Archived News

• Human Research Protection Program - Changes to the Standard Operating Procedures (Posted April 2024)

  The Office of Research Compliance, Human Research Protection Program would like to announce recent changes made to the Standard Operating Procedures. These changes include the following:

  Added a definition of “federal regulations”:

  • • • “Federal regulations”: Regulations are published by executive branch agencies to clarify their interpretation of a law and how a law will be implemented. Regulations also state requirements or prohibitions.

  Added information regarding “program evaluation”:

  • • • Program evaluation is defined as “the systematic collection of information about the activities, characteristics, and outcomes of programs to make judgments about the program, improve program effectiveness, and/or inform decisions about future program development. What distinguishes program evaluation from research is that they serve different purposes. While research seeks to prove; evaluation seeks to improve.” (Center for Disease Control, Office of Policy, Performance, and Evaluation) Individuals can assess the value and impact of the program when they ask questions, consult partners, make assessments, and obtain feedback. The information collected is then used to improve the program.

  Added information regarding “classroom activities”:

  • • • College classes ask students to perform certain activities for course requirements. To meet the definition of research according to federal guidelines, the project must be for the purpose of developing or contributing to generalizable knowledge. Most classroom projects are not done for the purpose of contributing to generalizable knowledge, but to teach the student about research methods. Information gathered from classroom projects or coursework is then reviewed by fellow classmates and instructors rather than published as a journal article

  Added information regarding “Data Management and Sharing”:

  • • • • The NIH Data Management and Sharing Policy applies only to research grants, not training grants, fellowships, infrastructure grants, instrument grants, nor non-competitive renewals. The policy dictates how data generated using support from these grants must be managed and shared. Scientific Data is defined as “recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications.”The NIH definition excludes “data not necessary (or of sufficient quality) to validate and replicate research findings”, laboratory notebooks, preliminary analyses, completed case report forms, peer reviews, communications with colleagues, and physical objects. (For additional information regarding the NIH Data Management and Sharing Policy see section 17.13 of the Human Research Protection Program policies and procedures.)

  Added information regarding the Family Educational Rights and Privacy Act (FERPA)

  • • • The Family Educational Rights and Privacy Act (FERPA) is a federal law regarding privacy of student records and the obligation of institutions to protect that privacy restricting access to those records. Educational institutions that receive federal funding (administered by the US Secretary of Education) are bound by FERPA requirements. Funding can be withheld if institutions do not comply with FERPA. For FERPA to be set in motion, the information has to be directly related to a particular student and maintained by an educational institution. (For more information regarding the Family Educational Rights and Privacy Act see section 17.18 of the Human Research Protection Program policies and procedures.)

  Added information regarding reporting events that are not serious, unanticipated, or related to the research plan.

  • • • Adverse events that do not meet the criteria of serious, are anticipated and related to the research may be batched, summarized and submitted at the time of continuing review.

• New Research Monitoring Position (Posted Februrary 2024)

  Dear Colleagues,

  The Office of Research Compliance has hired a “Research Monitor”. This position is a new position and the individual hired to conduct these activities is Stephanie Roncone. Since the position is new, Stephanie is undergoing training to learn the Human Subject Protection Program policies and procedures, federal regulations as well as how reviews are conducted for exempt, expedite and full board studies.

  Activities include but are not limited to the following:

  • Pre-study resource evaluations
  • Monitoring of ongoing trials
  • Close-out monitoring of completed trials
  • For-cause audits at the request of the IRB

  The research monitor will conduct monitoring activities in accordance with established written procedures; using appropriate monitoring checklists, report templates and source documents to record and report monitoring findings.  The goal is to work collaboratively with the study team and communicate findings that lead to improved clinical research.  Following the monitoring, a report is created which is sent to the Principal Investigator outlining the results of the audit. 

  For information about the Research Monitor position please feel free to contact Stephanie Roncone at Stephanie.Roncone@stonybrook.edu or 631-632-1559.

• National Science Foundation Implements New Responsible And Ethical Conduct of Research (RECR) Training Requirements (August 2023)

  Dear Colleagues,

  The National Science Foundation (NSF) has issued a new mandate that expands the existing Responsible and Ethical Conduct of Research (RECR) training requirements.

  What is new?

  For proposals submitted to NSF on or after July 31, 2023, all researchers, including faculty, post-docs, graduate and undergraduate students, and other senior personnel named on proposals to NSF must complete RECR training before engaging in research projects sponsored by the NSF. 

  How is this different from NSF’s previous policy?

  This requirement reflects two changes:

  • the RECR training requirement has expanded, and now applies to faculty and other senior personnel, as well as undergraduates, graduate students and postdoctoral researchers, and

  • the RECR training must include training on mentorship.

