The below HRPP Acronyms and HRPP Glossary are intended to provide clarity for our research community regarding terms routinely used in institutional policies, SOPs and guidance documents used by Brown's HRPP and on our website.
I. HRPP Glossary
A/B/C/D/E/F/G/H/I/J/K/L/M/N/O/P/Q/R/S/T/U/V/W/X/Y/Z
A
Any adverse event/effect caused by or associated with the use of a device that is unanticipated and has not been included in the protocol or the Investigator’s Brochure.
Any untoward or unfavorable occurrence (physical or psychological) in a human participant, including any abnormal sign, symptom, or disease, temporally associated with the participant’s time in a research study, whether or not considered related to their participation. These events can occur in the context of biomedical or social/behavioral research. This term is construed broadly.
Note: This is defined by OHRP guidance.
A public announcement that is intended to be seen or heard by a prospective participant to solicit that person's enrollment in a research study.
Note: This can include newspaper, radio, TV, bulletin boards, posters, and flyers in electronic advertising or in print.
The age of consent is the legally defined age at which a person has the capacity to voluntarily agree to sexual activity, and in some cases, may no longer be required to obtain parental consent to marry. The age of consent must not be confused with the age of majority.
The age of majority is the threshold of adulthood as recognized or declared in law. It is the moment when a person is no longer considered a child and can assume legal control over their person, actions, and decisions, thus terminating the control and legal responsibilities of their parents or guardians over them. The age of majority must not be confused with the age of consent.
Indication of noncompliance.
Note: This is defined by OHRP guidance.
An Amendment is a change to an approved research study (Expedited or Full Board) that is subject to IRB review and approval before implementation, unless the immediate change is necessary to eliminate an apparent hazard to participants. Currently-enrolled and active participants must be informed of the change if it could affect their willingness to continue participation in the study. The Amendment review process is required by federal regulations.
Unidentified data (i.e., personally identifiable information was not collected, or if collected, identifiers were not retained and cannot be retrieved); information or materials (e.g., data or specimens) that cannot be linked directly or indirectly by anyone to their source(s).
Request for reconsideration of an IRB determination in research involving human subjects, including (but not limited to) decisions regarding approval status, conditions for approval, or noncompliance.
Note: An appeal is reviewed by the convened IRB responsible for the determination being appealed; for a decision made by expedited review, the corresponding convened IRB may review the appeal.
Application Integrity Policy (AIP):
The FDA's policy for the integrity of data or information submitted in an Investigational Device Exemption (IDE) application. If it is suspected that an applicant has submitted false or misleading information, the data are thoroughly investigated. Submitting false or misleading information may result in FDA refusal to review submissions until certain requirements are met.
Note: This is defined by FDA policy.
The first date that research can be performed (following notification from the IRB), consistent with federal regulations, state and local laws, and university policy. The approval date is the date that the research is approved by convened or expedited review, or if modifications are required (to secure approval), the date that modifications/conditions are met by the investigator.
For initial review, the interval that begins on the day research is approved by convened or expedited review, or if modifications are required (to secure approval), the date that modifications/conditions are met by the investigator. For continuing review, the interval that begins on the day research is re-approved (by convened or expedited review) or modifications are required.
Note: An approval period for initial or continuing review may not be approved for a maximum period of one year from the date of approval or for a shorter period of time, as determined by the IRB.
An IRB action taken when the required determinations are made that allow research involving human subjects to proceed consistent with federal regulations, state and local laws, and University policy.
Affirmative agreement to participate in research or clinical investigation expressed by an individual (child or adult). Failure to object is not assent.
Note: This is defined by the DHHS and FDA federal regulations.
A contract or agreement that establishes standards for human subjects research as approved by the Office for Human Research Protections (OHRP). It promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.
A systematic review, inspection, or verification, typically conducted by an independent individual or group.
An individual who is authorized by an institution or organization to use their signature to (i) bind the institution or organization or (ii) approve a specific action for or on behalf of the institution or organization.
Personal capacity to consider alternatives, make choice, and act without undue influence or interferences of others.
B
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.
Basic Experimental Studies with Humans (BESH)
Studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.
Note: This is defined by the NIH.
Systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (32 CFR 272.3)
Note: This is defined by the Office of the Secretary of Defense.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules:
- do not harm; and
- protect from harm by maximizing possible benefits and minimizing possible risks of harm.
A valued or desired outcome; an advantage.
Biological Product (Biologic):
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Note: Biological products also include immunoglobulin products, monoclonal antibodies, products containing cells or microorganisms, and most proteins intended for therapeutic use.
The process by which investigators and/or participants do not know to which study group the participants are assigned. There are single blind studies (in which the participant is blind) and double blind studies (in which both the participant and the investigator are blind).
In the revised Common Rule, "broad consent" is an alternative consent process only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research. The use of broad consent requires that the investigator maintain a sophisticated tracking system. For this reason, and because the regulations permit the secondary research use of identifiable data/biospecimens through study-specific consent, IRB waiver of consent, or removal of identifiers, Brown does not plan to implement the broad consent option at this time. Limited exceptions will be considered.
For full details about broad consent including the requirements (in addition to tracking), limitations, and considerations for use, see SACHRP's Recommendations for Broad Consent Guidance.
C
The act of transferring IRB review and oversight.
Certificate of Confidentiality (CoC):
A Certificate of Confidentiality (CoC) helps researchers protect the confidentiality of participants enrolled in sensitive human subjects research studies. Certificates protect against compulsory legal demands, such as U.S. court orders and subpoenas, for identifying information or identifying characteristics of a research participant.
Any researcher can apply for a CoC to protect their participants, however a CoC is issued automatically for applicable NIH awards as part of the award terms and conditions.
Persons who have not attained the legal age for consent to treatments or procedures involved in the research or clinical investigation, under the applicable law of the jurisdiction in which the research will be conducted.
Note: This is defined by the NIH, and DHHS and FDA federal regulations. For most studies, this means individuals under 18 years of age, however not all U.S. states and foreign countries recognize 18 as the age of majority. There are locations that consider adulthood as young as 9 and as old as 21.
Any experiment that involves a test article, one or more human subjects, and that is either subject to requirements for prior submission to the Food and Drug Administration (FDA), or is not subject to requirements for prior submission to the FDA but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
Note: This is defined by the FDA federal regulations.
Research with human subjects that is (i) patient-oriented: with participants (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or research personnel) directly interacts with participants, including mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies (excludes in vitro studies that use human tissues that cannot be linked to a living individual); (ii) epidemiological and behavioral studies; (iii) outcomes research and health services research.
