*Tip of the month
January 2022:
Time’s running out! Make sure you have downloaded copies of all your Legacy eIRB materials, including approval letters, before February 4, 2022! See the IRB Intranet site for Job Aids and additional details: https://umassmed.sharepoint.com/sites/RMS/IRB/Shared%20Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2FRMS%2FIRB%2FShared%20Documents%2FLegacy%20eIRB%20What%20to%20Download&FolderCTID=0x0120005C4B6A519ADDB04AB1C84DE333A1450E
December 2021:
Be sure to download copies of Legacy eIRB materials BEFORE Friday, February 4, 2022 at 5pm. When uploading these materials to the new eIRB, be sure the file names follow the UMass Chan naming and version control conventions (see Job Aids on https://umassmed.sharepoint.com/sites/RMS/IRB).
Don’t have a version number listed on these documents? Unsure what version you are on without reviewing the long document history in Legacy eIRB? In such a case, you may use the number between the document name and the word History on the Legacy eIRB documents page for the study (e.g. 0.01, 0.12, 0.22, etc.). The next time you modify the document, change the version number to the next one in the sequence for the sake of consistency (e.g. 0.02, etc.).
November 2021:
Having trouble logging in to RMS eIRB page from the clinical network or off-site? Try going incognito! See the new Job Aid here: https://umassmed.sharepoint.com/sites/RMS/IRB/Shared%20Documents/Forms/AllItems.aspx?id=%2Fsites%2FRMS%2FIRB%2FShared%20Documents%2FRMS%20Job%20Aid%20Clinical%20and%20Other%20External%20User%20Log%20in%20tips%2011%2D1%2D2021%2Epdf&parent=%2Fsites%2FRMS%2FIRB%2FShared%20Documents
October 2021:
The new RMS eIRB launches on October 12th! For Job Aids, the calendar, training videos, and other important information see the new IRB Intranet site: https://umassmed.sharepoint.com/sites/RMS/IRB
August 2021 & September 2021:
When the new eIRB system launches later this year, it will only be accessible via UMass Chan Medical School Single Sign-On (UMass Chan SSO). All eIRB users – including study staff from UMassMemorial, sister UMass campuses, and external sites – will be required to log into the new eIRB with their umassmed.edu credentials.
Not sure if you have UMass Chan SSO or forgot your password? Contact the UMass Med IT Help Desk at 508-856-8643 or UMWHelpdesk@umassmed.edu . If you are a resident, dual doc, or employee of MassBiologics, Meyers Primary Care, or other UMass Chan entity, you likely already have umassmed.edu credentials.
Do you need a UMass Chan SSO Account? Contact the Academic Administrator (AA) in your department if you need help getting UMass Chan SSO credentials through an (unpaid) job requisition in ICIMS. The AA will need to know whether you are a collaborator-off campus, collaborator-on campus, or other category of contingent worker.
July 2021:
“Bringing a multi-center grant to UMass Chan? Check out our Reliance Agreements/General Information link for initial steps to take when setting up a reliance agreement between institutions.”
June 2021:
“When the new eIRB launches later this year, CITI Training will be imported directly into the new system. To make sure you can see your training, please make sure your UMass Chan email address is listed as your institutional email address. Any other email address will keep your training from importing correctly. To do this, go into your CITI account and, using the pulldown menu under your name, select Profiles. Go to the Institutional Profile for University of Massachusetts Worcester and add your UMass Chan email address as the Institutional Email Address.”
May 2021:
“Submitting a Continuing Review? Remember to upload the summary documents that will help inform the IRB about the progress of the research during the last approval period. Federally funded? Submit your federal progress reports. A clinical trial? Upload the Sponsor’s progress report and/or the DSMB reports or meeting minutes.”
April 2021:
“Time for Spring Cleaning! Clean up your eIRB workspace by: 1. Placing any abandoned studies on hold (Under My Current Actions, select Withdraw and then Place On Hold); 2. Canceling any abandoned modifications (Under My Current Actions, select Cancel – Do NOT use Google Chrome for this, it will not work. Use a different browser to Cancel submissions); and 3. Closing any studies that are eligible for closure (see the CR Job Aid for the closure criteria: https://www.umassmed.edu/globalassets/ccts/ccts-media/irb/job-aid-updates/umms-pi-cr_crmod-v6_20150810_final.pdf).”
March 2021:
The Bank of America Prepaid Card Program is now the preferred program for research subject stipends of $200 or less per visit with a total in a calendar year not exceeding $599. If you plan to use this program, please be sure to include the new language found in the updated Investigator Study Plan Template with Instructions on the IRB website. For more information regarding the program itself, please visit the Grants & Contracts Administration (GCA) website, Cost Analysis & Compliance page, for guidance: https://umassmed.sharepoint.com/sites/gca
February 2021:
Most Researchers tend to think that expedited review means an accelerated review. To the contrary, Expedited Review is a list of (9) specific review categories defined by OHRP. This review is conducted independently by designated members of the IRB, rather than at a meeting by the whole convened Committee.
January 2021:
Distinction between Not Human Subjects Research (NHSR) & Exemption:
NHSR are activities that do not involve human subjects or do not meet the definition of research defined by the federal regulations (45 CFR 46.102). EXEMPTIONS are human subjects research activities that fall within 8 different, SPECIFIC categories. Check out the worksheets for more details: HRP-421 WORKSHEET: Human Research -- HRP-423 WORKSHEET: Exemptions BOTH should be submitted in eIRB for formal determinations by the IRB.
