P

Parallel Track IND

The FDA's Parallel Track policy permits wider access to new drugs for life-threatening diseases under a separate treatment protocol (Parallel Track IND) that "parallels" the controlled Phase II and III clinical trials performed to establish the safety and effectiveness of investigational new drugs. For example, under this prospective mechanism, persons with AIDS and HIV-related diseases who are not able to take standard therapy or for whom standard therapy is no longer effective, and who are not able to participate in ongoing controlled clinical trials, can have access to promising investigational new drugs. Applications to permit expanded availability of an investigational new drug under the Parallel Track mechanism must be submitted (typically by the manufacturer of the drug) to the FDA as an amendment to the existing IND.

Parent

A child’s biological or adoptive mother or biological or adoptive father.

Participation

When participation is anonymous, it is impossible to know whether or not an individual participated in a study. When participation is confidential, the study participation of a specific individual is recorded, but cannot be known by anyone except the researcher and authorized research staff that has legitimate access to participation records.

Patent

A patent for an invention is the grant of a property right from a country's patent office to the inventor which excludes others from making, using, offering for sale, selling or importing the invention into the country that granted the patent. US patent grants are effective only within the territories of the US and are granted by the US Patent and Trademark Office.

Patent Pending

Term used to inform the public that an application for a patent on that article or process is on file in the Patent Office.

Paternalism

Making decisions for others against or apart from their wishes with the intent of doing them good.

Peer Review

Involves the analysis of scientific merit of a proposed research by a group of professionals of comparable knowledge and expertise in a specific scientific or medical field.

Percentile

As used by NIH in relation to peer review: represents the relative position or rank of each priority score (along a 100.0 percentile band) among the scores assigned by a particular study section.

Permission

The agreement of the parent(s) or guardian to the participation of the child, handicapped individual, or ward in the research.

Pharmacokinetics

The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.

Pharmacology

The scientific discipline that studies the action of drugs on living systems (animals or human beings).

Phase 0 Trial

Phase 0 is a designation for exploratory, first-in-human trials conducted in accordance with the FDA’s Guidance on Exploratory IND Studies. Phase 0 trials are also known as human micro-dosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single sub-therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.

Phase I Trial

Phase I trials are the first stage of testing in human subjects. Normally, a small group of 20-100 healthy volunteers will be recruited. This phase is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in a clinical trial clinic, where the subject can be observed by full-time staff. These clinical trial clinics are often run by contract research organizations who conduct these studies on behalf of pharmaceutical companies or other research investigators. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation studies, so that the best and safest dose can be found and to discover the point at which a compound is too poisonous to administer. The tested range of doses will usually be a fraction of the dose that caused harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options. Volunteers are paid a fee for their time spent in the volunteer center. Pay depends on length of participation. There are different kinds of Phase I trial: Single Ascending Dose; Multiple Ascending Dose; and Food effect. 

Phase II Trial

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects. Phase II studies are sometimes divided into Phase IIA and Phase IIB.

• Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
• Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Phase III Trial

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug.
Studies in this phase are by some companies categorized as "Phase IIIB studies." While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as the FDA. Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life.
This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities. They will review the submission, and, it is hoped, give the sponsor approval to market the drug. Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.

Phase IV Trial

Phase IV trial is also known as Post-marketing surveillance Trial. Phase IV trials involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term AE over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Phase V Trial

Phase V is a growing term used in the literature of translational research to refer to comparative effectiveness research and community-based research; it is used to signify the integration of a new clinical treatment into widespread public health practice.

Phenotype

• the observable physical or biochemical characteristics of an organism, as determined by both genetic makeup and environmental influences;
• the expression of a specific trait, such as stature or blood type, based on genetic and environmental influences.

Phlebotomist

An individual trained to draw blood.

PHS 2590

Application for Continuation of a PHS Grant (NIH).

PHS 398

Application Form for a PHS Grant (NIH).

