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Introduction
Highly trained medical writers are typically familiar with case 

studies of scientific misconduct, defined as data fabrication, 

data falsification, and plagiarism.1 However, less than 2% of 

researchers are thought to engage in scientific misconduct.2 In 

recognition that avoiding scientific misconduct is only a small 

part of research ethics, the National Institutes of Health (NIH) 

released the following statement in 2009: “[R]esponsible con-

duct of research is defined as the practice of scientific investi-

gation with integrity. It involves the awareness and application 

of established professional norms and ethical principles in the 

performance of all activities related to scientific research.”3 

This guiding principle can be used to shape every aspect of our 

work when developing grant proposals.

 The ethical codes from the American Grant Writers’ 

Association4 and the Grant Professionals Association5 high-

light key ethical issues for grant writers, including avoid-

ing conflicts of interest, following confidentiality guidelines, 

avoiding plagiarism, and accurately representing the  

prior work and future capabilities of the funding recipient. 

They also describe the importance of not allowing payment 

to be contingent on grant success.

 This article addresses additional areas in which we com-

monly see room for improvement for the medical writer 

regarding research ethics, with a focus on NIH proposals. The 

NIH supports the work of over 300,000 biomedical scientists 

through competitive research funding amounting to $41.7 

billion in 2020,6 making the NIH the largest public funder of 

research worldwide. The NIH received 54,903 research grant 

proposals in 2019,7 many of which were written or edited by 

professional medical writers.

 In the last half decade, the NIH has taken concrete action 

to improve the responsible conduct of research. In late 

2015, the NIH released a major change to the application 

instructions and review criteria for research projects, called 

“Implementing Rigor and Transparency in NIH & AHRQ 

Research Grant Applications,”8 which was updated in 2018.9 

Chris S. Gandhi1 and Nancy Linford2 / 1Beckman Research Institute of City of Hope, 
Duarte, CA; 2Linford Biomedical Communications, Seattle, WA

EVERYDAY ETHICS

Considerations for Developing Ethical Biomedical 
Grant Proposals for the National Institutes Of Health

In 2020, the NIH also released an updated Policy for Data 

Management and Sharing (DMS),10 which builds upon exist-

ing requirements for disseminating research results to the 

public. These policy statements cover a range of ethical issues 

in biomedical research, which will be discussed in the next 

sections. The portions of these policy statements that focus 

on clinical research design and dissemination of human sub-

jects’ research data will not be covered here, as those topics 

are beyond the scope of this article.

 Given that one of the medical writer’s responsibilities is to 

ensure that the text is compliant with the funder’s policies, 

the new NIH policy statements represent important areas in 

which the medical writer can make a positive impact on  

ethical conduct in the grant development process.

Research Plan: Enhancing Rigor and Reproducibility 
The reviewers will assess 4 elements of rigor.8,9,11 Below are 

descriptions of those elements and recommendations to  

consider.

1. Rigor of the prior research. When justifying the research 

aims, typically in the Significance section, applicants may be 

tempted to focus solely on their work and to emphasize only 

the positive. However, such a narrow focus can give review-

ers a biased impression of the state of the field. Therefore, 

applicants are encouraged to write a more balanced narrative 

describing the strengths and weaknesses of prior work in light 

of the whole field and acknowledging competing viewpoints.

Table 1. Considerations for Describing Rigor of the Prior Research

✓ Does the Significance section refer to work performed by
other research groups?

✓ Does the Significance section critically appraise the
technical and/or intellectual rigor of prior work by the
applicant and by others?

✓ Does the Significance section address whether the prior
work led to consensus or controversy?