Note: This is defined by the NIH. Studies falling under 45 CFR 46.101(b)(4) - Exemption 4 - are not considered clinical research by this definition.
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Note: This is defined by the NIH and the DHHS federal regulations.
Coded Information/Biospecimens:
Identifying information (such as name or social security number) or biospecimens that would enable the investigator to readily ascertain the identity of the individual to whom the private information or biospecimens pertain that has been replaced with a number, letter, symbol, or combination thereof (i.e. the code); and for which a key to decipher the code exists that enables linkage of the identifying information or biospecimens to the private information or biospecimens.
Note: This is defined by the NIH and the DHHS. Individuals who provide coded information or biospecimens for proposed research and who also collaborate on the research involving such information or biospecimens are considered to be engaged in the conduct of human subject research.
Overt or implicit threat of harm intentionally presented by one person to another in order to obtain compliance.
Note: This could be a physician telling a patient that they will lose access to their health services if they do not enroll in clinic's research.
Having a psychiatric, organic, or developmental disorder that affectHaving a psychiatric, organic, or developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished and may also compromise a person's ability to make decisions in their best interest.
Note: This may include those suffering from degenerative diseases affecting the brain, the terminally ill, severely physically disabled individuals, and persons under the influence of, or dependent on drugs or alcohol.
A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
An institution working with Brown University on a multi-site human subjects research study that is either (a) the institution to whom we will relinquish IRB oversight or (b) the institution(s) ceding review to Brown’s IRB.
Payment, merchandise, class credit, or other gifts or services provided to research participants or their legally authorized representatives for their time and effort associated with research participation. Compensation should be appropriate to the population, the cultural norms of the research location, and research activities.
Used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.
How a researcher has agreed to handle, manage, and disseminate the information disclosed by or data regarding a participant. There is a relationship of trust between these parties, and the expectation that confidential information or data will not be divulged to others by the researcher without the participant’s permission in ways that are inconsistent with the agreement regarding disclosure of the information or data.
An IRB action that specifies conditions under which research can be approved. Comments by IRB members must be directive requesting simple concurrences or specific, non-substantive changes.
Upon receipt of the required changes, the IRB Chair or another member designated by the Chair will verify that the appropriate additions/corrections were made and will either approve the study or return it to the Full Board for further review at a convened meeting.
A Financial Conflict of Interest, a Non-Financial Conflict of Interest, or an opportunity for personal benefit of an IRB member or Immediate Family member that exerts, could exert, or could be perceived to exert an influence on the individual’s professional judgment in exercising the individual’s role as an IRB member.
Category of review of human subjects research, and subject to IRB review and approval to assure the continued protection of the rights and welfare of the participants in that research. In order to re-approve the research, the IRB must assess the study based on the federal requirements for approval: minimized risks to participants, equitable selection of participants, informed consent process, appropriate data management and security, appropriate participant privacy and confidentiality of data, and safeguards for vulnerable populations. The continuing review process is defined by federal regulations.
Any demonstrated pattern of noncompliance that may indicate (i) an insufficient understanding or misapplication of federal, state, or local regulations that govern human subjects research, or institutional policies and procedures that apply to human subjects research; (ii) a compromise of the study quality or scientific integrity such that important conclusions can no longer be reached; or (iii) frequent instances of noncompliance suggesting a likelihood that noncompliance will continue without intervention.
A meeting of the IRB at which a majority of IRB members are present.
Suggestions for corrections or improvements to be made to assure regulatory agency inspection readiness and alignment with regulations and standards and a listing of current good practices.
A cultural consultant assesses research that will take place in a foreign country or in the U.S. that involves a unique population (for example, Little Haiti in Florida). The cultural consultant will examine the awareness of and the sensitivity to the particularities of the national, cultural, and/or linguistic group of the study site and population.
D
The process for reviewing data collected as research progresses to ensure the continued safety of current and future participants as well as the scientific validity and integrity of the research.
Data and Safety Monitoring Board (DSMB):
A formal, independent board of experts including investigators and biostatisticians that advise study investigators regarding the safety progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I, Phase II, or other clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.
Note: This is defined by the NIH.
Data and Safety Monitoring Plan (DSMP):
The plan for reviewing research data to ensure the safety of participants and scientific validity of the research, including who will perform the monitoring, the type and frequency of review, and procedures for notifying appropriate entities (e.g., investigators, sponsor, etc.) of the results.
A place that holds research data and makes that data available for future use by the broader research community. Data repositories may have specific requirements concerning the research topic, data re-use and access, file format and data structure, and the types of metadata that can be used. Many data repositories have restrictions on who can deposit and access data.
Note: Data repositories may also be called registries, banks, or libraries
A written agreement between two (or more) parties to ensure that research data will only be used for specific uses and disclosures. DUAs can be incoming (data coming to Brown) or outgoing (data being sent outside of Brown) or involve sharing across multiple parties. Investigators are not permitted to sign DUAs on behalf of the University. More information is available here.
Fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
Note: This is defined by the DHHS federal regulations.
Information about the research that is provided to participants after study completion. A debriefing session is used to provide important information about the nature of the research, additional information for educational purposes, or additional resources that may be appropriate for, or useful to, participants. Debriefing is often required when the research involves deception or incomplete disclosure. In general, this type of debriefing explains any deception or incomplete disclosure, provides information about why it was necessary to use deception or incomplete disclosure to conduct the research, and provides other options available to participants (e.g., the ability to withdraw their data).
Occurs when an investigator gives false information to, or otherwise intentionally misleads, a research participant about some key aspect of the research to avoid biased responses. If participants are given false information or are otherwise misled during a study, then the participants are not provided with all of the required elements of informed consent: in these instances, approval for a waiver or alteration of informed consent is required.
A prospective participant's ability to make a meaningful decision about whether or not to participate in a research study. The four elements of decisional capacity are a participant's ability to (i) understand the information presented to the participant, (ii) appreciate the risks and benefits involved, (iii) reason and engage with research personnel about the information presented to the participant, and (iv) express a choice about whether or not to participate.
Note: Decisional capacity may be temporary, permanent, progressive, or fluctuating.
A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.
An IRB action taken when the convened IRB cannot fully evaluate the research under review and make the determinations required for IRB approval without (i) modifications to the Application and/or informed consent document(s), or (ii) submission of clarifications or additional materials prior to reconsideration of the research.
Note: Deferring a submission requires that the entire study with the additional information or modifications be reviewed by
the Full Board at a convened meeting.
All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s).
Note: For purposes of HRPP policy, health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule). Other demographic information, such as gender, race, ethnicity, and marital status are not included in the list of identifiers that must be removed.
Research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.
