HPRB Instructions: Request for Renewal/Amendment of Approved Proposal 1. When do I use the Request for Renewal/Amendment form? Use the Request for Renewal/Amendment form to request changes to any approved research proposal, regardless of type of review (exempt, expedited, or full) conducted at the time of approval and whether or not you think you are making a major or minor change to your approved research protocol. Changes to your research protocol may lead to full board review; decisions are made on a case-by-case basis. Major revisions include changing a principal investigator (i.e., listed on the Consent Form as a contact person), introducing a new procedure or research materials, revising the consent process or form (e.g., from Anonymity to Confidentiality), changing the risk/benefit analysis, or adding a new participant group. HPRB will review your requested amendments to determine if other changes are minor (e.g., adding questions that do not change the risk or experience of the respondent to an approved survey, revising documents to improve readability). 2. How do I show the changes I am requesting or have been asked to make? You may not need to re-submit the entire original HPRB proposal. Provide any proposed changes—such as the text for a revised procedures section or an additional statement within the consent form or recruitment script— by identifying the item(s) on the Request for Renewal/Amendment form and providing the text of the changes in a separate Word document that you send to HPRB along with the Renewal/Amendment form. Note that HPRB may request a “fresh” copy of HPRB proposals or documents with all changes incorporated into the protocol if there are any substantive revisions. The HPRB Request for Renewal/Amendment form does not allow for showing changes as instructed below so provide all revisions on a separate document. 3. Please submit ONLY those documents that include changes. For example, if you are requesting changes in the number of participants and the recruitment script, check the box for Item #5 on the Request for Renewal/Amendment form, list the item in the attachment, and identify each of the changes requested as follows: (a) If new text is being added within a document, cite several of the preceding words and insert the word "(INSERT)" along with the inserted text in bold. For instance, following a few words of the text that remains as part of the recruitment script you would add: (INSERT) This is the text that I am adding. (b) Do not delete any text from your original documents. Instead, insert the word "(DELETE)" in bold before the text to be deleted and use the “Format/Font/Strikethrough” function within Word to indicate the text that will be deleted. An example of deleted text would be: (DELETE) This is the text that I am deleting. (c) To revise text such as the number of participants (as in HPRB Proposal Item #5a) from 15 to 50, strikeout the number 15 (using the “Format/Font/Strikethrough” function) and insert "(REVISION) 50" in bold. This example would appear as: 15 (REVISION) 50. (d) If numerous revisions occur throughout a document (e.g., in the Written Consent or Debriefing form), attach the document with the additions, deletions, and revisions identified as above. Finally, remember to update your final documents with the approved changes by removing the REVISION/INSERT/DELETE language and bold font before you use the revised documents with research participants in your study. 4. How do I label revised documents and the Request for Renewal/Amendment form? A revised document should have the extension “.amend” added before the .doc or .docx or .pdf extension so that it reads [last name(s)] consent.amend or [last name(s)] survey.amend, etc. (You get the idea.) The Request for Renewal/Amendment form you submit should be labeled [last name(s)] form-request-renew or [last name(s)] form-request-amend before the Word (i.e., .doc or .docx) or .pdf document extension. 5. How do I submit the request for renewal or revision to HPRB? Send an email to hprb@plu.edu with the HPRB Identification (Project Reference) Number and appropriate request for action (i.e., Renewal or Amendment) in the Subject Heading of the e-mail. State that you are submitting either a request for renewal or request for approval of revisions to your project within the text of the email. Attach the HPRB Request for Renewal/Amendment form along with all revised documents labeled according to the instructions above and listed in HPRB Proposal Item #12 Research Materials. All documents must be submitted as Word (i.e., .doc or .docx) or .pdf files. Pacific Lutheran University: HPRB Instructions to Request Renewal/Amendment (2015-2016)