IRB News Archives - 2018
December 11, 2018
The JHSPH IRB is posting new consent form templates to comply with the Revised Common Rule (RCR) requirements. All New Applications may use the new templates. New Applications under IRB review with current Common Rule (CR) consent templates that are not approved before January 21, 2019, must submit consent forms on the new RCR templates before final approval.
December 6, 2018
The NIH recently announced changes in the NIH Management of Genomic Summary Results Access Policy (available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html) , which will permit unrestricted download of genomic summary results data by third parties from the NIH Database of Genotypes and Phenotypes “dbGaP”). Please note these changes apply to the sharing of summary results only and do not impact requirements for sharing of individual-level data.
For new NIH funded studies that will collect genomic data that is subject to the NIH Genomic Data Sharing Policies, all JHU Institutional Review Boards (“IRBs”) have developed new template language for informed consent documents to inform research participants about the further dissemination of genomic summary results data. Investigators should make certain that they are using the current template language for new or on-going studies subject to the data-sharing requirements.
For studies that have already deposited data into dbGaP, the NIH has acknowledged that this change in policy may heighten the privacy risks to subjects for studies that are particularly sensitive; including studies involving populations from isolated geographic areas, populations with rare traits, or populations with stigmatizing traits. The NIH has given institutions until May 1, 2019, to designate, through the Institutional Certification process under dbGaP, whether any studies previously submitted will be designated as “sensitive” by the institution and which therefore should be maintained as controlled access only. Johns Hopkins University IRBs have convened a small group of internal experts to develop a consistent rubric to review already deposited studies and will be communicating with impacted investigators directly about any further action required. Investigators who have been contacted by their program officers, or who have questions about an existing study, may contact the relevant IRB office with questions about their particular study.
December 6, 2018
On January 21, 2019, new consent form requirements go into effect. The JHSPH IRB will soon post new consent templates that include those new requirements. While the Office of Human Research Protections (OHRP) has not yet issued guidance on these new requirements, the OHRP Director has permitted the circulation of his Dec. 5, 2019 slide presentation on New Informed Consent Requirements.
November 12, 2018
On January 21, 2019, the DHHS regulations governing human subjects research will change. Research applications Approved or Approved with Administrative Changes after that date must follow the Revised Common Rule. To help investigators understand the changes, the JHU IRBs have worked together on a common guidance called “What You Need to Know about the Revised Common Rule”. Please contact the IRB if you have any questions or concerns.
November 5, 2018
Effective November 1, 2018 the IRB will no longer send an administrative amendment approval memo for changes to funding, study personnel, or previously approved instruments that do not require stamping. (As a reminder, changes to the PI require submission of an Amendment Application.)
Instead of an approval memo, the IRB will send an email approval to the study PI/study contact. This email serves as the official IRB approval notice of the administrative amendment and must be retained by the study team for their records.
August 29, 2018
JHU has developed a guidance about the European Union's new General Data Protection Regulation (GDPR) and how it may affect research. Please review it if you are collecting information about a person who is physically located in the EU.
August 13, 2018
The IRB is changing its terminology with respect to continuing review to be consistent with other IRBs. Our “Progress Report” will be referred to as a “Continuing Review Form” going forward. Please use the updated Continuing Review Form going forward. Please contact the IRB if you have any questions
July 26, 2018
The JHSPH IRB’s “Self-Assessment Modules” are available for anyone to use – find them on our Quality Improvement Program webpage. Please let us know if you have any questions.
July 23, 2018
The IRB has updated its consent forms to include new, shorter HIPAA language generated in collaboration with the SOM IRB and the JHH Privacy Office. The instruction templates for each form have also been revised. Please let us know if you have any questions or comments.
June 29, 2018
The JHSPH IRB has posted new guidance and forms to guide investigators through the requirements for Reliance Agreement arrangements between the JHSPH and external IRBs. Not all of these arrangements involve NIH mandated “Single IRBs”, or sIRB, so we have separated those two topics. We are integrating our reliance agreement process into our PHIRST submission system so that we can have a file and IRB number for each study that involves one of these arrangements. Please review these materials and let us know if you have any questions.