Note: This is defined by the NIH. A delayed onset study aligns with 45 CFR 46.118 designation in the DHHS federal regulations.
Research plans can be described at time of application, but research will not immediately begin (will occur later in the funding period).
Note: This is defined by the NIH.
Complete separation of the fetus from the person able to give birth by expulsion, extraction, or any other means.
Note: This is defined by the DHHS federal regulations.
Department of Health and Human Services (DHHS):
The federal agency charged with enhancing and protecting the health and well-being of all Americans by providing for effective health and human services and fostering advances in medicine, public health, and social services.
A protocol deviation is not defined by DHHS or the FDA. Broadly, a protocol deviation is an unapproved departure from the procedures described in the IRB-approved materials. Deviations may occur for a variety of reasons, maybe anticipated and/or intentional, may be known or identified before they occur or discovered after the fact.
Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article (including a component part), or accessory that is recognized in the official National Formulary or United States Pharmacopoeia (or any supplement to these) and is:
- Intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
- Intended to affect the structure or any function of the body of man or other animals, that does not achieve any of its primary intended purposes through chemical action within or on the body, and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the Application and/or informed consent process/document(s).
Note: Only the Full Board may disapprove a study.
The release, transfer, access to, or divulging of information in any other manner outside the covered entity holding the information.
Substance recognized in the United States Pharmacopoeia, Homeopathic Pharmacopoeia of the United States, or National Formulary (or any supplement to any of these), and is an article:
- Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or intended to affect the structure or any function of the body (other than food), or
- Intended for use as a component of any substance described above.
Durable Power of Attorney for Health Care
A type of advance medical directive in which legal documents provide the power of attorney to another person in the case of an incapacitating medical condition.
E
Early Feasibility Study (EFS):
A limited clinical investigation of a device early in development. It typically (i) enrolls a small number of subjects; (ii) is used to evaluate the device design concept with respect to initial clinical safety and device functionality; and (iii) may guide device modifications.
Note: This is defined by FDA policy.
For purposes of HRPP policy, the following persons under the legal age of 18, who because of their unique circumstances have the legal rights of adults, including the right to consent to treatments or procedures involved in research:
- Persons under the age of 18 on active duty in the military
- Married persons under 18 years of age
Embryonic Stem Cell Research Oversight (ESCRO) Committee:
Oversight committee tasked with reviewing the scientific and ethical merits of all Brown University research activities involving the derivation of human embryonic stem cells (hESCs). More information about the ESCRO can be found here.
The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval.
Note: This is defined by the FDA federal regulations.
The process of converting information, particularly information such as social security number and name that identifies individuals, into a code.
Involved in human subjects research in such a way (or to the extent) that the ethical and regulatory requirements for human subjects protection are applicable. An individual (or organization) becomes engaged in human subjects research when the individual (or organization’s employee or agent):
- Receives a direct federal award to support research,
- Obtains information or biospecimens about research participants through intervention or interaction,
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens about research participants, or
- Obtains informed consent of research participants.
Note: Brown University applies this definition to all Exempt and non-Exempt research.
Individuals who have given informed consent or assent to participate in the screening or study procedures. Individuals can enroll in a study and not complete any or all procedures, including being deemed ineligible through screening procedures.
Note: Vulnerable population exceptions may apply.
Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens or research are fairly distributed.
Category of review of human subjects research defined by federal regulations that may be minimal or greater than minimal risk. The entire research study must meet at least one of the Exempt research categories. Exempt research is reviewed by the HRPP, and not subject to review and approval by an IRB.
Note: Researchers conducting Exempt research must comply with the requirements of the HRPP and Brown University.
A change to an Exempt research study that is subject to HRPP review and approval before implementation, unless the immediate change is necessary to eliminate an apparent hazard to participants. Currently enrolled and active participants must be informed of the change if it could affect their willingness to continue participation in the study. The Exempt Modification review process is required by Brown policy.
A dataset that may be constructed of different types of data, including but not limited to, survey data, demographic information, health information, genomic information, and/or data derived from existing samples of cells, tissues, or other types of materials that may have been previously collected for a different purpose or research question but will now be used to answer a new research question.
Note: This is defined by the NIH. In general, studies using existing datasets will meet the NIH definition for clinical research with a prospective plan to analyze the existing data and/or derive data from an existing resource and where no ongoing or future contact with participants is anticipated.
Category of review of human subjects research defined by federal regulations that must be minimal risk. The entire research study must meet at least one of the Expedited research categories. Expedited research is subject to IRB review and approval.
The date that the IRB’s approval of research has lapsed and research can no longer be performed.
Note: An expiration date may not be longer than one year from the date the approval period begins.
When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the informed consent document. No activities can occur after the expiration date.
F
Any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the participant is the equivalent of a family relationship.
Note: This is defined by the FDA federal regulations.
Federal Regulations for the Protection of Human Subjects (45 CFR 46):
The Department of Health and Human Services (DHHS) code of federal regulations on the protection of human participants in research. These regulations apply to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the regulations applicable to such research. Note: This is defined by the DHHS federal regulations.
Note: This is defined by the DHHS federal regulations.
The Federalwide Assurance (FWA) is granted by the Department of Health and Human Service's (DHHS) Office for Human Research Protections (OHRP). It is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-Exempt human subjects research conducted or supported by DHHS. Under an FWA, an institution commits to DHHS that it will comply with the requirements set forth in 45 CFR Part 46, as well as the Terms of Assurance.
Note: Brown University: FWA #00004460
The product of conception from implantation until delivery.
Note: This is defined by the DHHS federal regulations.
Financial Conflict of Interest:
An interest of an IRB member or Immediate Family member of monetary value (a) that is, could be, or could be perceived to be impacted by the research under review, including an IRB member or Immediate Family member’s interest in or relationship to an entity that the research impacts, may impact, or could be perceived to impact; or (b) that influences, could influence, or could be perceived to influence the IRB member’s professional judgment in exercising his/her role as an IRB member. Financial interests may include, but are not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
Food and Drug Administration (FDA):
The federal agency responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the U.S. food supply, cosmetics, and products that emit radiation. The FDA is also responsible for regulating the manufacturing, marketing, and distribution of tobacco products, and for advancing the public health by helping to speed innovations that make medical products and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medical products and foods to improve their health.
Food and Drug Administration Policy for the Protection of Human Subjects (21 CFR 50):
This policy applies to all clinical investigations regulated by the Food and Drug Administration (FDA), as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including foods, dietary supplements that bear a nutrient content or 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.
