NEW APPLICATION INSTRUCTIONS

1. Please read Marywood IRB's Policies and Procedures concerning the protection of human participants in research.
   
   
2. Please browse our IRB Meeting Schedule and Deadlines Calendar page. The current turnaround time is 3 weeks for exempt and expedited applications. Full board meetings are held monthly. Plan accordingly.
   
   
3. In order to submit your application via IRBNet, please refer to Marywood University's IRBNet Instructions . 
   
   
   
   
   

   A new project submission training video is available through a password protected site.  Please contact the IRB office for a user name and password access to this video and accompanying document.
   
   
    

    
   
4. Please gather all supporting documentation for your IRB submission.  You will need:
   
   
• Cover Sheet
  
  
• Application form
  
  
• CITI training certificate(s) for investigator, advisor/sponsor and any co-investigators or research assistants 
• If already on file from a previous application, list date of completion on application.  If newly completed, please generate certificate at the CITI website, then save to your computer or flash drive (as an HTML document) for uploading with your submission.  BE SURE TO CLICK ON PRINT CERTIFICATE/COMPLETION REPORT TWICE IN CITI SITE.  WE NEED THE CERTIFICATE WITH THE MODULES LISTED. See CITI FAQs page for important information on CITI training.
  
  
• Consent form (for Expedited or Full review) or participant letter (for Exempted review) 
  
  
• Parental consent form and assent form or script (for research w/ minors)
  
  
• Permission letter for access to data or participants (including Marywood - see Permission Chart)
• Must be on institution or entity's letterhead, with signature by an official.  If this letter cannot be provided to you electronically, please scan it and upload with your IRBNet submission.
  
  SCANNING: SCAN DOCUMENTS AT 200 DOTS PER INCH, IN BLACK & WHITE, AND SAVE IN THE .PDF FORMAT.  Scanners are available in all computer labs on campus, as well as in the training alcove in LRC. You may access scanning tutorials, here: Scanning Images | Scanning Text
  
  If you still need assistance, please see one of the computer lab assistants or contact Karen Boland (x. 2355) or Kay McClintock (x. 2391) regarding training.  Thank you.
  
  
• Advertisements, brochures, flyers, email solicitation messages or other recruitment materials
  
  
• Survey instruments, interview questions or data collection forms
• If standardized, address validity and reliability (with evidence of such); if older than 10 years, provide justification for use.
• If standardized, has instrument been copyrighted?  If so, please attach permission for use in research.
  
  
• For researcher-developed instruments or interview questions, provide evidence of piloting, pre-testing or review by 3 professionals in the field of study
• If using professional review, supply names, degrees held, contact information and a brief statement from each of why they endorse your tools. Professionals must hold a Master's degree or higher, and may be faculty or dissertation committee members.
  
  
• Any other documentation critical to your research
  
  
5. Please do not include chapters of your dissertation or thesis.  Instead,  follow the narrative outline included in the application, as it provides the exact detail the IRB needs. 
   
   
6. For the Consent Form / Parental Consent Form, Assent Form, Assent Script or Participant Letter:
   
   
• Follow the appropriate template.  All areas must be addressed. 
• Background, how they were selected, procedures, risks and benefits, confidentiality, voluntary nature of study, contacts for questions and research integrity.  Payment is never a benefit and must be listed under procedures. Benefits should include those to participant, to others and/or to the field of study. Records must be maintained for a minimum of 3 years, and you need to describe how they will be destroyed (shredding, deletion, etc.). Participants have a right to withdraw at any time without affecting relationships, and if research is not anonymous, participants should be given instructions on how to withdraw and what happens to their data if they do.
  
  
• If using a participant letter (Exempted review),  follow the consent form template. Include all sections, but remove the signature line.  
  
  
• Make sure the participant letter or consent/parental consent forms are readable to the average participant.  Do not use jargon and explain all terminology. Readability may be checked in Microsoft Word (under 'tools'/'options'/'spelling & grammar'/'show readability statistics'). 
  
  
• Make sure the assent form or script is written in age or developmentally-appropriate language.  Check readability for these as well.
  
  
• For Expedited research, if you cannot obtain signed consent (e.g. Internet or telephone survey research, research where primary risk occurs by linking signature to participation in study, etc.), you must  submit a Waiver of Documentation of Consent form. If you want to alter or completely waive consent, you must submit a Waiver or Alteration of Informed Consent form. Parental consent waivers will not be granted for Internet research including minors. 
  
  
7. Advertisements must state that the project is research, state the purpose, state criteria that will be used to determine eligibility, list benefits (if any), list time commitment required and location of research, and list researcher name, affiliation and contact information. They should also be worded appropriately so as not to coerce participation.
   
   
8. Log on to IRBNet.org and submit your application packet.  
   
   
   • Don't forget to upload your CITI training certificate, and that of your sponsor/advisor, unless already on file from a previous application (fill in completion date on application).  Your application will be administratively suspended until evidence of training is submitted.   Co-investigator and research assistant certificates must also be uploaded before final approval will be granted. 
     
