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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
    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.
    concerns been addressed and answered?
  • For those studies with a 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))
    , have approvals been obtained?
  • Has 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.
    approved your protocol, Informed Consent 
    Informed Consent
    a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research.
    forms, monitoring plan and recruitment milestones?
  • Has NHLBI received documentation of all 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).
    approvals of your protocol, consent forms and data monitoring plan?
  • Has the IND 
    Investigational New Drug (IND)
    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
    or IDE 
    Investigational Device Exemption (IDE)
    similar to an IND, this allows an unapproved medical device to be used for investigational purposes.
    information (number, name and institution of the holder, written comments from FDA 
    Food and Drug Administration (FDA)
    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
    and date that you filed) been forwarded to NHLBI?
  • Have all human subject training documents been received by NHLBI?
  • Has Fogarty clearance been obtained for work in a foreign institution?
  • 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)
    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).
    requirements?


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

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