Food and Drug Administration Policy for Institutional Review Boards (21 CFR 56):
This policy contains the general standards for the composition, operation, and responsibility of an Institutional Review Board that reviews clinical investigations regulated by the Food and Drug Administration (FDA), as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including foods, dietary supplements that bear a nutrient content or 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. Compliance with this policy is intended to protect the rights and welfare of human subjects involved in such investigations.
Category of review of human subjects research that is greater than minimal risk, and subject to IRB review and approval.
g
Knowledge from which conclusions will be drawn that can be applied to populations beyond the specific population from which it was collected.
Genetic Information Nondiscrimination Act (GINA)
Genetic Information Nondiscrimination Act (GINA) is a Federal law that prohibits discrimination in health coverage and employment based on genetic information. Along with the nondiscrimination provisions of HIPAA, GINA generally prohibits health insurers or health plan administrators from requesting or requiring genetic information of an individual or an individual's family members, or using such information for decisions regarding coverage, rates, or preexisting conditions. GINA also prohibits employers from using genetic information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment.
A standard established by the International Conference on Harmonisation for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Note: In the United States, FDA has adopted GCP as guidance for the ethical conduct of clinical trials.
Financial support provided for research study designed and proposed by the Principal Investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant.
The probability and magnitude of harm or discomfort anticipated in the research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
An individual who is authorized under applicable state or local law to make personal, health, and financial decisions for the individual's ward (an adult with impaired decision-making capacity).
An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.
Note: This is defined by the DHHS and FDA federal regulations.
H
Health-Related Biomedical or Behavioral Outcome:
Pre-specified goal(s) or condition(s) that reflect the effect of one or more intervention(s) on study participants' biomedical or behavioral status or quality of life.
Note: This is defined by the NIH. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers, reading comprehension, and/or information retention); disease processes, health-related behavior, and, well-being or quality of life.
Human Research Protection Program (HRPP):
The Human Research Protection Program (HRPP) exists to promote high quality, ethical research. It does this by serving as the advocate for the rights and welfare of persons who participate in research programs conducted by faculty, staff, students, and researchers at Brown University. The HRPP has responsibility for review of research involving human subjects conducted at Brown University, and assists researchers in complying with federal, state and Brown policies regarding experimentation involving human subjects.
A living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Note: This is defined by the DHHS federal regulations and the NIH, and complies with Brown policy. The FDA defines a human subject as "An individual who is or becomes a participant in research either as a recipient of a test article or as a control. A participant may be either a healthy human or a patient."
Human Subjects Research Advisor (HSR Advisor):
An active mentor to a student researcher who shares the responsibility for the ethical conduct of the research with the student. The HSR Advisor is expected to have previous experience conducting human subjects research, completed human subjects research education requirements, sufficient time and resources to advise the student in the conduct of the research, and discuss the general principles of research ethics prior to the initiation of any project involving human subjects. For more information about this role's qualifications and resonsibilities, see the guidance on Principal Investigators & Human Subjects Research Advisors.
I
A biospecimen for which the identity of the participant is or may readily be ascertained by the investigator (or research personnel) or associated with the biospecimen.
Note: This is defined by the DHHS federal regulations.
Identifiable Private Information:
Private information for which the identity of the participant is or may readily be ascertained by the investigator (or research personnel) or associated with the information.
Note: This is defined by the DHHS federal regulations.
Spouse, domestic partner, or child.
A device that is placed into a surgically or naturally formed cavity of the human body and is intended to remain there for a period of 30 days or more. In order to protect public health, the FDA may determine that devices placed in subjects for shorter periods are also implants.
Note: This is defined by FDA policy.
Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.
Financial payments and/or other inducements to investigators, research staff, or referring physicians to promote enrollment of subjects in research study. These do not include payments to subjects themselves. Examples include:
- the sponsor provides financial reimbursement to the research and/or study staff that exceeds the fair market value of the services provided.
- the sponsor provides payment or services outside the scope of the research study requirement, such as, unrestricted educational grants.
Occurs when an investigator withholds or conceals information from a participant about the specific purpose of, or activities involved in, the research. If material information or activities are withheld that could potentially influence the decision of prospective participants to take part in the research, then the participants are not provided with all of the required elements of informed consent: in these instances, approval for a waiver or alteration of informed consent is required.
The identity of the participant is or may readily be ascertained by the investigator or the investigator’s staff, or is associated with the information.
Note: Individually identifiable for the purposes of HRPP policy may be similar to, but is not the same as, protected health information as defined by the HIPAA Privacy Rule at 45 CFR Part 160. Limited data sets released from data repositories with IRB approval to release such data sets are not considered to be individually identifiable.
Prospective agreement to participate in research expressed by an individual (or their legally authorized representative) giving the individual the opportunity to choose what may or may not happen to them during the research study based on the elements of information, comprehension, and voluntariness.
Institutional Biosafety Committee (IBC):
Committee that evaluates and provides oversight of the use of biohazardous agents to ensure compliance with appropriate regulations and guidelines and to safeguard the health and safety of Brown University personnel, the community, and the environment. IBC oversight also includes human source material, including blood, body fluids, tissues and/or cell lines, infected clinical specimens or biologically contaminated specimens.
The individual identified on Brown University’s Federalwide Assurance with the Office for Human Research Protections who is legally authorized to act for Brown University, on behalf of Brown University, and obligates the Unversity to the Terms of the Assurance. At Brown University, the IO is the Vice President for Research.
Institutional Review Board (IRB):
A specially constituted review body established to protect the rights and welfare of human subjects recruited to participate in biomedical or social / behavioral research conducted under the auspices of its affiliated institution.
Communication or interpersonal contact between an investigator (or research personnel) and participant (e.g., interviews, observations, or physical measurements in person, online, or by phone).
Note: This is defined by the DHHS federal regulations.
International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) (also: International Conference on Harmonisation):
Voluntary, international initiative to increase coordination of the requirements for developing and marketing new drugs. The ICH includes representatives from the pharmaceutical industry and regulatory authorities from the United States, Japan, and the European Union.
Involves social associations, connections, or affiliations between two or more people that may vary in their degree of intimacy, duration, reciprocity, and power distribution. These relationships may be intimate, familial, professional, or informal. Relationships may, but need not, be regulated by law, custom, or mutual agreement, and form the basis of many other social groups or organizations.
Includes both physical procedures by which data or biospecimens are gathered (e.g., venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes.
Note: This is defined by the DHHS federal regulations and the NIH. Examples include surgical techniques; telemedicine; strategies to change health-related behavior; diet, exercise, cognitive therapy, and/or development of new habits; and/or treatment, prevention, and diagnostic strategies.
The project director or principal investigator and any other persons, regardless of title or position (e.g., full or part-time faculty member, staff member, student, trainee, collaborator, or consultant), who is responsible for the design, conduct, or reporting of sponsored research.
