News & Announcements

Good Clinical Practice Training Announcement

November 6, 2018

Yale Human Research Protection Program and Yale Center for Clinical Investigation are hosting three in-person Good Clinical Practice training sessions available to the research community in November.
 
Initial Training: Essentials of Good Clinical Practice, Friday, November 30th from 9a.m. till 4p.m..
Refresher Training: Advanced Good Clinical Practice Training,  Wednesday, November 28th, 5p.m. till 8p.m. OR Thursday, November 29th, 9a.m. till 12p.m..
 
The training will be held at Park St. Auditorium, #201 at 55 Park Street, New Haven. Lunch and/or refreshments will be provided.

Registration is required. Please, click on the name of the session and register through Training Management System (TMS). If you are unable to complete the registration using TMS, please contact irb.training@yale.edu.
 
Who needs to complete Good Clinical Practice training?
Good Clinical Practice training is required for anyone listed on a research study that meets the NIH definition of a clinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
 
How is a clinical trial indicated in IRES IRB?
Basic Information page of the IRES IRB application asks about prospective assignment of subjects and the existence of health-related or behavioral outcomes. If the answer to both questions is YES, the study is considered a clinical trial. A Good Clinical Practice requirement will be assigned in Training Management System the day after an individual is listed on that study.
 
How long is Good Clinical Practice training valid for?
The training is valid for 3 years.  Refresher courses will satisfy the continuing education requirement.
 
Contact
You can email irb.training@yale.edu with any questions about the GCP and Human Subject Protection training requirements.
 

National Institutes of Health discontinuing the Human Subject Protection Training tutorial

September 14, 2018

On September 7, 2018 the National Institutes of Health announced their decision to cease the operation of their online tutorial ‘Protecting Human Research Participants’ as of September 26, 2018.  The site will be shut down in its’ entirety, and users will not be able to access course certificates after that date.   Archived course content will be available, but certificates will not.  Individuals who require human subject protection training should access the Collaborative Intuitional Training Initiative (CITI) Program, available through the Yale Training Management Website.

Letter Templates Updated

September 06, 2018

In an effort to increase efficiency and readability, the HRPP revised format of the letters issued via the IRES IRB system, effective September 6, 2018. The new format more clearly delineates the type of review performed, streamlines references to documents reviewed, includes the Yale letterhead, as well as information that may be helpful for industry sponsors and other regulatory bodies.

Six Month Delay of the General Compliance Date of Revisions to the Common Rule

June 29, 2018

It was previously communicated that changes would be made to the Yale University HRPP and IRB review processes on July 19, 2018 in conformance with the effective date of the revised Common Rule. The Common Rule is a set of federal regulations governing a significant amount of human subjects research conducted at Yale University. Official notification has been published in the Federal Register that the Common Rule revisions have been further delayed with a new implementation date of January 21, 2019 (read more about the Federal Policy for the Protection of Human Subjects). During the delay, institutions may implement a limited number of the revised Common Rule “burden-reducing” provisions prior to the new implementation date. The Yale HRPP is in the process of reviewing these provisions and the feasibility of their implementation, which remain voluntary prior to January 21, 2019. Information on implementation of the revised Common Rule both before and after January 21, 2019 will be forthcoming.

European Union General Data Protection Regulation

May 25, 2018

Effective May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) (EU 2016/679) replaces the 1995 Data Protection Directive (Directive 95/46/EC). The primary objective of this new regulation is to protect the fundamental rights and freedoms of data subjects and standardize requirements regarding covered data processing activities. Although the GDPR makes many important changes to EU data protection law, the GDPR is not a complete departure from existing principles. Many of the obligations outlined in the GDPR are not new for many organizations in the area of human subjects research. However, as noted below, the territorial reach of the new regulation has expanded and will impact U.S. organizations, including universities and academic medical centers.

The following Frequently Asked Questions (FAQs) provide an overview of the new regulation in the context of Human Subjects Research where the research involves the processing of personal data and special categories of personal data such as sensitive data or data concerning health. This document also briefly touches upon other key University activities that should be monitored for GDPR compliance.

View Frequently Asked Questions, European Union General Data Protection Regulation

Download Frequently Asked Questions, European Union General Data Protection Regulation

Single IRB (sIRB) Review for Multi-site Research

January 24, 2018

Overview of the NIH sIRB Policy

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

A sIRB model allows multiple institutions that are conducting the same protocol to use a single IRB for review, instead of using multiple IRBs to review the research at the sites individually. 

The NIH policy applies to all biomedical and behavioral studies that:

  • Are funded through grants, cooperative agreements, or contracts submitted to NIH on or after January 25, 2018, and
  • Involve non-exempt human subjects research, and
  • Involve multiple domestic sites, all of which are conducting the same protocol.

The sIRB NIH policy does not apply to:

  • Foreign sites; or
  • Studies funded through career development (K), institutional training (T), and fellowship (F) awards; or
  • Sites for which federal, state, or tribal laws, regulations or policies require local IRB review; or
  • collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.

Other exceptions to allow for local IRB review may be considered by NIH based on compelling justification. These other exceptions must be reviewed and approved by NIH.

Click here for or more information regarding exceptions to the NIH sIRB Policy.

Single IRB Plan for Applications and Proposals

Applicants are expected to include a plan for the use of a sIRB in the grant applications and contract proposals submitted to the NIH (for due dates on or after January 25, 2018). For details, see Section 3.2 of the PHS Human Subjects and Clinical Trials Form Information Application Guide.

In general, your plan for the use of a sIRB should include a description regarding how you intend to comply with the sIRB policy and the name of the IRB that will serve as the IRB of record. For delayed multi-site research (studies in which there is no well-defined, detailed plan for human subjects involvement at the time of submission), the delayed onset justification attachment must include information regarding how the study will comply with the sIRB policy and state that a sIRB plan will be provided prior to initiating the study.

Designating the Single IRB in Applications and Proposals

For a NIH-funded multi-site project, investigators must designate the sIRB as part of the grant application and contract proposal. For example:

  • The IRB at the lead PI’s site;
  • The IRB at a participating site;
  • The IRB at a non-participating site;
  • Commercial IRBs (e.g., WCG/WIRB, Quorum Review, Advarra (previously Schulman and Chesapeake), Brany, and Hummingbird);
  • An IRB specifically set up for an already-established-and-funded research network or consortium.  This option is available only if the study you are proposing will be conducted under the auspices of the network/consortium.
  • A Trial Innovation Network (TIN) IRB. 

Note: In most situations, the lead PI, in collaboration with the HRPP at the lead PI’s institution, will select the sIRB. The selected IRB must be willing to serve as the sIRB and all of the participating sites must agree to rely on the sIRB. The IRB also must be registered with the Office for Human Research Protections (OHRP) to serve as a sIRB.

Yale approved IRBs for sIRB

When a Yale Investigator is the awardee of a multi-site grant, Yale plans to cede IRB oversight to an external IRB to serve as the sIRB on Yale’s behalf. If a commercial IRB is selected, Yale will cede IRB oversight to one of the 5 external IRBs below.

  • Advarra (previously known as Schulman and Chesapeake)
  • Brany
  • Hummingbird
  • Quorum Review
  • WCG/WIRB

If you have questions regarding any of the commercial IRBs, please contact the HRPP office at hrrp@yale.edu.

If you prefer to employ services of a commercial IRB not listed above, please contact the HRPP office at hrpp@yale.edu prior to submitting the grant application as there may be additional contractual considerations that must be taken into account when choosing an external IRB that does not have a master agreement with Yale.

If there is a compelling reason for the Yale IRB to serve as the sIRB for a specific study, the HRPP will evaluate such a request on a case-by-case basis.

