Public Health Emergency Research Review Board - PHERRB 

Overview

The purpose of the Public Health Emergency Research Review Board (PHERRB) is to provide institutional review board (IRB) review of public health emergency research (PHER) protocols that are:

  • conducted, supported, or regulated by the U.S. Department of Health and Human Services (HHS);
  • subject to 45 CFR 46 and, as applicable, 21 CFR 50 and 56, and
  • are multi-site studies or studies that would otherwise require multiple IRB review.

The National Institute of Health (NIH) Intramural IRB (NIH IRB) serves as the PHERRB. The mandate of the PHERRB is to provide investigators with expert, expeditious IRB review of human subjects protections within PHER protocols. By eliminating the need for multiple IRBs to review multi-site protocols, PHERRB review is envisioned be an efficient review process that should save both time and resources. The PHERRB is administered by the Office of IRB Operations (IRBO) within the Office of Human Subjects Research Protections (OHSRP), in the NIH Intramural Research Program (IRP).

Contact the PHERRB


AAHRPP Activities 2021- 2022 - Reaccreditation of the NIH IRP HRPP


eIRB System Selection and Transition Communication #2


NIH Research Community,


As you know, the Office of Human Subjects Research Protections with the guidance of the NIH eIRB Steering Committee is beginning the process of considering alternative eIRB systems to our current system, iRIS by iMedris. We wanted to provide a brief recap around what has happened since our last communication in July.


August 2020


A few months ago we sent out an eIRB system selection survey to collect feedback from the research community around what they desired in a new system. This survey was created based on information provided by the steering committee members. Below is a high-level overview of around the feedback we received. For more details, please see the appendix to this document.


  • 439 responses to the survey
    • Percentage of responses by ICs listed in Appendix I
  • Top 10 highest rated requirements from survey determined by research community listed in Appendix II
  • Received 396 individual comments under “other comments not included in survey.” Major themes covered:
    • Intuitive system
    • User friendly
    • Better document versioning
    • Improved ability to “search”
    • Improved reporting capabilities
    • Welcome page/dashboard to understand where your protocols stand
    • Improved status tracking of protocol
    • Easier access to protocols/documents in system
    • Improved ability to upload documents in system
    • Access to “help” while using the system
    • Ability to add comments on forms where appropriate


The feedback has been compiled and is being used to make decisions around functionality. We want to thank the research community for taking the time to take the survey and make additional suggestions.

 

October 2020

 

Since then, we have started working with Axle Informatics, a consulting firm, to further guide us through the system selection process. They have taken the survey response data, as well as the raw data from the steering committee that went into creating the survey, to begin to create a comprehensive list of system requirements to ensure a new system can function successfully within the constraints of the NIH IT landscape, while meeting the functionality needs of the NIH research community. Axle has engaged stakeholders individually across the NIH to provide additional feedback about their needs in a system, to ensure no stone goes unturned, and that we make an informed decision. These stakeholders include:


  • OHSRP iRIS IT team
  • Assembly of Scientists (representatives)
  • NIH Investigators who use iRIS (representatives)
  • Staff Clinician Council Chairs
  • Jason Levine (NCI CCR Office of Information Technology)
  • Jon McKeeby (CIO for the Clinical Center)
  • Kim Mitchell from the Clinical Center Office of Protocol Services
  • Office of Research Support and Compliance (ORSC)
  • Protocol Management Leadership across NIH


Axle has also started reaching out to vendors suggested by the eIRB Steering Committee, but also vendors they have found through their own independent research, to determine possible solutions. The eIRB Steering Committee will be made aware of which vendors at a high level can meet our needs. Once a deeper dive is completed, we will be reaching out to the NIH research community to attend vendor demonstrations of systems that are our top contenders. More information to come on dates for these sessions.

 

Closing


We will be updating the research community in blasts like this one throughout the duration of the project, so please check back here for additional information in the future. They will become more frequent as we have more information to share. Should you have any questions, please reach out to Meredith Mullan, who is leading this effort.


Thank you!

The Office of Human Subjects Research Protections


Appendix I:


Appendix II:

Top 10 highest rated requirements from survey determined by research community:

Question

Rating

(Scale: 1-3)

Provide easy access to and identification of the currently approved study documents (ie, most recent approved consent, protocol etc).

2.95

Ability to enable electronic notification of study team when protocol approval is due for renewal at the defined points in time and when a study lapses.