Investigational Device Exemption (IDE):
A device, including a transitional device, that is the object of a clinical investigation.
Note: This is defined by FDA policy.
Investigational New Drug (IND) Application:
A request for authorization from the FDA to administer an investigational drug or biological product to humans. Such authorizations must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.
IRB Authorization Agreement (IAA):
A written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities. This agreement may also be referred to as a reliance agreement or cede review agreement.
The IRB that has been designated through an IRB Authorization Agreement (IAA) to provide ethical oversight of a study in which more than one organization is engaged in the research.
An IRB Organization (IORG) operates one or more Institutional Review Boards (IRBs). The IORG and its IRBs must register with the Office for Human Research Protections (OHRP) and be updated/renewed, per OHRP policy.
The Health and Human Services (HHS) registration number for an IRB that reviews human subjects research conducted or supported by HHS.
Brown University, IRB#00000556
J
An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
Any person who may interact with the justice system (e.g. law enforcement, court system, etc.) and have insufficient power or resources to protect their own interests, which may make them susceptible to undue influence and/or coercion depending on their situation, their condition, or the research.
Note: This population does not have to meet the federal definition of "prisoner" to be involved with the justice system. Probationers and individuals wearing monitoring devices are considered "justice-involved participants."
K
Any individual who provides information on topics other than themselves with respect to a specific research study.
Note: Examples may be describing a clinic's intake policy or demographics of a local community. When conducting surveys or interviews, a key informant is not considered a human subject since they do not share personal information or opinions, therefore this activity does not require IRB review.
L
Legally Authorized Representative:
An individual, judicial, or other body authorized under applicable law to consent to research participation on behalf of a designated person. If there is no applicable state law addressing a legally authorized representative in the context of research, this term is defined as a person recognized by Brown policy who may provide consent in a non-research context on behalf of the prospective participant's enrollment in research.
Note: This is defined by the DHHS and FDA federal regulations.
A person conducting clinical assessments or making a clinical judgment who has the independent authority to treat patients. The licensed medical provider should have appropriate expertise in the area of research inquiry.
Protected Health Information (PHI) that does NOT include any of the following 16 categories of direct identifiers, but that may include city, state, ZIP code, or elements of dates, concerning an individual or an individual’s relatives, employers, or household members:
- Names; or
- Postal address information, other than town or city, state, and ZIP Code; or
- Telephone numbers; or
- Fax numbers; or
- Electronic mail addresses; or
- Social security numbers; or
- Medical record numbers; or
- Health plan beneficiary numbers; or
- Account numbers; or
- Certificate/license numbers; or
- Vehicle identifiers and serial numbers, including license plate numbers; or
- Device identifiers and serial numbers; or
- Web universal resource locators (URLs); or
- Internet protocol (IP) address numbers; or
- Biometric identifiers, including fingerprints and voiceprints; or
- Full-face photographic images and any comparable images.
An individual appointed by a court whose responsibilities for the personal affairs of the individual's ward (an adult with impaired decision-making capacity) are limited only to those areas where the ward lacks capacity. In Rhode Island, the limited guardianship law has four areas of decision-making capacity: finances, healthcare, relationships, and residence.
In the context of international student research, when the Brown faculty advisor will not be present in the country with the student, the student must designate a local contact for the participants in the foreign site. They should be a neutral party knowledgeable of the student's research, local cultural norms, policies, and laws (for example, non-governmental organization (NGO), a local IRB, or a university professor). This contact should be available to answer a participant's questions about the research or about their rights.
Note: The student investigator may not act in the dual capacity as the local contact.
M
Memorandum of Understanding (MOU):
A formal agreement between Brown University and another institution that identifies the Brown Institutional Review Board as the IRB of record for that institution.
The probability and magnitude of harm or discomfort anticipated in the research as not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Note: This is defined by the DHHS and FDA federal regulations. What is considered ordinary for "daily life" and "routine" may vary depending on the study population. Researchers should be aware of the risks that may be considered standard for a prospective study population.
Changes to research that in the judgment of the IRB do not affect assessment of the risks and benefits of the study by substantially altering any of the following: research aims or methodology, nature of subject participation, level of risk, proposed benefits, participant population, qualifications of the research team, or the facilities available to support the safe conduct of the research.
Note: A minor change does not increase risk more than minimally or add procedures in research categories other than those that qualify for expedited initial review.
Protocol deviations from IRB-approved procedures that (i) do not cause harm and have no potential to cause harm to research participants or others, and (ii) do not impact the integrity of research data.
Note: Minor protocol deviations include: over-enrollment of participants in a minimal risk study; follow-up visits occurring outside the protocol's required time frame because of the participant’s schedule; blood samples obtained at times close to, but not precisely at, the time points specified in the protocol.
An IRB action that specifies conditions under which research can be approved, pending the following: confirmation of specific understandings by the IRB about how the research will be conducted, submission of additional documentation, precise language changes to the protocol and/or informed consent document(s), and/or substantive changes to documents with specific parameters the changes must satisfy.
Note: Verification that the investigator’s response(s) satisfies the conditions for approval set by the IRB may be performed by the IRB Chair and/or other designated individual(s).
An individual designated by a sponsor or contract research organization to oversee the progress of a clinical investigation. The monitor may be an employee of a sponsor, or a consultant to the sponsor, or an employee of or consultant to a contract research organization.
Note: This is defined by FDA policy.
N
National Institutes of Health (NIH):
The federal agency charged with improving the health of the people of the United States. The NIH is the largest biomedical research agency in the world and is part of the Department of Health and Human Services (DHHS).
Note: This is defined by the NIH.
Newborn.
Note: This is defined by the DHHS federal regulations.
Includes, but is not limited to, any incident involving (i) a failure to comply with federal, state, or local regulation that governs human subjects research; (ii) a violation of institutional policies or procedures applicable to human subjects research; (iii) any unapproved deviation from stipulations imposed by the institution as a condition of IRB/HRPP approval; and (iv) any unapproved deviation from an IRB/HRPP-approved protocol, unless such deviation is necessary to preserve the life or health of a participant and the IRB/HRPP is notified as soon as possible after the deviation occurs.
Non-Financial Conflict of Interest:
An interest, other than monetary, of an IRB member or Immediate Family member in the design, conduct, or reporting of the research under review, or other interest that compromises, could compromise, or could be perceived to compromise the individual’s professional judgment in exercising the individual’s role as an IRB member.
Neonate after delivery that, although living, is not viable.
Note: This is defined by the DHHS federal regulations.
