NIH Transitions from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018

Excerpt from NIH Notice (NOT-OD-18-179)
NIH has developed a new Human Subjects System (HSS), which consolidates human subjects and clinical trial information in one place.

Information captured in HSS is generally submitted on the PHS Human Subjects and Clinical Trials Information form in application packages submitted for due dates January 25, 2018 or later and Research Progress Performance Reports (RPPR).

Post-submission updates to human subjects and clinical trial-related information (including human subjects protections, participant and enrollment information, and Clinicaltrials.gov registration and reporting information) must be made in HSS via the eRA Commons Status page after June 9, 2018.

HSS will replace the Inclusion Management System (IMS), used for reporting participant sex/gender, race, and ethnicity information.  The Inclusion link will no longer appear on the Commons Status page as of June 9, 2018.

Please read NOT-OD-18-179 for complete information on key changes.

Other Resources

NIH’s Human Subjects System (HSS) Info Page

On Line Video Tutorials

Overview of the New HSS System

Accessing Human Subjects System for SOs and PIs

Questions? Please reach out to the Grants and Contracts Office at grants@mssm.edu.

 

ClinicalTrials.gov Spotlight Series: Understanding ClinicalTrials.gov Registration and Reporting Dates

As of January 17th, 2018 the new NIH penalties for non-compliance with Clinicaltrials.gov registration and reporting went into effect. The potential penalties are financial, at over $11,000 per day of non-compliance, and may impact continued funding of both existing and future NIH awards.

What you need to know to achieve compliance:

Understanding the Date & Deadline requirements

When registering a study in ClinicalTrials.gov, specific dates must be provided – if the PI is uncertain about an exact date, the best anticipated date must be provided until an actual date is available.  Dates cannot be left blank.

What are the dates that must be provided?
*A primary outcome measure is the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one. For more information see, ClinicalTrials.gov Outcome Measures & Statistical Analyses Module.
Source: https://clinicaltrials.gov/ct2/about-studies/glossary

NOTE:

  • In some cases the primary completion date and study completion dates are the same.
  • In other cases, the primary outcome measures may be collected much earlier than the secondary. And yes, results for the primary outcome measure must be posted within 1 year of this date.

Other deadlines to remember

  • Records must be updated every 12 months.
  • Records must be updated within 30 days of Recruitment Status changes or amendments that affect information in ClinicalTrials.gov record, especially recruitment status, location and contact information.
  • Records must be updated within 30 days after the completion date (last data collection).
  • After initial submission of registration data, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 15 days (yes, this includes weekends).
  • After initial submission of Results, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 30 days.

All unmet dates and deadlines trigger errors in ClinicalTrials.gov  and a status of “non-compliance” in ClinicalTrials.gov.

Questions? Please open a ticket via the ORS Research 411 Portal’s ClinicalTrials.gov Assistance form.

 

GCO Helpful Hints- To Be or Not Be (An NIH Clinical Trial) That is the Question

To Be or Not To Be…. The single most powerful soliloquy ever written by man..

Encapsulating the frailty of  the human condition in one stark sentence.
One man overwrought by feelings of despair, indecision, and confusion.
Is there any wonder this quote can be applied to NIH’s new definition of a clinical trial (eff w/ competitive apps. w/ due dates 1/25/18 and later)?

Have you asked yourself these other 4 questions… the ones that will provide the answer you need… the ones that will pull you out of any existential NIH clinical trial conundrum, and put you on the path leading to a successful application?

  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 you’ve answered Yes to all of these questions, you’ve got yourself an NIH Clinical Trial.  Note that no other entity but the NIH (although there are no guarantees in this fast paced world, folks.. we will do our best to keep you informed) uses this definition.  So be sure you remember to whom you are speaking or to which funding agency you are applying before stating unequivocally, “To Be or Not to Be!” I mean “Yes, I have a clinical trial!”  If you’re still not sure or need additional resources to help navigate you through, please see the list towards the bottom of this email.

Besides this NIH definition, all should be aware of NIH’s new Human Subjects and Clinical Trial (HS/CT) form in which the top portion must be completed even if you are doing research on potato spuds.*  This form has a sub-form called the “Study Record” form and embedded in that is the sub-sub form entitled the “Inclusion Enrollment Report,” which should sound familiar to veteran applicants.  Recently, Research IT released its instructions for completing this form, which includes what’s required in each section. Click here to view Research IT’s instructions on the form.