      AMWA Journal / V36 N2 / 2021 / amwa.org    91

2.  Rigor of the proposed work. When describing the cur-

rent research plans in the Approach section, applicants must 

justify their experiments in light of the weaknesses in prior 

work. This justification could be as obvious as clarifying the 

research milestone that made the present work possible, 

or it could be more complicated, especially if the proposed 

work attempts to overcome a controversy. Asserting the 

rigor of the proposed work also means providing enough 

detail on the experimental plans and statistical analysis for 

reviewers to have confidence that the research team can 

navigate experimental subtleties to arrive at meaningful 

answers. Consensus guidelines for reporting research results, 

such as ARRIVE (Animal Research: Reporting of In Vivo 

Experiments), can clarify how much detail to include in the 

study design.12,13

3.  Biological variables. To enhance reproducibility, appli-

cants are expected to justify the experimental design and 

analysis choices in light of the relevant biological variables 

that may impact the interpretation of results. The NIH uses 

a broad definition of biological variables, including intrin-

sic factors (eg, sex, weight, age, and genetic background) and 

extrinsic factors (eg, food source and housing conditions for 

animal studies).14 In particular, for work with human sub-

jects or vertebrate animals, reviewers will evaluate whether 

the proposal adequately considers sex as a biological variable, 

and strong justification is required for experiments using only  

one sex.15,16

4.  Authentication. Research performed with reagents that 

are unreliable or mislabeled can lack reproducibility. Thus, 

applicants must briefly describe the plan for validating key 

biological and chemical resources, such as cell lines, antibod-

ies, specialty chemicals, and transgenic animals.17 The goal is 

to describe the methods used to validate reagents, including 

validation performed by commercial sources.

Data Management and Sharing Plan: Storing and 
Disseminating Biomedical Research Data
Because science advances through building on past findings, 

sharing data is a best practice that positively benefits appli-

cants, their fields, and funding agencies. Additionally, because 

the NIH uses public funds, there is an additional ethical duty 

to share research findings with the public.

 The current NIH Data Sharing Policy18 went into effect 

in 2003 and remains in effect until January 2023. Under 

the 2003 policy, all investigator-initiated applications seek-

ing >$500,000 in direct costs per year, or as specified in the 

individual Funding Opportunity Announcement (FOA), are 

required to include a plan for the sharing of final research 

data or a justification for why data sharing is not possible  

(eg, privacy concerns, third-party agreements, and national 

security issues). This policy was extended in 2014 by the 

Genomic Data Sharing policy, which establishes expectations 

for the broad and responsible sharing of genomic research 

data.19 Beginning in 2023, all NIH applications must include 

a DMS Plan and adhere to the updated NIH policy10 and 

supplemental information,15,20,21 including abiding by FAIR 

(Findable, Accessible, Interoperable, and Reusable) data prin-

ciples.22 Because the 2023 policy includes all of the elements 

of the 2003 policy and expands upon several key concepts, 

we will focus on the ethical considerations for writing a DMS 

Plan that complies with the newer guidance.

 DMS plans will be evaluated for compliance in the follow-

ing areas20:

1.  Data type, common data standards, and repository selec-

tion. Applicants are expected to describe what types of data 

and accompanying metadata will be preserved and shared 

and what common data standards will be applied to the 

shared data and metadata, if applicable. Decisions on what 

to preserve and share should be based on justifiable ethical, 

legal, and technical considerations. Applicants are strongly 

encouraged to use existing data repositories, especially those 

that follow FAIR principles. The NIH does not always require 

deposition into an NIH-supported repository, so it can be 

appropriate to consider third-party repositories.

EVERYDAY ETHICS

Table 2. Considerations for Describing Rigor of the Proposed Work

✓ Does the Approach section explain how the current research 
plans fill any knowledge gaps left by prior work?

✓ Does the Approach section provide sufficient methodologi-
cal detail to demonstrate that the applicants know the  
pitfalls in their field and how to avoid them?

✓ Does the Approach section provide a statistical analysis 
plan, including a power analysis when appropriate?

Table 3. Considerations for Accounting for Biological Variables

✓ Does the Approach section consider sex as a biological  
variable in the design and analysis of work with human 
subjects or vertebrate animals?

✓ Does the Approach section consider additional biological 
variables, especially those recognized as important in prior 
research in the field?

✓ Are any proposed analyses based on relevant biological vari-
ables sufficiently powered to generate meaningful results?