  What is the Principal Investigator’s responsibility?

  Principal Investigators are responsible for ensuring all researchers, including faculty, post-docs, graduate and undergraduate students, and other senior personnel supported through their grant(s) complete training at the start of work on the research project.

  What training is required to satisfy the NSF RECR requirement?

  The Office of the Vice-President for Research is reviewing current RECR training modules in the CITI Program and the implementation of this new requirement. More information will be coming soon.

  What do you need to do now?

  The Office of Research Compliance will be issuing additional guidance for this new training requirement. The implementation of this guidance will be in a manner that minimizes burden on investigators and study team members.  New guidance will include both CITI Program modules to be completed as well as a timeframe for completion.

  Who do I need to contact for more information?

  For questions about this the NSF RECR policy or questions about RECR training, please contact Rebecca Dahl at rebecca.dahl@stonybrook.edu in the Office of Research Compliance.

• Human Research Protection Program – Emergency Preparedness and Response Plan (“Plan”) (August 2023)

  The Human Research Protection Program (HRPP) has recently completed work on an Emergency Preparedness and Response Plan ("Plan") for human subject research. This Plan can be accessed at: https://www.stonybrook.edu/commcms/research-compliance/Human-Subjects/sops

  This Plan establishes HRPP specific emergency planning and is intended to supplement, not replace, emergency response planning by Stony Brook University (SBU) leadership and/or SBU-wide response measures.

  Information contained in the Emergency Preparedness and Response Plan establishes HRPP-specific emergency response planning and measures that are limited to those functions for the HRPP not otherwise covered by institutional-level plans. If you have questions about the Plan, please contact Rebecca Dahl  at 631-632-6541.

• Human Research Protection Program - Changes to Ancillary Review Requirement** (November 2022)

  The Office of Research Compliance, Human Research Protection Program and the Chief HIPAA Privacy Officer would like to announce a recent change made to the requirement for ancillary review. Ancillary review by the Chief HIPAA Privacy Officer is now only required if there is a Limited Data Set necessitating a Data Use Agreement.

  Limited Data Sets are Protected Health Information (PHI) that exclude 16 categories of direct identifiers and may be used or disclosed for purposes of research without obtaining either an individual’s Authorization or a waiver or alteration of an Authorization. A Limited Data Set can include city; state; zip code; elements of date; and data that is coded.

  Data Use Agreements are agreements into which the covered entity (SB) enters with the intended recipient of a Limited Data Set that establishes the ways in which the information in the Limited Data Set may be used and how it will be protected.

  Even if the person requesting a Limited Data Set from a covered entity is an employee or otherwise a member of the covered entity’s workforce, a Data Use Agreement must be in place between the covered entity and Limited Data Set recipient. Meaning, if you are an employee and you want to do research using patient information that could be part of a limited data set, you would need to sign a Data Use Agreement.

• Human Research Protection Program - Changes to the Standard Operating Procedures (May 2022)

  The Office of Research Compliance, Human Research Protection Program would like to announce recent changes made to the Standard Operating Procedures. These changes include the following:

  Added regulatory information about medical device research and in vitro diagnostics

  Added language about research not beginning until all necessary approvals have been obtained

  Added information about drugs and device storage and maintenance; specifically that the research pharmacist or other designated individual will maintain the following:

  Records of the product's delivery to the trial site. Records will include:

  Dates

  Quantities

  Batch/serial numbers

  Expiration dates (if applicable)

  Unique code numbers assigned to the investigational products and trial participants

  Inventory at the site

  Use of the product by each participant

  Return or the product to the sponsor or alternative disposition of unused products (as applicable)

  Added information about conducting satisfaction surveys with research study personnel regarding the service from the Human Research Protection Program

  Added information about consent for exempt research. This includes the requirement for the following information:

  The activity involves research

  Description of the procedures

  Participation is voluntary

  Name and contact information for the researcher

  Adequate provisions are in place to maintain the privacy interests of the participants

   

  Added language regarding requirements for continuing review. This includes the following:

  As applicable:

  Data safety monitoring board reports

  Gov’t or sponsor audit/monitoring reports

  The status report on the progress of the research includes:

  The number of participants accrued.

  A summary since the last IRB review of:

  Adverse events and adverse outcomes experienced by participants.

  Unanticipated problems involving risks to participants or others.

  Participant withdrawals.

  The reasons for withdrawals.

  Complaints about the research.

  Amendments or modifications.

  Any relevant recent literature.

  Any interim findings.

  Any relevant multi-center trial reports.

  The researcher’s current risk-potential benefit assessment based on study results.