2.90

Ability to verify that required fields are completed prior to finalizing submission and prevent submission of an incomplete application.  Contain validations that will alert if submission contains inconsistencies.

2.85

System should provide easy access to most currently approved consent document.

2.83

Ability to manage documents taking into account the following: PDF creation for approved forms and attachments, manage approved study documents for study teams/IRB office review, ability to generate letters without active X, system generated pre set naming conventions for documents, version control and tracking of documents, easy comparison of different selections of application.

2.81

Ability to track the date the submission is received.

2.78

Ability to track who completed the IRB documents and who to contact if there are questions.

2.78

Ability for system to document and track regulatory determinations, and the ability to incorporate determinations into outcomes. Ability to select and document more than one pediatric risk category to support component analysis.

2.75

Ability to submit non-compliance and unanticipated problems in the system.

2.74

System should provide dashboard/easy visualization of ongoing and upcoming tasks, events, submissions (all work-in-progress, queues, etc. for IRBO).

2.74

eIRB System Selection and Transition Communication #1


NIH Research Community,


As you have already been informed, the Office of Human Subjects Research Protections with the guidance of the NIH eIRB Steering Committee is beginning the process of considering alternative eIRB systems to our current system, iRIS by iMedris. We have formed a steering committee that meets monthly to bring key NIH stakeholders together. The members of the steering committee include:


  • Bradley Alvarez
  • Bibi Bielekova, M.D.
  • Melissa Bryant
  • Marcelo Fontinha
  • Nancy Fryzek
  • Tiffany Gommel
  • Nicole Grant
  • Jonathan Green, M.D.
  • Ramesh Karuppiah
  • Jason Levine, M.D.
  • Jon McKeeby, DSc
  • Tracey Miller
  • Meredith Mullan
  • Sue Tindall


This is to ensure that various NIH interests are represented in determining an alternative eIRB system since this system will impact the entire NIH research community. However, input to this process does not stop with the NIH eIRB Steering Committee. We also need the input of the entire NIH research community to be able to make an informed decision. Over the next few months, we will be engaging you to provide your opinion in the following ways:


  • NIH eIRB System Selection Requirements Survey
    • The purpose of this survey is to gain an understanding of what the NIH research community needs in a system from a functionality perspective. The information gathered here will be used to determine which eIRB system vendors can meet the needs of NIH. The results will be anonymous
  • Vendor Demonstration Attendance
    • eIRB vendors will be brought in, (in person or virtually depending on circumstances at that time), to present their system to the research community. Feedback will be requested after each demonstration. More information around dates and times of these demonstrations to be announced


Based on the feedback received from the two forums listed above, the Office of Human Subjects Research Protections with the eIRB Steering Committee will work to come to a decision on which vendor to move forward with. When this decision is made, it will be communicated out, and an implementation plan will be put in place. The research community will be engaged again at a later date to better understand current state workflows that will help to mold the future state system.


We want to thank you for your participation in advance. The decision to move to a new system is not being taken lightly, and we want to thank you for your support as we consider making this change. Should you have any questions, please reach out to Meredith Mullan, who is leading this effort.


Best,

The Office of Human Subjects Research Protections


Home    /    News    /    OHSRP Newsletter - 2020 Q3


IRBO Update - 2020 Q3


Since our last update, the following new staff have joined the office: Lisa Bingaman- IRB Coordinator, Kelly Pauly-IRB Coordinator, Mollie Fraser -Program Specialist, Kevin Rasmussen-iRIS Trainer. We are excited to have them as part of our team!

During this past quarter, the IRBO sent out a number of notifications to the research community through the NIH iRIS Notification System which included important information for investigators and research support staff. We have summarized this information here for your convenience.

July 7, 2020 - Avoiding Having Your Protocol Lapse

Continuing Review (CR) of research by the IRB provides assurance that research activities remain approvable and that appropriate human subjects protections are in place. Ensuring that continuing review (when required) occurs in a timely manner, is a shared responsibility of both the Principal Investigator and the IRB. When IRB approval for a study lapses, all research activity must cease, except for those activities necessary to ensure the safety of research participants (with permission from the IRB Chair). Lapses in IRB approval are disruptive to the research and place the investigator and institution at regulatory risk as well as risk our status as an AAHRPP-accredited Human Research Protections Program (HRPP).

