Apr 19

As we are always reviewing our processes to streamline where we can, it is clear that the requirement to obtain co-investigator certifications on IRB and IBC submissions is a time-consuming process for all parties involved. These sign-offs were originally initiated to ensure: that all members of the study team were aware that they were, in fact, members of the study team; that they would know the study details and their role in it; and finally, that they would not perform any research procedure for which they were not qualified/certified/licensed (as applicable).

Removing these certifications from the members of the study team does not mean that the certifications go away completely. As the principal investigators have the critical and ultimate responsibility of the compliant and safe conduct of the research activity, their e-certifications (detailed at the end of the IRB and IBC applications) on the IRBNet package now include the responsibility of ensuring that each member of their study team knows the study details, their roles, their qualifications etc. We are confident that this change in procedure will help to speed up approval processes, while still ensuring the presence of an aware, knowledgeable, and qualified team for the study.

Please note that if you are a principal investigator of studies with external IRBs of record (e.g., Chesapeake, NCI CIRB), you will need to review and upload the 'External IRBs: Principal Investigator Certification' document (located within the forms and documents area of IRBNet) before e-certifying (signing) the IRBNet package.

Apr 19
Winter 2017

If yes, you may have noticed a new section on your approval letter. It states:

“When you are ready to schedule and undergo the consent process with your first post-approval subject, please contact Mary O'Neill at Mary.Oneill@stonybrook.edu to coordinate having her present to witness your consent process. This process is part of our ongoing effort to ensure maintained quality in our human research protection program.”

So, if you are still in the accrual phase of your research, please let Mary know (if at all possible), when you will be consenting your next research subject, so she can observe your consent process. Together, we need to make sure that the people who volunteer in our research activities get all the information they need to make a decision regarding participation, in an understandable, un-rushed manner.

Apr 19
Winter 2017

As a follow-up to our article on the NIH GDS policy in the Fall 2016 Research News, we are happy to report that our efforts to create SBU-specific guidance, GDS plan template, institutional certification, and consent language has been completed. We again thank our colleagues from Stanford University for their generosity in allowing us to ‘not re-invent the wheel’ when coming up with these documents.

We have added a special topic on Genomic Data Sharing for NIH grant submissions to our Standard Operating Procedures that includes guidance, instructions, FAQ’s, and resources regarding compliance with this NIH policy. Similarly, our CORIHS application and consent templates have been modified to capture necessary GDS information, and the GDS plan template (“Human Genomic Data Sharing Plan Template”) now resides within the forms and template area of IRBNet for your use.

Apr 19
Winter 2017

ORC is pleased to announce the availability of a new tool for our researchers to assist in subject recruitment. Stony Brook has recently signed a contract with the national registry ResearchMatch (RM), that connects researchers with volunteers who wish to get involved in research studies. This national registry provides a secure, web-based approach to address a key barrier to advancing research: participant recruitment.

This new tool allows you to conduct targeted searches for potential volunteers based on location and specific demographics. If you would like to ‘look around’, feel free to register for feasibility access. This will allow you to go into the system to explore what it is all about and even see how many people registered might fit the criteria for a study currently ongoing or one you are thinking about. Here’s all you have to do:

1. Navigate to https://www.researchmatch.org/

2. Click “Researchers” at the top of the page

3. Green button “Register Now” (If you think you’ll need help registering, click on the tutorial link below the green button)

4. Select “Stony Brook University” as the institution

5. Type in your Stony Brook email address

6. Retrieve verification code from your email, cut and paste it into RM

7. Read site instructions

8. Read Researcher Acknowledgement form and “ACCEPT”

Like what you see? The “ResearchMatch Recruitment Method Instructions”, available in the forms and templates area in IRBNet provides the details for adding this recruitment method to both new and existing studies. Once you have IRB approval for your study, including an approved RM contact message, one of our RM liaisons can approve your message to be sent to registered RM users (i.e., potential subjects). If a user is interested in volunteering for your study, they accept your invitation and release their information to you for direct contact. That’s it! We hope you find this new tool useful in facilitating your research efforts.

Apr 19

a) CITI refresher course content is changing

Remember when you'd take a refresher course every three years on the same topics over and over again? Well, those days are over. Starting next week, when it's time to recertify your training, you will still do refreshers on a *few* topics, however you will now also choose three (3) elective modules (out of about 25 choices) on topics that interest you! "Consent and Subject Recruitment Challenges: Therapeutic Misconception", "Research with Critically Ill Subjects", "Illegal Activities or Undocumented Status in Human Research" to name just a few.

b) The Good Clinical Practice (GCP) course through CITI satisfies NIH's new (1/1/17) training requirement

The NIH policy (https://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) applies to all NIH-funded investigator and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials . NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of these interventions on health-related biomedical or behavioral outcomes [emphasis mine]. And don't forget the clinicaltrials.gov requirement for these studies as well (as reported in previous VPR Research News-see #4 below)

c) The CITI course for Clinical Research Coordinators (CRC) is now available

Those of you who are "on file" as Research Coordinators through the SOM's Office of Clinical Trials recently received a message from me regarding the appreciation and importance of training initiatives for this extremely critical group in our HRPP. To this end, the CRC course through CITI is available for you to casually peruse so that you can learn for the first time or review your knowledge about the responsibilities of your profession. It's casual now, but of course it is important enough to make it a mandatory part of your training portfolio, effective June 30, 2017.

