January 2019


NEW -  Proposal Submission Deadline Policy  - Begin March 4th, 2019

As of February 27, 2019, all new study and continuing review/study closure submissions must be submitted in myResearch IRB

Resumption of Operations at NSF 

Resumption of Operations at NSF page has been developed that includes Important Notice No. 145, Resumption of Operations at the National Science Foundation, dated January 28, 2019, as well as supplemental guidance that addresses grant and cooperative agreement-related policy and systems issues.  This page will continue to be updated as new information becomes available. 

Policy-related questions regarding resumption of operations at NSF may be addressed to policy@nsf.gov.

UPDATE, Feb. 1, 2019: Important revisions have been made to the Resumption of Operations at NSF page on the NSF website, including identification of new deadline dates for specific solicitations and Dear Colleague Letters.

Final Rule – Changes to the Common Rule

Just a reminder that the Final Rule changes to the Common Rule are coming January 21st, 2019. These changes apply to studies that were submitted but have not been approved prior to the January 21st, 2019 deadline. What this means is studies that have been deferred by the Institutional Review Board (IRB) or were conditionally approved need to get their response in and the study approved before January 21st, 2019.

Here is a brief overview of the major changes that will be coming in January 2019. It is important to note that ongoing research studies that were initially approved by an IRB or determined to be exempt before the effective date will not be required to comply with the changes.

  • Exempt research contains many new requirements, primarily due to added regulations when using human-derived biospecimens in research
  • Exempt categories have been expanded. There are more types of research that now qualify for the expanded exempt categories.
  • Elimination of continuing review for expedited studies (unless the reviewer justifies that it would enhance the protection of subjects). Expedite studies would still need a “status report” every 2 years.
  • Addition of “key Information” to the informed consent form (see recent “blast” regarding key information)
  • Greater than minimal risk research initially reviewed by the convened IRB, now does not require continuing review when the research involves either one or both of the following:
    • Data analysis, including analysis of identifiable private information or identifiable biospecimens; or
    • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical car

​​​​​​​For more detailed information about these changes, please go to the following link: https://research.stonybrook.edu/officenews/2516

Common Rule Changes and Exempt Review

As we are getting closer to the implementation of changes to the Common Rule we would like to continue communicating upcoming changes to the research community. Another major change to the Common Rule is the increased ability to use the exempt category. There are more types of research that now qualify for these expanded exempt categories than in the past. These include the following:

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if the following criteria is met:
-The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.
-For these types of studies, the IRB would conduct a “limited IRB review” to determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.

Research involving what is called “benign behavioral interventions”** (see below for definition) in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
-Identity of subject cannot readily be ascertained.
-A disclosure of subject responses outside the research would not place the subject at risk. In this type of research, and the identity of subjects cannot readily be ascertained.
-The information obtained is recorded in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.

For studies meeting this last criteria, the IRB would conduct a “limited IRB review” to ensure that there are adequate protections to protect privacy of subjects and confidentiality of the data

Research in this category can also receive an exemption if the research involves deceiving the subjects regarding the nature or purposes of the research. However, an exemption is not applicable unless
the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the
nature or purposes of the research.

**A benign behavioral intervention is an intervention that is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

Provided all such criteria are met, examples of such benign behavioral interventions would include having the subject play an online game, having the subject solve puzzles under various noise conditions, or having the subject decide how to allocate a nominal amount of received cash between themselves and someone else.

Common Rule Changes and Continuing Review

January 3, 2019

As we are getting closer to the implementation of changes to the Common Rule we would like to continue communicating these changes to the research community. Another major change to the Common Rule is the elimination of the requirement of continuing review for all minimal risk research submitted on or after January 21st, 2019**. Reviewers will still have the option to require continuing review to enhance the protection of human subjects for particular studies on a case-by-case basis.

There will be a requirement to submit a “status update” every two years. The update method (continuing review or “status update”) will be specified in the initial approval letter. We are asking that the following be included in the “status update”:

Status of the study (actively recruiting, closed to enrollment, etc.)
Training of study personnel
Change in personnel (if applicable)
Conflict of Interest information (if applicable)
Redacted consent (for QA/QI purposes
Unanticipated problems/serious adverse events (if applicable
Changes to the study including changes to the consent form (if applicable)
Funding (if applicable)

You can find the “Research Status Report form” located in IRBnet library.

Although the renewal requirements have changed with the Common Rule, the amendment process remains the same. All changes to a study must be submitted and approved before they can be implemented. Additionally, the consent form will no longer have an expiration date. You will still continue to see an expiration date on the study, as a status report would be due every 2 years.

Continuing review requirements still apply to research reviewed by the IRB that is greater than minimal risk research unless the research involves one or both of the following:
Data analysis, including analysis of identifiable private information or identifiable biospecimens;
Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care

**Please Note: Any studies approved prior to January 21, 2019 will fall under the current common rule guidelines and are required to undergo continuing review annually

Common Rule Changes and the Informed Consent Form

December 14, 2018

As we are getting closer to the implementation of changes to the Common Rule we would like to begin communicating these changes to the research community. One major change is to the informed consent form. The new requirement is to include “key information” and that the “key information” must appear at the beginning of the informed consent form. The rationale behind this change is that the inclusion of “key information” will help the potential participant better understand the research.

What comprises “key information”? There are five factors that encompass “key information”. The five factors include the following:
1. Consent is being sought for research purposes and that participation is voluntary
2. Purpose of the research, expected duration of participation and procedures that would need to be followed
3. Any reasonably foreseeable risks/discomforts to the participant
4. Any reasonably expected benefits to the participant or others
5. Any alternative procedures that might be advantageous to the prospective participant

Additionally, investigators need to present the information in the informed consent form in enough detail and in a way that a prospective participant can comprehend the information.

