NIH Grant-Writing Workshop

Dlab Workshop Session 4: Human Subjects and Other Documents

Leora Lawton, Ph.D.

Executive Director, Berkeley Population Center Summer 2015 1

Other Documents

 Human Subjects  Other Documents:     Project Abstract/Summary* Project Narrative* Facilities and Resources* Women and Minorities     Children Targeted planned enrollment Animals, Equipment Resource sharing*    Budget Justification* Appendices Multi-PI plans (rare) * Always required 2

Human Subjects

   This document indicates that you have a full understanding of human subjects issues in your research project. If considered insufficient your proposal will not be reviewed. See the example on bspace, also use the NIH official guidelines document: Parts II (Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan) and III (Policies, Assurances, Definitions, and Other Information) http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf

.

It is not highly intuitive, so use the example, which must have these sections:   Characteristics of the study population (from strategy, targeted/planned enrollment) Sources of materials (format of collected and stored data).

 Recruitment and consent procedures (how reached, at what point do people give consent and how do they do so?)    Potential risks (privacy, health) Adequacy of Procedures for Protecting against Risks (data security)  Potential Benefits of the Proposed Research to the Subjects and Others (a cure, better health, or most likely, other than the incentive, just being a better person for participating).

Importance of the Knowledge to be Gained (why it’s worth while to subject humans to my research) 3

Project Summary/Abstract

7. Project Summary/Abstract

The Project Summary must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate lay reader. This Summary must not include any proprietary/confidential information. Please click the

Add Attachment

button to the right of this field to complete this entry.

The

Project Summary

is meant to serve as a succinct and accurate description of the proposed work when separated from the application. State the application’s broad, long term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the

mission of the agency

). Describe concisely the research design and methods for achieving the stated goals. This section should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate reader. Avoid describing past accomplishments and the use of the first person. Finally, please make every effort to be succinct. This section must be no longer than 30 lines of text, and follow the required font and margin specifications . An abstract which exceeds this allowable length may be flagged as an error by the agency upon submission. This would require a corrective action before the application will be accepted.

Check The Book, too. 4

Project Abstract/Summary

 This document is very important because it’s viewed by reviewers who vote, but who don’t necessarily read the entire proposal.  It’s limited to 30 lines.

 It is the abstract of the study, whereas the Specific Aims is the proposal in one page. So it says what you are going investigate (topic and population), why (importance and significance) and how (data used).

 It is the public-facing document that you see on Project Reporter (in Description), so   You have thousands of examples at your fingertips. It must be written in everyday academic language, without jargon.

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Project Narrative

8. Project Narrative

Provide Project Narrative in accordance with the announcement and/or agency specific instructions.

For NIH and other PHS agencies applications, u

sing no more than two or three sentences, describe the relevance of this research to

public

health. In this section, be succinct and use plain language that can be understood by a general, lay audience.

Check The Book, too. 6

Project Narrative

 Just 2-3 sentences (not lines) long.

 It is also public-facing (in Project Reporter, in Description).

 It states the public health benefit and why it fits with the mission of the IC.

 

Example 1:

This project is important for public health because the availability and use of personal networks is very important for health and well-being, especially in times of difficulty. In this longitudinal panel study of social networks of two cohorts of persons in the United States, it will be possible to see how a person’s social networks – and their attendant social support– develop, change, maintain and reorganize as a result of life course changes, such as residential mobility, retirement, illness, marital disruption, and other events. Because social support networks have been shown to shape physical and emotional well-being, understanding how and why networks change will have important health implications, especially as the US population trends toward small family size, fewer children, and a higher proportion of persons living alone

Example 2:

The proposed randomized controlled trial investigates how the effectiveness of smoking treatment can be enhanced by applying recent advances in behavioral economics theory regarding financial commitment and monetary incentives. We test the extent to which adding social pressure and cash rewards to financial agreements can increase quit rates as part of a workplace wellness intervention in Thailand. The findings have the potential to influence tobacco policy in many settings and to advance the literature on the use of financial commitment and incentives to improve preventive health behavior. 7

Resource Sharing

 It’s good to share your results, data, and anything else you’ve learned.  Some projects have specific requirements, e.g. GWAS, budgets with direct costs of $500k or more in any year.

 Say how you plan to do so:  Publications, e.g., in peer-reviewed journals, monographs, and/or layperson reports for policy makers.

 Presentations at conferences.

     On a website, or build a new one for the project Engaging with community leaders.

Putting data up on a website, yours, ICPSR, or wherever. Teach workshops to a specified audience.

???

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Documents Regarding Study Population

Documents about children, women and minorities in the study population

 Not so long ago clinical trials tested medicines and treatments on white males only. This led to overdoses, unanticipated side effects, and even catastrophic effects.

 So now research must include children, women and minorities unless there is a scientific research not to do so.  When you are collecting your own data and have human subjects issues, then you must include these documents.

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Children

   

For the purpose of implementing these guidelines, a http://grants.nih.gov/grants/funding/children/children.htm child is defined as an individual under the age of 21 years.

