January 22, 2015

Feature Articles

Top Ways to Prevent a Human Subjects Bar to Award

Opportunities and Resources

In The News

Advice Corner

New Process for Making Changes to Inclusion Data Records for Grants
Reader Questions
- Can NIH funding support a foreign postdoctoral fellow?
- I'm not sure I understand early awards. How can I tell if I will qualify?

New Funding Opportunities

See the list

Top Ways to Prevent a Human Subjects Bar to Award

To avoid ending up in the same boat as applicants who get a human subjects bar to award, take preventive measures to help ensure smooth sailing. We give you a handful of suggestions below, with examples to consider when completing your application.

Note: Even if you think your research wouldn't fall under human subjects regulations, it's worth pausing to consider that possibility again. Read Are You Conducting Human Subjects Research?and the other links at the end of this article. Consult a program officer if you still aren't sure whether you are proposing human subjects research.

Also keep in mind, if a proposed study using human data or biological specimens does not meet the definition of human subjects research, you must still provide an explanation of why the proposed study does not constitute research involving human subjects, as explained in Scenario A ofSupplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan.

Our Top Five Recommendations for Avoiding a Human Subjects Bar to Award

1. Specify the sources of your research materials.

Perhaps you deal only with specimens and data in your lab, not patients. But have you carefully traced and can you clearly identify where the specimens and data come from? Could they have come from sources NIH considers "human subjects," for example, data that includes individually-identifiable private information?

Make sure you clarify your sources and why they do or don't fall under human subjects rules.

And don't forget to consider activities at other performance sites and through subawards. For multiproject applications, this is the most common stumbling block that triggers a bar to award. Your overall application's human subjects classification might be determined based on a single site's activity.

Alternatively, if you are conducting a substudy or are using samples or data from another project that is not part of your application, be clear about which aspects pertain to your application. For example, a career development (K) grant applicant using data collected from his or her mentor's clinical trial should not complete the information required for clinical trials (Scenarios E or F of the Supplemental Instructions); doing so would give the appearance that he or she is conducting a new clinical trial.

See the HHS decision charts under Related Links below for more guidance.

2. Address all the human subjects elements in your application.

Analyze each person's role on your grant and the potential for identifying coded specimens and data.

For example, could your statistician have access to a code that links identifiers to subjects? Even if you and your staff aren't planning to access an identification key, think about whether the potential exists.

You might be proposing human subjects research after all. If so, be sure to complete the human subjects section in your application.

3. Adequately address risks and protections.

Make sure you describe the potential risks to your human subjects and how you plan to protect them. Here are some examples to consider:

Risks to confidentiality.
Risks of a drug you're using in a clinical trial.
Risks of any procedures you use—e.g., radiation from x-rays, biopsies, or other complications.
Psychological risks for your participants—e.g., if you test for HIV and a person finds out he or she is positive.

4. Consider informed consent issues.

Did you describe your process for providing informed consent? How will you make sure your prospective subjects know the purpose, procedure, and potential risks and benefits of your research? For example, if you're using children in your research, how are you getting consent from parents and documenting that consent?

Is there a possibility that future studies might be performed using the same samples? Does the original consent form cover this possibility?

In your application, be sure to explain your informed consent process and fully address potential consent issues. This is a must.

5. Address privacy, confidentiality, and human genetics issues.

In the confidentiality section of your application, did you thoroughly describe plans for protecting the privacy of and data on people in your study?

Foreign research can raise additional confidentiality issues since local regulations may differ from your institution's. For example, if you plan to ship samples outside the country for genetic research, first confirm that you're allowed to do so.

Think through how genetic data, if any, and samples will be used. Is it integral to your study, or can a subject opt-out and still participate? Who will have access to information from your study?

If you do end up with a bar to award despite your best efforts, learn how to get it lifted in our June 4, 2014, article "Don't Get Caught Behind a Bar to Award if You Want Your Grant Money." Visit the links below for more information on human subjects.

Act Quickly for FOA on Empirical Research on Human Subjects-Related Ethical Issues

Time is of the essence if you want to apply for the funding opportunity announcement (FOA) on Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data.

The application deadline is February 19, just a month away. If you're interested, we recommend consulting with NIAID's scientific/research contact Dr. Liza Dawson as soon as possible.

Applications should address ethical issues with significant policy relevance relating to either central institutional review boards (IRBs) for multisite clinical trials or research involving clinical records and data.

If addressing central IRBs, focus on at least one of the specific issues listed in the FOA, for example, principles to guide formation and conduct of central IRBs, or new resources or tools to support their operation.

Also address one or more of the issues listed in the announcement if you propose research with clinical records and data. For example, patient preferences regarding research use of clinical information, or privacy protections for sharing of clinical records and data for research.

