NEW APPLICATION INSTRUCTIONS

1. Please read Marywood IRB's Policies and Procedures Page for more detailed information on human participants protection.  
   
   
2. Please refer to our IRB Meeting Schedule and Deadlines calendar so you will know when to expect a decision to be rendered by the IRB.  PLEASE PLAN ACCORDINGLY.
   
   
3. Please refer to Marywood University's  IRBNet Instructions and IRBNet's Training Energizer to learn how to submit new applications online.  All forms and templates may be found below or in the Forms and Reference Library within IRBNet's system. 
   
   
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: Scanners are available in all computer labs on campus, as well as in the training alcove in the LRC.  If you do not know how to use one, please refer to the instruction located here: http://cwis.marywood.edu/training/documentation.html (scanning tab). If you experience any difficulty, 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.
  
  
• 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
  
  HINT: If you need to scan any documents, you should scan at 200 dpi and save them as .pdf files.  
  
  
5. Your application should not include chapters of your dissertation or thesis.  Instead, please 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. 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 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.  These will be scanned by the IRB office and uploaded 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 promptly, 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 you've received notification that modifications are required by the IRB, 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) and IRBNet's Training Energizer to learn how to submit modifications online.
   
   
3. Log on to IRBNet.org , select your existing study and submit your modifications.  Be sure to include a new cover sheet and to DELETE ANY OLD VERSIONS of documents you are resubmitting, as the system automatically clones your original materials in your new packet.
   
   
4. 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. 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).
   
   
2. Log on to IRBNet.org, select your existing study and submit the appropriate report.  Report forms may be found below or in the Forms and Reference Library within IRBNet's system.
   
   
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.
   
   
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).
   
   
2. Log on to IRBNet.org, select your existing study and submit the revised documents, using a 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, and delete any documents in your packet that may not be necessary or that you are replacing, as IRBNet clones all documents from your last uploaded packet.
   
   
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. The IRB will respond via IRBNet.