O
The investigator simply records observations and analyzes data, without administration of an intervention or alteration of the care participants receive. These studies may focus on risk factors, natural history, variations in disease progression or disease treatment without delivering an intervention. They often assess specific health characteristics of the enrolled human subjects by collecting medical/dental history, exposure, or clinical data; obtaining biospecimens (e.g., for biomarker or genomic analyses); or obtaining photographic, radiographic or other images from research participants.
Note: This is defined by the NIH.
The Office for Human Research Protections (OHRP):
The federal office providing leadership in the protection of the rights, welfare, and wellbeing of participants involved in research conducted or supported by the U.S. Department of Health and Human Services by offering clarification and guidance, developing education programs and materials, maintaining regulatory oversight, and giving advice on ethical and regulatory issues in biomedical and social/behavioral research.
Office of Research Integrity (ORI):
The Office of Research Integrity (ORI) partners with the Brown research community to facilitate research guided by governing policies and regulations to cultivate a culture of ethical and transparent research.
The use of a prescription or over-the-counter FDA-regulated drug, biologic, or device for an unapproved indication or in an unapproved age group, dosage, or route of administration.
The use of a prescription or over-the-counter FDA-regulated drug, biologic, or device for the approved indication.
An individual with competence in special areas, invited by the IRB/HRPP in its discretion, to assist in the review of issues that require expertise beyond or in addition to that available on or in the IRB/HRPP. This individual may not vote with the IRB/HRPP.
Note: This is defined by the DHHS and FDA federal regulations.
P
A child’s biological or adoptive mother or father.
Note: This is defined by the DHHS and FDA federal regulations.
A research methodology involving participation, observation, and analysis of the daily life of the people being studied.
Funds issued by a federal agency that are then transferred to other eligible groups per the award eligibility terms. The "prime awardee" issues the subawards as competitive or noncompetitive as dictated by the prime award terms and authorizing legislation. Prime awardee institutions on a pass-through funding grant are considered engaged by the Department of Health and Human Service's (DHHS) Office for Human Research Protections (OHRP) and must ensure ethical oversight for their role in the research.
The agreement of parent(s) or legal guardian to the participation of their child or ward in research or clinical investigation.
Note: This is defined by the DHHS and FDA federal regulations.
Personally Identifiable Information (PII):
Information that can be used to distinguish or trace an individual’s identity, such as name, social security number, and biometric records, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual, such as date and place of birth or mother’s maiden name.
Note: This is defined by the NIH. Some information that is considered to be PII is available in public sources such as telephone books, public websites, and university listings (e.g., first and last name, address, contact information, and general educational credentials). Non-PII can become PII when combined with other available information.
A substance that has no therapeutic effect, used as a control in testing new drugs or biologics.
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.
Possibly Related to the Research:
There is a reasonable possibility that the adverse event, incident, experience or outcome may have been caused by the procedures involved in the research.
Note: This is defined by the OHRP guidance.
Relationship in which one or more individuals has a role that is perceived to have or actually has more authority, agency, or knowledge over another.
A person able to give birth shall be assumed to be pregnant if they exhibit any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. Pregnancy encompasses the period of time from implantation until delivery.
Note: This is defined by the DHHS federal regulations.
Any premarket approval application for a Class III medical device, including all information submitted with or incorporated by reference therein (21 CFR 814.3).
Note: This is defined by FDA regulations.
Premarket Notification (PMN) or 510(k):
The type of submission to the FDA described under 21 CFR 807, Subpart E in which the applicant must establish that their device is substantially equivalent to a legally marketed device. This type of submission is used for most Class II devices and some Class I devices.
Note: This is defined by FDA regulations.
The process performed by HRPP staff to determine that a submission for IRB review is complete, including the required materials, copies, and signatures, and that institutional requirements, such as completion of human subjects’ protection education and conflict of interest disclosure, have been met.
The lead institution or organization that is the recipient of a federal award.
An individual with the appropriate scientific and/or scholarly training and expertise to assume direct responsibility for the ethical conduct of a study involving human subjects, and who provides technical and administrative oversight of the research and makes important study-related decisions. For purposes of HRPP policy, only one individual is designated as the Principal Investigator of a human research study.
Any individual involuntarily confined or detained in a penal institution (e.g., prison, jail, or juvenile offender facility) encompassing (i) individuals sentenced to such an institution under a criminal or civil statute, (ii) individuals detained in other facilities (e.g., psychiatric units, hospitals, or drug treatment centers) by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and (iii) individuals detained pending arraignment, trial, or sentencing.
Note: This is defined by the DHHS federal regulations. Probationers and individuals wearing monitoring devices are generally not considered to be prisoners.
Refers to a participant’s right to control who has access to them or their information, location, and space. It is the recognition that a participant has the right to determine the extent, timing, and circumstances of sharing themselves or their information (physically, behaviorally, or intellectually) with researchers.
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 individual can reasonably expect will not be made public (e.g., medical, employee, or student records).
Note: This is defined by the DHHS federal regulations.
A series of actions conducted in a certain order or manner; operational method by which policy is put into practice.
An activity conducted to evaluate a specific program in order to provide information for and about that program regardless of any professional benefit to the investigator.
Pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research participants (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.
Note: This is defined by the NIH.
Protected Health Information (PHI):
Under the Health Insurance Portability and Accountability Act (HIPAA), "protected health information" is considered to be individually identifiable information relating to the past, present, or future health status of an individual that is created, collected, or transmitted, or maintained by a HIPAA-covered entity in relation to the provision of healthcare, payment for healthcare services, or use in healthcare operations (PHI healthcare business uses).
Note: PHI is only considered PHI when an individual could be identified from the information.
PHI includes one or more of the following 18 identifiers. If these identifiers are removed the information is considered de-identified protected health information, which is not subject to the restrictions of the HIPAA Privacy Rule.
1. Names; or
2. All geographic subdivisions smaller than a state, including street address, city, or county, precinct, ZIP code, and their equivalent geocodes, except for the initial three digits of the ZIP code if, according to the current publicly available data from the Bureau of the Census:
a. The geographic unit formed by combining all ZIP codes with the same three initial digits
contains more than 20,000 people; and
b. The initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer
people is changed to 000; or
3. All elements of dates (except year) for dates that are directly related to an individual, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; or
All elements of dates (except year) for dates that are directly related to an individual, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; or
4. Telephone numbers; or
5. Fax numbers; or
6. Email addresses; or
7. Social security numbers; or
8. Medical record numbers; or
9. Health plan beneficiary numbers; or
10. Account numbers; or
11. Certificate/license numbers; or
12. Vehicle identifiers and serial numbers, including license plate numbers; or
13. Device identifiers and serial numbers; or
14. Web Universal Resource Locators (URLs); or
15. Internet Protocol (IP) addresses; or
16. Biometric identifiers, including finger and voice prints; or
17. Full-face photographs and any comparable images; or
18. Any other unique identifying number, characteristic, or code, including any code that includes or is derived from any of the identifiers on this list.
