News (Archive)

February 7, 2023

New Yale HRPP Policy and Standard Operating Procedure Manual, Investigator Manual, and Additional Documents

The Yale Human Research Protection Program (HRPP) is excited to announce the launch of the new Yale HRPP Policy and Standard Operating Procedure Manual, with an effective date of January 30, 2023. This purpose of this manual is to consolidate existing standalone Yale HRPP policies, procedures, and select guidance documents into one streamlined manual. The manual also includes new topics related to human subjects research conduct and oversight, reflecting the most up-to-date regulatory information. We are confident our Yale research community will find this new manual both valuable and easy to navigate.

The Yale HRPP has also updated: 1) the HRPP Investigator Manual, which provides detailed information on research preparation, IRB submission, and study team responsibilities, and 2) checklists, worksheets, submission forms, and templates that aid in successful application submission to the Yale IRB.

Training sessions on these updated documents were provided to the Yale research community throughout January 2023. Please review the session slides and a high-level summary document that outlines the purpose and major points pertaining to each new/updated document below. All referenced documents can be found on the Yale HRPP website. For any questions, please contact HRPP@yale.edu.

New Yale HRPP/IRB Manuals & Related Documents
Summary of Yale HRPP Document Changes
Recording: Yale Research Community Training January 2023

August 19, 2021

Research Activation

Effective August 16, 2021, safety protocols related to conducting human subjects research during the pandemic, will be reviewed by the Human Research Protection Program (HRPP) before the IRB review. In certain circumstances, the HRPP will consult with the representatives from the Office of Environmental Health and Safety, Off Campus Research and Fieldwork Committee, and Human Subjects Research Review Committee, who have conducted these reviews since the beginning of the research reactivation phase.

Investigators will submit safety plans in IRES IRB, the HRPP electronic system. EHS Integrator will no longer be used for this purpose.

Instructions

• Investigator must complete ‘Supplement to IRB Submission and Requests to Use External IRB – Safety During Pandemic’ form available in Other Forms tab in IRES IRB Library. Exception: investigators conducting secondary data analysis research and clinicians requesting an emergency use of a test article or device do not need to complete this form. 
• The form should be uploaded as a supporting document along with the research documentation and submitted in IRES IRB.
• The HRPP will contact the investigator and primary contact for the study within 2 business days should there be any questions about the proposed safety plan.
• Once the safety plan is accepted, the study will proceed to the IRB for review or will receive authorization to use external IRB.

August 7, 2021

IRES IRB Upgrade

The IRB and HRPP electronic system, IRES IRB, is scheduled to undergo an upgrade to the most recent version of the system. The upgrade is scheduled to begin after 5 pm on Thursday, August 12th. It should become available to users on Tuesday, August 17th, mid-afternoon hours. There will be no access to IRES IRB between these dates.

There is no change in the schedule of the IRB meetings. In case of emergencies and urgent actions that require IRB approval, contact the HRPP office at hrpp@yale.edu. The IRB will be able to conduct urgent reviews during the time the system is down.

What changes to expect

There are three types of changes that are being implemented: changes to navigation, changes in questions on pages in the electronic submission, and changes to the submission and reviews processes. Examples of some of these changes are listed below:

1. Navigation
   • My Inbox moves to a tab called Dashboard
   • Shortcuts to Library, Help Center, IRB Submissions, IRB Reports move from Menu on the left side to the top of the screen
   • The study record shows a MENU of all pages on the left side of the screen to visually represent progress while completing the electronic application
   • Overall feel and look of the system is changed to allow for an easier navigation
2. Screens
   • Questions are removed from several pages of the electronic application
   • A new page with research location is added
   • New questions regarding repositories and sharing of the specimens are added
   • Supporting Documents page is consolidated with local consent and recruitment materials page
3. Processes
   • Changes are introduced to the process for requesting use of external IRBs and updating the system after the study is approved by the external IRB
   • Several minor changes are made to the internal IRB processes with no impact to the researchers

First Actions after the Upgrade

The upgraded system will include new questions on two existing study screens (Study Scope and Use of Technology in Research) and a new page (Local Research Locations). The estimated time to answer these questions is less than 5 minutes. Investigators will need to provide answers to the new questions and verify information on the new page at the time of the first modification on the protocol or before any pending modification or initial study receives IRB approval. A new function called ‘Validate’ is available to help identify missing answers throughout the electronic application. See below for details:

First Modification, Continuing Review with Modification, Study Update on an approved protocol

Before submitting these actions to the IRB, go through all screens to verify and correct the information on all pages. Answer any missing questions.