If there was ever a time to submit to the Grants and Contracts Office (GCO) EARLY or at least 5 business days prior to your NIH deadline, now is the time.

But before you submit, make that way before you submit, choose the correct funding opportunity announcement (FOA). (Parenthically speaking, the updated FOAs include some pretty important information within the parentheses in the FOA title, namely “(Clinical Trial Not Allowed),” or “(Clinical Trial Required)” or “(Clinical Trial Optional.)”)

And no worries..if you are holding a specimen like this Shakespeare playing Hamlet, you can safely say No to Clinical Trials.  If your protocol does contain a resuscitation intervention, answer Yes.

NIH Clinical Trial Resources

Videos and Podcasts

Video (approx. 15 minutes) – Overview of New NIH Policies on Human Subjects Research and Clinical Trials

* Did you know that according to Wikipedia,  “The word (spud) has an unknown origin and was originally (c. 1440) used as a term for a short knife or dagger, probably related to the Latin “spad-” a word root meaning “sword”; cf. Spanish “espada”, English “spade” and “spadroon”?”  This was approximately 160 years before Shakespeare wrote Hamlet.

 

GCO Helpful Hints- Believe It or Not, YOU are Doing an NIH Clinical Trial

It is not business as usual at the NIH for competitive applications due Jan 25, 2018 and after. The NIH has a new definition of a clinical trial and with that comes a new Human Subjects and Clinical Trials Info (HS/CT) form and new requirements even for basic science researchers.

Step 1 –  BEFORE You Apply, Answer These 4 Questions.

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?

If you say No – ask yourself when I read question 3 above did I read “efficacy” rather than “effect?” NIH is asking about ANY “effect.” This is much broader.  Please reconsider.

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

If you say No – ask yourself when I read question 4 above did I read “improve or cure any disease or symptom of a medical or psychological condition or syndrome?”  NIH is asking about ANY  “health-related biomedical or behavioral outcome.”   This is much broader.  Please reconsider.

If the answer is Yes to all 4 questions, your study is an NIH clinical trial.

Step 2 – Choose the CORRECT Funding Opportunity Announcement (FOA)

Many of NIH’s updated FOAs include the following information in the title:
– Clinical Trial Not Allowed
– Clinical Trial Required
– Clinical Trial Optional

If you apply to the wrong FOA, your application will be rejected.

Step 3 – Complete the Human Subjects and Clinical Trials Information (HS/CT) Form

Your application will be rejected if completed incorrectly. Please see list below of possible reasons.

  • You did not answer the Clinical Trials Questions correctly at the top of this form.  See Step 1 for more information.
  • You completed sections of the form that are not required for your study.
  • And the opposite – you didn’t complete the sections of the form that are required for your study.
  • You did not follow the character limitation rule.

Click here to view Research IT’s instructions on the form.  These instructions highlight requirements to help you avoid the pitfalls written above.

Other Resources
Contact the Program Officer on the FOA if you have questions. Get in writing whether your study is a clinical trial.

NIH Clinical Trial Resources

Videos and Podcasts

GCO FAQs
Below are some questions GCO Staff has received regarding NIH’s new HS/CT form and the NIH’s new Clinical Trial Policy in general.  We are passing the answers along to you.

FAQs on NIH’s new Human Subject and Clinical Trials Information Form

1. Q: I am not doing human subjects research. Therefore, I don’t need to complete the new form, correct?
A: Incorrect. There are questions that must be answered in the top portion of the form even if you are not doing human subject research.   All competitive NIH applications include the new form.

