“Generalizable knowledge” is
information where the intended use of the research findings can be applied to populations or situations beyond that studied
.
What is research according to IRB?
Research –
a systematic investigation
, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.
What is DHHS in research?
The
Department of Health and Human Services
(DHHS) was the first federal agency to codify regulations governing human research protection. The Code of Federal Regulations at 45 CFR 46 describes the DHHS requirements for the protection of human research participants.
What is IRB approval needed for?
IRB review and approval is required for projects that:
Meet the definition of research
.
Involve human subjects
and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
What is research according to Harvard University?
“
A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
”
What is the purpose of OHRP?
The Office for Human Research Protections (OHRP)
provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by
the U.S. Department of Health and Human Services (HHS).
Is FDA part of DHHS?
The Food and Drug Administration (FDA) is
an HHS agency
that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
What counts as a research study?
Research is a systematic investigation,
including research development, testing, and/or evaluation
, designed to develop or contribute to generalizable knowledge. … Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
What is research need determination?
Obtains
information or biospecimens through intervention or
interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
What does IRB stand for?
What is the IRB? IRB stands for “
Institutional Review Board
”. The IRB is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
What are the three types of IRB review?
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review:
Exempt, Expedited, and Full
.
Do all studies need IRB approval?
IRB approval is required regardless
of the site of the study or the source of funding (if there is funding).
What happens if you do research without IRB approval?
2.3.
The IRB cannot require the investigator destroy data
or prevent the investigator from analyzing or publishing the data collected without prior IRB approval. Federal regulations do not state how data collected without IRB approval may be used.
How do you get into Harvard research?
A strong knowledge of English
is essential for successful study at Harvard, including the ability to understand and express thoughts quickly and clearly. Although you are not required to take an English proficiency exam (such as the TOEFL, IELTS, etc.), you may submit scores if you wish to do so.
Can I do research at Harvard?
Research Opportunities
Yes – available to students as early as their freshman year
. You may find research projects through individual inquiries with departments and professors, through the Harvard College Research Program (HCRP), or through the Mellon Mays Undergraduate Fellowship Program (MMUF).
Is Harvard a research university?
Harvard University is a
private Ivy League research university
in Cambridge, Massachusetts.