Find the full list of issues for each topic and complete details in the December 18, 2014, Guide notice.

New Updates to NIAID's Resource on International Clinical Regulations

In our September article "A Solution if You're Struggling With Foreign Clinical Regulations," we shared a new NIAID resource on international clinical regulations, ClinRegs.

We wanted you to know about the following updates to that resource:

New country content.
- Liberia
- Sierra Leone

Country updates.
- India: Updated the Competent Authority Oversight, Scope of Assessment, Clinical Trial Lifecycle, and Clinical Trial Authorization topics pursuant to a Central Drugs Standard Control Organization (CDSCO) Order issued September 5, 2014, regarding review parameters for new clinical trial applications. Updated the Sponsorship topic to include a CDSCO Order issued December 15, 2014, regarding compensation in the case of clinical trial injury (other than death).
- Kenya: Updated the Specimens topic.
- South Africa: Corrected the age of minors in the Informed Consent topic, Children/Minors subtopic.

Share ClinRegs With the Community

Our ClinRegs team would love your feedback and invites you to share the tool with other potential users.

If you are interested in a media kit to support communicating ClinRegs to your community or would like to provide feedback, email the ClinRegs team at NIAIDClinRegsSupport@mail.nih.gov.

What is ClinRegs? Why Would I Use It?

ClinRegs is an online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing international clinical research. The Web site enables users to explore regulations within a country and compare requirements across countries.

Topic areas covered include clinical trial lifecycle, competent authority oversight, ethical review, informed consent, investigational products, specimens, and sponsorship.

ClinRegs provides regulatory information on a wide range of topics, including Sponsorship, Informed Consent, and Ethics Committee requirements, among others. It covers the following countries: Brazil, China, India, Kenya, Liberia, Malawi, Sierra Leone, South Africa, Peru, Tanzania, Thailand, Uganda, United Kingdom, and the United States.

To access the database, go to ClinRegs. You can also sign up for GovDelivery Alerts to stay informed of ClinRegs country and topic updates.

Create a Big Data Training Coordination Center

NIH wants you to build a network of big data scientists and construct a discovery index for personalized access to publicly available biomedical data science educational resources.

If that sounds appealing, check out a funding opportunity that can give you up to $1.4 million for a big data Training Coordination Center (TCC).

Your TCC will convene workshops, facilitate collaborations among researchers, and develop "ERuDIte," a personalized, predictive discovery index for educational resources related to big data.

Learn more in the December 18, 2014, Guide notice. Application deadline is March 17, 2015.

Remembering Richard Krause, Former NIAID Director

We at NIAID are saddened by the passing of Dr. Richard Krause, director of NIAID from 1975 to 1984.

During his illustrious career, Dr. Krause played a pivotal role in shining a brighter light on emerging infectious diseases. His successor, current NIAID Director Dr. Anthony Fauci, stated, "His scientific recognition that humanity faces a perpetual challenge from emerging and reemerging microbes was prophetic."

While at the helm of the Institute, Dr. Krause had many accomplishments, including leading NIAID into recombinant DNA research and technology as well as organizing field studies in Haiti and Zaire during the AIDS epidemic.

To learn more about Dr. Krause's life and life's work, read NIAID's January 9, 2015, News Release and In Memoriam

from his alma mater Marietta College.

Salary Cap and NRSA Stipend Levels Announced

As of January 11, 2015, the salary cap for grants, cooperative agreements, and contracts is $183,300. The cap restricts salaries to the rate of $183,300 annually; for example, $45,825 for three person-months.

The salary limitation applies to an individual’s direct or institutional base salary and does not include fringe benefits or facilities and administrative costs (also called indirect costs). However, the fringe benefits are calculated based on the allowable salary as well as the indirect costs. Your institution may pay you beyond the cap with non-grant funds.

FY 2015 awards issued January 11, 2015, or later will reflect the new salary limitation. For awards issued before that date, you may rebudget your grant to accommodate the increased salary level using unused funds. NIH will not provide additional funding for this purpose.

To learn more, including Questions and Answers and examples of calculating the salary limitation, read the December 30, 2014,Guide notice.

NRSA Stipends

In another December 30, 2014, Guide notice, NIH announced the FY 2015 stipend levels for Ruth L. Kirschstein National Research Service Award (NRSA) awards.

They are as follows:

Career Level (Years of Experience)	12 Months	1 Month
Predoctoral	$22,920	$1,910
Postdoctoral 0	$42,840	$3,570
Postdoctoral 1	$44,556	$3,713
Postdoctoral 2	$46,344	$3,862
Postdoctoral 3	$48,192	$4,016
Postdoctoral 4	$50,112	$4,176
Postdoctoral 5	$52,116	$4,343
Postdoctoral 6	$54,216	$4,518
Postdoc 7 or more	$56,376	$4,698

The FY 2015 stipend levels listed above apply only to Kirschstein-NRSA awards made with FY 2015 funds.

