*Tip of the month
Does that Serious Adverse Event require prompt reporting to the IRB? Find out at HRP-801 INVESTIGATOR GUIDANCE: Prompt Reporting Requirements (https://www.umassmed.edu/ccts/irb/investigator-guidance/)
“Doing a chart review? Need medical record data for recruitment? Before you submit your study in eIRB, contact UMCCTS Informatics about using the Data Core to access Epic for research purposes: https://www.umassmed.edu/informatics/services/data-science-core/”
Did you know that UMMS IT has a set of best practices for storing, securing, and destroying research data? Learn more here: https://www.umassmed.edu/it/policies-and-guidelines/best-practices/
Does your study have a HIPAA Waiver? Remember to complete the required Accounting of Disclosures. If the use/access/disclosure will involve 49 or fewer patients, complete the Accounting for Use/Disclosures form for each patient as you go. If the use/access/disclosure will involve 50 patients or more, complete the Accounting of Research Disclosures-Summary Form as soon as IRB approval for the HIPAA waiver is granted. Not sure you’ll reach the 50 patient mark? Start with individual accounting and then switch to the summary form when you reach 50. Be sure to coordinate with external sites to complete the required Accounting if your HIPAA waiver extends beyond UMMHC.
This tip is all about location, location, location! Did you know that all research happens under the auspices of the University of Massachusetts Medical School (UMMS)? Research participants may be patients from UMass Memorial Medical Center (UMMMC) or UMass Memorial Health Care (UMMHC), but your IRB application should never refer to UMass Medical Center. It doesn’t exist!
Does this need IRB review? What does the IRB need from me? IRB staff are available to answer these and other IRB questions at the Library’s “Ask an Expert” drop-in sessions held on the 2nd and 4th Thursday of each month from 12:30 to 1:30pm in the Library’s Computer Lab.
Take a few minutes to learn about the Revised Common Rule, which is scheduled to take effect January 21, 2019: https://www.umassmed.edu/ccts/irb/what-you-should-know-about-the-2018-regulations/
Planning a retrospective chart review? Remember to make sure that the initial submission includes an Investigator Study Plan, HIPAA Waiver of Authorization, and Data Collection Sheet. The Data Collection Sheet should show all of the data categories to be collected. Unlike the Study Plan and HIPAA Waiver, there is no formal template for the Data Collection Sheet. Investigators may submit a Word document, Excel spreadsheet, or a PDF of the RedCap form to be used.
Take a minute to review the 18 HIPAA identifiers at https://privacyruleandresearch.nih.gov/pr_08.asp. If your data sets include any of these elements, bear in mind that they still require special protection as they are not de-identified to HIPAA standards
Completing a Continuing Review? Make sure the enrollment numbers build upon any prior Continuing Reviews. Because the total number of subjects enrolled in a study is cumulative, the total number at this year's Continuing Review cannot be less than the total number at last year's Continuing Review. See the March 2017 tip for how to find what was reported at last year's Continuing Review.
Remember that you must submit a Modification to capture changes in Funding Source or any other element of the eIRB application. All changes to non-exempt human subjects research require prior IRB review and approval.
Did you know that encryption is required for all laptops, workstations, mobile devices and portable drives that may be used to store or access UMMS data – including research data? https://www.umassmed.edu/globalassets/it/security/signed-encryption-policy.pdf Contact UMMS IT with questions: https://umassmed.service-now.com/sp
July presents the opportunity to brush up on your human research protection skills. Make time to join your peers at one or more of the AAHRPP Boot Camp Presentations scheduled for 7/11, 7/16, 7/18, 7/23, and 7/25: https://www.umassmed.edu/ccts/human-research/qa-qi-education/hrpp-educational-presentations/aahrpp-boot-camp-presentations/
Are you uploading new or revised documents to Section 7.0 Attachments? Hit SAVE after each document and check to see that the document appears with the appropriate name. Do not use OK and Add Another.
Don’t wait for your just-in-time notice from NIH to submit to the IRB. Instead submit to the IRB as soon as you hear that you have favorable scores!
If you’re considering using an external IRB or having UMMS serve as the IRB of record for external sites, it’s important to contact the UMMS IRB directly as soon as possible. Procedures for WIRB and NCI CIRB are already online (https://www.umassmed.edu/ccts/irb/submission/). For all other single IRB cases, please contact the UMMS IRB office to discuss options.
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.
“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.
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.
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.
Requesting an eIRB account for a new user? Find your Student or Employee ID on your transcript or paystub!
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/services/research-computing/clinical-data-solutions--consulting/
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/
If IRB watermark(s) on stamped documents 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.
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.
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!
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.
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
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.
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.
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.