Documentation of study objective, design, methods, statistical methods and organization. This term also includes amendments made to the original document.
Refers to data and/or biospecimens when used for human subjects research that are accessible to anyone in the general public, without the need for special permissions or privileges.
Note: Examples include data/biospecimens available for purchase, searchable online, or available at a library. Researchers may be subject to an agreement with the entity releasing the data/biospecimens prior to receipt and use (such as a Data Use Agreement). However, not all information online is publicly available. Public Twitter posts are publicly available, while posts from a closed Facebook group are not.
Q
Quality Assessment/Improvement (QA/QI):
An activity conducted to assess, analyze, critique, and improve current practice or process in an institutional setting or ensure it conforms to expected norms, involving data-guided, systematic activities designed to bring about prompt improvements regardless of any professional benefit to the investigator.
R
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.
The process by which participants are assigned to a group of study procedures by chance rather than by choice.
The process of identifying and reaching potential participants to enroll in a research study. It is considered the beginning of the participant selection and informed consent/assent processes.
May include (but are not limited to) printed materials, newsletters, recruitment lists, phone scripts, e-mails, electronic advertisements, and video/audio scripts. Recruitment materials must contain enough information to provide potential participants a sense of the study and the ability to decide if they may be eligible to participate.
Payment provided to research participants or their legally authorized representatives that reflects their out of pocket expenses associated with participating in a research study. These expenses could be parking, transportation, childcare costs, lost wages, accommodations, food, etc.
The entity that agrees to rely upon the reviewing IRB when entered into an IAA or reliance agreement. The relying institution agrees to depend on the IRB of Record for review of human subjects research and ensuring compliance with all relevant mandates and reporting requirements.
A type of unanticipated event or occurrence related to a human subjects research study that requires review by the IRB as defined in the IRB Reportable Events Policy.
For the purposes of mandatory reporting, any identified serious or continuing noncompliance, unexpected adverse event, unanticipated problem involving risks to participants or others, and/or suspension or terminations of IRB approval.
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Note: This is defined by the DHHS federal regulations. A systematic investigation is the use of a predetermined method (e.g., eligibility criteria, surveys, blood draws, etc.) to gain information by collecting and analyzing data. Generalizable knowledge is conclusions that can be applied to a larger population beyond the specific site of data collection or the participants who provided the information.
Any information (identifiable or anonymous) obtained through intervention or interaction with human subjects, or any identifiable private information obtained, used, studied, received, or accessed by a member of a research team for the purposes of conducting human subjects research.
Any biospecimens (identifiable or anonymous) obtained through intervention or interaction with human subjects, or any identifiable biospecimens obtained, used, studied, received, or accessed by a member of a research team for the purposes of conducting human subjects research.
Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion.
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.
Research Personnel (or Researchers/Key Personnel):
Persons who have direct contact with participants, contribute to the research in a substantive way, have contact with a participant's identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use a participant's personal information for research purposes.
Research utilizing human participants’ specimens/data that were previously collected (e.g., on the shelf) before the research was submitted to the IRB.
The IRB of record performing review on behalf of one or more institutions, also referred to as the single IRB, central IRB, and/or IRB of record.
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.
S
Human biological material, including solid material (e.g., tissue, organs) body fluid (e.g., blood, urine, semen, cerebrospinal fluid), and cells.
Participants in human subjects research about whom an investigator indirectly collects identifiable private information through interactions with primary participants (those who have enrolled in the study through a consent process).
Study of existing information or materials (e.g., data or specimens) that have been previously collected for a purpose (including non-research purposes) other than the currently proposed activity.
Information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.
Any adverse event that (i) results in death; (ii) is life-threatening (places the subject at immediate risk of death from the event as it occurred); (iii) results in inpatient hospitalization or prolongation of existing hospitalization; (iv) results in persistent or significant disability/incapacity; (v) results in congenital anomaly/birth defect; or (vi) based upon appropriate medical judgement, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Note: This is defined by the OHRP guidance.
Any incident of noncompliance that involves a willful disregard or knowing violation of the federal, state, or local regulations that governs human subjects research, or the institutional policies and procedures that apply to human subjects research, which may have included or led to a (i) significant harm, or a risk of significant harm, to the rights, welfare, or safety of participants; or (ii) significant compromise of the quality or scientific integrity of a human subjects research study.
The individual authorized to represent and commit the entire institution and all of its components to a legally-binding agreement.
Significant Financial Interest (SFI):
A “Significant Financial Interest” (SFI) is the receipt by you, your spouse, or your dependent children of any of the following, if related to your University responsibilities or professional expertise:
- Income that exceeds $5,000 from any outside entity, measured on a rolling 12‐month basis. This may be one payment from a particular company of more than $5,000, or multiple payments from the same company that, in the aggregate, exceed $5,000.
- Acquisition of equity in a public company that exceeds $5,000 in value;
- Aggregated income and equity/ownership interest from a public company that exceeds $5,000, as measured on a rolling 12‐month basis;
- Any equity/ownership interest in a privately‐held company;
- Any income received from rights in intellectual property, as measured on a rolling 12‐month basis.
An investigational device that is (i) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (ii) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject; (iii) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (iv) otherwise presents a potential for serious risk to a subject.
Note: This is defined by FDA policy.
Data or other information necessary to perform the research received from a party external to Brown via a properly executed agreement. Source Data does not include original data generated by Brown researchers or the results of analyses conducted using Source Data.
A person or other entity who initiates a clinical investigation, but does not actually conduct the investigation (e.g., the test article is administered, dispensed to, or used involving a subject under the immediate direction of another individual).
Note: This is defined by the FDA federal regulations. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.
External or internal funding of research through formal application, competitive award, or an achievement/recognition award where the sponsor is legally obligated to commit funds and/or facilities to the principal investigator (PI) to conduct research.
An individual who both initiates and actually conducts, alone or with others, a clinical investigation (e.g., under whose immediate direction the test article is administered, dispensed to, or used involving a subject).
Note: This is defined by the FDA federal regulations. This term does not include any person other than an individual (e.g., corporation, or agency). The obligations of a sponsor-investigator include both a sponsor and an investigator.
An award provided by a prime awardee to a sub-recipient for the sub-recipient to carry out a portion of the research or substantive effort of a federal award received by the prime awardee.