Physical Risk

Any strenuous or unusual physical activity or procedure required of a subject, use of compounds which might alter the subject’s biochemical milieu, exposure to strong stimulation or placement in a situation which could lead to violence. The investigator is responsible for anticipating circumstances which might endanger the subject’s physical well-being and for bringing these circumstances to the attention of the IRB.

Physiological Risk

Any experimental condition that induces personality change or intense changes in a subject’s feelings or motivations, or that may induce such changes which extend beyond the experimental or debriefing period. Subjection to deceit, to demeaning or dehumanizing procedures, to humiliation and embarrassment are examples. The investigator has the responsibility to eliminate or minimize the effects of psychological risk to subjects and to bring these matters to the attention of the IRB.

Pilot Project

A research project that is tested or "piloted" on relatively few subjects so that preliminary data and parameters can be assessed before a full-blown study is developed.

Placebo

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

Placebo Controlled Study

• A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested 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.
• A chemically inert substance given in the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.

Placebo Effect

A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.

Placenta

A membranous, highly vascularized organ of metabolic interchange between a fetus and its mother; partly of embryonic origin and partly of maternal origin.

Planned Emergency Research

Research involving human subjects who are in need of emergency medical intervention (e.g., comparison of methods for providing cardiopulmonary resuscitation), but who cannot give informed consent because of their life-threatening medical conditions and who do not have an available legally authorized representative to provide consent.

Policy

Formal statement of principles on which action(s) for a specific issue are based.

Post-Award

In the context of the life cycle of a contract or grant, the post-award period begins after award negotiation and acceptance and ends after closeout of the award. Compare: Pre-Award

Pre-Award

In the context of the life cycle of a contract or grant, the pre-award period begins with project development and concludes after the award negotiation and acceptance.

Pre-Clinical Studies

• It involves in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. Such tests assist pharmaceutical companies to decide whether a drug candidate has scientific merit for further development as an investigational new drug.
• Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be carried out.

Predicate Devices

Currently legally marketed devices to which new devices may be found substantially equivalent under the 510(k) process.

Pregnancy

The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test. This "confirmation" may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.

Pre-Market Approval

Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices.

Pre-Review

The process performed by a IRBMED Regulatory Team to determine that a submission for IRB review is complete, including the required materials, and that institutional requirements, such as completion of human subjects protection education and conflict of interest disclosure, have been met.

Prevention Trials

Refers to trials to find better 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 changes.

Previously Unreported Adverse Event

A specific adverse event that has not yet been reported to the IRBMED. For example, the hospitalization of a subject due to infection after the second dose of a study medication would be a "previously unreported adverse event" even if there had been an earlier report submitted to IRBMED when that same subject had been previously hospitalized due to similar infection after the first dose. All previously unreported adverse events are reported to IRBMED using the AE submission in eResearch.

Prime Award

In the context of sub-awards or subcontracts, the prime award is the award made directly from the sponsor to the recipient institution. When a recipient institution makes a sub-award or subcontract under the terms and conditions of the award to a second organization, the sponsor's award is labeled the prime award and the terms and conditions are generally included as part of the agreement to the sub-award or subcontract site.

Principal Investigator (PI)

The scientist or scholar responsible for the conduct of research or other activity, described in a proposal for an award. The PI is responsible for all programmatic and administrative aspects of a project or program. The scientist or scholar with primary responsibility for the scientific, technical and administrative conduct of a funded research project. See also: Investigator and Lead Researcher

Prior Approval

The requirement for written documentation of permission to use project funds for purposes not in the approved budget or to change aspects of the program from those originally planned and approved. Prior approval must be obtained before the performance of the act that requires such approval under the terms of the agreement.

Priority Score

A numerical rating that reflects the scientific merit of the proposed research. The score is derived from the rating given a research proposal by each member on a review committee. It is used to help determine which approved proposals will be granted awards, based on funds available.

Prisoner

Federal Regulations define "prisoner" as "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.

Privacy

Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. The state of being free from the observation, intrusion, or attention of others.