Cost of Single IRB Review - sIRB Budget in the Grant Application

The costs for IRB review at a single institution by that institution’s IRB have typically been considered an indirect cost covered under an institution’s Facilities and Administration (F&A) rate (except for industry-initiated-and-sponsored studies). NIH, however, expects that many sIRBs will charge fees to serve as a single IRB and review other sites. The grant budget must therefore include appropriate provisions for IRB review fees to avoid gaps in coverage.

The Yale Center for Clinical Investigation (YCCI) offers a Research Budget Development service and can help investigators with budgeting. Please contact clinicalresearchresources@yale.edu if you have questions.  You may also contact the HRPP office at hrpp@yale.edu if you have questions or need information regarding commercial IRB pricing for any of the 5 IRBs below.

  • Advarra (previously known as Schulman and Chesapeake)
  • Brany
  • Hummingbird
  • Quorum Review
  • WCG/WIRB

Request for HRPP approval to use an External IRB

A request to use an external IRB for the review of research conducted by a Yale investigator must be submitted to the HRPP Office through IRES IRB. A submission to an external IRB may not be made without prior authorization from the Yale HRPP.

Although agreements with external IRBs may include different division of responsibilities, Yale as an institution will generally remain responsible for review of compliance with local requirements such as training, locally required ancillary reviews, conflict of interest disclosures, or Yale specific language in the consent forms. 

Letter of Support

If you are requested to provide an institutional letter of support to cede review to a specific sIRB for your grant application, please contact the HRPP office at hrpp@yale.edu. In your request, please include the name of the PI at the Yale site, the name of the proposed single IRB, the RFA number, and the funding opportunity title.

Billing Contact for External sIRB Review

When Yale cedes review to an external IRB, Yale HRPP is listed as the primary billing contact and YCCI (or the PI’s business office or other designated billing department) as the secondary contact. The HRPP will work with the external IRB and designated billing contact to ensure payment to the external IRB.

Primary Billing Contact
Human Research Protection Program (HRPP)
hrpp@yale.edu
Attention: Meriam Worzella

Secondary Billing Contact
Yale Center for Clinical Investigation (YCCI)
Research Budget Development Unit
clinicalresearchresources@yale.edu
Attention: Juliann Murphy

Note: If YCCI is not the correct secondary billing contact, the Research Budget Development Unit will direct you to correct business office contact for the specific study.

Questions

If you have questions about the NIH policy or questions about choosing a single IRB for your upcoming grant applications, you may contact hrpp@yale.edu. Additional guidance is forthcoming. Training sessions regarding the use of external IRBs and reliance agreements will be offered soon.

NIH Resources

  • NOT-OD-16-094  Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-17-076 Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-16-109 Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
  • NOT-OD-18-003 Guidance on Exceptions to the NIH Single IRB Policy
  • NOT-OD-18-004 Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • Frequently Asked Questions

Delay in the Implementation of the Revised Common Rule

January 17, 2018
This is an important update regarding revisions to the regulations governing research involving human subjects, the Common Rule. The revised rule was issued on January 19, 2017 and it was to be become effective on January 19, 2018. The revised rule was not applicable to FDA and DOJ (Department of Justice) regulated research.

On January 17, 2018, the Department of Health and Human Services issued a statement that the effective and compliance date of the new rule is delayed until July 19, 2018.

Over the past few months, Yale HRPP has worked on implementation of the revised regulations. This included updates to policies and procedures, submission forms, consent templates, and IRES IRB system configuration. The delay means that we cannot implement these changes until July 19, 2018, unless there is a decision to further delay the revised Common Rule beyond the July 19, 2018 date. This additional time will allow the regulatory agencies to provide guidance necessary for institutions to implement the rule.  It is also hoped that FDA will have issued revised regulations intended to harmonize with the new requirements by that time. This would eliminate confusion that may result from applying different regulatory standards. 

