In this article, you will learn about NIH grant policies in a way that makes the process of administration of federal funds easy to understand. This piece of writing will discuss policy implementation and oversight in the area of applied science.
As is evident in the global scientific corridors, the United States of America has been reigning supreme for decades as a world leader in biomedical research through clever harvesting of fresh scientific talent and integrating them into a sustainable environment of the National Institute of Health. (Peifer, 2017).
It is well known that when you get federal help to carry out your research, you are required to abide by certain laws and terms & conditions. Similarly, receiving organizations are required to be responsible for NIH grant policy regulations.
The following policy subjects are particular in nature because they further explain the range of resource matters.
NIH Grants Policy Statement
The NIH Grants Policy Statement (NIH GPS) is published annually for every fiscal year. The NIHGPS contains the terms and conditions of the grant award. Keep an eye out for notices of policy change that you can also find in the NIH guide in order to keep yourself updated on required rules and regulations. You can find current NIHGPS easily available online in both HTML and downloadable PDF formats. In line with the American fiscal year, NIH’s financial year runs from Oct 1-Sept 30; therefore, its policy statement is applicable to all grant awards within the same fiscal year.
Below is the selected policy notices index for you to be familiarized with:
Conditions & Information for NIH Grants
Besides NIH GPS, the information present on the Award Conditions and Information for NIH Grants website act as an award’s applicable terms and conditions.
Standard Award Terms & Conditions
The thing to keep in the forefront of your mind is the application as the deciding factor. Everything comes down to your application submission, henceforth, approval by the NIH upon certain terms and conditions as follows:
- Notice of award (NoA) entails legal formulations and rules.
- Notice of award includes terms of reference for documents and attachments.
- NIH Grants Policy Statement requirements and National Policy requirements in accordance with the current fiscal year.
- 45 CFR Part 75
- Funds expenditure is conditioned to be closely monitored along with other statutory requirements. For instance: those that call for appropriate actions.
- In some cases, the periodic progress report in RPPR is required by Federal Award Performance Goals.
Animal Welfare Policy
It is a well-known fact that animal subjects are quintessential for human and animal well-being in some scientific research and experimentation. In order to prevent animal cruelty, NIH is aware of its responsibility in training and examination involving the use of vertebrate animals, as a science leader and to that end NIH’s animal policy is conscientious. Animal welfare act (7 U.S.C. 2131 et seq.) comes into action with the following rules:
- Animal experimentation should be performed strictly in relevance to the well-being of living organisms, knowledge development, and overall social betterment.
- The selected animals should belong to an appropriate species, and the procedure should require minimum numbers to achieve results.
- It is imperative to utilize animals in a sound scientific manner that minimizes distress and pain.
- Procedures liable to cause pain and distress to the selected animal must always be performed with appropriate sedation or anesthesia.
- Animals likely to suffer chronic and incurable pain should be put to rest (killed without causing pain) at the end of the procedure.
- The living conditions of animals used for biomedical research must be supervised by a veterinarian in a manner contributes to their health and comfort.
- Investigators conducting experiment procedures on alive animals must always be highly qualified and experienced.
- Decisions regarding principle provisions should not rest with the directly related investigators but with an appropriate review group such as animal care institutions.
Human Research Policy
The history of human subjects’ research is well established, so is the ethical background of it. Over the last 4 decades, the standards of human subjects’ safety and protection have developed substantially. Human subject research is a systematic investigation into a diverse and broad range of scientific matters, therefore, vital to medicinal development and overall life mortality & expectancy. NIH has a structured human research mechanism keeping participants’ interests, welfare, and protection sacred. You will find NIH safety, research conduct, monitoring, and reporting policies of comprehensive nature. Federal regulatory bodies consider human subject research specifically serious, so if you are planning on conducting human subject research, you should familiarize yourself with all the rules and regulations. Study 45 CFR 46 keenly in order to understand critical regulations. We live in the age of individualized medication and targeted therapies that are essential to achieving a disease-free world. (Bledsoe and Grizzle, 2013).
Intellectual Property Policy
Intellectual property policy is like everything else in life in that you are required to share the fruits of your endeavors with sponsor agencies, in a typical give some gain some manner. Bayh-Dole Act of Patent and Trademark Law instructs entities to maintain ownership while giving license of utilization to a government agency (e.g., NIH) that funded your research project in the first place.
NIH Public Access Policy
Accessibility plays a crucial role in scientific advancement. As a young scientist, you will be delighted to know that the availability of recorded archives of NIH funded publications has enabled both the NIH and scientists alike in meeting their targets as well as exchanging data. (Zerhouni, 2004). For the greater good NIH asks you to submit peer-reviewed periodicals manuscripts to PubMed Central for public availability.
