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.