     
   • Be sure all required parties have SIGNED the submission electronically. Your application will be administratively suspended until the Principal Investigator (PI) and advisor/sponsor signature(s) are present.  Co-investigator and research assistant signatures must be present before final approval will be granted.
     
     
   
   
   
9. You will receive an automated e-mail message once the IRB has rendered a decision.  You may log in to access the status and decision letter. 
   
   
10. If the IRB requests modifications, submit them via IRBNet.  See instructions below.
     
11. NO RESEARCH PROCEDURES, INCLUDING RECRUITMENT, MAY BEGIN UNTIL YOU ARE GRANTED FINAL APPROVAL!  
    
    
12. IF YOU ARE APPROVED, YOU STILL NEED TO DO SEVERAL THINGS:
    
    
• Use only the stamped, approved versions of the participant letter, consent/parental consent/assent form(s) or advertisements.  The IRB office will stamp, scan and upload these documents into the system after your study has been approved. 
  
  
• If an adverse event or deviation/violation of the protocol occurs, submit the proper form to the IRB in the required timeframe, and include a cover sheet. Forms are available below or via the Forms and Reference Library within IRBNet's system.
  
  
• Submit a status report every 6 months.  A form is available below or via the Forms and Reference Library within IRBNet's system.  Prior to 12 months from the original approval, if you've finished your study, submit the status form with 'complete' checked and the date of completion listed.  Research is not complete until after data collection and analysis are finished.
  
  
• Approval is granted for one year only.  If your research will extend beyond the one year period, please reapply prior to the expiration date. Use the annual /continuing review form, found below or via the Forms and Reference Library within IRBNet's system.  Be sure to include a new cover sheet, the form and any consent/assent documents.  Also attach any changes.
  
  

1. If  modifications are requested by the IRB, please make the necessary modifications, being sure to TRACK (feature in Microsoft Word) or BOLD your changes. 
   
   
2. Please refer to Marywood University's IRBNet Instructions (particularly section XI) .  
    
   
   A new training video concerning post-submission is available through a password protected site.  Please contact the IRB office for a user name and password access to this video and  accompanying document. 
   
   
   
   
   
   
3. Log on to IRBNet.org, select your existing study and then click on the "Project History" tab on left menu.  Your study will be locked, so proceed by clicking on the "create new package" button.  Select the new package and upload your modifications. Be sure to include a new cover sheet.
   
   
4. Once the IRB has rendered a decision, you will receive an automated e-mail message .  You may log in to access the status and decision letter. If your study had required minor modifications, you should receive a decision within 1 week.  If your study was deferred, you should receive a decision within 2 weeks.
   
   
5. If your study with modifications is then approved, see #12 above.
   

REPORT INSTRUCTIONS

1. If you need to submit a status, adverse event (incl. safety) or deviation/violation report, please refer to our IRBNet Instructions to learn how to submit reports online (particularly section XIV).
   
   
   
   
   A new training video concerning post-submission is available through a password protected site.  Please contact the IRB office for a user name and password access to this video and  accompanying document. 
   
   
   
   
   
2. Log on to IRBNet.org, select your existing study and then click on the "Project History" tab on left menu.  Your study will be locked, so proceed by clicking on the "create new package" button at the bottom of the screen.  Click on the new document package and upload your report. Report forms may be found below or in the Forms and Reference Library within IRBNet's system (will be shown under Step 1 on the designer screen).
   
   
3. All reports, except for reports on status, require a cover sheet.
   
   
4. If your report requires action from the IRB (e.g. safety report acknowledgment), the IRB will respond via IRBNet, which will send you an automated email message about the action.  Only adverse event, safety and deviation/violation reports will receive an acknowledgment letter.  
   
   
5. Please note that with status reports, automatic reminders are sent by IRBNet, and they are generated based on the expiration date of your study.  If you've submitted a report prior to receiving such a reminder, please disregard the message, as it's just a courtesy.
   
   

   REVISIONS TO APPROVED RESEARCH INSTRUCTIONS
   

1. If you need to make a revision to your approved study, please refer to our IRBNet Instructions to learn how to submit the revision online (particularly section XIV).
   
   
   
   
   A new training video concerning post-submission is available through a password protected site.  Please contact the IRB office for a user name and password access to this video and  accompanying document. 
   
   
   
   
   
2. Log on to IRBNet.org, select your existing study and then click on the "Project History" tab on left menu.  Your study will be locked, so proceed by clicking on the "create new package" button at the bottom of the screen.  Click on the new document package and upload your revisions form.  The form may be found below or in the Forms and Reference Library within IRBNet's system.  Be sure to include a cover sheet.
   
   
3. NO RESEARCH PROCEDURES THAT HAVE BEEN REVISED MAY BEGIN UNTIL YOU ARE GRANTED FINAL APPROVAL!  
   
   
4. You will receive an automated e-mail message once the IRB has rendered a decision within the same time frame shown on our IRB Meeting Schedule and Deadlines page (currently 3 weeks). The IRB will respond via IRBNet.