Human Research Protections
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Parallel Design:

Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group who receive drug B.


A natural or adoptive parent whose parental rights over the child have not been terminated by the Courts

Parental Permission:

The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].

Parental Permission Document :

See "Consent Document(s)"


The agreement of parents to the participation of their child in research.

Phase 1, Phase 2, Phase 3, Phase 4 Clinical Trial:

See "Clinical Trial"


A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.

Placebo Control Trial:

A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.

Pre-Market Approval:

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices (For more information, visit the FDA's Pre-Market Approval page).


Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before human trials.


For purposes of OHRP policy, the period of time from implantation until delivery.

Prevention Trials:

Refers to trials that find improved ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle interventions.

Primary Data Collection:

Primary data collection involves direct contact with, or observation of, one or more people for the purpose of collecting data from or about them.

Principal Investigator (PI):

The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).

Principal Investigator (PI):

The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).


An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution. The definition of "minimal risk" for research involving prisoners differs somewhat from that given for non-institutionalized adults.

Private Information:

Private information includes 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.


The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.


Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.

Prospective Studies:

Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.

Protected Health Information (PHI):

Information about the past, present, or future physical or mental health of an individual that identifies or could be used to identify the individual and is created or received by a Covered Entity. (45 CFR 160.301, 164.501; information about the provision of health care and payment for health care is included; some educational and employment records are excluded.)

Individually identifiable health information that is covered under HIPAA consisting of the following:

  • Names;
  • Geographic subdivisions smaller than a state;
  • All elements of dates except year (including birth, admission and discharge dates; date of death; and individuals over 89 years old);
  • The following categories of numbers: telephone and fax, social security, medical record, health plan beneficiary, account, certificate and license numbers;
  • Electronic mail (e-mail) and internet protocol (IP) addresses;
  • Internet universal resource locators (URLs);
  • Vehicle and device identifiers and serial numbers;
  • Biometric identifiers (e.g., finger and voice prints);
  • Full-face photographic or comparable images; and
  • Any other unique identifying number, characteristic or code.

A document that describes the objective(s), design, methodology, statistical consideration, and organization of a trial.

Protocol Amendments:

A written description of a change(s) to or formal clarification of a protocol.

Protocol Deviation Report:

Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.

Protocol Deviations:

Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:

  • failure to obtain/maintain approval for research,
  • failure to obtain informed consent when required,
  • failure to file adverse event reports,
  • performance of an unapproved study procedure,
  • performance of research at an unapproved site,
  • failure to file protocol modifications and
  • failure to adhere to an approved protocol.
Protocol Review and Monitoring Committee (PRMC):

The Protocol Review and Monitoring Committee (PRMC) was formed in 1993 to comply with National Cancer Institute guidelines in establishing a scientific review and monitoring system of cancer studies - it is a mechanism for quality assurance. The PRMC membership includes faculty, statisticians, pharmacy, imaging, patient advocate, research nurse and other ad hoc reviewers from various disciplines within the Health Sciences. The PRMC reviews cancer-related protocols for scientific merit and progress, including participant accrual. It also prioritizes cancer protocols that may compete for the same patient population. Its function is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects in research. If a study is designed to involve cancer patients, it must receive PRMC approval before it can be IRB approved. If a study includes cancer patients by default (as part of a broader patient population) and not by study design, it doesn't need PRMC review.

Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200