  1. Q: I am not doing a safety and efficacy study. In fact I am only using healthy volunteers.  Therefore, NIH’s new policies on Clinical Trials do not apply to me, correct?
    A:  Incorrect.  You might be doing a study the NIH defines as a clinical trial and therefore be subject to the new requirements.  NIH’s definition of clinical trials is very broad and includes research that one intuitively would not think is a clinical trial.  Please review NIH’s new definition, case studies/examples plus the training and resource material available to make the determination.
  2. Q: I am not doing a safety and efficacy study. In fact I am only studying the pharmacokinetics of a drug.  Therefore, NIH’s new policies on Clinical Trials do not apply to me, correct?
    A: Incorrect. Same response at # 2 above.
  3. From the NIH Case Studies website
    Q:  The study involves the recruitment of healthy volunteers who will be randomized to different durations of sleep deprivation (including no sleep deprivation as a control) and who will have stress hormone levels measured. It is designed to determine whether the levels of stress hormones in blood rise in response to different durations of sleep deprivation. Is this a clinical trial?
    A: Yes, this is a NIH Clinical Trial. See Case #9 on the NIH site for more complete information.

Questions about Sponsored Projects? Please click here for a listing of Departmental Grants Specialists at the GCO who can help you.

 

Changes to Human Subjects Certificates of Confidentiality

As previously indicated in communication from the Program for the Protection of Human Subjects (PPHS), all NIH funded protocols that were active on December 31, 2016 (or commenced after that date) and involve human subjects, activities using or generating identifiable human subject data or samples, or the generation of individual level, human genomic data was automatically granted a certificate of confidentiality (CoC) by the NIH, effective October 1, 2017 (Please see the PPHS announcement for details).

In order to assure that the affected participants in qualifying protocols have been, or will be, notified, the PPHS requires that the Principal Investigator submit a copy of the Investigator’s CoC Notification Form for each protocol that received a CoC on October 1, 2017. While it is not required that the plan be fully executed at this time, it is important that the form(s) acknowledging that the plan is being implemented are sent to IRB@mssm.edu as soon as possible, if not done so already.

The PPHS has drafted a letter describing the pertinent information for participants (Spanish translation available upon request); however, research teams that choose to mail/email the letter to participants must also draft a cover letter reminding participants of the study and providing contact information for the study team in the event the participants may have questions. Please note that the original deadline for sending the letter to all participants, or notifying the PPHS that the task has not yet been completed was October 31, 2017.

If you have chosen to contact participants directly (e.g. phone, in-person), you should still complete the Investigator’s CoC Notification Form as soon as possible, if not done so already. If you have not spoken with all participants by November 30, 2017, you will need to re-contact the PPHS with an update on your progress.

If you have not already completed the above mentioned steps, please submit the Investigator’s CoC Notification Form upon receipt of this email, and reference the Guidance and Policies section of the PPHS website for additional details.

 

InfoEd Instructions For Submissions Started Prior to Upgrade

The Grants and Contracts Office conducted a major upgrade of InfoEd on Friday, November 17, 2017, and it may have affected some users’ submissions. Researchers may need to take additional steps to ensure that their submissions are properly completed.

If you started your project in InfoEd prior to the upgrade, which began at 5 pm of 11/17, and it has not already been received by the GCO, please be aware that finalizing, routing and sign off may be impaired since the old template will not convert to the new template properly without a manual intervention.  Below are the steps to fix it:

  1. Go into the Setup Questions > Please select a Submission Mechanism/Screen Template.  In this drop down, select any choice.  Then re-select yours. This refreshes the program and creates the correct InfoEd application.
  2. You must re-upload your Lay Summary, Research Plan, Progress Report, and/or Final Report in the appropriate tabs.
  3. You should now see the eForm as a stand alone tab.  If it’s new, the eForm is called “New/Competitive Renewals/…”.  For other projects, it is called “Non-Competi Cont/Supplement…”
  4. On the eForm, please answer q. 16 re: location again.

Technical support for InfoEd applications is available by opening a Ticket with Research IT.

 

Must See Videos and Podcasts for Human Subjects Researchers

The Grants and Contracts Office (GCO) strongly recommends that human subjects researchers take advantage of educational resources issued by the National Institutes of Health (NIH) to inform grants applications submitted for due dates on or after January 25, 2018.

A primary component of NIH’s initiative to enhance the stewardship of clinical trials is the creation of a new application form that consolidates all Human Subjects and Clinical Trial related information into one place, and also expands the information required for studies that meet the NIH definition of a clinical trial. This new form will be included in the new FORMS-E Application Packages and will be required for all applications with due dates on or after January 25, 2018.