Privacy Board

Privacy Board is the subsection or subcommittee of the IRBMED charged with handling HIPAA matters referred to the IRBMED and in accordance with the Standard Operating Procedures (SOPs)

Private

Affecting or belonging to private individuals rather than to the general public for public use or consumption.

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 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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. See the UMHS HIPAA Web site for further information. (hyperlink)

Proband

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.

Procedure

A series of actions conducted in a certain order or manner; operational method by which policy is put into practice.

Program / Project Officer

A sponsor's designated individual who is officially responsible for the scientific and technical aspects of a particular grant or cooperative agreement.

Program Announcement

Describes existence of a research opportunity. It may describe new or expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program.

Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS)

PEERRS consists of educational modules and short tests covering basic rules, procedures and professional norms for the responsible conduct of research by anyone involved in research and scholarship at UM.

Program Research and Development Announcement

Similar to a BAA, PRDAs are solicitations for proposal and are intended to be used when the area of interest is more specialized but still has general application and is associated with the needs of a program or programs. It may be appropriate for exploratory research that has general application and is not system specific.

Progress Report

Periodic, scheduled reports required by the sponsor summarizing research progress to date. Technical, fiscal, and invention reports may be required.

Project Period

The total time for which support of a project has been programmatically approved. A project period may consist of one or more budget periods. See also: Budget Period.

Prophylactic

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

Proposal

An application for funding that contains all information necessary to describe project plans, staff capabilities, and funds requested. Formal proposals are officially approved and submitted by an organization in the name of a principal investigator.

Prospective Studies

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

Protected Health Information (PHI)

(Including demographic information) about a patient that (i) is created or received by a health care provider or health plan; (ii) relates to the past, present, or future physical or mental health of the patient; and (iii) identifies the patient or with respect to which there is a reasonable basis to believe it could be used to identify the patient

Protein

A large molecule composed of one or more chains of amino acids in a specific order; the order is determined by the base sequence of nucleotides in the gene coding for the protein. Proteins are required for the structure, function, and regulation of the body’s cells, tissues, and organs, and each protein has unique functions. Examples are hormones, enzymes, and antibodies.

Protocol

The formal design or plan of an experiment or research activity; specifically, the plan submitted to a Scientific or Peer Review committee for review and to an agency for research support. The protocol usually also gives the background and rationale for the trial. The protocol includes a description of the research design, methodology to be employed, the eligibility requirements for prospective participants and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a project, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

Protocol Amendment

A written description of any change(s) to or formal clarification of a protocol. Submit protocol amendments to the IRBMED using the Amendment submission in eResearch. Except to avoid the possibility of immediate harm to subjects, protocols should not be changed without prior IRB authorization. When changes for safety are made, an amendment should be submitted to the IRBMED within 7 days of the action.

Protocol Deviation

Accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject's rights, safety or welfare; and/or on the integrity of the data. Deviations may result from the action of the subject, researcher, or research staff. Departure from the IRB approved research protocol without prior IRB approval for the variation.

Protocol Exception

Term used by FDA and some sponsors to refer to a departure from the protocol that receives approval from the IRB before implementation (a one-time exception as distinguished from an amendment to the protocol). Approval requests for a protocol exception should be submitted using the ORIO submission in eResearch. Investigator should specify the extent of the exception (e.g., one-time only for patient X and note if data will be included in the study analysis).  If the exception is to become a permanent change, an Amendment submission in eResearch needs to be submitted.

Protocol Violation

Accidental or unintentional changes to or non-compliance with the IRB approved protocol without prior sponsor and IRB approval. Violations generally increase risk or decrease benefit, affects the subject's rights, safety, or welfare, and/or the integrity of the data.

Psychological Trauma

See Social or Psychological Trauma.

Public

Pertaining to an entire community, state, or nation; proceeding from, relating to, or affecting the whole body of people. Open to all.