First Continuing Review on an approved protocol

No changes can be made to the protocol record at the time of continuing review. If you wish to provide answers to the newly added questions, you will need to create Continuing Review and Modification. Pending Continuing Reviews will be processed as usual.

Modifications, Continuing Review with Modifications, and Initial Submissions pending IRB review

You will be asked by the IRB and HRPP staff to provide answers to the newly added questions before the IRB approval is issued. If the submission receives a determination of Modifications Required to Secure Approval or Deferral, you will need to answer the new questions before submitting your response in IRES IRB.

Updates to studies under external IRB purview

Any pending update to the study under an external IRB purview will be discarded at the time of the upgrade. Updates currently pending HRPP acknowledgment that cannot be successfully processed prior to the upgrade (as a result of a pending ancillary review) will be recreated on behalf of the PI after the upgrade.

Training

Recorded sessions on changes in the new system and revised quick guides will be available on the HRPP website prior to the upgrade. They will also be posted in the Help Center in IRES IRB once the upgrade is completed.

There are two different types of live training sessions available via Zoom throughout the end of August:

• Changes in IRES IRB for studies under Yale IRB purview
• Changes in IRES IRB for studies under External IRB purview

Registration is available through Training Management System.

Sessions on using IRES IRB for individuals who have not used the system before will resume in September.

May 1, 2021

Procedure on Research Staff Engaged in Research Projects

Effective May 1, 2021 a new procedure was published regarding listing research staff members in the IRES IRB record

The research record in the IRB electronic system, IRES IRB, must include the names of at least the following team members engaged in human subjects research under Yale IRB or HRPP purview:

• Principal Investigator (PI),
• PI Proxy, if one is identified for the study,
• Investigators,
• Individuals external to Yale who require a reliance agreement OR Unaffiliated Investigator Agreement, and
• Other members of the research team who report financial interests related to the research.

Team members who do not meet these criteria do not need to be listed in IRES IRB.

If the Principal Investigator wishes to list all of the members of the research team in IRES IRB, the study team members page in the system includes a selection of available roles to further describe research roles of each individual.

Note: The IRB can always require listing additional members of the research team.

December 2, 2019

A new requirement for review of research protocols with ionizing radiation by the Yale University Radioactive Investigational Drug Committee (RIDC) and a revised process of submission of protocols for Radioactive Drug Research Committee (RDRC) review.

Background

Research with unapproved drugs or biologics require an FDA approved IND for the drug/biologic to be used in research. Per 21 CFR Part 316 certain studies that use the radioactive materials can be conducted without an IND if Radioactive Drug Research Committee (RDRC) approves the study in lieu of the FDA. The criteria for when RDRC review is allowed is listed at the bottom of this communication.

Studies with an FDA approved IND, FDA-approved radiopharmaceuticals, or FDA allowed IND exemption do not undergo the review by RDRC. For years, Yale investigators conducting research with such agents submitted their protocols to Yale New Haven Hospital Radiation Safety Committee to evaluate radiation dosimetry even though the research was taking place at Yale PET Center and not the hospital. To close the gap and provide the investigators with the necessary review at Yale, the Yale Office of the Provost established Radioactive Investigational Drug Committee (RIDC). Dr. Albert Sinusas agreed to serve as the Chair of the Committee. The HRPP will help with administrative support. Studies reviewed by the RIDC will no longer require a review by Yale New Haven Radiation Safety Committee unless research related radiation is also used in hospital.