To support this endeavor for Mount Sinai Health System (MSHS) researchers, the GCO would like to highlight the following NIH resources:

To learn more about the new Human Subjects and Clinical Trial Information form which will be included in grant application packages and contract for all human subjects and/or clinical trial research applications beginning for January 25, 2018 due dates, visit the NIH New Human Subjects and Clinical Trial Information Form web site.

For more information about conducting human subjects research at MSHS, please contact the Program for the Protection of Human Subjects.

For more information about NIH grant submissions at MSHS, please click here for a listing of Departmental Grants Specialists at the GCO who can assist you.

 

Helpful Hints – Summer Time and NIH Other Support

...Oh summer time,

… a beautiful time of year to relax in the sun by the beach listening to the restorative sounds of the ocean waves or at least dream about it while stuck in your clammy cubicle at work. 
… Oh summer time,

… a slower time to get to know each other better or at least to daydream about that opportunity. 
… Oh summer time,

… no time like the present to talk about how the NIH wants to get to know you better, dear senior/key personnel, through a document they call the “Other Support” page.

One type of Other Support page that the NIH wants is requested before the NIH might make that exciting award for new, resubmission or renewal applications as part of the Just In Time (JIT) process. The other type of Other Support page wants is part of the annual RPPR (i.e., non-competing) application process.  You can find instructions and helpful samples of both Other Support types here.

The Other Support (OS) page is not a portion of your Biosketch repackaged.  Pay attention to the details below and may you be rewarded with a more timely award and fewer delays in the process.

Ever hear of the “Overlap” statement that goes at the bottom of each Other Support page?  Be sure to read all about it in section “1.8 Other Support” in this NIH Supplementary Instructions document.

Other Support Page: New, Resubmission and Renewal Applications
Do Include:

  • Both active and pending sponsored projects.
  • A page for each Senior/Key Personnel.
    Is there a subaward on your project? Don’t forget to get their pages too. Same rules above and below apply for the subs.
  • An OS page for each senior/key person that says “None” if he/she has no active or pending projects.
  • Calendar months effort (e.g., 6 CM) for each sponsored project, not percent effort (e.g., 50%).  Note at Mount Sinai we use “calendar month” effort.  If you’re working with subs, they may use calendar, academic, and/or summer months effort as per their institutional policy.
  • The annual direct cost amount and not the total cost amount for each project.
  • An overlap statement at the bottom even if the overlap is “None.”
  • A commitment overlap statement at the bottom if awarding this new grant will put you over 95% effort on active sponsored projects.  Add a note to the overlap section at the bottom explaining what change you plan to make.
    Read more about Faculty Effort on Sponsored Projects in Sponsored Projects Accounting’s policy.
  • Industry awards (e.g., pharma funded clinical trials) and sponsored projects in no cost extensions.

Don’t Include:

  • The new grant –  the one you have your fingers crossed for funding.  Leave that one off.
  • Expired projects.
  • Training grants where you are listed as a Mentor.  However, are you a training grant director or participating with measurable effort (i.e., check budget – are you listed with effort)? If yes, then yes, do include on the OS page.
  • Prizes or Gifts or Major/Minor User Status on Equipment Grants.
  • Other significant contributors unless their involvement has changed so that they now meet the definition of senior/key personnel.

Other Support Page: Research Performance Progress Reports (RPPRs)
Do Include:

  • A page for each Senior/Key Personnel only when
    –  there is a new active project or projects to report on
    and/or
    –  a sponsored project that was previously reported on expired or the person is no longer participating.
    Is there a subaward on your project? Don’t forget to check on their pages too. Same rules above and below apply for the subs.
  • Calendar months effort (e.g., 6 CM) for each sponsored project, not percent effort (e.g., 50%).  Note at Mount Sinai we use “calendar month” effort.  If you’re working with subs, they may use calendar, academic, and/or summer months effort as per their institutional policy.
  • The grant for which you are submitting the RPPR.  When doing so, include the effort that will be devoted in the next reporting period.
  • Active sponsored projects.
    –   Annotate what the change is; which previously active awards ended and/or which previously pending awards are now active.
  • Industry awards (e.g., pharma funded clinical trials) and sponsored projects in no cost extensions.
  • The annual direct cost amount and not the total cost amount for each project.
  • An overlap statement. See the JIT OS section above for more info.