The Tuition and Fees, Training Related Expenses, and Institutional Allowance funding that NIH provides NRSA recipients will not change with the implementation of the FY 2015 budget.

News Briefs

Include Genomic Data Sharing Plan in Your Application. If your research involves genomic data, make sure you include a sharing plan for any application you send on or after January 25, 2015. Learn more at NIH’s Genomic Data Sharing site, including forms and instructions for Researchers. Whenever we have news and advice from NIAID on this topic, we’ll pass it along in this newsletter.

Grants.gov Downtime Expected in Mid-February. Upgrades to Grants.gov are planned for mid-February, which will cause downtime and may lead to deadline extensions for due dates falling between February 13 and 18, 2015. NIH will issue a Guide notice when the dates are confirmed. The updates will include allowing special characters to be used in application titles and other fields.

Video Tutorials for Internet Assisted Review. For tips on efficiently completing review responsibilities and obligations online,Internet Assisted Review (IAR) users should check out nine video tutorials, which can be viewed at For Reviewers: Navigating Internet Assisted Review.

Save the Date: Upcoming Seminar on Grants Policy. The first of two 2015 NIH Regional Seminars on Program Funding and Grants Administration will take place in Baltimore, Maryland, from May 6 to 8, 2015. The seminar will have session tracks specifically designed for administrators and new investigators, as well as an "all interest" track. Find more details in the December 17, 2014, Guide notice.

Help Spread the Word About Amgen Scholars Program. The 2015 Amgen Scholars Program at NIH brings rising undergraduate juniors and seniors to NIH's main campus to spend the summer working on basic, translational, and clinical research. Let your students know as soon as possible; they will need to submit their application packages, including reference letters, by February 2, 2015.

New Process for Making Changes to Inclusion Data Records for Grants

Principal investigators (PIs) and signing officials (SOs): make sure that you are aware of the process for making changes to inclusion data records (IDRs). The administrative steps are straightforward, but PIs and SOs who aren’t aware of their responsibilities may inadvertently delay their awards.

So, if you are unfamiliar with Routing and Submitting IDRs in the Inclusion Management System (IMS), take a moment to learn how.

When a program officer has a concern with your IDR, he or she will contact you directly by email with instructions on what changes or updates are needed. This typically occurs before competing awards are funded or after progress reports are submitted.

As the PI, you must enter changes to the IDR directly in IMS. Then you will notify your SO that the changes are complete by clicking Route to SO. Your SO can then return the IDR to you for additional changes by clicking Return to PI or send the IDR on to NIAID by clicking Route to Agency. IMS will alert the program officer through email once the SO has submitted the IDR.

In the past, PIs corrected PDF versions of their IDRs and emailed them to their business offices, who then emailed the file to NIAID. This is no longer an option. We’ve seen some awards unnecessarily delayed because PIs and SOs didn’t make IDR changes in IMS or weren’t familiar with how to do so.

One last point to keep in mind: You will use IMS to complete your Planned Enrollment Report and your Cumulative Inclusion Enrollment Report. Be sure you are working on the correct form. That mistake cannot be easily undone in IMS, so double check that you have the right form before you start entering data.

Related Resources

Instructions for Accessing the Inclusion Management System (IMS) Via Commons Status
5.2.4 Editing Inclusion Enrollment Data in NIH and Other PHS Agency Research Performance Progress Report (RPPR) Instruction Guide
eRA Help Desk for immediate support on technical issues

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

"Can NIH funding support a foreign postdoctoral fellow?"—anonymous reader

Sometimes. Foreign postdoctoral fellows may be supported by NIH-funded research grants (e.g., an R01), but not by fellowships, training grants, or small business awards. If a grant has a citizenship requirement, it will be listed in the funding opportunity announcement.

Read Foreign Workers on NIH Awards SOP to learn more.

“I'm not sure I understand early awards. How can I tell if I will qualify?”—anonymous reader

NIAID makes early awards, meaning before NIAID advisory Council meetings, for several types of grants:

Investigator-initiated grants that are within the NIAID payline and have no special concerns or unresolved appeals.
Applications responding to requests for applications and program announcements.
R56-Bridge awards.

These grants go through second-level review by a subset of NIAID Council members.

Grants that cannot be expedited are selective pay, MERIT awards and MERIT extensions, appeals, barred applications with unresolved issues, applications exceeding the 20 percent cap for renewal awards, foreign grants, and other special issue grants.

For the January or February and May or June Councils, we can fund qualifying applications a few weeks after initial peer review. For full details on the early award process, check out Expedited Council Review and Award SOP and Early Grant Awards Questions and Answers.