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Study Closure

Notifying the IRB
When all research-related interventions or interactions with human subjects 

Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 
Interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
have been completed, and all data collection and analysis has been finished, then the human subjects research study has been completed. When a human subjects research study has been completed, the investigators no longer are required to obtain continuing review and approval of that study by the IRB. The investigators should follow any applicable institutional policies and procedures for notifying the IRB 
Institutional Review Board (IRB)
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
of the study's completion.

Storage and Distribution of Study Materials
Study materials are defined broadly as anything other than data, of potential research use, including biologic samples, experimental animals, tissues, cells, clones, intervention materials, manuals, forms, or coding software. It is the intent of NHLBI 

National Heart, Lung, Blood Institute (NHLBI)
a NIH 
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.
and NIH that data and materials from NIH-supported studies should be made available to the scientific community at large, with suitable protections for participants’ confidentiality and compliance with their informed consent, and after some period of protected time for the original investigators. The policies of Sharing Biomedical Research Resources are discussed here.   

NHLBI Repository: NHLBI maintains a repository in Rockville, Maryland which includes samples from over a dozen studies. Samples from other studies can be deposited there at no cost to the study.  The Biological Specimen Registry (BioLINCC) is described in detail, including the process for requesting samples. 

Contracts: Anything produced under federal contract 

Contract
award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition 
Office of Acquisition (OA)
OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy)
Management and Policy (OAMP) web site provides additional information
is considered to be public use, including manuals, software, biologic samples and typically are specified in the “Deliverables” section of the contract. These usually request delivery of a specified product by a specific date.

Grants: NHLBI policy is continuing to evolve with regard to cooperative agreements and regular research grants, and no standard policies for storage and distribution of study materials are yet available. NIH is moving toward requiring a data and materials sharing plan in investigator awards. Review and approval of such plans is the responsibility of program staff.  Program staff may recommend a plan in which case, language will be added to the Terms and Conditions of the Notice of Awards ( NOA 

Notice of Award (NOA)
a legally binding document, notifying the grantee and others that an award has been made, including all terms and conditions of the award and outlining the obligation of Federal funds. Previously known as Notice of Grant Award(NGA).
). Language requesting or specifying a sharing plan may also be found in a Request for Applications in Institute-initiated programs if materials appropriate for sharing are anticipated to be produced under the award.

Final Grant 

Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
Reports
Within 90 days after a grant ends, PIs must submit the following closeout 
Closeout
process by which the awarding agency determines that all applicable administrative actions and all required work of the award have been completed by the grantee.
reports.

Report

Purpose

How to file

Final Financial Status Report
( FSR 

Financial Status Report (FSR)
shows the status of funds for a grant or cooperative agreement. Mandatory for continued funding, FSRs are due to the Grants Management Officer from a grantee within 90 days of the end of a budget period.
)

Details grant fund expenditures. NIH requires a final FSR for grants that are terminated, transferred to a new grantee, or not extended through award 

Award
provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.
of a new competitive segment.

Web-based FSR module of the NIH eRA Commons or paper SF-269pdf format(131 KB) , SF-269Apdf format(30 KB)

Final Invention Statement and Certification

Lists all inventions conceived or reduced to practice during grant or award; indicates "None" if no inventions were developed. The PI 

Principal Investigator (PI)
a qualified person designated by an applicant institution to direct a research project or program, oversee scientific and technical aspects of a grant and the day-to-day management of the research.
and an authorized institutional official both must sign the form.

HHS-568pdf format(46 KB)

Final Progress Report

Summarizes project accomplishments during the entire funding period, including a statement of progress made toward project goals, significant results, and a list of publications originating from the grant.

Mail original (on plain paper) and one copy to: GOB

Data Dissemination
Your NHLBI-supported research may result in a newsworthy finding which represents a dramatic breakthrough in diagnosis or treatment, a new understanding of a condition or physiological process or one that will impact a large number of people.  NHLBI would like to be well informed about newsworthy developments in research or programs that we are supporting.  Please contact your Program Director 

Program Director
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Official.
if the results of your research may merit some type of media release so that we can work with you and the Media Relations Department to determine the best means to disseminate the information. 

Once your study is completed, it is important to share the results with your research participants as well as the scientific community.  A policy for making your peer-reviewed final manuscripts of NIH funded research available to other researchers and the public is discussed in the NIH Public Access Policy document. Please acknowledge NHLBI as the source of support whenever you publish a paper in a scientific journal or present at a scientific meeting. When possible, the grant number should be listed. NIH policy requires that grantees acknowledge Federal funding in publications, news releases, and other documents describing projects or programs funded in whole or in part with Federal money. 

You may be required or asked to provide a data set that can be accessed by other investigators under according to the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies.   The Guidelines for NHLBI Data Set Preparation describes the process for preparation of an NHLBI Data Repository data set for selected epidemiology studies and clinical trials.  

Keeping Research Records
You must keep your project records accessible for three years after the grant ends. This includes financial records, supporting documents and all records pertinent to the award.   OHRP 

Office for Human Research Protections (OHRP)
HHS office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS and helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage.
answers this question in more detail in FAQs on Investigator Responsibilities. If any issue arises, we need to be able to verify the records, which must include all data and fiscal information.   

Ending the DSMB
With clinical trials, at the final meeting of the DSMB 

Data and Safety Monitoring Board (DSMB)
an independent committee that reviews clinical trial progress and safety, and advises the appointing body whether to continue, modify, or terminate a trial. This is sometimes called a Data Monitoring Committee (DMC). (see Data and Safety Monitoring Policy image of word document icon (120 KB))
, the members should be given the opportunity to take a last look at the full set of data. When a clinical trial is terminated earlier than expected or if there is a particular controversy, DSMB members are usually called upon to work with the Principal Investigator (PI)/Steering Committee ( SC 
Steering Committee (SC)
a group, in a Network or multi-center study, composed of the principal investigators, sponsor representatives, the study statistician(s), and others who oversee the design, execution, analysis, and dissemination of results of a study.
) in determining how to communicate the results to the community. When a study is terminated on schedule, the communication of the results to the community is usually the responsibility of Principal Investigator or Steering Committee. Whether a trial is terminated prematurely or as originally scheduled, the DSMB should remain intact until its members and the study team both agree that no major issues pertaining to the released data remain to be resolved.

The DSMB may be helpful in reviewing a main results paper and should be generally acknowledged in the paper (with permission).  Once the data collection is final, the DSMB may be formally discharged. 



Page Last Updated: July 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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