Role and Responsibility of the Radioactive Investigational Drug Committee

HRPP Guidance 940, ‘Guidance on Committee Reviews Required for Human Subjects Research Protocols Using Radiation’, describes roles and responsibilities of each Committees that may review the research with radiation.

The following is the summary of the RIDC responsibilities:

• Ensures the underlying science and research protocol are of sound design.
• Reviews and approves the consent form language related to the radiation.
• Evaluates radiation dosimetry.
• Confirms consistency between the FDA application and Yale University study-related documents.
• Ensures that the PI and research staff are current on any required training.

How it affects your research

If your study is already approved by an IRB, initial review by the RIDC will NOT be required. Any modifications to your protocol that affect the use of radioactive materials will require RIDC review. The HRPP is creating a database of all the existing studies that will fall under RIDC purview. Basic information about your study will be provided to RIDC. HRPP will work in collaboration with PET Center to obtain the necessary information if the IND is held by the PET Center. The RIDC review does not replace the requirement for Yale Radiation Safety Committee review.

Submission Process for Initial RDRC/RIDC Review or Modification

Protocols requiring RIDC or RDRC review will be sent to RIDC/RDRC using IRES IRB. The PI’s responsibility is to fill out an Application to Involve Human Subjects in Biomedical Research with Ionizing Radiation and RSC Human Use Review Cover and upload both as Supporting Documents. When studies are submitted in IRES IRB, the HRPP staff will request review from both RIDC/RDRC and Yale RSC, and electronically notify PET Center about the upcoming research protocol. RIDC/RDRC and RSC will review the protocol and submit their findings in IRES IRB.

The workflow and details are below:

Upon submission of the protocol in IRES IRB, the HRPP staff will:

• Verify that the RDRC/RIDC Request Form is completed and submitted in IRES IRB,
• Verify that the RSC Human Use Review Cover sheet is uploaded in IRES IRB,
• Confirm that the PET Center required language is included in the consent forms (see Consent Glossary document in IRES IRB for the language),
• Confirm that the documents are uploaded appropriately,
• Verify that the Authorized User is listed on the protocol,
• Notify RDRC/RIDC, RSC, and PET Center contacts via IRES IRB about the protocol submission.

Upon receipt of the notification that a protocol requires RIDC/RDRC review, the committee will schedule the protocol to the next available meeting, review it, issue determination, and upload the determination in IRES IRB:

• Approval with no comments to the IRB,
• Approval with recommendations/comments to the IRB,
• Revisions Requiring RIDC/RDRC rereview,
• Conditional Approval/Revisions Needed NOT Requiring RIDC /RDRC Rereview.

Upon receipt of the notification that a protocol requires Yale RSC review, RSC will review the submission, issue determination, and upload the determination in IRES IRB:

• Approval with no comments to the IRB,
• Approval with recommendations/comments to the IRB,
• Revisions Requiring Yale RSC rereview,
• Conditional Approval/Revisions Needed NOT Requiring Yale RSC rereview.

IRB Actions:

1. IF RIDC/RDRC/Yale RSC Approved: Modification is submitted on behalf of the PI to release consent forms.
2. If Revisions Requiring RIDC/RIDC/RSC Re-review: Modification is created and submitted in IRES IRB on behalf of the PI by the HRPP staff and the RIDC/Yale RSC decision letter is sent with any required modifications. The workflow is repeated but IRB approval NOT issued until approval is obtained.
3. If Conditional Approval/ Revisions NOT Requiring Re-review: Modification is created and submitted in IRES IRB by HRPP staff on behalf of the PI and the RIDC/RDRC/Yale RSC decision letter is sent with any required modification.

Contacts

If you have questions about the RIDC or RDRC review process, please contact the following individuals:

• Amy Blakeslee, HRPP Manager at amy.blakeslee@yale.edu – Amy is the liaison between the Yale HRPP and the Yale IRB. She is available to help the investigators fill out the RIDC form and help calculate the dosimetry. She will work closely with PET Center to ensure the information you provide is accurate.
• Donna McMahon, RIDC Manager, at ridc@yale.edu – Donna provides administrative support to RIDC. She will submit the RIDC determinations in IRES IRB.

