Glossary, CRG, NHLBI, NIH

The 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.

defines Clinical Research

Clinical Research
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.

as:

(1) Patient-oriented research. Research conducted 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.

(or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize previously collected human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.

(2) Epidemiologic and behavioral studies.

(3) Outcomes research and health services research.

You will want to determine if your study meets the definition for human subjects research, which is not the same as clinical research. HHS

Health and Human Services(HHS)
a federal government department to which NIH belongs whose mission is to protect the health of Americans and provide essential human services. Also referred to as Department of Health and Human Services (DHHS). HHS Homepage.

regulations (45 CFR Part 46.102) define a human subject as a living person with whom an investigator conducts research:

To obtain data through intervention or interaction with a person or
To obtain identifiable private information.

HHS has provided Human Subject Decision Charts to help you determine whether your research involves human subjects or could be considered exempt. If your research meets the criteria for human subjects research, you will find the remainder of the information on this site helpful in your preparation, conduct and management of your study.

Other resources:
In 2008, the Office for Human Research Protections ( 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.

) offered further Guidance on Research Involving Coded Private Information

Coded Private Information

Private Information
Information for which a person can expect that observations or recording are not taking place, and the information will not be made public. Information must be individually identifiable to constitute human subjects research.

Identifiable private information, such as a person's name or social security number, that is replaced with a code, e.g., number, letter, or symbol.

or Biological Specimens Download PDF file.

Many questions about human subjects and cell lines, repository specimens/data, proposals with subprojects or exemptions from human subjects research are answered in the FAQ’s from Applicants presented on the NIH Office for Extramural Research ( OER

Office of Extramural Research (OER)
a NIH office that supports extramural research by providing policy and guidance to the NIH ICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage

) Human Subjects Web Site.

FAQs on Investigators Responsibilities

Code of Federal Regulations Protection of Human Subjects

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

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Home » Clinical Research Guide» Application» Is my study considered clinical research?
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	Is my study considered clinical research? The 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. defines Clinical Research Clinical Research patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects. as: (1) Patient-oriented research. Research conducted 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. (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize previously collected human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. You will want to determine if your study meets the definition for human subjects research, which is not the same as clinical research. HHS Health and Human Services(HHS) a federal government department to which NIH belongs whose mission is to protect the health of Americans and provide essential human services. Also referred to as Department of Health and Human Services (DHHS). HHS Homepage. regulations (45 CFR Part 46.102) define a human subject as a living person with whom an investigator conducts research: To obtain data through intervention or interaction with a person or To obtain identifiable private information. HHS has provided Human Subject Decision Charts to help you determine whether your research involves human subjects or could be considered exempt. If your research meets the criteria for human subjects research, you will find the remainder of the information on this site helpful in your preparation, conduct and management of your study. Other resources: In 2008, the Office for Human Research Protections ( 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. ) offered further Guidance on Research Involving Coded Private Information Coded Private Information Private Information Information for which a person can expect that observations or recording are not taking place, and the information will not be made public. Information must be individually identifiable to constitute human subjects research. Identifiable private information, such as a person's name or social security number, that is replaced with a code, e.g., number, letter, or symbol. or Biological Specimens. Many questions about human subjects and cell lines, repository specimens/data, proposals with subprojects or exemptions from human subjects research are answered in the FAQ’s from Applicants presented on the NIH Office for Extramural Research ( OER Office of Extramural Research (OER) a NIH office that supports extramural research by providing policy and guidance to the NIH ICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage ) Human Subjects Web Site. FAQs on Investigators Responsibilities Code of Federal Regulations Protection of Human Subjects Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Is my study considered clinical research?