To facilitate timely continuing review, we ask that study teams submit their CR application to the IRBO 6 weeks ahead of the study expiration date. iRIS will send system generated messages to the study contacts at 75, 60 and 30 days prior to the expiration date to prompt you to submit your CR Application to the IRBO.

If a study team fails to submit the CR application and the study lapses, the IRB will enforce the following policies:

  • The IRBO will not review any new studies submitted by the Principal Investigator of the lapsed study until the CR has been submitted or the study has been properly closed.
  • If 45 days after study expiration, no CR application or study closure has been submitted, the IRB will administratively close the protocol. Continued research will require submission of a new protocol to the IRB.

August 10, 2020 – Updated Consent and Protocol Templates

  • Consent Library: The consent library, found on the OHRSP website, has been greatly expanded to include descriptions and risks of numerous common procedures. Please note that most of this is suggested language. However, the GINA language and language regarding the risks of radiation should not be altered. We have now expanded the radiation risks to include the language for therapeutic radiation and radiation reviewed by the RDRC. This is a living document, and we will continue to add to it, so make sure to periodically check it out.
  • Interventional Drug and Device Clinical Trials Protocol Template: This template has been updated with minor updates to make it consistent with new policy and the Natural History Protocol Template.
  • NCI CIRB Approved Local Context Consent Templates (English & Spanish): These templates are to be used for studies reviewed by the NCI CIRB which are conducted in the Clinical Center. Please note that you cannot alter the template language in any way.

The Consent Library and the templates referred to above can be found on the “IRB Templates” page of the OHSRP website.

August 31, 2020 & September 18, 2020 - “Tips & Tricks for Submitting to the NIH IRB”

Continuing Reviews (CRs)

  • You cannot make any changes to the protocol or consent form(s) at the time of continuing review.
  • If you have consented subjects since the last CR, you must submit a redacted consent form(s). Redacted means that you have removed all PII associated with the subject (e.g. his or her signature). The date the subject signed the consent should not be removed.
  • If NIH is the coordinating site and other sites have local IRB approval, you must attach copies of the most recent local IRB approvals.
  • You must include a high-level summary of any minor and major protocol deviations (PDs), non-compliance, AEs and SAEs that have occurred since the last review, and all unanticipated problems (UPs) that have been reported during the last CR period.

Amendments (AMs) and New Protocols

Protocol

  • Remove all NIH personnel aside from the PI from the title page and include these individuals as part of a separate Study Personnel Page.
  • Delete the “Investigator Qualifications” section.
  • Include the blood volume amounts that will be obtained at each blood draw and the total amount of blood volume obtained over a two-week time period.
  • Screening and Natural History protocols: Ensure you have only listed research procedures and removed clinically indicated procedures or have clarified which procedures are being done for research vs. clinical purposes.
  • Remove the “Classification of Risk” Section and all IRB determinations of risk, including statements such as, “This study has direct benefit, so only one parent signature is required.”
  • If the study involves a non-significant risk (NSR) device, ensure this is described.
  • Pregnant Women: If you wish to enroll pregnant women or allow women who become pregnant to remain as part of your protocol, you must revise the protocol to provide a justification that demonstrates that the study objectives cannot be met without including pregnant women. In accordance with 45 CFR 46.204(b), you must make the case that “The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means”.
  • For studies approved before January 21, 2019: If you are conducting screening activities before consenting and obtaining a signature from subjects, include a request for a waiver of informed consent (or a request for a waiver of documentation of informed consent, e.g. if you are using a phone script to consent subjects).
  • Remove the use of a witness during the long form and telephone consent processes.
  • Remove a request for approval to use the short form consent process.
  • Secondary Research protocols: Ensure there is a section requesting a waiver of informed consent along with a justification which addresses all of the criteria in the regulations. (See the “Secondary Research” protocol template on our website).
  • If enrolling children, describe the planned assent process and indicate ages of verbal and written assent.
  • Update to include safety and event reporting information that is consistent with Policy 801.

