*Tip of the month

March 2018:

Use the checklist that appears on the final page of the current Investigator Study Plan template to help ensure that your submission is ready for the IRB. Common missing documents include data collection sheets, HIPAA waivers, and DSMB charters.

February 2018:

“Do I have to update the consent forms for all of my approved studies?”

Only newly submitted studies are required to use the 12/20/17 consent document template. Please note that we may ask that the new required elements of consent disclosure be included during Modifications and Continuing Reviews.

January 2018:

Download templates fresh from the IRB website when preparing any type of submission and stop recycling old ones. With the new human subjects regulations scheduled to take effect January 19, 2018, the IRB is updating many forms and templates on a regular basis.

December 2017:

Need to revise a document? Always download the currently approved version from the Original Submitted File column of the Documents tab. Be sure to accept all existing track changes before making additional revisions.

November 2017:

Requesting an eIRB account for a new user? Find your Student or Employee ID on your transcript or paystub!

October 2017:

Remember – just because you have ACCESS, does not mean you have AUTHORIZATION. Even with EPIC, the use of clinical information for Human Subjects Research requires prior IRB review and approval. Contact the UMMS IT Clinical Data Portal for ready access to de-identified data and after IRB approval for access to identified data. https://www.umassmed.edu/it/cdp/

September 2017:

Remember to check the blue box in eIRB for the status of your study or follow-on submission. If the blue box in the upper left hand corner says Pre-Submission or Pre-Review Clarifications Requested, it’s under your control and is not in the IRB office.  See the job aids for step-by-step instructions for how to submit or respond to clarifications requested: https://www.umassmed.edu/ccts/irb/job-aids-ii/

August 2017:

If IRB watermark(s) on stamped documnents are missing or not displaying properly, remember to maximize the browser window or adjust the  printer settings. As the institution prepares for the rollout of EPIC, properties may have to be adjusted for printing with watermarks. 

July 2017: 

Information that directly identifies a subject (e.g. first name, last name) should never be entered into eIRB. Additionally, upload only blank data collection sheets and case report forms into Section 7.0 Attachments of eIRB. The IRB needs to know the variables to be collected, without any pre-filled data.

June 2017:

New to Research at UMMS? Check out the “Getting Started with UMMS IRB” page for a step-by-step look at what to do to complete the IRB process. Find checklists, guides, and instructional videos right at your fingertips!

May 2017:

When revising existing study documents in eIRB, do not use the ADD button. For version control purposes, it’s important to replace existing documents by clicking on the document name in section 7.0 Attachments, and then using the UPLOAD REVISION function. For the Investigator Study Plan, click on UPDATE next to its name and then UPLOAD REVISION. When you upload new or revised documents in eIRB, make sure the title field is blank. That way, eIRB will use the file name to label the document.

April 2017: 

File management is important in eIRB. Best practice for version control is to have the document version and/or date created or modified appear in the file name and on the actual document. Additionally, best practice for naming documents is to have the file name contain the IRB docket number and/or study nickname, document type (ICF, ISP, flyer, etc.), version, and date created/modified. When you upload the document in eIRB, make sure the title field is blank. That way, eIRB will use the file name to label the document. Here are some example file names that follow best practice:

  • Cat Scratch Fever_ISP_v.1_ 20160114
  • H0008006_HIPAAauthorization_v.2_20160114

March 2017:

Are you working on a Continuing Review? Want to review what you reported to the IRB last year? To review last year's continuing review submission, go to the "Parent Study" (i.e. the initial submission) and select the "Follow-On Submission's tab. Locate the last Continuing Review (or Continuing Review/Modification) in this tab by reviewing the "Submission Type" column, and clicking on the submission nickname located in the "Name" column. Once in the previous Continuing Review workspace (this will say "Approved" in a blue box in the upper left hand of the screen), click "PRINT CR/Modification." This will allow you to review last year's submission.

February 2017:

Did you know that your sponsor will most likely need a copy of the IRB Membership Roster for the initial approval of your Drug/Device protocol? Use this link http://www.umassmed.edu/ccts/irb/meetings/ to print a copy of the current Roster when your study is assigned to Full Committee Review.

January 2017:

Are you preparing a grant? Use NIH's online decision tool to see if your research activity is Exempt or Not Human Subjects Research. The answer might surprise you. Click https://humansubjects.nih.gov/questionnaire to see the online decision tool.