The Office of Research Compliance is reformatting the consent template to include this “key information”. The template will be available by December in the IRBNet Forms and Templates Library. All applications submitted after December 21, 2018 will require the use of the new template which includes a “key information” section as well as other required changes.

Guidance for Investigators Regarding the Partial Government Shutdown

With the continuation of the partial government shutdown, which began on December 22, 2018, Stony Brook University investigators are reminded that only those agencies that did not receive FY2019 appropriations are affected.  These include: National Science Foundation, National Aeronautics and Space Administration, Department of Homeland Security, National Institute of Standards and Technology, National Oceanographic and Atmospheric Administration, Department of Agriculture, National Endowment for the Arts, National Endowment for the Humanities, and Environmental Protection Agency (this list is not comprehensive, but names the affected federal funding agencies of primary interest to Stony Brook).  Investigators with active awards from affected federal sponsors should continue to work as normal.  Agency contingency plans are currently posted on the White House Office of Management and Budget website, which will be updated as additional plans become available. Although unlikely, if any investigator should receive a “Stop Work Order” or other correspondence from their federal sponsor, the Office of Sponsored Programs must be notified immediately. 

The federal agencies affected by the partial shutdown have limited operations, and investigators should not expect responses to questions posed to program managers or other agency representatives during the shutdown.  Web pages of affected agencies may not be updated with current information, including new funding opportunities and changes to proposal submission deadlines.  Furthermore, panel reviews are likely to be postponed, and no new grants or funding increments will be awarded.  Approvals for changes to awards, including no-cost extensions, are also expected to be delayed.

At the present time, a resolution to the current partial shutdown remains uncertain.  The Office of the Vice President for Research continues to monitor developments, and will update the status accordingly.  At this time, we anticipate that the shutdown will have no immediate impact on research activities for Stony Brook investigators with existing awards.  This assessment may change depending on the duration of the partial shutdown.  We are working closely with The Research Foundation for The SUNY to develop contingency plans if the shutdown continues for a prolonged period.

Investigators should continue to prepare research proposals, no-cost extension requests, and progress reports in accordance with the sponsor’s program guidelines and stated deadlines.  Continue to advise your Grants/Contracts Administrator in the Office of Sponsored Programs of planned submissions well in advance of deadlines.  They will advise you if an affected federal agency is continuing to accept proposals during the shutdown, even when the proposals may not be processed according to their normal timeline.  You are encouraged to continue with your plans to develop and submit proposals; the partial shutdown should not be considered a reason to delay new proposals.

We will update the information as federal agencies release further guidance.  Any questions should be directed to the Vice President for Research.

Update: Partial Federal Government Shutdown – Proposal and Award Review

The Office of Sponsored Programs (OSP) is closely monitoring the partial Government Shutdown. While parts of the federal government (such as DHHS) are fully funded for the entire Fiscal Year ’19, other agencies are not.

Information in this guidance applies only to a number of affected agencies, such as:

Agriculture, Rural Development, Food and Drug Administration

  • National Institute of Food and Agriculture (NIFA)
  • US Forest Services (USFS)

Other USDA Agencies

Commerce, Justice, and Science

  • National Science Foundation (NSF)
  • National Oceanic & Atmospheric Administration (NOAA)
  • National Aeronautics and Space Administration (NASA)

Other Commerce Bureaus & Agencies and DOJ Agencies

Homeland Security

Homeland Security Operational Components

Transportation, Housing and Urban Development

Transportation Administrations

HUD Offices

Interior and Environment

  • Bureau of Indian Affairs (BIA)
  • Fish & Wildlife (FWS)
  • National Endowment for the Humanities (NEH)
  • US Geological Survey (USGS)

DOI Bureaus & Offices

State, Foreign Operations

State Dept. Bureaus and Offices 

The Office of Management and Budget (OMB) has published agency contingency plans along with FAQs and Special Instructions for Agencies Affected.

Affected Sponsor Applications

Grants.gov: It is expected that Grants.gov will be up and that proposals can be submitted, but they will not be forwarded to affected federal sponsor agencies. These applications will be in a holding pattern in Grants.gov.

Other: We will provide details on affected sponsor systems used for proposal submission, as they become known.

If a federal sponsor system has been shut down, applications will be submitted once these systems are back online.


Federal awards from affected agencies will not be issued during the federal shutdown. Awards that have already reached OSP prior to a shutdown will be processed accordingly.

Awards from affected agencies that have been issued an award/project/task number in Oracle can begin or continue work unless notification is received from the sponsor. Cooperative agreements could be affected if federal participation is required, but not available.

Once affected agency systems are back online, OSP will resume processing affected awards after all outstanding current proposals are submitted.


In the unlikely event a sponsor sends a stop-work order, OSP will immediately notify the PI. If you receive a stop-work order, send to osp_contracts@stonybrook.edu.

Budget Extensions

OSP will review Budget Extension requests and put them on hold until affected sponsor notification/approval processes are available.

Other Post Submission/Post Award Requests

For other requests not yet in OSP, please wait until those affected federal sponsor systems and staffing are available and use the standard process.

During the Shutdown

Affected federal agency operations cease during a shutdown. These federal agencies may temporarily stop making payments. Expect a lack of federal communications related to affected agency proposals and awards.

The Office of Sponsored Programs will continue with business as usual within any constraints created by unavailable sponsor systems and staff. OSP’s goal is to process items received to the extent possible.



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