Consent Forms (CFs)

  • If you are transferring old consents over to the new template, or creating a new consent, form, always use the most current consent template that is posted on the OHSRP website.
  • In the most recent consent template version (Revised Common Rule), the language regarding the storage of specimens/data for future use and sharing is now in blue. If you are conducting your study in the United States, you must include this language and may not alter it (except to choose those sections which apply to your protocol). If your study is being conducted internationally, you may alter this language, as appropriate to the locale of the research.
  • Remove inclusion/exclusion criteria.
  • Update to include the current radiation safety language.
  • Include blood volume amounts obtained at each blood draw and the total amount of blood volume obtained over a two week period. The volumes should be labeled in household terms (teaspoons and/or tablespoons); e.g. 5mL=1 teaspoon, 3 teaspoons =1 Tablespoon.
  • Address the use of non-significant risk (NSR) devices
  • Covered protocols: Include the proper COI language.
  • For COVID studies, unless behavioral research where research procedures are limited to questionnaires, include the PREP ACT language.
  • Prior to submitting the consent forms to the IRB, keep only the signature blocks that are applicable to your study and delete the blocks which are not applicable.

Responding to Stipulations during Pre-Review

  • When responding to stipulations, please keep all changes in tracked form, during the various rounds of submissions to the IRB, i.e. the cumulative changes should be visible to the IRB.


The complete “Tips & Tricks” document can also be found on the “Policies & Guidance” page under “Other Guidance Documents” section of the OHSRP website.



Home    /    News    /    OHSRP Newsletter - 2020 Q3


Compliance & Training Update - 2020 Q3


During this past quarter of 2020, the OHSRP Education Series included a 2-part presentation by the IRB Office Reliance and Single IRB team (July and August 2020) that is now available in the archived presentations section on the OHSRP website. This link provides access to the slides and videocasts for all past sessions of the OHSRP Education Series. The Reliance and Single IRB team is also hard at work updating their presence on the IRBO website including revisions of existing resources and preparing new tools to assist investigators/study teams to conduct multisite research. These will be available later in 2020 and will include resources for those relying on an external IRB, such as NIH Institutional Review guidelines and consent templates. For NIH study teams leading multi-site research, resources will include a revised decision tree to help establish if and what type of agreement may be needed e.g., reliance agreement. Additionally, the slides and videocast link for the September session, NIH Policies Related to Enrollment of Pregnant Women, Participants Lacking Capacity to Provide Informed Consent, and Prisoners: Current Status and Recent Updates are also available on that link. The next session on October 6th from 3-4 PM will be available via live NIH videocast at which time Dr. Jonathan Green and Meredith Mullan from OHSRP will present “Transition to a new eIRB [electronic IRB] System: Where we are now, and where we are going.” The videocast and slides will also be available after the session on the OHSRP archived presentations.

As new investigators join NIH, OHSRP has been receiving more questions lately related to human subjects research training requirements, and individuals can refer to Policy 103, Education Program, which spells out the NIH HRPP training requirements based on what type of human subjects research will be conducted. Additional information is available in the guidance document that accompanies the policy. We also have been responding to queries regarding accessing the current site for the required CITI training via the NIH CITI portal. The only portal that NIH investigators should use to access CITI training is the one that links from the Compliance and Training page on the ORSRP website. This is critical because this is the only site that allows CITI training completion records to download automatically into iRIS, the system that the NIH Intramural Research Program uses for IRB document management purposes. These FAQs explain how to access the appropriate NIH CITI portal, how to create an account in CITI via that portal, how to transfer CITI completion records completed at another site into the NIH CITI portal and other questions that will help the user navigate the processes needed to complete and document the required training. The OHSRP Division of Compliance and Training has posted additional educational resources to the OHSRP website including a guide for completing reportable event forms (REF) in iRIS. This provides step by step instructions as well as screenshots and tips to assist investigators in REF submission. We have also added a Reportable Events Flow Diagram to assist investigators in understanding the process of REF submission and review as well as referral to the NIH IRB if the event is a possible unanticipated problem or to the NIH Research Compliance Review Committee if the event constitutes possible serious and/or continuing noncompliance. FAQs related to handling of IND and IDE Safety Reports have also been added, and these clarify when these reports should be submitted to the NIH IRB. Coming soon-we will be posting a topical index that lists the various resources available on the OHSRP Website as well as links to federal guidance documents for each topic.

Home    /    News    /    OHSRP Newsletter - 2020 Q3


Policy Update - 2020 Q3


Human Research Protection Program (HRPP) policy development is wrapping up. OHSRP began rolling out the policies late this Summer, the remaining policies will be rolled out through the end of 2020. To aid in understanding key information about each policy, OHSRP has also developed supporting tools for the community, an overview/change table and a narrated presentation.

