News

Sep 06

Conflict of Interest submissions went electronic on May 1st eliminating the paper forms in COEUS and IRBNet! An Annual Conflict of Interest Disclosures is required to be on file in myResearch.

This annual disclosure is then used for proposals, new awards, funded IRB protocols and PHS (NIH) award continuations!

Submissions can be completed here .

Sep 06

Wondering what’s going on with the revisions to the Final Common Rule?

Join the club! But while we wait, our colleagues at the CITI Program have done an incredible job of creating a set of resources to help our understanding of what is changing (when it actually does, in fact, change).

Have a look: https://about.citiprogram.org/en/final-rule-resources/

Sep 06

On July 24, 2017, the FDA announced that, effectively immediately, it will now permit IRBs to waive or alter informed consent for minimal risk*  clinical investigations, so long as the IRB determines and documents that the following criteria are satisfied:
● The clinical investigation involves no more than minimal risk* to the subjects;
● The waiver or alteration will not adversely affect the rights and welfare of the subjects;
● The clinical investigation could not practicably be carried out without the waiver or alteration; and
● Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

As these criteria are identical to the consent waiver criteria in the Common Rule (which doesn’t cover FDA) this is an important step in harmonization across federal agencies. Affected applications are expected to include certain registries, observational
studies, and studies using existing data and specimens.

The guidance can be accessed here.

* Minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in theresearch are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological
examinations or tests.”

Sep 06

The staff of ORC and IT (Research) have been working diligently to customize and test myResearch for IRB with the goal of making the transition from IRBNet to myResearch as seamless as possible. Once the system is ready for ‘prime time’, expected early fall, ORC will be offering in-person workshops and other training opportunities (including sending you training materials with screenshots and instructions) so that you can hit the ground running in preparing your submissions for IRB review.

We are planning a ‘phase in’ approach for use of the system such that we will first be accepting initial (new) submissions (expedited or full review) starting November 20, 2017. Then, sometime in the Spring, we will start moving over active studies that currently live in IRBNet to myResearch via the continuing review process. More on that early next year.

In the meantime, here are some little tidbits of helpful information to start building up your knowledge about the new system:

There’s some new terminology you will need to get used to. Here are three for now (and more to follow!):

● Reportable New Information (RNI): this is the term in myResearch that is what we currently refer to as, e.g., unanticipated problems involving risks to subjects or others, protocol deviations, protocol violations, non-compliance, results of audits or inspections by external agencies or study monitors etc. That sort of thing. More on that as we get closer to launch.

● Non-committee Review: is the term used to describe all reviews done outside of a convened IRB meeting, including exemption determinations, expedited reviews, and ‘Not Human Research’ and QA/QI determinations.

● Designated Reviewer: this is the individual(s) who conducts the non-committee review. If it’s anything other than an expedited review (which requires that the designated reviewer be an actual IRB member), the designated reviewer will be a member of the ORC staff.

As you know, a standard submission in IRBNet requires (in part) completion of a registration smart form, an IRB application, and an uploaded protocol. In myResearch, the smart application form you complete within the system takes the place of the registration form. There will no longer be a separate IRB application to complete. However, in its place we have created the Protocol Template for Investigator-Initiated Studies to be submitted for studies that are initiated by you ( SBU researchers ). You will note that it is much more content-intensive than our previous template in IRBNet, but it provides all the information that is required for the SBU IRBs to assess the federally mandated approval criteria. This template is a blend of the template available through the Click ‘out of box’ program, as well as templates from fellow accredited institutions.

If you would like to “test drive” this new protocol template and start using it now, please feel free to do so. If you submit a new study in IRBNet using this template, you don’t have to also complete the IRB application.

Currently, the process for using an IRB external to SBU (e,g, Chesapeake, NCI-CIRB, or other multi-center studies in which an external IRB will serve as the IRB of record for all sites) involves an administrative process for ceding that IRB review that is a blend of IRBNet and external email. With myResearch, the entire process will occur within the system. New to the submission requirements for these studies that are not SBU investigator-initiated is the need to submit a Protocol Template Supplement: SBU-Specific Information in addition to the main (external) protocol . The information will provide information on issues pertaining to the conduct of the research here, and also provide information that will be helpful for not-for-cause monitoring visits and audits that are conducted as part of ORC’s QA efforts to maintain our high quality HRPP.

Any questions pertaining to these updates may be directed to Judy Matuk at judy.matuk@stonybrook.edu

 

Sep 06

Message to NIH grant applicants/awardees, contractors, researchers and research administrators:

If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:

● select the right NIH funding opportunity announcement

● write the research strategy and human subjects sections of your application

● comply with appropriate policies and regulations

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form.

For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here .

Second, take a moment to answer these four questions about your current or proposed research:

1) Does the study involve human participants?

2) Are the participants prospectively assigned to an intervention?

3) Is the study designed to evaluate the effect of the intervention on the participants?

4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.

Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:

● the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.

● Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.

● updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.

● new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018. ● use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.

● expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials. Improving the design, efficiency, and transparency of clinical trials is important because it:

● respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate

● facilitates design of clinical trials while reducing unnecessary duplication

● promotes broad, timely, and responsible dissemination of research information and results

● fosters responsible stewardship of the public’s investment in biomedical research

We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.

We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts , in the NIH Extramural Nexus , and on my blog. The success of clinical trials relies on the public trust in scientific rigor and ethical oversight. We all play a critical role in this process. We are most grateful to you for your help and support. Best, Michael S. Lauer, MD Deputy Director for Extramural Research, NIH One Center Drive, Building 1, Room 144 Bethesda, MD 20892

Sep 06

Just a few examples of when export regulations may come into play are international travel, hosting visitors, purchasing items, international shipping or sharing confidential information with others. If these are things that you do, please refer to our new guidance and procedure documents for export compliance.

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.

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