Don’t Include:

  • Any pending sponsored projects.
  • Training grants where you are listed as a Mentor.  However, are you a training grant director or participating with measurable effort (i.e., check budget – are you listed with effort)? If yes, then yes, do include on the OS page.
  • Prizes or Gifts or Major/Minor User Status on Equipment Grants.
  • When there are only changes in levels of effort of active support.  Let’s say your co-investigator reported last year that her effort on a grant was 15% and now it’s 10%. If that’s the only change, don’t submit the Other Support page.
  • Other significant contributors unless their involvement has changed so that they now meet the definition of senior/key personnel.

Now that we’ve got the Other Support page squared away for now, here’s one final wistful note about summer…

… Oh summer time, stay with us longer.  How we enjoy you so.

Less InfoEd Data Entry – Elimination of Requirement to Enter Non-Key Personnel on Select Submission Types

Effective August 18, 2017, if researchers are submitting an InfoEd proposal for which the budget tab is not required, they no longer need to data enter non-key personnel in the InfoEd Personnel tab.

Below are project types that do not require a budget tab:

  • ISMMS funded
  • Projects in which the extramural funding agency provides funding by per subject payments (e.g.,  Pharmaceutical sponsored multi center clinical trial, NIH CALGB protocol)
  • No cost extensions

Examples of typical non-key personnel positions are research coordinators, research assistants and technicians.  Please review GCO’s Glossary of Common Terms for  additional information.

Also, please be aware that this policy change is for GCO InfoEd submissions only.  This policy neither applies to documentation submitted to PPHS or IACUC nor personnel data entry on Sinai Central, Ideate, or any other software system. Please contact the GCO at grants@mssm.edu, if you have questions about this change.

Department of Corporate and Foundation Relations Announces Funding Opportunities

The Department of Corporate and Foundation Relations of the Mount Sinai Development Office provides this curated list of funding opportunities to find faculty who may be interested and to provide assistance with the application process. Please see below for some of their upcoming deadlines, and check out their website for more information: http://icahn.mssm.edu/research/portal/resources/corporate-foundation-relations.

Please note – if you are interested in general funding opportunities (not a specific RFP listed here), please fill out the form linked on the site with your inquiry.

Melanoma Research Foundation: https://www.melanoma.org/research-center/research-grants
The Melanoma Research Foundation (MRF) is committed to advancing research across the spectrum of melanoma – from prevention through diagnosis, staging and treatment. The MRF proactively partners with the NCI, Congress, the Department of Defense and other foundations to develop and collaborate on a broad agenda for melanoma research that takes full advantage of all opportunities, while also sharing challenges. Since 1998, the MRF has funded over 130 innovative, high impact, basic, translational and clinical research projects. Further, in 2016, the MRF awarded over $1.2 million dollars in new melanoma research.

  • Young Investigator Research Team Award
  • The MRF, in partnership with the MRF Breakthrough Consortium (MRFBC) and Bristol-Myers Squibb (BMS), is pleased to announce a new research award for 2017 for young investigator teams designed to advance the field of translational immuno-oncology research.
  • Applications will be accepted until September 15, 2017.

Whitehall Foundation Research Grants: http://www.whitehall.org/grants/
The Whitehall Foundation, through its program of grants and grants-in-aid, assists scholarly research in the life sciences. It is the Foundation’s policy to assist those dynamic areas of basic biological research that are not heavily supported by Federal Agencies or other foundations with specialized missions. In order to respond to the changing environment, the Whitehall Foundation periodically reassesses the need for financial support by the various fields of biological research.

  • Typical grants are for up to $225,000
  • Letter of Inquiry deadline is October 1, 2017.

Broad Medical Research Program @ Crohn’s and Colitis Foundation of America
Research grants are available for innovative proposals that will lead to improvements in the prevention, diagnosis, or therapy of Crohn’s disease or ulcerative colitis. BMRP-CCFA especially supports research that can be readily translated to improve the care of human IBD in the near future.

  • Rolling Deadline Opportunity
  • Please email CorpFoundHelp@mountsinai.org if you are interested in this rolling deadline program, and the Department of Corporate and Foundation Relations will facilitate approaching the foundation.