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Protocol and Informed Consent Tips

Tips for writing your protocol

Below are some general tips for writing your protocol.  If you have specific questions about how to respond to a protocol question or what information needs to be included in your protocol, please contact our office.

Be complete:

  • Make sure that you provide an accurate picture of your study to the Board.  The protocol questions are meant to encourage you to explain your study to the Board and to provide them with the information that they need to do a complete review.  Often, if you leave out information, this will discourage the Board from giving you full approval until they have their questions satisfied. 
  • Make sure that you provide all of the documentation requested by the Board (i.e. consent forms, instruments, advertisements); if you describe it in your protocol the Board will want to see it. 
  • Make sure that you fully describe your experience and expertise in your field of research so that the board can feel comfortable with your ability to successfully engage the targeted population for your study. 

Be concise:

  • In keeping with the first point, don’t say more than you need to.  Remember that your reviewer is often a busy professional who won’t be able to wade through pages and pages of theories. 
  • Make every response to the point, providing succinct answers loaded with information.
  • Be careful not to repeat yourself continuously.  Some of the questions ask for aspects of the study from different perspectives, so some repetition will be necessary.  However, if you find that you are saying the same thing over and over again, review some of the questions and see if there is information that you could include that hasn’t already been stated. 

Be clear:

  • Submitting a well-organized protocol will not only make review easier for your reviewer, it will help them to understand what you are proposing to do.
  • Microsoft Word has the capacity to add tables, bulleted and numbered points, graphs, etc. to the document.  Take advantage of these features to help explain your process to your reader. 
  • If your protocol is complex and includes multiple consent forms, instruments, etc., consider including an index to your appendices, a single page that lists the additional materials submitted in your protocol.
  • Make sure that your writing is error-free, particularly in your consent documents.
  • Don’t overburden your reader with technical jargon. Although your reviewer will be an expert, not every Board member who will read your protocol will have experience in your niche of the field.  If your protocol includes technical equipment, instruments, and/or technical jargon, make sure to provide definitions and explanations.  If this information is in the consent form, make sure that it is clearly explained at a sixth grade reading level.

Tips for writing Informed Consent Agreements: Please see Consents: Tips

Troubleshooting tips

The protocol form is a big table, so if you are having trouble filling in an area, try making the table visible.  Go to Table: Show Gridlines. 

Having problems with our forms?  For troubleshooting questions, please email Katie at katierees@virginia.edu.

 

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