You may have read about the changes and wondered how they will affect your research. Yale HRPP and YCCI will offer live training sessions in the next few months that will focus on the proposed changes to the regulations. You can sign up for Coffee and Conversation and Lunch and Learn series at yale.edu/training.

We value your opinions. If you have any questions or concerns regarding this notification, please send them to hrpp@yale.edu.  We expect a large volume of inquiries and will compile them into a FAQ document for the research community and address them in a subsequent communication.

Thank you for your patience during this transition period.


January 8, 2018

Effective January 2, 2018:  As a result of a joint effort to streamline the submission process regarding studies involving minors that require approval from the Pediatric Protocol Review Committee (PPRC), research protocols can now be submitted in IRES IRB without first obtaining PPRC approval outside of the system. 

When a study is submitted into IRES IRB, the HRPP Office will request PPRC review using the functionality available in the IRES IRB system. The HRPP pre-review comments along with any PPRC required revisions will be provided to the PI and the PI Proxy via the IRES IRB system. Once the PPRC approval is obtained, the research protocol will be scheduled to the IRB for review and approval.

We hope this change will improve your experience with submissions of protocols involving minors.   

Effective January 18, 2018: Biomedical studies will be assigned to the next available weekly IRB meeting regardless of the department the study comes from.  Oncology studies will continue to be scheduled to the oncology-focused IRB meetings on the 1st and 3rd week of the month, but they can also be sent to a week 2 or 4 biomedical IRB panel. The purpose of the change is to improve the Yale internal IRB’s timelines for review and approval.    

Designated HRPP staff will continue to work with investigators to ensure that the submissions are complete and ready for review by the IRB prior to scheduling to a meeting. To accommodate this change, an additional monthly meeting will be added to the first week of every month. Updated IRB Rosters and an IRB meeting schedule will be available and posted on the HRPP website in early January.

We are also happy to welcome new members to our HRPP family. Jessica (Jessie) Huening joined the office as Assistant Director, Regulatory, Compliance & Quality in early December. Dianna Mercier and Griselle Gandulla joined the office as IRB Regulatory Analysts in October 2017. 

Most importantly, we thank our dear colleague and mentor, Dr. Sandra Alfano, for her many years of service to the HRPP and HIC. We will greatly miss her guidance and presence in the HRPP Office and wish her well in her new role as Senior Research Analyst with the Yale Conflict of Interest Committee.

Please, see below for the revised assignment of the Chairs and the IRB panels.

Week 1:

  • HIC IA:  Wednesday, 3:00 PM (added meeting)
    • Chair:  Madelon Baranoski, Ph.D.
    • Vice-Chair: Stephen Latham, JD, PhD
  • HIC IB:  Wednesday, 5:00 PM                    
    • Chair:  John Roberts, MD
    • Vice Chair: Madelon Baranoski, Ph.D.

Week 2:

  • HIC II: Wednesday, 5:00 PM       
    • Chair:  Suchitra Krishnan-Sarin, PhD
    • Vice-Chair: Stephen Latham, JD, PhD

Week 3: 

  • HIC III: Wednesday, 3:00PM     
    • Chair:  Madelon Baranoski, Ph.D.
    • Vice-Chair: Suchitra Krishnan-Sarin, Ph.D.
  • HIC IB: Friday, 7:30AM                
    • Chair:  John Roberts, MD
    • Vice-Chair: Madelon Baranoski, Ph.D.

Week 4:

  • HIC IV: Wednesday, 5:00PM                      
    • Chair:  Suchitra Krishnan-Sarin, PhD
    • Vice-Chair: Stephen Latham, JD, PhD

Should you have questions about the full board reviews and schedule, please contact any of the designated Full Board IRB Regulatory Analysts: Dawn Pedevillano, Stacey Scirocco, Theresa Katz, Dianna Mercier, or Griselle Gandulla.

The Human Research Protection Program (HRPP) staff wish you a very Happy New Year 2018!