  Added information about the designation of an individual as a legally authorized representative:

  The Office for Human Research Protection (OHRP) and Food and Drug Administration (FDA) regulations state that designation of a subject’s legally authorized representative is to be determined by “applicable law” (45 C.F.R. 46.102(c); 21 C.F.R. 50.3(l)), which typically means state or local statutes, regulations or cases. OHRP guidance states that it would consider an individual to be a subject’s legally authorized representative for research as long as that state or local law provides a “reasonable basis” for allowing that individual to provide informed consent for the subject.

  Added definitions for children, guardians and legally authorized representatives

  Added information stating that the Investigator’s Brochure cannot be used to validate the IND or IDE and that an IND goes into effect 30 days after the FDA receives the IND, unless the sponsor receives earlier notice from the FDA

  Added information that an emergency use of a test article, other than a medical device, is considered to be a clinical investigation, the patient is a participant, and the FDA may require data from an emergency use to be reported in a marketing application

  Added information that there must be adequate resources to carry out research safely. This includes, but is not limited to, sufficient research time, appropriately qualified research team members, equipment, and space

  Added information that PIs and members of the research team including students:

  Must take CITI training for conflict of interest:

  Required every 4 years (regardless of funding)

  Education is required immediately when:

  Financial conflict of interest policies are revised in a manner that changes research requirements

  A researcher is new to the organization

  A researcher is non-compliant with financial conflict of interest policies and procedures

  Requests for a “review preparatory to research” must receive prior approval from the HIPAA Privacy Officer. The Institutional Review Board does not need to review this request.

  The National Institutes of Health have indicated that they will not issue discretionary Certificates of Confidentiality for the establishment and maintenance of data/biospecimen repositories where the main original source of the data/biospecimens was for clinical care or commercial purposes, rather than research sources. NOTE: a Certicate of Confidentiality (CoC) request for individual studies using data or biospecimens from the repository will be considered for a CoC.

• Notification of Transition from IRBNet to Qualtrics for Quality Improvement Projects (February 2022)

  During the fall of this year, the Office of Research Compliance (ORC) in conjunction with the Chief Medical Officer Stony brook University Health Sciences Center developed a new system for Quality Improvement projects. As of November 1, 2021 all Quality Improvement projects must be submitted in the Qualtrics system. Quality Improvement projects that are already in IRBNet will remain in IRBNet. The portal to the Qualtrics system is located at https://research.stonybrook.edu/myResearch.php/.

  In an effort to make this transition as smooth as possible, the ORC has been offering informational sessions for the campus community beginning in September. If you would like an informational session on changes to the Quality Improvement process, please contact Rebecca Dahl at dahl@stonybrook.edu.

  A quality improvement webpage was created to assist those individuals interested in developing a Quality Improvement project. The webpage is located at

  https://www.stonybrook.edu/commcms/research-compliance/Quality-Improvement/Submission_Guidelines

• Guidance for Human Subjects Research (February 2022)

  The protocol template for human subject exempt research is now available for use. This template is short and includes only those questions that pertain to exempt research. A corresponding consent document for exempt research is also available. Both of these newly designed documents can be found in the myResearch IRB library.

  Additionally, the protocol template for research that requires regulatory oversight has been redesigned to better meet the needs of researchers and study team members. Questions that were redundant or not applicable have been removed. Questions that were difficult to understand were re-written. Template questions have been organization into sections that pertain to the content of the question. The protocol template is shorter and easier to use. You can find the newly designed template in the myResearch IRB library.

• Human Research Protection Program - Changes to the Standard Operating Procedures (5/11/21)

  The Office of Research Compliance, Human Research Protection Program would like to announce recent changes made to the Standard Operating Procedures. These changes include the following:

  -Removed language that refers to “verbal consent”

  -Added definitions for “primary” and “secondary” endpoints

  -Added language about obtaining permission for conducting research “off-site”

  -Clarified that trained members of the study team can obtain informed consent for a clinical trial

  -Added information about the posting requirement for consent forms (Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h))

  -Added information about research requirements when the study is funded by the Department of Defense

  -Added information about research requirements when the study is funded by the Department of Justice

  -Added information about the Continuing Review Application and device research

  -Added information that Principle Investigators cannot participate as subjects in their own studies

  -Added language about General Data Protection Regulations (GDPR)

• Notification of Transition from IRBNet to myRESEARCH IACUC

  MyResearch IACUC will be launched Monday, October 19, 2020. The portal to the myRESEARCH IACUC system will be available at at myresearch.stonybrook.edu on October 19, 2020.

  The system will capture new studies and any continuing reviews submitted after October 19, 2020. New studies will not be accepted into IRBNet after October 18, 2020. Studies (initial and continuing review) as well as amendments that are already in IRBNet and that are not yet approved will remain in IRBNet. Final approval for these studies will take place in IRBNet. Future activity on these studies will be conducted in myResearch IACUC.