Update Regarding Revised Consent Forms, Consent Glossary, and Instructions for Converting Studies to Revised Common Rule

June 28, 2019

Changes to HRPP and Yale IRB Fees for Commercially- Supported Studies

The announcement regarding the HRPP and IRB review fees was sent to the research community. Please, contact hrpp@yale.edu with any questions.

January 22, 2019

The purpose of this communication is to provide you with updates since our last communication earlier in the month regarding the implementation of the revised regulations governing research involving human subjects, the “Revised Common Rule”, which went into effect yesterday, January 21, 2019.

This communication addresses the following aspects of the Revised Common Rule that may be important to you:

• Updated Consent Templates
• New Consent Glossary
• Updated Request for Exemption Determination
• Instructions for Continuing Review requests for a study to be converted to Revised Common Rule standards.

1. Updated Informed Consent Templates

Three revised consent templates were uploaded into the Library section of IRES IRB:

• Compound Authorization and Consent for Biomedical Research (HIPAA and Consent)
• Compound Authorization and Consent for Social, Behavioral, and Educational Research (HIPAA and Consent)
• (SBE) and Consent template for SBE research (without HIPAA elements)

The new consent templates include new required elements of consent, revised guidance for drafting of the consent forms, and updated suggested language.

Please, note that the purpose of the consent templates is to help investigators draft their consent documents when no other templates are provided. If you received a template for your research from other sources, either a sponsor of the study or the coordinating center, there is no need to revise that template to follow Yale’s suggested form. You should work with the sponsor to revise the consent for templates as necessary such as to add Yale required language.

In the next few weeks, the HRPP will be posting the remaining templates: parental permission, repository template, and assent forms.

The consent forms will be reviewed and updated based a predefined schedule unless there is a required regulatory/university policy change, significant human subject protection issue, or other reason that necessitates an immediate change.

2. New Consent Glossary

A Consent Glossary contains a compilation of commonly used terms and descriptions of research procedures organized in an alphabetical order. As noted in the Glossary, some of the language may be required (by applicable legal, regulatory, or other requirements such as by the Yale ancillary committees or Yale policy) and some may be preferred (but not required).

Review the terms in the Glossary to select the paragraphs that you may need to use.

The Glossary document will be reviewed and updated based a predefined schedule (e.g. quarterly, biannually, annually, etc.) unless there is a required regulatory/university policy change, significant human subject protection issue, or other reason that necessitates an immediate change.

The Glossary includes references and the reading level of each section. The goal is to use language that is at grade 8 or below, when possible.  A few sections (e.g., in case of injury, GINA, etc.) were not revised or minimally edited, but will be reviewed later.

The Glossary is uploaded in the Library Section of IRES IRB.

3. Updated Request for Exemption Determination

A revised Request for Exemption Determination was uploaded into the Library section of IRES IRB. As a reminder, Yale-specific category 7 was removed as the revised rule includes a new exemption category 3 (i) (A), (B), and (C), which allows for certain benign behavioral interventions to be considered exempt. As such, there is no further need for the largely redundant Yale-specific category 7. In addition, due to lack of agency guidance related to requirements and use of broad consent, Yale IRB will generally not grant exemption determinations utilizing categories 7 and 8. As such, they were not included in the Request for Exemption Determination. The Yale HRPP will re-evaluate the use of broad consent after the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) issues relevant anticipated guidance.