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? (p.I-129) • Provide either a description of the plans to include children, including the particular age ranges to be included, or, if children (or a subset) will be excluded from the proposed research, present an acceptable justification for the exclusion (see below). • If children are included, the description of the plan should include a rationale for selecting a specific age range of children. The plan also must include a description of the expertise of the investigative team for working with children at the ages included, of the appropriateness of the available facilities to accommodate the children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study. 10

Women and Minorities

6. Inclusion of Women and Minorities Refer to Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan . Complete this section if you answered “yes” to the question “are human subjects involved?” on the R&R Other Project Information Form and the research does not fall under Exemption 4.

Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.

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Women and Minorities

 http://grants.nih.gov/grants/funding/424/SupplementalIns tructions.pdf#4_2_Inclusion_of_Women_and_Minorities .  Included if Human Subjects mentioned.  Describe study population, why including/excluding by gender is appropriate (e.g., prostate studies don’t need women). Same for minorities (e.g., immigrant studies may not need immigrants from, say, Africa, because of the sample frame). 12

Targeted Planned Enrollment

 There is a specific form for this. You may need to calculate these numbers from census documentation for representative samples.  http://grants.nih.gov/grants/funding/phs398/PlannedEnrol lmentReport.docx

.  Not here, but in your research strategy, you will need to justify your sample population as being appropriate for testing your hypotheses. 13

Animals | Equipment

 Animals probably don’t arise in behavioral and social science research all that often but there are rules. Please check the Instructions.

 Equipment is for equipment that costs at least $5,000, e.g., servers, lab equipment.

 Generally if you don’t need to include the document you can just skip it. Others feel you should add it with a note such as this: “This project includes no vertebrate animals.” 14

Facilities and Resources

Facilities & Other Resources

Describe the facilities and resources that will be used in the proposed training program. Indicate in what ways the applicant organization will support the program, financial or otherwise (e.g., supplementation of stipends, protected time for mentoring, support for student activities). This could also include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and participating faculty, support for additional trainees in the program, or any other creative ways to improve the climate for the establishment and growth of the research training program. In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service. 15

Facilities and Resources

 Must include all project sites. If including locations other than UC Berkeley, must have letter.  Even if the resource is at UC Berkeley, it may still be beneficial to have a letter.  Describes: Computing, data, office space, administrative support, libraries, conference space, data collection equipment and services, data analysis capabilities, bio specimen storage, etc.  Course releases require a letter from the Dean or Provost. Any additional financial support offered must have a letter. I’ve concluded that when in doubt, provide a letter. 16

Appendices

 Acceptable appendix material is very limited (I-118 to I-120) Do not use the appendix to circumvent the page limits of the Research Strategy or any other section of the application for which a page limit applies. For additional information regarding Appendix material and page limits, please refer to the NIH Guide Notice NOT-OD-11-080, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-080.html

.

New, resubmission, renewal, and revision applications

may

include the following materials in the Appendix (note, however, that some FOAs do not permit publications): 

Publications – No longer allowed as appendix materials except in the circumstances noted below

up to 3 of the following types of publications: . Applicants may submit o

Manuscripts and/or abstracts accepted for publication but not yet published:

as a PDF attachment.

The entire article should be submitted o

Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available:

entire article should be submitted as a PDF attachment.

The o

Patents directly relevant to the project:

The entire document should be submitted as a PDF attachment.

  (Do not include unpublished theses, or abstracts/manuscripts

submitted

(but not yet accepted) for publication.) Surveys, questionnaires, and other data collection instruments; clinical protocols and informed consent documents may be submitted in the Appendix as necessary. For materials that cannot be submitted electronically or materials that cannot be converted to PDF format (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Officer for instructions following notification of assignment of the application to a SRG. Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application.

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Project Management: R03 Example

Task Due date: Final revisions to all documents Due to SPO Drafts of other documents Get reviews/edit Write other documents Finish draft of strategy Finish biosketches Write budget justification Ask for letters Get budget to Grant Analyst Write strategy - get feedback Send Specific aims to PO Find proper funding sources Develop basic idea, team Timing 16-Mar 9-15 Mar 9-Mar 8-Mar by Mar 8 Mar 1-8 1-Mar 15-Feb 5-Feb 1-Feb 1-Feb 15-Jan 5-Dec November November 18

General Advice

– Take advantage of existing documentation providing tricks of the trade and wisdom – Read The Book. Refer to it constantly. – Attend workshops at conferences sponsored by NIH – Go over reference documents on Popcenter, SPO and NIH websites – Read the FOA several times, at different stages of your grantwriting process.

– Talk to your advisors for their take on how you should approach the grant, especially seek out someone with NIH grant experience, and ideally, someone who has been a reviewer. – After everything is drafted, have someone familiar with the project go over the FOA and The Book and give the strategy and other documents an audit for formatting, section headings, content, page limits, typos and version control. – Ironically a mistake very senior researchers make is to assume they don’t need to explain themselves because surely people know who They Are. 19

Hot Off the Presses

– http://news-rac.berkeley.edu/ . 20

Homework

– Revise your Specific Aims.

– Think about timing for your project 21