NOHSP Definitions - P

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

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Parent: A child's biological or adoptive parent. (HSP#033)

Parental Permission: The agreement of parents or guardians to the participation of their child or ward in research. (HSP#027)

Participant: The term that is used to reflect the voluntary and active role of an individual participating in research versus the passive role of a ‘subject’ who is studied, or is the object of a research procedure. (HSP#043)

Pregnancy: The period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy such as missed menses, until the results of a pregnancy test are negative or until delivery. (HSP#070)

Principal Investigator: The individual named on the research application form and protocol as the person responsible for the administrative, financial, procedural and scientific aspects of a research project. The Principal Investigator (PI) assumes full responsibility and accountability for the proper conduct of the proposed protocol, including all related activities undertaken and performed by any member of the Research Team (RT), assurance of the fulfillment of training requirements for the RT, compliance with all applicable Federal and/or State regulations, IRB, CRRC or IACUCC determinations, and applicable Nemours policies. (HSP#001)

Prisoner: 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.

• A minor who is a resident of a juvenile detention facility is a prisoner. A minor who is placed on house arrest is a prisoner. For example, a minor wearing an ankle bracelet for electronic surveillance.
• A minor who reports that he or she has been arrested and detained in the period between visits, but is not currently incarcerated, is not a prisoner. A minor who is on probation is not a prisoner.

Privacy: Protection and / or maintenance of privacy refers to an individual’s interest to control access over one’s personal identity or self. (HSP#021)

Private Information: “Private information” as defined by DHHS regulations means 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]

Prompt reporting: See HSP#067

Protocol: The research plan. The IRB broadly defines ‘protocol’ as the entire application as submitted to, and reviewed by the IRB including: recruitment practices, consent procedures, plans to protect the privacy interests of participants, or provisions to maintain confidentiality of identifiable data.

Protocol exception: A change to an IRB approved protocol for an individual participant made with the permission of the Sponsor such as a minor change to inclusion or exclusion criteria that, in the opinion of the Sponsor, does not affect the integrity of the research or the risk to benefit analysis. Note: Implementation of an exception without prior IRB approval is a deviation. (HSP-062)