4. Instructions regarding Continuing Review

• For research submitted to the Yale IRB for approval after January 21, 2019 (without FDA or DOJ oversight), the Yale IRB will approve the following types of studies without requiring Continuing Review unless the IRB determines there are special circumstances that requires ongoing continuing review: (1) applicable minimal risk research; and (2) greater than minimal risk research if the research is closed to enrollment and the remaining research activities are limited to data analysis, including analysis of identifiable private information or identifiable specimens, or accessing follow-up clinical data from procedures that participants would undergo as part of clinical care.
• For research approved by the Yale IRB prior to January 21, 2019 (without FDA or DOJ oversight), the Yale IRB will reapprove a study at its next continuing review without requiring further continuing review by converting the study to the Revised Common rule standard. Those include: (1) applicable minimal risk studies; and (2) greater than minimal risk studies if the research is closed to enrollment and the remaining research activities are limited to data analysis, including analysis of identifiable private information or identifiable specimens, or accessing follow-up clinical data from procedures that participants would undergo as part of clinical care. 

In order for the Yale IRB to convert the study to Revised Common Rule standard, the research must meet all of the approval criteria of the Revised Common Rule.  This means that if a study meets the approval criteria of the Revised Common Rule and does not have consent forms, then the study will be converted to the Revised Common Rule at the time of your next Continuing Review unless the IRB determines there are special circumstances that required ongoing continuing review. However, if your study meets the approval criteria of the Revised Common Rule and has consent forms, the consent forms will need to be revised to include the new consent elements required under the Revised Common Rule. The list of all the elements is included in the Consent Glossary for your reference.

If you would like the Yale IRB to consider converting a study that includes consent forms to the Revised Common rule standard so that the study no longer requires continuing review, at the time of your next Continuing Review (with a CR date of January 21, 2019 or later), submit a Continuing Review with a Modification to upload the revised consent form that includes the following elements:  

1. Key Summary (required): Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. The following language can be used for the first page of the consent form:

Research Study Summary:

• We are asking you to join a research study.
• The purpose of this research study is to [Insert the purpose of the study.]
• Study procedures will include: [Insert summary of study procedures.]
• [Number of visits] visits are required.
• These visits will take [Number of hours] hours total.
• There are some risks from participating in this study. [Insert summary of the study risks.]
• The study may have no benefits to you. [Describe benefits of the study to others. If there are expected benefits to subjects, revise the sentence and describe the benefits.]
• There are other choices available to you outside of this research. [Describe alternative procedures or treatments outside of the study. If none, you can delete the entire bullet point.]
• Taking part in this study is your choice. You can choose to take part, or you can choose not to take part in this study.  You can also change your mind at any time.  Whatever choice you make, you will not lose access to your medical care or give up any legal rights or benefits.
• If you are interested in learning more about the study, please continue reading, or have someone read to you, the rest of this document. Take as much time as you need before you make your decision. Ask the study staff questions about anything you do not understand. Once you understand the study, we will ask you if you wish to participate; if so, you will have to sign this form.

2. Include one of the two sentences regarding use of private information or identifiable biospecimens for future research (required):

1. We will also share information about you with other researchers for future studies, but we will not use your name or any other identifiers. We will not ask you for any additional permissions.

OR

1. We will not share any of your information with other researchers for future research studies, even if we remove all identifiers such as your name.

The next three elements are only required if they apply to your research. Review them and decide whether they also need to be included:

1. If you are collecting biospecimens: Add a statement that the participant’s biospecimens (even if identifiers are removed) may be used for commercial profit and that there are no plans to share the financial gains with him/her (unless there is a plan, then describe it). 

2. If you are collecting biospecimens, explain whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) in the future.

3. If your research is likely to generate clinically relevant results: add a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to the participant, and if so, under what conditions.

Important: If your study is sponsored by a sponsor external to Yale, please verify with the sponsor or the coordinating center that the research can be converted to the Revised Common Rule. Some of the sponsors specifically request that the research continues to be approved under Pre-Revised Common Rule.

The IRB will generally not require reconsent when incorporating these updates into the informed consent documents unless other significant changes are made.  Once approved, the approval letter will list your obligations regarding submissions of modifications, reportable new information, and study closures.

Please, contact the HRPP Office at hrpp@yale.edu with any questions about this notification.