  • The overview/change table is a tool for investigators and study teams that highlights key points of the policy and any changes from the previous SOP(s).
  • The narrated slides are a brief overview of the key points of the policy and are aimed at a broader audience, for example IRB members or IRBO staff in addition to investigators. These slide decks also include helpful tips for investigators such as what the IRB expects related to the policy.

OHSRP recognizes that the rollout schedule is aggressive, particularly given the large number of policies. This schedule is due to the fact that the NIH HRPP is about to undergo reaccreditation with AAHRP (see Accreditation Updates below for more information).We understand that this can cause anxiety and raise questions about implementation of changes resulting from implementation of the policies.We hope you saw the email regarding the Guide to Implementation of HRPP policies sent on September 15th. Although the policies have a new format and the policy topics have been reorganized, there are not a lot of new policy requirements. The new policy requirements address the revised Common Rule (45 CFR 46), the reorganization OHSRP and consolidation of the NIH IRBs. In addition, we hope that we have fixed issues from the previous SOPs. Below are helpful tips for implementation of the HRPP policies:

  • Each policy has a release date and an implementation date.
    • The release date is the date we post the policy on the web and make it available.
    • The implementation date is when you should begin following the new policy requirement on your research.
  • If a new policy impacts what is written in your protocol or consents, you do not need to immediately revise the protocol or consent(s) to be consistent with the revised policy. In fact, we would prefer that you do not revise your protocol/consent(s) immediately, as this will lead to a surge in amendment submissions which would rapidly overwhelm the IRB office. When to implement these changes in your protocol and consents:
    • With your next planned amendment to the IRB. However, even if you do not update the sections with an amendment, the IRB will not stipulate that you update the documents at this time. OR
    • In early 2021, when the IRB office will begin requiring that the relevant sections of the protocols/consents be updated.
  • However, you should change your actions to implement the new policies on their effective date, even if your protocol or consent(s) is not updated.
    • For example, the new policy on enrolling subjects who cannot consent for themselves (Policy 403) changes who can serve as the LAR for research in Category C research, and specifies a new next of kin hierarchy. You should follow the new next of kin hierarchy described in Policy 403 upon the effective date of Policy 403 (September 14, 2020), even if your written protocol does not reflect this practice.
  • Lastly, we know that when your protocol/consent does not match your actions, concerns arise about protocol deviations and the need to report them. You do not need to submit a Reportable Event Form (REF) for a protocol deviation during the time period between the implementation of new HRPP policies and early 2021 when IRB will start enforcing compliance with the policies in protocols and consents, or when your protocol is revised to match the new policy requirement, whichever is earlier.

If you have any questions about policy implementation, please reach out to OHSRP at irb@od.nih.gov.


Accreditation Activities

The clock is ticking! On September 15, 2020, OHSRP received the 6-month reminder for the AAHRPP Step 1 Application for re-accreditation. The Step 1 Application is due on March 15, 2021. This Fall, OHSRP will be reaching out to IC AAHRPP Liaisons to kick off data collection for the Step 1 application. Once the Step 1 Application is accepted by AAHRPP, OHSRP will be begin the Step 2 Application process leading up to the site visit. Leading up to the site visit, OHSRP will start educating the members of the NIH HRPP community who have been selected by AAHRPP to be interviewed during the site visit scheduled for January 2022. AAHRPP selects a representative cross-section of the NIH HRPP to be interviewed during the site visit including: NIH and IC leadership, Principal Investigators, research team members, IRB members, IRB staff and OHSRP staff. Keep an eye on the OHSRP Policy page accreditation section for more information.

Home    /    News    /    OHSRP Newsletter - 2020 Q3

OHSRP Newsletter 2020 Q3


Letter from the Director

September 16th was my 2-year anniversary of coming to the NIH. When I reflect on what we have accomplished together during these past 2 years, it is no wonder that sometimes I feel tired….as I am sure you do also. The road has been and still is bumpy, although I think the potholes are less deep and not as frequent. There is no doubt the pandemic has adversely impacted the ability of our office to consolidate and streamline its operations and develop the critical team structures that are needed to function optimally. Despite this, we continue to...


IRBO Update

During this past quarter, the IRBO sent out a number of notifications to the research community through the NIH iRIS Notification System which included important information for investigators and research support staff. We have summarized this information here for your convenience.


What's New in iRIS?