June 28, 2018
Due to an IRB error, the June “reminder letters” notifying investigators to submit their Progress Reports were sent out late. We apologize for any inconvenience this may have caused. Please contact the IRB if you have any concerns.
June 28, 2018
IRB X and IRB FC will not meet the week of July 2 because of the July 4 holiday. The normal meeting schedule will resume the week of July 9.
June 22, 2018
UPDATE: Changes to the Federal Policy on Protection of Human Subjects (the Common Rule) Delayed to January 21, 2019.
A revised version of the federal rule governing Human Subjects Research (i.e. the Common Rule) was originally scheduled to go into effect on January 19, 2018 and was subsequently delayed to July 19, 2018 by an interim final rule. On June 19, 2018 a new final rule was published which delays the general compliance date of the revisions to January 21, 2019.
The new Final Rule can be accessed at the following link: https://www.federalregister.gov/documents/2018/06/19/2018-13187/federal-policy-for-the-protection-of-human-subjects-six-month-delay-of-the-general-compliance-date.
Until the Final Rule becomes fully effective on January 21, 2019, all human subjects research must continue to comply with the existing Common Rule. The JHSPH IRB will keep study teams apprised of any changes to the federal requirements for human subjects protections and will offer training sessions jointly with the other JHU IRBs this Fall to help study teams prepare for the changes. Please check the JHSPH IRB website frequently for any updates.
March 9, 2018
The IRB has updated the Data Security section of its two research plan templates, "Research Plan for New Data Collection" and "Research Plan for Secondary Analysis of Existing Data". Please use these new versions when you submit research applications.
March 7, 2018
The IRB is streamlining processes to improve efficiency in three ways: 1) Administrative Amendments changing study personnel will be acknowledged and confirmed via email rather than by letter; 2) IRB Progress Report reminder letters will be sent via email only, not by hard copy/interoffice mail; and 3) Consent and recruitment documents associated with Exempt Studies will no longer be stamped as “IRB Approved”. The documents associated with studies that the IRB determines to be exempt will continue to be listed in the IRB Exempt Determination letter, and no other consent documents or recruitment materials should be used. Please let us know (firstname.lastname@example.org) if you have questions about any of these changes.
March 7, 2018
For those investigators who need more information about submitting NIH grants that involve Single IRB, and the broader definition of “Clinical Trial”, this presentation by the ICTR team is very informative. See: http://webcast.jhu.edu/Mediasite/Play/80909db0b4f74d41b3f9f9278e8680011d.
March 6, 2018
The Hopkins ICTR group held a training session on March 5 that covered NIH’s Single IRB (“sIRB”) and reviewed the new NIH definition of “Clinical Trial”, and its impact on clinicatrials.gov registration requirements. It’s a very informative session, and we recommend it for investigators and their study teams: http://webcast.jhu.edu/Mediasite/Play/80909db0b4f74d41b3f9f9278e8680011d
January 23, 2018
The JHU IRBs are all posting a new guidance to help investigators and IRB members understand the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupil Rights Amendment (PPRA), and what is required when performing research that involves access to/use of student education records. Please contact the IRB if you have any questions.
January 18, 2018
UPDATE: Delay in Changes to the Federal Policy on Protection of Human Subjects (the Common Rule): The Federal government issued a notice on January 17, 2018, informing the public of a delay of the effective date of a revised version of the Common Rule from January 19, 2018 until at least July 19, 2018.
There is the possibility of a longer delay. You may access the Interim Final Rule at the following link: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.
Until the revised version of the Common Rule becomes effective, all human subjects research must continue to comply with the existing Common Rule. We will keep study teams apprised of any changes to the federal requirements for human subjects protections. Please check this website frequently for any updates. Training sessions outlining the planned rule changes and the status of the rule will still be held in January 2018. Please click here to register: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=734689