Public Health Service (PHS)

The PHS employs public health professionals for the purpose of delivering public health promotion and disease prevention programs and advancing public health science. Members often serve on the frontlines in the fight against disease and poor health conditions and are drawn from many professions, including environmental and occupational health, medicine, nursing, dentistry, pharmacy, psychology, social work, hospital administration, health record administration, nutrition, engineering, science, veterinary, health information technology, and other health-related occupations.

Public Responsibility in Medicine and Research (PRIMR)

PRIM&R advances the highest ethical standards in the conduct of biomedical, social science, behavioral, and educational research. We accomplish this mission through education, membership services, professional certification, and public policy initiatives.

Published information and software

Information that has become generally accessible to the interested public in any form. Examples of published information and software include the following:

• Information published in print or electronic media available for general distribution
• Information readily available at public or university libraries
• Information released at an open conference, meeting or seminar

Purity

The relative absence of extraneous matter in a drug or vaccine that may or may not be harmful to the recipient or deleterious to the product.

Q

Quality Assurance

A system of activities whose purpose is to provide assurance that the overall control of quality is being done effectively.

Quality Improvement

A process initiated to develop/enhance a practice or procedure and to institutionalize the practice or procedure. It specifically attempts to avoid attributing blame, and to create systems to prevent errors from happening.

Quality of Life (or Supportive Care)

Refers to projects that explore ways to improve comfort and quality of life for individuals with a chronic illness.

Quasi-experimental Study

A study that is similar to a true experimental study except that it lacks random assignments of subjects to treatment groups. See also Experimental Study

R

Radiation Exposure

In health physics, the quantity used to indicate the amount of ionization in air produced by X-ray or gamma radiation while conducting radiologic procedures.

Radioactive Drug

Any substance defined as a drug the Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. Included are any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products," as defined in 21 CFR 600.3(ee). Drugs such as carbon-containing compounds or potassium-containing salts containing trace quantities of naturally occurring radionuclides are not considered radioactive drugs.

Radioactive Drug Research Committee (RDRC)

An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members [21 CFR 36.1].

Radioactive Phosphorus (32P)

Radioactive isotope of 31P, an element found in DNA molecules.

Radioactive Sulfur (35S)

Radioactive isotope of 32S, an element found in proteins.

Radiologic (Radiological) Procedure

Any procedure involving radiation (e.g., X-ray) or a radioactive agent (e.g., radionuclide used in a nuclear medicine study).

Radiopaque Contrast Agents

Materials that stop or attenuate radiation that is passed through the body, creating an outline on film of the organ(s) being examined. Contrast agents, sometimes called "dyes," do not contain radioisotopes. When such agents are used, exposure to radiation results only from the X-ray equipment used in the examination. The chemical structure of radiopaque contrast agents can produce a variety of adverse reactions, some of which may be severe, and possibly life-threatening, in certain individuals.

Radio-pharmaceuticals

Drugs (compounds or materials) that may be labeled or tagged with a radioisotope. These materials are largely physiological or sub-pharmacological in action, and, in many cases, function much like materials found in the body. The principal risk associated with these materials is the consequent radiation exposure to the body or to specific organ systems when they are injected into the body.

Random, Random Assignment, Randomization, Randomized

Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an important element of some experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention. 

Randomized Control (RC) Study

A type of scientific experiment - a form of clinical research - most commonly used in testing the safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy or effectiveness of healthcare services (such as medicine or nursing) or health technologies (such as pharmaceuticals, medical devices or surgery). Study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study. Random allocation is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed up in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, follow-up calls, etc. should be those intrinsic to the treatments being compared. The most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments."

Rebudget

The act of amending the budget by moving funds from one category or line item to another. Some funding agencies require prior approval before re-budgeting can occur.

Recombinant DNA

In the context of the NIH Guidelines, recombinant DNA molecules are defined as either:

• molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
• molecules that result from the replication of those described in (i) above.