A group of individuals who identified themselves as being willing to participate in research. Signing up to join a subject pool does not enroll a person in a research study or make that person a research participant.
An action taken by an IRB that materially alters the substance and meaning of a protocol, informed consent form or process, or investigator status, including, but not limited to, restriction, suspension or termination of a study or investigator participation, and actions taken to prevent future occurrence(s) of the AE in research.
An action taken by the convened IRB or the IRB Chair to temporarily stop some or all approved research activities in order to protect participants pending completion of an investigation. Suspended studies remain open until the convened IRB determines to (i) lift the suspension or (ii) terminate the study or some activities of the study.
A prospective plan that incorporates data collection, either qualitative or quantitative, and data analysis to answer a question.
T
An IRB action that indicates that review was not initiated or was not completed, resulting in postponement of IRB review, usually due to loss of quorum or other administrative issue. Research tabled by the IRB will be reviewed at the next convened IRB meeting.
An action taken by the convened IRB or the IRB Chair to permanently stop all research activities in an approved research study.
Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation by FDA or the Public Health Service Act.
Note: This is defined by the FDA federal regulations.
An ethical problem in human subjects research when a participant mistakenly believes that the primary purpose of the study in which they are enrolled is to directly benefit the individual participants, rather than to produce generalizable knowledge.
In terms of recruitment, any person or vendor (outside of the research team) who recruits on behalf of that team.
Note: This may be physicians or school administrators who provide information to their patients or students, respectively, about a research study, or commercial entities hired to aid in recruitment.
A device subject to section 520(l) of the FD&C Act and which the FDA previously regulated as a new drug or an antibiotic drug before May 28, 1976.
Note: This is defined by FDA federal regulations.
U
Unanticipated Adverse Device Effect:
Any serious adverse effect on health or safety, any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the FDA Investigational Device Exemption application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Note: This is defined by FDA policy.
Unanticipated Problem Involving Risk to Participants or Others (UP):
Any incident, experience, or outcome in the course of human subjects research that is (i) unexpected (in terms of nature, severity, or frequency), (ii) related or possibly related to participation in research, and (iii) suggests that the research places participants or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
A device used for a purpose or condition for which the device would require, but does not have, pre-market approval or an approved investigational device exemption (IDE) from FDA.
Excessive or inappropriate reward or other overture in order to persuade a person to act against that person's own interests or without adequate consideration of the consequences in order to obtain compliance.
Note: Influence is contextual, so undue influence will likely depend on an individual's unique situation. This could be a professor promising their students extra credit for participating in the professor's research or a patient feeling obligated to enroll in their doctor's study.
The death of a research participant in which a high risk of death is not projected, as indicated by the written protocol, informed consent form, or sponsor brochure. This definition does not include deaths associated with a terminal condition unless the research intervention clearly hastened the participant’s death. A participant’s death that is determined to be clearly not associated with the research is also not an “unexpected death” for purposes of the reporting requirements of these procedures.
Unexpected Adverse Event (UAE):
Any adverse event (AE) occurring in one or more participants in a research study, the nature, severity, or frequency of which (i) is not considered consistent with either the known or foreseeable risk of AEs associated with the procedures involved in the research that are described in the protocol-related documents, investigator brochure, informed consent document, or other relevant sources of information regarding the research, such as product or device labeling and package inserts; or (ii) is not considered consistent with the expected natural progression of any underlying disease, disorder, or condition of the participant(s) experiencing the AE and the participant’s predisposing risk factor profile for the AE.
Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question. This definition should be considered in the context of determining whether an adverse events is related or possibly related to participation in research for purposes of determining whether it qualifies as a Reportable Event.
V
Neonate, after delivery, able to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
Note: This is defined by the DHHS federal regulations.
A group of participants that may have insufficient power or resources to protect their own interests, which may make them susceptible to undue influence and/or coercion depending on the situation, their condition, or the research. A population's vulnerability may change depending on the nature of the research and may fluctuate over time. Investigators must take special care and consideration when recruiting, consenting, and conducting research activities with these populations.
W
Waiver of Documentation of Informed Consent:
An allowance in the Federal Policy for the Protection of Human Research Subjects (45 CFR 46) for an IRB to waive the requirement for the investigator to obtain a signed consent document from participants when specific conditions are met.
A child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with applicable federal, state, or local law.
Note: This is defined by the FDA federal regulations.
An individual who makes a report in good faith to the Brown IRB regarding potential non-compliance issues or research activities that have potentially placed participants or others at increased risk in relationship to the conduct of the research.
Individuals who have given informed consent or assent to participate in study procedures, but who choose to no longer participate or who are removed by the PI from the study.
Note: Examples for why a participant may withdraw can include losing interest in the study, being lost to follow up, choosing to no longer participate without communicating with the study team, or no longer wanting to participate due to time or transportation constraints. An example of why a participant may be withdrawn by the PI is the research activities may impact the safety and well-being of the participant.
Reminder to researchers: Include in consent document(s) any anticipated reasons a participant may be withdrawn by the study team.
X
Y
Z
II. HRPP Acronyms
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Association for the Accreditation of Human Research Protection Programs, Inc. - Brown University's HRPP/IRB is not AAHRPP accredited |
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Adverse Device Effect |
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Adverse Event |
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Certificate of Confidentiality |
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COI |
Conflict of Interest |
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DHHS |
U.S. Department of Health and Human Services |
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Data Safety Monitoring Board or Committee |
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Data Safety Monitoring Plan |
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Data Use Agreement |
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Embryonic Stem Cell Research Oversight Committee |
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Food and Drug Administration |
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FERPA |
The Family Education Rights and Privacy Act |
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Federalwide Assurance |
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Good Clinical Practice |
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Health Insurance Portability and Accountability Act |
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Human Research Protection Program (formerly known as the Research Protection Office, or RPO) |
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Institutional Authorization Agreement |
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Institutional Biosafety Committee |
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Investigational Device Exception |
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Investigational New Drug |
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Institutional Official |
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Institutional Review Board |
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Memorandum of Understanding |
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NDA |
New Drug Application |
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NIH |
National Institute of Health |
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NSF |
National Science Foundation |
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Office for Human Research Protections (under DHHS) |
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ORI |
Office of Research Integrity |
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Protected Health Information |
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Principal Investigator |
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Quality Assurance/Quality Improvement |
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Significant Financial Interest |
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Sponsor-Investigator |
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sIRB |
Single Institutional Review Board |
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SMART IRB |
SMART IRB is an online reliance system used by Brown to facilitate sIRB review |
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Significant Risk |
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Unexpected Adverse Event |
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Unanticipated Problem Involving Risk to Participants or Others |