The iRIS team continues to streamline and make more efficient the iRIS workflow. Here are some of the improvements made for you in the late spring and summer...





Compliance & Training Update

During this past quarter of 2020, the OHSRP Education Series included a 2-part presentation by the IRB Office Reliance and Single IRB team (July and August 2020) that is now available in the archived presentations section on the OHSRP website. This link provides access to the slides and videocasts for all past sessions of the OHSRP Education Series. The Reliance and Single IRB team is also hard at work updating their presence on the IRBO website including revisions of existing resources and preparing new tools to assist investigators/study teams to conduct multisite research. These will be available later in 2020 and will include...


Policy Update

Human Research Protection Program (HRPP) policy development is wrapping up. OHSRP began rolling out the policies late this Summer, the remaining policies will be rolled out through the end of 2020. To aid in understanding key information about each policy, OHSRP has also developed supporting tools for the community, an overview/change table and a narrated presentation...


Contact us

Have questions/comments for OHSRP or IRBO? Need help with iRIS?


Home    /    News    /    OHSRP Newsletter - 2020 Q3


Letter from the Director - 2020 Q3


September 16th was my 2-year anniversary of coming to the NIH. When I reflect on what we have accomplished together during these past 2 years, it is no wonder that sometimes I feel tired….as I am sure you do also. The road has been and still is bumpy, although I think the potholes are less deep and not as frequent. There is no doubt the pandemic has adversely impacted the ability of our office to consolidate and streamline its operations and develop the critical team structures that are needed to function optimally. Despite this, we continue to make progress and are in every way I can think of a totally respectable IRB, staffed by dedicated, committed professionals.

Recently, the leadership of OHSRP came together and developed a vision statement.

We will promote the safe and ethical conduct of human subjects research by

  • providing timely, consistent and compliant reviews
  • educating our community
  • communicating effectively and responsively
  • collaborating with stakeholders

and thus, will be recognized as national leaders in human subjects protections.

We think this captures well what we believe it means to be the best IRB. We evaluate every decision we make against this vision to assure it is in alignment.

We have begun the process of investigating whether we should replace our current electronic IRB submission system, iRIS, with another system. Having a user friendly, streamlined IRB submission system aligns well with our vision by facilitating timely, consistent and compliant reviews. Believe me, we understand the impact of even thinking about such a change, and it is not something we are taking lightly. There are several reasons that we are considering this change. First, user satisfaction across all user groups for iRIS is very low. When we surveyed the NIH community, 70%of researchers, 62%of IRB members and 83%of IRB staff disagreed or strongly disagreed with the statement “Overall I am very satisfied with the iRIS system”. Second, the workflow processes within the system are such that they significantly hinder our review process. In addition, the system is designed in a way that makes it very difficult to accurately document important regulatory determinations. For these and several other reasons, we feel it is important to at least explore if there is a system that can better serve all of our needs. Rest assured, we will engage and collaborate with all stakeholders throughout this process. We will be presenting a session via videocast on October 6th to discuss this project in greater detail. Please be sure to tune into this to learn more.

The NIH Intramural Research Program is now a signatory to the SMART IRB Master Reliance Agreement. We are now part of a collaborative of 800 institutions nationwide that have signed the agreement. What this means for our researchers is that when we are participating in multi-site research that uses a single IRB, if our partners are also SMART signatories, we do not need to negotiate a separate reliance agreement. The SMART agreement serves as the reliance agreement. While this does not remove all the barriers to single IRB review, our hope is that it will significantly reduce burden and streamline the process. Our heartfelt thanks to all who worked so hard to get the agreement to a place where NIH could sign.

Our key metrics for the last period are shown below.





Home    /    News    /    OHSRP Newsletter - 2020 Q3


What's New with iRIS - 2020 Q3


The iRIS team continues to streamline and make more efficient the iRIS workflow. Below are some of the improvements made for you in the late spring and summer:

  • New -Auto Numbering of IRB Applications
    • iRIS was revised to auto create an application’s IRB number in the system upon creation of the form. This eliminated the manual process of assigning a number that was previously taking place.
  • Revised-Not Human Subjects Research (NHSR) application
    • The NHSR application was revised to be more streamlined and to be created in the same way as other iRIS applications.
  • Revised -Ancillary review trigger Qs
    • The amendment form was revised to only require completion of relevant sections if only the following were selected:
      • Investigator Brochure Submission Form
      • KSP Changes Form

“Ask the iRIS Trainers” Brownbag lunch session

These recurring monthly ‘Ask the Trainer’ brown bag lunchtime sessions will be held panel-style. Users should come prepared with their general questions for all to learn from. We hope that you join us!

