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

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.


IACUC Full Board Protocol Submission Deadlines Posted for 2018 Meetings

The Institutional Animal Care and Use Committee (IACUC) meets every two weeks to review protocols requiring Full Board Review (FBR) and have now posted their new schedule of full board protocol submission deadlines (click here to access). For review at a FBR meeting, researchers must submit their applications by the submission deadline. If a submission deadline should occur on a weekend or holiday, applications will be accepted the next business day. The IACUC reserves the right to move a protocol to the next meeting within the same month where required.

For more information about the MSHS IACUC and IACUC applications, researchers can visit the IACUC website. Please contact IACUC@mssm.edu, if you have any questions.


Call for Applications: STTEP-UP Initiative in Science and Medicine

ConduITS, the Institutes for Translational Sciences is once again seeking applications for the 2018-2019 NCATS funded training program entitled the STTEP-UP Initiative in Science and Medicine.

This program is designed to enable highly motivated underrepresented minority (URM) trainees in residency, subspecialty fellowship training or postdoctoral laboratory positions within our health care system, to become innovative leaders and entrepreneurs in clinical and translational research. The program is designed to provide candidates with the critical thinking skills to evaluate the validity and implications of the published literature and plethora of available information through digital and internet resources; formulate testable hypotheses, design informative, effective and efficient studies, analyze data correctly and interpret quantitative and qualitative findings and their potential impact on the health of individuals across the life cycle.

The components of the program include:

  • Academic Skills:
    • Time management & work/life balance
    • Mentorship
    • Communication Styles
    • Leadership
    • Team Science
    • Practical Tips for Negotiating your Career
    • Must Know Financial Concepts
  • INCHOIR Learning Lab, which will entail participation in hands-on training in clinical and translational science, utilizing an established data repository for secondary data analysis, and monthly didactics on fundamentals in interventional studies culminating in a two day virtual clinical trial development workshop.
  • Opportunities for Multidisciplinary Teamwork with other trainees throughout the education process.
  • Individual Career Development with Primary Mentor & Interdisciplinary Mentor Team
  • Career Development Seminars in the following topics:
    • Loan Repayment Program
    • Diversity Supplements
    • Mentored Awards Roadmap
  • T32 Networking Seminar Series
  • “Meet the Expert” Mentored Investigator “K Club Series”
  • Annual Next Steps Symposium, which will highlight nationally-renowned URM Clinical and Translational Investigators

We are currently seeking nominations for the academic year starting July 1, 2018 – June 30, 2019. This competitive program utilizes an NCATS funded NRSA TL1 mechanism and provides salary support and tuition dollars for four postdoctoral trainees per year. Applicants will be asked to complete a full application and submit to Christine Acevedo (christine.acevedo@mssm.edu) by April 15, 2018. Full application includes:

  • Completed application form (NRSA TL1 Application Form 2018) which should include a brief overview concerning prior, current and/or upcoming involvement in a research project as well as the motivation for embracing a career in clinical translational research.*
  • Current curriculum vitae including bibliography.
  • 1 letter of recommendation from your Training Program Director; 1 letter of recommendation from your Division Chief or Department/Institute/Center Chairperson. These respective letters should indicate that the training program director, division chief or department/institute/center chairperson is committed to make time available for the trainee to participate in the required academic programs.

If you have any specific questions, please feel free to email or contact the office at 212-824-7014. We look forward to receiving your application.

* If an applicant has recently developed or submitted a research proposal or protocol, the specific aim page or synopsis respectively can be used instead.