News

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

(SUMMER 2016)-----------------------------------------------------------------------------

A critical factor in ensuring the compliant and successful conduct of research is the availability of adequate resources. In addition to the obvious need for sufficient funds to do the work, Principal Investigators must be able to respond affirmatively to the following questions: 

  • Do you have the time to do the research? 
  • Do you have the staff to conduct the research, to help ensure that the study is being conducted as approved? 

and, in the case of research involving human participants:

  • Do you have the staff to effectively monitor the subjects’ safety and welfare?
  • Are the proposed subject populations available from within our community?

If you are unable to respond affirmatively to all of these questions for a proposed research activity, the stage may be set for future noncompliance, incomplete data sets, and, in the worst case scenario, the endangerment of research volunteers.

Research must not be treated as a hobby. A high standard of research excellence is a critical part of our University’s mission. Adherence to applicable Institutional policies and procedures is clearly essential throughout your research endeavors, but ensuring that you have appropriate resources is a fundamental first step. Therefore, it should be considered a priority to work with your chair to carefully assess and confirm the resources available to you that would enable you to conduct your proposed research activity compliantly, ethically, and successfully.

Pages

Go to top