  The following study information for all active IRBNet studies will be transferred to myResearch IACUC prior to the October 19, 2020 launch: IRBNet ID number, study title, and PI name. Study documents in IRBNet will be uploaded into your “shell” prior to your study coming up for review. If you are unable to locate a study “shell” for an upcoming continuing review, please contact Jamie Fuellbier at jamie.fuellbier@stonybrook.edu with the IRBNet ID number.

  In an effort to make this transition as smooth as possible, training videos for the myResearch IACUC are now available. You can view these videos at https://www.stonybrook.edu/commcms/research-compliance/Animals-Use/Submissions. The videos are also available directly on YouTube at:

  Team: https://youtu.be/J5LJPhyCdW4

  Substance: https://youtu.be/uopuAdLPY5o

  Procedure: https://youtu.be/xjMlSHJyavQ

  Protocol: https://youtu.be/m461ABI84-Q

  Mods: https://youtu.be/DnUTg5AjUcs

  A training manual for myResearch IACUC can be found at: https://www.stonybrook.edu/commcms/research-compliance/Animals-Use/Submissions

  If you have questions or concerns about the system, you can contact Jamie Fuellbier at jamie.fuellbier@stonybrook.edu.

• IRB Fees

  The Human Research Protection Program is raising fees for sponsored research. The fee supports the administrative and regulatory compliance for these sponsored studies.

  The fee is a one-time service fee and is separate from any charges incurred by the sponsor for using the external IRB. Payment of the fee is not contingent upon the approval of the study.

           - If an external IRB (Advarra, WIRB, etc.) reviews the study, the institutional fee will now be $1,500 (increase of $500)

           - If the local Stony Brook University IRB reviews the study, the combined IRB/institutional fee will now be $3,500.00 for full board review (increase of $500) or $1,450 for expedited review (increase of $500).

  If the sponsor fails to pay the fee within 90 days, the PI’s department will be responsible for payment.

  These fees will be implemented October 1, 2020. Any studies submitted on or after this date will be required to use the updated form that will be available in the myResearch IRB library.

• COVID-19 Guidance for Human Subjects Research can be accessed HERE or at the below links:

  Guidance for Researchers Conducting Human Subject Research  (July 16, 2020)

  Uniform Guidance Provided to Study Participants (Handout in English)

  Uniform Guidance Provided to Study Participants (Handout in Spanish)

  Additional Guidance - Studies Previously Placed on Hold (June 23, 2020)

   FAQs: Frequently Asked Questions regarding your human subjects activities can be accessedhere . 

• Notification of Transition from IRBNet to myRESEARCH Safety:

  Beginning Monday, December 16, 2019, the Office of Research Compliance (ORC) will require that all new and continuing reviews for Biosafety and Stem cell research be submitted in the myResearch Safety system. The portal to the myResearch Safety system will be available at myresearch.stonybrook.edu on December 16, 2019.

  Amendments will continue to be submitted to IRBNet. Studies (initial and continuing reviews) as well as amendments that are currently in IRBNet and that are not yet approved will remain in IRBNet.

  The following study information for all active studies will be transferred to myResearch Safety on December 16^th: IRBNet ID number, study title, PI name, initial approval date, submission date and project expiration date.

  As studies come up for continuing review, documents from the last approval will be uploaded into myResearch Safety for that study. If you are unable to locate a study shell for an upcoming continuing review, please email ovpr_orc_ibc@stonybrook.edu. Please include the IRBNet ID number in your email.

  In an effort to make this transition as smooth as possible, the ORC will continue to offer training sessions for the campus community. Training sessions will be available at locations on both West and East campuses. To sign up for training, please contact Erin Augello in the Office of Research Compliance at ovpr_orc_ibc@stonybrook.edu.  

• Notification of Transition from IRBNet to myRESEARCH IRB:

   As a reminder, all studies that were approved in IRBNet since February 27^th 2019 will need to be renewed in myRESEARCH IRB at the time of continuing review. These studies will not remain indefinitely in IRBNet. Once your study reaches the time period for continuing review you will be required to open a continuing review and modification application. Opening both applications will allow you to complete all required pages for the first continuing review for your study in myRESEARCH IRB. Additionally, studies in IRBNet that have not been approved either initially or through the continuing review process must now be opened in myRESEARCH IRB.

  The portal to the myRESEARCH IRB system is available at myresearch.stonybrook.edu. The myResearch IRB instruction manuals and checklists is available here.

  For questions, please contact the Office of Research Compliance at ovpr_myresearchirb@stonybrook.edu.