Sincerely,
Human Research Protection Program

Yale HRPP Plan to Implement Revised Regulation

January 9, 2019

The purpose of this announcement is to provide you with the Human Research Protection Program (HRPP) plans to implement the revised regulations governing research involving human subjects, the Common Rule. We refer to the revised regulations as the revised common rule or 2018 regulations throughout this notice.

Summary

The revised common rule was initially issued on January 19, 2017 and was to become effective on January 19, 2018. The implementation was delayed twice in the last year. The final implementation and compliance date is now January 21, 2019. 

The revised rule is not applicable to FDA and DOJ (Department of Justice) regulated research. However, FDA plans to post a notice of draft revised FDA regulations intended to harmonize with the revised rule requirements. If you are involved in the conduct of FDA-regulated research, you should be aware that these changes may be directly applicable to your research in the future. We will let you know if and when those changes occur.

This communication addresses the following aspects of the revised common rule that may be important to you:

1. Application of the revised common rule to research approved by the IRB prior to the implementation date–Grandfathered Research
2. Minimal risk research
3. Exempt research/modified and new exemption categories
4. Informed consent requirements
5. Single IRB of Record requirements
6. IRES IRB system updates
7. Changes in IRB practices to accommodate the revised rule
8. Next Steps

1) Application of the revised common rule to research approved prior to the implementation date/Grandfathered Research

Research projects conducted at Yale University are held to varying standards depending upon what set of regulatory criteria applies to the research activity. As noted above, the revised rule is not applicable to FDA and DOJ (Department of Justice) regulated research.

Applicable research approved prior to January 21, 2019 will continue to be reviewed under the pre-2018 common rule regulations. Later this year, we will evaluate whether to transition applicable research approved prior to January 21, 2019 to the revised common rule at the time of continuing review. A communication about the plan will be sent out to the research community at that time.

2) Minimal Risk Research

The revised common rule allows for most minimal risk research to be conducted without IRB continuing review.

• The Yale IRB will NOT require continuing review for applicable minimal risk research approved after January 21, 2019.
• The Yale IRB will NOT require continuing review for greater than minimal risk research approved after January 21, 2019 if the research is closed to enrollment and the remaining research activities are limited to data analysis, including analysis of identifiable private information or identifiable specimens, or accessing follow-up clinical data from procedures that participants would undergo as part of clinical care.
• The Yale IRB will require continuing review for greater than minimal risk research (unless it meets criteria described above) and any research that is under FDA or DOJ jurisdiction regardless of the phase of the study.

Regardless of the continuing review category above, you must still report modifications and reportable new information to the IRB, including, but not limited to, changes in research or study personnel, study closures, events that may constitute serious or continuing noncompliance, and potential unanticipated problems involving risks to subject or others.

The Yale HRPP Office also will check in with the investigator on an annual basis regarding the progress of the study.

3) Exempt Research

The revised common rule changed the categories of research that can be deemed exempt.

• The revised exemption request form will be posted in the Library section of IRES IRB the week of January 14th.
• Two of the revised exemption categories include the use of broad consent (categories 7 & 8).

Due to lack of agency guidance related to requirements and use of broad consent, Yale IRB will generally not grant exemption determinations utilizing these categories. The Yale HRPP will re-evaluate the use of broad consent after the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) issues relevant anticipated guidance. Due to the lack of guidance and large impact broad consent will have on institutions, the strategy to delay the use of broad consent is being taken by a clear majority of IRBs and academic institutions.  

• The Yale IRBs will no longer issue exemptions under Yale-specific category 7.  This category did not exist in the pre-2018 regulations and was created specifically for use by the Yale IRB and Yale researchers. The revised rule includes a new exemption category 3 (i) (A), (B), and (C), which allows for certain benign behavioral interventions to be considered exempt. As such, there is no further need for the largely redundant Yale-specific category 7.  

Regardless of the exemption category, the requests for exemption determination must be submitted to the Yale IRB via IRES IRB per institutional requirements.  Exempt research cannot commence without a Yale IRB exemption determination.

