When can I begin enrolling participants?
You can begin to enroll patients when all of the following
issues have been resolved:
- Have all human subjects
Human Subject concerns been addressed and answered?
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.
- For those studies with a DSMB
Data and Safety Monitoring Board (DSMB) , have approvals been obtained?
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
- Has NHLBI
National Heart, Lung, Blood Institute (NHLBI) approved your protocol, Informed Consent
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
Informed Consent forms, monitoring
plan and recruitment milestones?
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.
- Has NHLBI received documentation of all IRB
Institutional Review Board (IRB) approvals
of your protocol, consent forms and data monitoring plan?
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).
- Has the IND
Investigational New Drug (IND) or IDE
an application, filed by a drug sponsor with FDA (Form FDA 1571
) to conduct clinical trials. It includes detailed descriptions of all trial phases, protocols, IRB members, and investigators
Investigational Device Exemption (IDE) information (number, name and institution
of the holder, written comments from FDA
similar to an IND, this allows an unapproved medical device to be used for investigational purposes.
Food and Drug Administration (FDA) and date that
you filed) been forwarded to NHLBI?
is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Food and Drug Administration Homepage
- Have all human subject training documents been received
- Has Fogarty clearance been obtained for work in a foreign
- Has your institution filed a Federalwide
Assurance with 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
- Have you registered your study to comply with ICMJE
International Committee of Medical Journal Editors (ICMJE) requirements?
Initially known as the "Vancouver Group," this group first met in 1978 to establish formatting guidelines (known as the Uniform Requirements for Manuscripts) for manuscripts submitted to their journals. As it began to respond to issues beyond the scope of manuscript preparation, the group expanded and became more formalized and is now known as the International Committee of Medical Journal Editors (ICMJE).
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov