Glossary

the agreement of parent(s) or guardian to the participation of their child or ward in research or clinical investigation and includes the elements of consent set forth in federal regulations and outlined in the informed consent template included in the IRB expedited and full review applications.

a physical location where research activities or protocol-directed procedures are performed.

Any active or inactive drug, biologic, reagent, etcetera, which is approved by the FDA for which a chemical purity standard has been written or established by any recognized pharmacopeia, which is a book or a compendia, such as the US Pharmacopeia (USP), the National Formulary (NF), the British Pharmacopoeia (BP), the Pharmacopoeia of the Council of Europe (EP). Note that both the USP and the NF have combined their standards into one compendia (http://www.usp.org/usp-nf).

includes both the theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work.  Plagiarism is a form of research misconduct.

1. The theft or misappropriation of intellectual property includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review.

2. Substantial unattributed textual copying of another's work means the unattributed verbatim or nearly verbatim copying of sentences and paragraphs which materially mislead the ordinary reader regarding the contributions of the author.

3. Plagiarism does not include authorship or credit disputes.

a consented individual who undergoes minimal procedures or gives authorization to obtain additional health records prior to a complete screening activity. The information obtained in prescreening is used to determine if a subject meets the minimum requirements to proceed to be screened.

a pre-screened individual determined to be ineligible to proceed to screening.

encompasses the time from confirmation of implantation (through any of the presumptive signs of pregnancy, such as missed menses, or by a medically acceptable pregnancy test), until expulsion or extraction of the fetus.

individual with primary responsibility for the design and conduct of a project approved under the authority of the IRB or IACUC. Includes the intellectual conduct of the project, fiscal accountability, administrative aspects, and the project's adherence to relevant policies and regulations.

any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial or sentencing.

control over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Is for an animal procedure room but does not meet specifications for animal Housing Room.

1. Physical or Chemical restraint lasting more than 4 hours, OR
2. Diagnostic procedures such as laparoscopy or needle biopsies, OR
3. Surgery procedures, OR
4. Ocular blood collection in mice, OR
5. Terminal cardiac blood collection, OR
6. Ascites tumors for monoclonal antibody production, OR
7. Complete Freund's Adjuvant, OR
8. Tumor growth, OR
9. Research that requires continuation until clinical symptoms are evident or death occurs, OR
10. Ocular or skin irritancy testing, OR
11. Food or water deprivation beyond that necessary for ordinary pre-surgical preparation, OR
12. Application of noxious stimuli such as electrical shock if the animal cannot avoid/escape the stimuli and/or it is severe enough to cause injury or more than momentary pain or distress, OR
13. Tail snip if more than 5mm or if done after weaning (21 days old in rats or mice), OR
14. Toe clip if done after 12 days old.

assessments of the success of established programs in achieving objectives when the assessments are for the use of program managers, for example, a survey to determine if program beneficiaries are aware of the availability of program services or benefits. Not generally considered a research activity as long as the evaluation is designed to assess or improve the program or service rather than to generate knowledge about a disease or condition.

A PI report notifying the institution and the designated IRB or IACUC when specific urgent issues are identified.

Individually Identifiable Health Information transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium. PHI excludes education records covered by the Family Educational Rights and Privacy Act and employment records held by a covered entity in its role as employer.

step-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues.

all procedures, therapies, interventions or interactions that are required by the protocol. Even procedures that are considered to be standard practice are still protocol directed if the protocol requires it.

Data and/or biospecimens that are accessible to anyone in the general public, without the need for special qualifications, permissions, or privileges. Examples include: data/biospecimens available for public purchase, searchable online, or available at a library.
Can data/biospecimens be publicly available if I have to register or sign an agreement to access the data/biospecimens? Yes, if the opportunity to register or sign an agreement is open to the general public, the data/biospecimens are still deemed publicly available.
https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/publicly_available_data.html