December 2020:
“Asked to Withdraw a new study as part of a Clarification Request? The Withdraw button is on the bottom left-hand side of the study page. You can withdraw temporarily, you will not lose any information, and you will be able to easily resubmit at your convenience.”
November 2020:
Having trouble submitting a New User Access Request for an eIRB account? Remember to fill out ALL required fields (all the ones with asterisks), or you will get an error. Don’t forget the Employee ID/Student No. field!
October 2020:
To keep survey data secure, use REDCap or Qualtrics instead. Do NOT use Google Docs.
September 2020:
Trouble logging in to eIRB? Remember the following tips: 1. Your username and password are not the same as your UMass single-sign on login. They may be different! Even if your username is the same, the password may be different. 2. TYPE in your username and password, every time you log in. Do not copy and paste, as this adds extra spaces to the password and the system will not recognize it.
August 2020:
Do you have a submission that requires revising your existing documents? Expedite the IRB review process by uploading revised copies that use the TRACK CHANGES function to clearly outline the proposed changes. Do not highlight or change the font/text color of your proposed changes. Those types of markings are too easy to miss during review and don’t get cleaned up by eIRB during the approval process. They will slow you down instead of speeding you up!
July 2020:
No naming names! Do not list study staff by name in the Investigator Study Plan, Item #23, Resources Available. List each staff role (e.g., Principal Investigator, Co-Investigator, Research Coordinator, Faculty Advisor, etc.), without specifically listing people by name. If everyone entered on the Project Personnel tab in eIRB is given a role that matches one of the ones in Item #23, you’re all set! This keeps you from having to submit extra Modifications later on, just to add or remove study staff.
June 2020:
To ensure that eIRB can finalize your documents, use a current version of Word. Convert any Word 97/2003 files to a current format.
May 2020:
Check https://www.umassmed.edu/ccts/covid-19/ frequently for updated Coronavirus (COVID-19) Related Guidance to Reasearchers.
April 2020:
Visit https://www.umassmed.edu/ccts/covid-19/ for Coronavirus (COVID-19) Related Guidance to Researchers, including a Memo to share with sponsors re: restrictions on human subjects-related research visits (https://www.umassmed.edu/globalassets/ccts/other/resources/covid-19-clinical-research-memo-march-13.pdfdistribution.pdf)
March 2020:
Submitting a retrospective chart review? Be sure to include an investigator study plan, HIPAA waiver of authorization, and data collection template(s). The IRB will automatically consider whether the research fits one or more exemption categories. All exempt and non-exempt research uses the same investigator study plan to facilitate review. Just erase the instructions and mark "NA" when items do not apply
February 2020:
The Office of Clinical Research Portal mentioned in November’s tip of the month is now captured in the Translational Research Accelerator (TRAcs) portal. Visit https://www.umassmed.edu/ccts/request-services/ to request services.
January 2020:
The Code of Federal Regulations are catching up with NIH’s existing single IRB policy! Effective January 20, 2020, all human subjects research that is funded or supported by a Common Rule agency and involves multiple US institutions is required to have a single IRB for the portion of the research conducted in the US, unless otherwise precluded (e.g., by tribal law) or deemed by the sponsoring agency as not required. Be sure to contact the IRBs involved before writing and submitting a grant so that you can plan accordingly.
December 2019:
End of year is a great time to destroy research records that are no longer needed. See HRP-800 INVESTIGATOR GUIDANCE: Investigator Obligations (https://www.umassmed.edu/ccts/irb/investigator-guidance/) and your IRB approved study plan for data retentions requirements. See UMass Chan IT for tips on destroying research data: https://www.umassmed.edu/it/policies-and-guidelines/best-practices/destroying-research-data/
November 2019:
Is your funding source or sponsor not listed in eIRB? Request to have them added to eIRB via the Office of Clinical Research Portal https://www.umassmed.edu/ccts/request-services/
October 2019:
Get ready for fall and clean up those Inboxes! It’s time to respond to pending clarification requests, or to clear new study submissions that you no longer need by selecting Withdraw and Place on Hold under My Current Actions.
September 2019:
Be sure to update the IRB with any changes to study personnel as they happen. Lists of active study staff should always be current.
August 2019:
At each Continuing Review, the four boxes at Current Protocol Status tell the IRB whether the study meets the criteria for permanent closure. Because some investigators elect to keep a study open even though all four boxes are checked, be sure to tell the IRB whether you are closing the study or keeping it open – for example to be able to collect or analyze private identifiable information in response to peer review of manuscripts. Add “closure” to the submission nickname and indicate in the brief summary of the progress of the research that you are ready to close the docket.
July 2019:
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/)
June 2019:
“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/”
May 2019:
Did you know that UMass Chan 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/
April 2019:
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.
March 2019:
This tip is all about location, location, location! Did you know that all research happens under the auspices of UMass Chan Medical School (UMass Chan)? 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!
February 2019:
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.
January 2019:
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/
December 2018:
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.
November 2018:
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
October 2018:
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.
September 2018:
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.
August 2018:
Did you know that encryption is required for all laptops, workstations, mobile devices and portable drives that may be used to store or access UMass Chan data – including research data? https://www.umassmed.edu/globalassets/it/security/signed-encryption-policy.pdf Contact UMass Chan IT with questions: https://umassmed.service-now.com/sp
July 2018:
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/
June 2018:
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.
May 2018:
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!
April 2018:
If you’re considering using an external IRB or having UMass Chan serve as the IRB of record for external sites, it’s important to contact the UMass Chan 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 UMass Chan IRB office to discuss options.
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 UMass Chan 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/
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 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.
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 UMass Chan? Check out the “Getting Started with UMass Chan 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.