Research integrity is an area of utmost trust and of an acutely sensitive nature. In the vast field of science, research integrity is the Holy Grail that is coveted by all scientists worth their salt. You must devise your own chain of custody to maintain the integrity and authenticity of your research work.
Professional values in any scientific search are:
Honesty: You must deliver upon your commitment in an honest, truthful manner.
Accuracy: You must rise above the margin of error in order to be accurate in your discoveries and reporting.
Efficiency: You must learn to plan intelligently so as to be on time and cost-effective.
Objectivity: You must be able to slay the dragon of biased temptations in that you deal in the currency of facts and exactitude.
Public Health Service Policies on Research Misconduct ensure that all NIH funded projects and affiliated organizations are beyond reproach and have a mechanism in place to prevent research misconduct. Intellectual dishonesty is regarded as a cardinal sin by public and honest scientists alike. Researchers who pay no attention to the integrity of the process do great damage to the institution of science and research as well as harm to the public welfare.
NIH Policy for Certificates of Confidentiality
Confidentiality is a matter of high priority in which you must have certain controls in place to ensure that all identifying information is kept private. Participant ought to feel confident about the fact that knowledge of their participation is safe. As a matter of fact and caution, NIH issues certificates of confidentiality (CoCs) for the very purpose of safeguarding against unauthorized disclosure like many other federal agencies.
Rigor and Transparency
The gold standard for discovering partiality and error is the rigorous implementation of transparency. Groupthink is the enemy of objectivity of investigation along with unnecessary secrecy. As the old saying goes, “if the process is right, so will be the results.” You must build quality as well as accountability into your work. NIH attempts to make its affiliated entities socially conscious of their responsibility toward accountability and research integrity. Application of secure scientific methods and impartial experimental mechanisms in a tightly controlled environment is the primary duty of receiving organizations. NIH believes in giving equal opportunities to those fulfilling scientific merit, so make sure that you showcase a deep understanding of technical mechanisms, instruments, and experimental structure through grant application criteria.
NIH Anti-Harassment Policy
NIH leads in creating a thriving work environment for all genders, not only in its own boundaries but also in receiving organizations. NIH insists upon institutions having their own strict mechanism in place to ensure a harassment-free atmosphere conducive for efficiency and productivity. Awardee entities are expected to establish a stern code of professional conduct and evaluation system in any case of breach of the stated code of conduct. You, as an institution, are liable to provide effective and compassionate work culture to prevent any misdeed or/and abuse of authority as it is the moral duty of all organizations to provide their employees with safe accessibility to report harassment.
NIH Sharing Policies
NIH has a policy aimed at making research data publically available, so you must have a data management plan and data sharing practice in place. As a researcher, you must train yourself in order to facilitate data sharing with the research community as well as the public. Sharp data management and sharing practices enable researchers to progress in a swift manner to achieve their targets for the general benefit of everyone and a disease-free world.
- NIH Public Access Plan for Access to Scientific Publications and Digital Data from NIH Funded ResearchThis article explains NIH’s policies to improve its enduring efforts of making scholarly publications, and digital data NIH-funded research ensues.
- Genomic Data Sharing (GDS) Genomic Data Sharing (GDS) final policy provides for the sharing and research purposes of extensive human and non-human genomic data produced from the NIH-funded research.
- NIH Grants Policy Statement (Availability of Research Results) This file describes sections of the NIH Grants Policy Statement debating the availability of research outcomes established with NIH funding. It includes data publications, exclusive research means, and intellectual property.
- Common Data Element (CDE), Resource Portal Common Data Element (CDE) source platform, offers access to NIH-funded CDE initiatives and other apparatuses which can help research scientists utilize common data elements (CDEs) in human subject research to advance data quality.
- Table of NIH Data Sharing PoliciesThis table lists down further data sharing policies in operation at NIH and IC program stages that apply to wide-ranging sets of investigators as well as data.
- Table of NIH Data Sharing RepositoriesThis board lists several NIH-funded data repositories that accept submissions from NIH-supported investigators of appropriate data, along with resources that combined material about biomedical data and information sharing structures.
- Peifer, M. (2017, November 1). The Argument for Diversifying the NIH Grant Portfolio. Mol Biol Cell, 28(22), 2935-2940. http://dx.doi.org/10.1091/mbc.E17-07-0462
- Zerhouni, E.A. (2004, December 10). Information Access. NIH Public Access Policy. Science, 306(5703), http://dx.doi.org/10.1126/science.1106929
- Bledsoe, M.J., & Grizzle, W.E. (2013, September). Use Of Human Specimens In Research: The Evolving United States Regulatory, Policy, And Scientific Landscape. Diagn Histopathol (Oxf), 19(9), 322-330. http://dx.doi.org/10.1016/j.mpdhp.2013.06.015