Apr 19

SMART IRB?

We are in the company of other fine institutions,​ all seeking to simplify the IRB process for multi-center studies.

Apr 04

NEW! Training Chart to assist you in determining the training requirements for your activity.

Mar 29

Did you know that Office of Research Compliance website provides training resources to help the campus community understand such important topics as research misconduct, authorship, mentorship, peer review (to name just a few)

Training resources include available videos created by SBU faculty and staff (from past GRD 500 sessions), articles, other short videos, infographics from external sources; as well as references to applicable SBU compliance policies. These resources are updated as they become available to us. Some new materials just recently added include (from the federal Office of Research Integrity): 

· “Case Studies: Dr. Thompson’s Lab” , that addresses topics such as mentoring relationships, authorship, publication, data integrity, and potential research misconduct.

· “The Research Clinic”, that educates researchers on the importance of protecting research subjects and avoiding research misconduct.

· A set of Infographics (“Everyone Plays a Role in Research Integrity", "5 Ways Supervisors Can Promote Research Integrity", "The Research Community Safeguards Scientific Integrity", " Possible Red Flags of Research Misconduct", "Tips for Presenting Scientific Images with Integrity", "Research Trainees: What You Should Know about Research Misconduct", "Write Ethically from Start to Finish", and "You Suspect Research Misconduct. Now What?").

Feel free to use these, or any of the training resources available on our website. If you know of others, let us know and we will post them as well! If you have any questions regarding training in the responsible conduct of research and scholarship, please contact the Office of Research Compliance at 2-9036.

Mar 29

An understanding of the basics of export controls and potential red flags are important when conducting research or participating in international collaborations, travels or shipments. Penalties and sanctions for non-compliance can be imposed on both the researcher and the institution.  Training options are available on the Export Control Website.

Dec 06

(FALL 2015)------------------------------------------------------------------------------------

Notice of Proposed Rule Making (NPRM): On September 8th, the DHHS published in the Federal Register an NPRM for revisions to the Common Rule (Subpart A of 45 CFR 46; the federal regulation regarding human subjects protections that provides the basis of our human research protection program). There are significant changes proposed that, if finalized, will greatly impact our program. ORC has summarized the major proposed changes, and is available for your review: http://research.stonybrook.edu/sites/default/files/SummaryofNPRM.pdf. 

The DHHS website for the NPRM is located at http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html. Although SBU is involved in issuing comments via a working group headed by the Association of American Universities (AAU) and the Association of Public & LandGrant Universities (APLU), you are encouraged to review the NPRM and submit comments to DHHS as well (instructions on how to submit are available on the DHHS website provided above).

More on NIH’s Genomic Data Sharing (GDS) Policy: As follow up to the information provided to you in the January 2015 Research News regarding this policy (effective date 1/25/15), the NIH Office of Science Policy has issued a two part series on Genomic Data Sharing. This policy is consistent with a key proposed change outlined in the NPRM above, which speaks to the importance of obtaining consent from subjects for their use of their biospecimens (even those that are de-identified).

Part I, which includes links to NIH Guidances and FAQ’s on the GDS policy is available here: http://osp.od.nih.gov/underthe-poliscope/2015/08/genomic-data-sharing-tw... Part II is available here: http://osp.od.nih.gov/under-the-poliscope/2015/09/genomicdata-sharing-pa...

Research Involving Adults with Impaired Decision Making Capacity: Sections 5.2 (http://research.stonybrook.edu/human-subjects-standardoperating-procedur...) and 6.9 (http://research.stonybrook.edu/human-subjects-standardoperating-procedur...) of our Standard Operating Procedures have been updated to: Section 5.2: Clarify the definition of ‘Legally Authorized Representative’ to be consistent with Federal law (45 CFR 46.102 [c]) and the New York State Family health Care Decisions Act, and Section 6.9: To permit, under circumstances and with appropriate additional protections, the involvement of decisionally-impaired adults in research which is more than minimal risk, without the prospect of direct benefit to the subject.

Important Notice Re: Research Consents Scanned into Patients' EMR: If your research involves patients of University Hospital, and you are scanning the signed research consent form into the patient's electronic medical record, Joint Commission standards require that the signature of the patient/subject and of the person obtaining consent include not only the date, but also the time, the signature is obtained. If you have any questions about this requirement, please contact the Chief of Regulatory Affairs for Stony Brook University Hospital. Any questions regarding these updates from the Office of Research Compliance may be directed to Judy Matuk, 632- 9036, or judy.matuk@stonybrook.edu

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