Recombinant DNA Advisory Committee (RAC)

An NIH advisory committee whose principal role is to provide advice and recommendations to the NIH Director on the conduct and oversight of research involving recombinant DNA, including the content and implementation of the NIH Guidelines, and other NIH activities pertinent to recombinant DNA technology.
A major element of this role is to examine the science, safety, and ethics of clinical trials that involve the transfer of recombinant DNA to humans.

Recombinant DNA Molecules

Under the current NIH Guidelines, these are molecules constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from their replication.

Recombinant DNA Technologies

Procedures used to join together DNA segments in a cell-free system (an environment outside a cell or organism). Under appropriate conditions, a recombinant DNA molecule can enter a cell and replicate there, either autonomously or after it has become integrated into a cellular chromosome.

Recruiting

The period during which a trial is attempting to identify and enroll participants. Recruitment activities can include advertising and other ways of soliciting interest from possible participants. See recruitment status and enrolling.

Recruiting Methods

Materials, compensation, and other practices or procedures used to inform potential participants about research.
Methods for recruiting research participants are generally distinguished from those of marketing, advertising, or public relations’ efforts, which have promoting a product, service, or idea as goals.

Recruitment Bonus

Payment, merchandise, or other gift or service offered by a sponsor as an incentive or reward to an organization, investigator, or key personnel conducting research designed to accelerate recruitment that is tied to enrollment rate, timing, or numbers.

Recruitment Materials

Announcements; advertisements; flyers; posters; scripts for telephone or other oral communication; letters or email messages; bulletin board tear-offs; Internet postings; newspaper, radio, television, or video broadcasts, or other media used to attract potential participants for research.

Recruitment Status

Indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:

• Not yet recruiting: participants are not yet being recruited or enrolled
• Recruiting: participants are currently being recruited and enrolled
• Enrolling by invitation: participants are being (or will be) selected from a predetermined population
• Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
• Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)
• Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
• Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
• Withdrawn: study halted prematurely, prior to enrollment of first participant

Regs

Short for regulations.

Regulations

The contractual rules and procedures governing sponsored research projects.

Regulatory Compliance

Following the rules set by a governing body.  There is a category called ‘continuing non-compliance’ where an investigator or study team repeatedly fails to follow the regulations.  For example, year after year they are late in submitting their scheduled continuing reviews, therefore their study lapses each year.

Regulatory Concern

As it relates to the need to report to the IRB, this would be an issue or incident of non-compliance with laws and regulation or to an incident or information that regulations require an IRB consider. In the ORIO guidance the term is used as a criterion for determining what kinds of submission should be sent to the IRB within 7 days. Examples include but are not limited to:

• Unanticipated problems.
• Deviations from the research in order to eliminate hazards to subjects or others.
• New information about safety concerns.
• Failure to obtain consent.
• Documenting informed consent of a non-English speaking/reading subject or the legally authorized representative of the subject on an English-only informed consent document.
• Improper training of study team (e.g., the PI did not require new staff, fellows, or students to complete the appropriate PEERRS human subject modules).

Regulatory Non-Compliance

Failure to adhere to regulations, policies, procedures or special conditions related to the conduct of research. Examples of such noncompliance include, but are not limited to, failure to obtain/maintain approval for research; coercion of human subjects; performing unapproved procedures; and conducting research at unapproved sites.

Related

An assessment regarding the causal relationship between a drug or intervention and an adverse event (see also Related Event, Unrelated Event and Cause). Regardless of relatedness, unless otherwise approved in the protocol data safety monitoring plan, all adverse events should be reported to the IRBMED whether or not they are in any way related to the investigational agent or intervention.

• Definitely Related: The adverse event is clearly related to the investigational agent(s) or research intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a known pattern of response, and no alternative cause is present.
• Possibly Related: There is a reasonable possibility that the event may have been caused by or is linked in a significant way to the research; the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a suspected pattern of response, but an alternative cause is present.
• Probably Related: The adverse event is likely related to the investigational agent(s) or intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a known or suspected pattern of response, but an alternative cause may be present.
• Unlikely to be related: The adverse event is doubtfully related to the investigational agent(s) or intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, but follows no known or suspected pattern of response, and an alternative cause is present.
• Unrelated (or Not Related): The adverse event is clearly NOT related to the investigational agent(s) or intervention: the adverse event has no temporal relationship to the administration of the investigational agent(s) or research intervention, follows no known or suspected pattern of response, and an alternative cause is present.