You can find more information, including upcoming schedules, on the iRIS Training page.

New Policy Implementation Guidance


September 15, 2020


Dear Research Community


Over the past 18 months, we have rewritten the HRPP policies to be compliant with the revised common rule and consistent with the reorganization of OHSRP and the NIH IRBs.  As these policies are all inter-related, with few exceptions we were not able to implement them as they were developed and cleared.  Now that they are complete, we are rolling them out in groups between now and years end.  We understand that releasing so many new policies rapidly is a little overwhelming.  Hopefully, as you become familiar with the new policies, you will see that in many cases there is not a lot of change in the actual policy requirements, and for those that there is change, it is for the better.


To guide you in the implementation of these new policies, please review the following:

  • Each policy has a release date and an implementation date.  The release date is when we post it on the web and make it available.  The implementation date is when you should begin following the new policy requirement in your research.
  • If a new policy impacts what is written in your consent or protocol, you do not need to immediately update the consent/protocol to be consistent with the revised policy.  In fact, we would prefer that you don’t, as this will lead to a surge in amendment submissions which would rapidly overwhelm the office.  You can update the documents with the next planned amendment to the IRB.  Even if you do not update the sections with an amendment, the IRB will not stipulate that you update the documents at this time.  At some point in early 2021, the IRB office will begin requiring that the relevant sections of the protocols/consents be updated.

For example, the new policy requires that the protocol and consent describe the compensation plan, even if the plan is that there will be no compensation.  Some protocols that are not compensating subjects are silent on this.  At this time, you do not need to amend your protocol to add a new section stating there is no compensation. With your next planned amendment you can change this.

  • You should implement the new policies on their effective date, even if your protocol is not updated.  For example, the new policy on enrolling subjects who cannot consent for themselves (Policy 403) changes who can serve as the LAR for research in Category C research and specifies a new next of kin hierarchy.  You should follow the new policy as of the effective date of September 14, but you do not need to immediately amend your protocol.  You should change this section of your protocol only with your next planned amendment.  In this case, even though your protocol does not match your actions, you do NOT need to submit a Reportable Event Form (REF) for a protocol deviation.

OHSRP Education Series 2020: What You Need to Know About Single IRB Review: Principles and Practice (Part 1)



July 07, 2020 / Jeffrey Rollins and Shirley Rojas


Videocast


This is an interactive PDF. Use the arrows to navigate between slides. You may also download the entire PDF by selecting the download icon next to the slide navigation.

Home    /    News    /    OHSRP Newsletter - 2020 Q2

OHSRP Newsletter 2020 Q2


Note from the Director

We are approaching the 6-month mark for the consolidation of all the legacy IRBs into the new NIH Intramural IRB (NIH IRB).  I know that this has not been the easiest transition for the NIH community, and I thank you for your support and patience as we continue to build our new organization.  Our goal is to serve the intramural research community by providing optimal protections for our research subjects and facilitating the ethical conduct of the life-saving research conducted here at NIH....


IRB Operations Update

IRBO at home, Considerations When Writing a Protocol During the COVID-19 Pandemic, Amending Studies, New Protocols, & Continuing Reviews/Progress Reports for Studies REviewed on or after January 21, 2019


What's New in iRIS?

The iRIS team continues to streamline and make more efficient the iRIS workflow.  We thank all of the research community for their feedback in the development and testing of these improvements.  Click below to read about some of the improvements made for you in the first half of this year.





Compliance & Training Update

The OHSRP Education Series for 2020 continues, albeit virtually for now, and the archived presentations can be found here on the OHSRP webpage.  Once you click on the title of a specific session, a link to the videocast is also provided. The IRB Office Reliance and Single IRB team will be presenting a two-part education session in July and August. Part I will cover fundamental concepts...


Policy Update

The revision of the human research protection program (HRPP) policies is ongoing. To date 22 HRPP policies have been approved, of which three (3) have been released and are implemented. The implemented policies are located on the Policy page on the newly updated OHSRP website. All other HRPP Standard Operating Procedures (SOPs) continue to...


Contact us

Have questions/comments for OHSRP or IRBO? Need help with iRIS?