4) Informed Consent Requirements

Yale IRB will apply additional revised common rule consent provisions to new research approved by the IRB after January 21, 2019.  Yale IRB will not apply the additional consent provisions of the revised common rule to research that is under FDA or DOJ jurisdiction unless it is also federally funded as it is not required for this research.  New consent templates that reflect the new provisions will be posted in the Library section of IRES IRB. This includes a “concise and focused presentation of the key information” as required under the revised section .116 of the revised common rule, along with other changes. If your new study has been submitted and is under review by the Yale IRB on January 21, 2019 but is not yet approved, and the consent form submitted does not comply with the  new regulatory requirements, a HRPP Regulatory Analyst will work with you to ensure that the new elements are added.

• Short Form: The IRB must still approve the use of a short form in research conducted at Yale.  Under the revised rule the short form written informed consent document must now also state that the study key information was presented to the participant first before other information, if any, was provided. The translated versions of the short forms that are currently posted in the Library section of IRES IRB do not include the new required element. As such, the currently posted short forms can be used ONLY for studies that are not subject to the revised rule, such as research only under FDA or DOJ oversight (and without NIH, NSF, or other Common Rule entities’ funding), or research approved by the IRB prior to January 21, 2019.  Revised short form templates for research subject to the revised rule will be available in IRES IRB in late January.  Please, refer to 200 Guidance 2 on enrollment of non-English speaking individuals for instructions regarding how the short form must be used and documented.

5) Single IRB of Record

The revised rule requires a single IRB to review certain NIH-funded multi-site research. The Yale IRB generally does not serve as the single IRB of Record for multi-site research. We are working with external IRBs that can provide this service.

If you are planning a budget for a grant application for a multi-site research study, ensure that the budget includes appropriate provisions for the external IRB review fees. The Yale Center for Clinical Investigation offers a Research Budget Development service and can help investigators plan accordingly. The HRPP office can also assist. Please contact hrpp@yale.edu if you have questions regarding the external IRB budgeting process. For more information regarding the Yale HRPP Single IRB position, see also the Single IRB (sIRB) Review for Multi-site Research section on the News & Announcements page.

6) IRES IRB System Updates

We are working with a vendor and IRES IRB Support group to implement minor custom changes to the IRES IRB system that will help track studies approved under the revised rule. These changes will be implemented over the course of the next two weeks. A separate communication will be sent out when the change is made to the system.

7) Changes in IRB practices to accommodate the revised rule

Changes to the Approval Watermarks on Consent Forms and Protocol: Beginning January 21, 2019, Yale IRB-approved consent forms and research protocols will include an approval date only in the header and footer of the document. The approval watermark will no longer include a protocol expiration date. This change is necessary in order to manage the different regulatory requirements related to continuing review, and to allow for research no longer requiring continuing review per revised regulations to not have a IRES-IRB system-generated expiration date added to the consent form. Below is the explanation of the new practice for approvals of initial, modification, and continuing review submissions.

• New Research Study: The Yale IRBs will issue the consent and protocol documents with the initial approval date. 
• Modification to the consent document: The Yale IRBs will issue the revised consent and protocol documents with approval date of the modification.
• Continuing Review: The Yale IRBs will issue the consent and protocol documents with the approval date of the continuing review.

The approval watermark on currently approved documents will not be changed until the next action on the protocol.

The principal investigator and the research study team is responsible for monitoring the expiration date of the study for continuing review purposes. To help with this responsibility, IRES IRB sends system-generated reminders to the PI and the PI Proxy 75 days, 45 days, and 30 days prior to the expiration date of the protocol. In addition, an expiring study report in IRES IRB is available to the investigator and study team at any time. The report includes a list of the studies associated with the PI in order of study expiration.

We recognize that this change may require adjustments to your practices regarding versioning of documents. For ideas regarding how to best track versions of your documents and keep track of the expiration dates, please, see Researcher Guide: Guide: Consent Version Control and Tracking located  in the Help Center of IRES IRB.