Remission

A period in which the signs and symptoms of a disease are diminished or in abeyance. The term "remission" is used when one cannot say with confidence that the disease has been cured.

Remuneration

Payment for participation in research. It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries. Also known as Compensation.

Renewal

Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.

Repository

Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.

Request for Applications (RFA)

Announcements that indicate the availability of funds for a topic of specific interest to a sponsor. Proposals submitted in response to RFAs generally result in the award of a grant. Specific grant announcements may be published in the Federal Register and/or specific sponsor publications. Also see: Broad Agency Announcements.

Request for Proposal (RFP)

Announcements that specify a topic of research, methods to be used, product to be delivered and appropriate applicants sought. Proposals submitted in response to RFPs generally result in the award of a contract.

Request for Quotations (RFQ)

A formal request to vendors for a price quotation on equipment or supplies to be purchased.

Research

Under HHS Regulations (46.102) research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. For example, some “demonstration” and “service” programs may include research activities.

Under FDA Regulations (21 CFR 56.102) the term “clinical investigation” is synonymous with “research” and is defined as “any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Food, Drug and Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Clinical investigations regulated by the FDA under Sections 505(i) and 520(g) of the Act, include investigations of food, dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. The term “clinical investigation” does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part. Research is subject to 21 CFR 50 and 56 when it involves the use of any drug other than the use of an approved drug in the course of medical practice. Research is subject to 21 CFR 50 and 56 when it involves the use of any medical device other than the use of an approved medical device in the course of medical practice.  

Research Administration

Research Administration is a very broad term that means the full scope of administrative activities and responsibilities necessary to facilitate the conduct of research and ensure compliance with federal, state and institutional regulations, laws, statues, policies and procedures.

Research Performance Site

Location/site at which human subjects research may be performed because of an understanding of the local research context and appropriate oversight mechanisms that ensure protection of research participants.

Respect for Persons

An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and persons with diminished autonomy are protected.

Retrospective Studies

Research conducted by reviewing records (i.e., birth and death certificates, medical records, school or employment records) or information about past events elicited through interviews with persons who have, and controls who do not have, a disease under investigation.

Review (of research)

The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.

Revision

A modified and resubmitted request for funding for a project that was previously not funded either because it was denied by the sponsor or withdrawn by the principal investigator.

Ribonucleic Acid (RNA)

A chemical found in the nucleus and cytoplasm of cells; it plays an important role in protein synthesis and other chemical activities of the cell. The structure of RNA is similar to that of DNA. There are several classes of RNA molecules, including messenger RNA, transfer RNA, ribosomal RNA, and other small RNAs, each serving a different purpose.

Risk

The probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.” See also “Minimal Risk.”

Risk Benefit Ratio

The risk to individual participants versus the potential benefits to the individual and/or society. The risk/benefit ratio may differ depending on the condition being treated.  The IRB must determine that the risk benefit ratio of a research project is sufficiently favorable in order to approve the research, and reexamines that determination in light of adverse event, other reportable incidents, and unanticipated problems.

Roentgen Equivalent in Man (REM)

The unit of measurement for a dose of an ionizing radiation that produces the same biological effect as a unit of absorbed does (1 rad) of ordinary X-rays. One millirem is equal to 1/1000 of a rem.

Routine (Not-for-Cause) Review

An assessment or examination of something (e.g., a practice or procedure) with the possibility or intention of instituting change if necessary.

Routine Research Educational and Regulatory Review (RRERR)

Routine Research Educational and Regulatory Review (RRERR) conducted by the Office of Human Research Compliance Review (OHRCR)