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.
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.
Process by which researchers can keep HRPP’s records aligned with their research records regarding changes that are administrative in nature and do not affect the research design, procedures, populations of a study, etc. Using this method, HRPP can quickly review and accept administrative modifications to already-approved Expedited and Full Board studies.
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.
An adverse event is defined broadly to include 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.
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.
An active mentor to a student researcher who shares the responsibility for the ethical conduct of the research with the student. The Advisor is expected to discuss the general principles of research ethics prior to the initiation of any project involving human subjects, help the student determine whether the project requires Institutional Review Board (IRB) review, and guide the student through the IRB application process. Advisors on undergraduate research studies must serve as the PI of the study, and will take on the role and responsibility of the PI.
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.
A report that noncompliance may have occurred, and requires further investigation to determine if noncompliance has, in fact, occurred.
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.
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 expressed by an individual (child or adult). Failure to object is not assent.
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 or staff position delegated by the Institutional Official to approve a specific action of document by virtue of their signature.
Personal capacity to consider alternatives, make choice, and act without undue influence or interferences of others.
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.
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.
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 they are assigned. There are single blind studies (in which the participant is blinded) and double blind studies (in which both the participant and the investigator are blinded).
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.
The act of transferring IRB review and oversight.
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, under the applicable law of the jurisdiction in which the research will be conducted.
Note: 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.
Defined as any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA, or 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.
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 definition is shared by the Common Rule and the National Institutes of Health.
(1) Identifying information (such as name or social security number) or biospecimens in which the identifying information has been replaced with a code (such as a number, letter, or combination thereof), so that the investigator is unable to readily ascertain the identity of the individual to whom the private information or biospecimens pertain; and (2) there is a key to decipher the code, enabling linkage of the identifying information or biospecimens to the private information or biospecimens.
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 disorder (e.g., psychosis, neurosis, personality or behavior disorder), an organic impairment (e.g., dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interest.
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 gift or service provided to research participants or their legally authorized representatives to reimburse them for their time, effort, and/or for any out-of-pocket expenses associated with research participation.
Note: Compensation is sometimes distinguished from an incentive or inducement, which is generally thought of as a payment or other offering that is “over and above” reimbursement and intended to encourage research participation.
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.
Refers to 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.
A pattern of noncompliance that indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others, compromises the scientific integrity of a study such that important conclusions can no longer be reached, suggests a likelihood that noncompliance will continue without intervention, or involves frequent instances of minor noncompliance. Continuing noncompliance may also include failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance.
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.
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.
A formally appointed independent group consisting of at least three (3) members assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics, and research study design.
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.
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.
Decisional Capacity refers to 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 is a participant's ability to Understand the information presented to them, Appreciate the risk and benefits involved, Reason and engage with the research personnel about the information presented to them, and Express a choice about whether or not to participate.
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.
The U.S. Department of Health and Human Services is a 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.
Refers to a prospective participant's ability to make a meaningful decision about whether or not to participate in research (e.g., as a result of trauma, intellectual disability, certain mental illnesses, cognitive impairment, or dementia).
Note: Diminished decision-making capacity may be temporary, permanent, progressive, or fluctuating.
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.
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.
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
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 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.
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 that is minimal risk, and not subject to review and approval by an IRB. Categories of Exempt research activities are defined by federal regulations.
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.
Available or “on the shelf” (e.g., data, specimens) at the time the research is submitted for a determination of whether the research is exempt.
Category of review of human subjects research that is minimal risk, and subject to IRB review and approval. Categories of Expedited research activities are defined by federal regulations.
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.
The basic Department of Health and Human Services policy on the protection of human participants in research. This policy applies 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 policy applicable to such research.
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 co
mpliance 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
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).
The FDA is the federal oversight 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.
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.
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.
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) 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 their 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.
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.
An individual who becomes a participant in research regulated by the Food and Drug Administration (FDA), either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient. In the case of research involving medical devices, a human subject includes an individual on whose specimen a medical device is used.
A biospecimen for which the identity of the subject is, or may readily be, ascertained by the investigator or associated with the biospecimen.
Private information for which the identity of the subject is, or may readily be, ascertained by the investigator or associated with the information.
Spouse, domestic partner, or child.
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 them 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.
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.
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 team) and participant. For example, interviews, observations, or physical measurements. Interactions may be in person, online, or by phone.
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.
Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the participants’ environment that are performed for research purposes.
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.
An Investigational Device Exemption (IDE) is a request for authorization from the FDA to use an investigational device in a clinical research study in order to collect safety and effectiveness data. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.
An Investigational New Drug Application (IND) is 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.
FDA granting of permission that a new drug, agent, or biologic may be used in humans prior to FDA review of clinical data that has determined that a particular product is safe and effective for a specific use. The FDA permission is evidenced by the assignment of an IND number by the FDA or the granting of an IND exemption.
Individual with both responsibilities of initiating and conducting a clinical trial.
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
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 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.
