served basis. The deadlines and decision turnaround times are as follows.
- Initial Full Review: These applications to the IRB must be submitted at least two calendar weeks prior to the date of the next regularly scheduled IRB meeting. Applications received after the deadline, or received by the deadline but in an incomplete state, will be held for review at the following meeting. Decision turnaround times are up to one week after the convened IRB meeting. We recommend applying at least three months prior to your planned start date.
- Initial Expedited Review: These applications to the IRB are accepted any time, but deadlines are every Monday by 4:30PM. Decision turnaround time is up to three weeks from each Monday's deadline, depending on current volume and staffing. Applications received by the deadline but in an incomplete state will be subject to the next weekly deadline's cycle. We recommend applying at least two months prior to your planned start date.
- Initial Exempt Review: These applications to the ERC are accepted any time without deadlines. Turnaround time is usually about one week, if the submission is in a complete state. The turnaround time is also dependent on current ERC volume and staffing.
Submissions received after the close of business on the day of any deadline will be held for the next meeting or review cycle.
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.
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, an exempt, expedited, or full study that 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 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 another convened meeting of the IRB.
If the IRB or ERC has reviewed an investigator's application and requires modifications, those modifications must be submitted by the investigator within six months, otherwise it will be administratively withdrawn by the IRB or ERC. The investigator must then reapply if s/he plans to continue with the application process.
Turnaround times for revisions to approved research or annual renewal/continuing reviews are usually subject to the same schedule as an initial review. There are a few exceptions allowable in the regulations, where some may be moved from full to expedited. These instances will be determined by the Director.
Please see our meeting and application submission schedule for specific deadlines.
- The investigator and all research team members (co-investigators, research assistants and advisors/sponsors) complete mandatory online ethics training.
- The investigator reads policies and procedures concerning research with human subjects, a checklist of what to submit, and instructions on how to submit (center of page).
- The investigator visits www.irbnet.org to register (affiliating with Marywood University), and confirms registration via e-mail. Co-investigators and research advisors/sponsors must also register. Registration by research assistants is optional.
- The investigator downloads necessary forms and templates, completes them, and gathers supporting documentation, as needed. IRB forms and templates are available on the IRB's website , the ERC's website, or via IRBNet's forms and reference library.
- The investigator proofreads and runs a spellcheck on all completed documents.
- Following the written instructions for IRBNet (video tutorials are also available), the investigator creates a project, shares it with research team members (if applicable), applies an electronic signature, and then submits it to the IRB or ERC.
- The investigator monitors his/her e-mail account for communications from the IRB or ERC. Once it publishes its decision letter at IRBNet, it will email a notice containing instructions on how to access the letter.
- The IRB or ERC's decision letter will communicate required modifications, if any, how to apply tracking to documents prior to modifying them, and how to submit the modifications via IRBNet.
- Once approved, the IRB or ERC will email a notice about approval, prompting the PI to access the approval letter and all stamped documents (documents part of the consent process) in IRBNet. Stamped versions of documents must be used in the research, unless otherwise noted.
- After approval, the investigator submits to the IRB or ERC any requests for revisions, deviations/violations from the approved protocol or materials, unanticipated problems or serious adverse events, should they occur. See appropriate policies and procedures about these topics.
- The investigator submits a status report six months after approval (IRB only), or a closure report if the study is completed prior to this period. The due date may be found in the approval letter and in the email message sent by staff upon approval.
- As approval is granted for one year only (unless otherwise noted), the investigator submits either a closure report upon completion (at or by expiration date), or if not closing, a continuing review application to the IRB or ERC, allowing enough time so there is no lapse in approval.
- Approval of Research
- Expedited Review of Research
- Exempt Review of Research
- Full Review of Research
- Mandatory Training
- Revisions to Approved Research
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)