Notifying the IRB
When all research-related interventions or interactions with human subjects
Human Subject 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
Legally defined term for living persons about whom an investigator obtains specimens or data through direct 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.
Institutional Review Board (IRB) of the study's completion.
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).
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
National Heart, Lung, Blood Institute (NHLBI) 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.
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
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 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
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
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) ). 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.
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).
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.
Within 90 days after a grant ends, PIs must submit the following
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.
How to file
Final Financial Status Report
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
a new competitive segment.
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.
Web-based FSR module of the NIH eRA
Commons or paper SF-269(131 KB) , SF-269A(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) and an authorized
institutional official both must sign the form.
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.
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
Mail original (on plain paper) and
one copy to: GOB
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 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.
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.
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) 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.
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
Ending the DSMB
With clinical trials, at the final meeting of the DSMB
Data and Safety Monitoring Board (DSMB) , 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
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
Steering Committee (SC) ) 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.
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.
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