Table 4. Considerations for Describing Authentication of 
Reagents and Key Resources

✓  Is there a separate Authentication Plan for Key Biological 
and/or Chemical Resources?

✓ Does the Authentication Plan contain information about 
reagents and resources and not preliminary data or methods?

✓ Does the Authentication Plan sufficiently detail how and at 
what frequency key resources will be authenticated?



92    AMWA Journal / V36 N2 / 2021 / amwa.org        

2.  Timelines and plans for data preservation, access, and 

sharing. Data and metadata should be preserved, at a mini-

mum, in accordance with all applicable guidance (eg, data 

repository policies, specific award requirements, and journal 

policies). Final research data and metadata should be acces-

sible no later than the time of publication or the end of the 

performance period, whichever is earlier, unless there are justi-

fiable exceptions explained in the DMS Plan.

3.  Limitations on access, reuse, and distribution. Certain 

types of data and metadata may be confidential, sensitive, or 

proprietary. The NIH expects data and associated metadata to 

be shared to the maximum extent allowable. Any limitations or 

controls on their access, reuse, and distribution must be justi-

fied on ethical, policy-based, or legal grounds.

 In addition to the above considerations, the NIH will also 

expect a statement on how the DMS Plan will be managed and 

monitored and by whom.

Conclusions
Recent world events have underscored the ethical justifica-

tion to ensure biomedical research is conducted in a rigor-

ous manner and that the fruits of research are shared with the 

larger scientific community and the public. For example, the 

coronavirus disease 2019 (COVID-19) pandemic has demon-

strated what the scientific community can quickly achieve 

when rigorous methods are applied and when high-quality 

data are disseminated widely and rapidly. We have focused on 

a subset of ethical considerations to guide the development of 

biomedical research grant applications for the NIH; however, 

the underlying ethical ethos of ensuring scientific rigor and the 

timely sharing of scientific data can guide the development of 

proposals for all funding agencies.

Author declaration and disclosures: The authors note no commercial 
associations that may pose a conflict of interest in relation to this article.

Author contact: chrgandhi@coh.org, nancy@linfordbiomedical.com 

 

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Table 5. Considerations for Describing Data Types, Common 
Data Standards, and Repository Selection

✓  Does the DMS Plan briefly summarize the types of data and 
associated metadata to be preserved and shared?

✓ Does the DMS Plan indicate what common data standards 
will be applied to the data and metadata? If no applicable 
common data standards exist, is that noted in the Plan?

✓ Does the DMS Plan identify appropriate NIH-supported or 
third-party data repository archive(s)?

✓ Does the DMS Plan indicate if the selected archive(s) is  
limited to certain data types? If required by the FOA, does 
the DMS Plan affirm the use of a designated NIH-supported 
repository?

Table 6. Considerations for Describing Data Preservation, 
Access, and Sharing

✓  Does the DMS Plan conform to FAIR principles for the iden-
tification, access, and reuse of shared data and metadata? 
Does the DMS Plan indicate how shared data and metadata 
will be findable and identifiable?

✓ Does the DMS Plan affirm an acceptable timeline for  
sharing data and metadata?

✓ If specialized tools are needed to access or manipulate 
shared scientific data and metadata to support reuse or rep-
lication, will these tools be available as long as the data are 
shared? How can these tools be accessed?

Table 7. Considerations for Describing Limitations on Access, 
Reuse, and Distribution

✓  If the data and/or metadata are confidential, sensitive, or 
proprietary, has a reasonable justification for exclusion from 
sharing been provided in the DMS Plan?

✓ Are there any restrictions on how data can be accessed, reused, 
or distributed, for example, only with explicit approval?

✓ If there are no limitations, has that been indicated?

EVERYDAY ETHICS

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EVERYDAY ETHICS

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https://nexus.od.nih.gov/all/2016/01/29/consideration-of-relevant-biological-variables-in-nih-grant-applications/
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-068.html
https://grants.nih.gov/grants/guide/notice-files/not-od-03-032.html
https://grants.nih.gov/grants/guide/notice-files/not-od-03-032.html
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html
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