Glossary, CRG, NHLBI, NIH

You must obtain approval of your research plan and protocol from each Institutional Review Board ( 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).

), Institutional Ethics Committee (IEC) or Research Ethics Board (REB), at which the research will be conducted, before any subjects can be enrolled in the study. (The term IRB will be used to describe these committees in this tutorial.) The purpose of the review is to:

Ensure that 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.
will be protected in your study.
Evaluate risks versus benefits.
Ensure equitable subject selection.
Ensure proper administration of informed consent process.
Ensure protection of privacy and confidentiality.
Ensure protection of subjects from coercion.

You must contact your institution to determine which documents to submit for review. Most IRBs require that you submit the protocol, consent forms and any forms of advertisement or patient education. You may be asked to send data collection forms, surveys or questionnaires and institution-specific paperwork, as well. The board or committee will meet to discuss your research and may approve your research plan, may require modifications or disapprove the research.

Once your protocol (which includes your data monitoring plan) and consent forms are approved by your IRB, copies must be sent to your Program Official (PO)

Program Official (PO)
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

Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ).

if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director.

for review.

If you are planning to use a clinical trial website to advertise for or enroll participants, you may need to obtain IRB approval for this also. For details, read Guidance on Institutional Review Board Review of Clinical Trial

Clinical Trial
A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I

Phase I Clinical Trial
testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).

, Phase II

Phase II Clinical Trial
study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.

, Phase III

Phase III
study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.

, Phase III(as defined by NIH)

Phase III(as defined by NIH)
is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.

, Phase IV

Phase IV Clinical Trial
studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use.

)

Websites from 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.

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

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Home » Clinical Research Guide» Funding» Do I need IRB, IEC or REB approval?
CRG Home Contracts Overview What is clinical research? What is the role of NIH and NHLBI in clinical research? What are the Project Officer's responsibilities in clinical research? What is the role of the Principal Investigator/Institution in clinical research? Application How can I find funding opportunities (RFAs, RFPs and PAsG)? What do I need to know before submitting a clinical research application? Am I a new investigator and what if this is my first NIH application? Which NHLBI staff can help me? Is my study considered clinical research? Is my study observational or interventional? What is the best award mechanism for my clinical research proposal? What if my project exceeds $500,000 in direct costs in any given year? Where can I get help with writing the application? What must I include in "Protection of Human Subjects"? How and when do I submit my application? Review What happens to my grant after submission? Who will review my application and when? Did the reviewers like my application? What is a summary statement and what does it mean? What if I don't agree with the review? Funding How do I know if I am funded? Who needs human subjects protection training? Who approves my data monitoring plan? What is a Certificate of Confidentiality and do I need one? How do I develop consent forms and who reviews them? Are there ethical concerns and conflicts of interest I must consider? Do I need IRB, IEC or REB approval? What other approvals are needed? How do I track recruitment of research participants? My study involves Medicare or third party support. My study involves foreign grants and contracts. How do I register my study? When can I begin enrolling participants? Management How do I comply with Good Clinical Practices (GCP)? How do I manage changes to my grant? How do I report amendments, suspensions and terminations? Must I obtain continuing review from the IRB? Who should monitor subject recruitment/retention? How do I report adverse events? How is data quality monitored? What if I wish to add extra sites or studies to my project? How do I manage my budget and when are reports expected? What is HIPAA and how do I abide by the requirements ? Study Closure Tools & Training Glossary	Do I need IRB, IEC or REB approval? You must obtain approval of your research plan and protocol from each Institutional Review Board ( 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). ), Institutional Ethics Committee (IEC) or Research Ethics Board (REB), at which the research will be conducted, before any subjects can be enrolled in the study. (The term IRB will be used to describe these committees in this tutorial.) The purpose of the review is to: Ensure that 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. will be protected in your study. Evaluate risks versus benefits. Ensure equitable subject selection. Ensure proper administration of informed consent process. Ensure protection of privacy and confidentiality. Ensure protection of subjects from coercion. You must contact your institution to determine which documents to submit for review. Most IRBs require that you submit the protocol, consent forms and any forms of advertisement or patient education. You may be asked to send data collection forms, surveys or questionnaires and institution-specific paperwork, as well. The board or committee will meet to discuss your research and may approve your research plan, may require modifications or disapprove the research. Once your protocol (which includes your data monitoring plan) and consent forms are approved by your IRB, copies must be sent to your Program Official (PO) Program Official (PO) 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 Project Officer the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ). if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director. for review. If you are planning to use a clinical trial website to advertise for or enroll participants, you may need to obtain IRB approval for this also. For details, read Guidance on Institutional Review Board Review of Clinical Trial Clinical Trial A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I Phase I Clinical Trial testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects). , Phase II Phase II Clinical Trial study in a larger group of people (several hundred) to determine efficacy and further evaluate safety. , Phase III Phase III study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use. , Phase III(as defined by NIH) Phase III(as defined by NIH) is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials. , Phase IV Phase IV Clinical Trial studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use. ) Websites from 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. . Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Do I need IRB, IEC or REB approval?