Please note that the Yale HRPP may require specific versioning of documents in the future. When this occurs, we will inform you prior to the implementation of this change.

8) Next Steps

The Yale HRPP and Yale Center for Clinical Investigation (YCCI) will offer live training sessions that will focus on the changes to the regulations and how they affect research.  We will also provide specialized training, including training for central campus. A separate communication will be sent when registration for the training offerings is available.

If your study is authorized for review by any of the external IRBs, the HRPP will work with the IRB to ensure the same implementation standard.

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

Thank you for your patience during this transition period.

Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality

Effective October 1, 2017, all NIH-funded research that was commenced or ongoing on or after December 13, 2016 and collects or uses identifiable, sensitive information is deemed to be issued a Certificate of Confidentiality, and is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act.

Note:

• “Identifiable, sensitive information” means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research, where the following may occur:
  • An individual is identified; or
  • For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.
• The NIH will continue to consider request for Certificates for non-federally funded research in which identifiable, sensitive information is collected or used.
• For more information, please visit the Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality website
• Visit the National Institutes of Health’s internet site on Certificates of Confidentiality website
• Visit CoC Contacts at NIH and Other DHHS Agencies that Issue Certificate website
• Please contact the Yale HRPP Office (hrpp@yale.edu) with any questions. Training materials on CoCs are being developed.

April 28, 2017
The HRPP office has received questions regarding ClinicalTrial.gov disclosure requirements. To assist in better understanding of the ClinicalTrials.gov registration and reporting requirements, please refer to HRPP Policy 1000, Clinical Trial Registration and Results Reporting Requirement. See also the 04/27/2017 Office of Research Administration notice.

Principal Investigators may contact the Yale Center for Clinical Investigation (YCCI) for assistance with ClinicalTrials.gov registration and reporting for more information.
 
Principal Investigators who are unsure as to whether a clinical trial is subject to ClinicalTrial.gov disclosure requirements should contact Yale.CTgov@yale.edu or HRPP@yale.edu for assistance.

Monday, April 3, 2017
A revised HRPP procedure 920 PR.4 titled ‘Use of External IRBs for Review and Oversight of Research Involving Human Subjects’ went into effect Monday, April 3, 2017.

The revised procedure allows the HRPP to consider and allow the use of external (commercial) IRBs for a broader range of research studies. The procedure delineates the process in which Yale investigators can request review by an external IRB and describes the responsibilities of Yale, the investigator, and the external IRB after the study is approved for external IRB review.

Currently, Yale maintains agreements with Western IRB (WIRB) and Quorum Review. Agreements with additional IRBs including BRANY, Chesapeake, Hummingbird, and Schulman will be finalized soon. Each of the IRBs will be invited to provide live training to the Yale research community regarding the use of their electronic portals, protocol submission processes, reporting requirements, and other aspects of their operations and review capabilities. Announcements with training dates will be emailed later this month.

A quick guide on requesting review by an external IRB is available in the Help Center section in IRES IRB. Questions regarding the revised procedure can be sent to HRPP@yale.edu.

Good Clinical Practice Training Requirement

January 2, 2017

The requirement for Good Clinical Practice training for all investigators and staff involved in the conduct, oversight, or management of clinical trials was announced to the research community on December 22, 2016. The details regarding the training are available in the memo from Pamela Caudill, Senior Associate Provost for Research Administration.

New IRES IRB Electronic Protocol Submission System

January 2, 2017

The HRPP is pleased to announce a new IRES IRB electronic protocol submission system is LIVE for our research community!

The first group of researchers to migrate over to the new system was in July 2016. Other departments migrated over in the weeks/months after with all departments migrated in December 2016. Training sessions have been offered prior to each department going live.

Many hours have been dedicated to making this new system user friendly, reliable and efficient. We strived to provide Principal Investigators and study personnel with a system that aids in a smoother protocol submission, review and approval process.

Thank you for working with us throughout this exciting transition period! Any questions please contact IRB.Support@yale.edu.