An individual, judicial, or other body authorized under applicable law to consent to research participation on behalf of a designated person.
Note: If there is no applicable state law addressing a legally authorized representative, this term is defined as a person acceptable for providing consent in the non-research context on behalf of the prospective participant's enrollment in research.
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 the court whose responsibilities for the personal affairs of their ward (an adult with impaired decision-making capacity) are limited only to those areas where the ward lacks capacity.
Note: Rhode Island's 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.
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 physical or psychological harm that is normally encountered in the daily lives or in the routine medical, dental, or psychological examination of healthy persons.
Note: The regulatory definition of “minimal risk” for research involving prisoners differs from the definition of minimal risk for research involving participants who are not prisoners.
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.
Any non-compliance that is not serious or continuing noncompliance. For example, minor noncompliance might include the following violations:
- missing an original signed and dated research consent form;
- missing pages executed research consent forms;
- inappropriate documentation of informed consent (e.g., missing one or more signatures or date);
- obtaining informed consent using an invalid/outdated research consent form that contains all of the information required by the IRB;
- failure to submit continuing review forms/documents prior to expiration of IRB approval;
- unplanned deviation from the approved protocol where the deviation does not impact the rights and welfare of subjects or the integrity of the research.
Minor Protocol Deviations are deviations from IRB-approved procedures that (i) do not cause harm and have no potential to cause harm to the research subject or others, and (ii) do not impact the integrity of research data. Minor protocol deviations include: over-enrollment of participants in a minimal risk study; follow-up visits occurring outside the protocol 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).
Noncompliance is defined broadly to include (i) a failure to comply with any federal, state, or local regulation that governs human subjects research; or (ii) a violation of any Brown University policy on human subjects research; or (iii) any unapproved deviation from an IRB / HRPP-approved protocol or stipulations imposed by the IRB / HRPP as a condition of approval, unless such deviation is necessary to preserve the life or health of a subject and the IRB / HRPP is notified following such deviation as soon as possible after the deviation occurs.
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.
The Office for Human Research Protections provides 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 providing clarification and guidance, developing education programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social / behavioral 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.
A child’s biological or adoptive mother or biological or adoptive father.
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 a parent(s) or legal guardian to the participation of his/her child or ward in research.
Refers to information that can be used to distinguish or trace an individual's identity, such as their name, social security number, biometric records, 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.
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.
Relationship in which one person has a role that is perceived to have or actually has more authority, agency, or knowledge over another.
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.
An individual (whether convicted felon or untried person) involuntarily confined or detained in a penal institution (e.g., prison, jail, or juvenile offender facility) with restricted ability to leave the institution encompassing:
- individuals sentenced to such an institution under a criminal or civil statute
- individuals detained in other facilities (including psychiatric units, hospitals, and drug treatment facilities) by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution
- individuals detained pending arraignment, trial, or sentencing. Probationers and individuals wearing monitoring devices are generally not considered to be prisoners.
Note: Consult with the HRPP when planning to work with this population, as your study may require an analysis of the population's particular circumstances.
Refers to a participant’s right to control who has access to them, their location, and their space. It is the recognition that a participant has the right to determine the extent, timing, and circumstances of sharing themselves (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 record, employee, or student records).
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.
Research utilizing human participants’ specimens/data that will be collected after the research is approved by the IRB.
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.
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.
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.
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Note: A systematic investigation is the use of a predetermined method (i.e. 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 or biospecimens (identifiable or anonymous) obtained through intervention or interaction with human subjects, or any identifiable private information or 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.
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.
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.
Noncompliance that (i) significantly increases risks, or significantly decreases potential benefits, to participants; (ii) adversely affects the rights, welfare and safety of participants; (iii) adversely affects the scientific integrity of a study; or (iv) is the result of a willful violation of any federal, state, or local regulation that governs human research, or (v) is a willful violation of any Brown University policy on human subjects research.
The individual authorized to represent and commit the entire institution and all of its components to a legally-binding agreement.
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:
- Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
- For use in supporting or sustaining human life and represents a potential for serious risk to the health safety, or welfare of a subject;
- For 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
- Otherwise presents a potential for serious risk to a subject.
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.
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 initiates (i.e., obtains an IND or IDE) and conducts an investigation and under whose immediate direction an investigational drug or device is administered, dispensed, or used.
Note: The regulatory requirements applicable to a sponsor-investigator include those applicable to both an investigator and a sponsor.
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 planned scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or answer a question.
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 (including a biological product) or medical device for human use, human food (including dietary supplements), food or color additive, infant formula, electronic product, or any other article subject to regulation by FDA.
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.
Any incident, experience, or outcome in the course of human 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.
An adverse event occurring in one or more participants in a research study, the nature, severity, or frequency of which is not considered consistent with either the known or foreseeable risk of adverse events 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 is not considered consistent the expected natural progression of any underlying disease, disorder, or condition of the participant(s) experiencing the adverse event and the participant’s predisposing risk factor profile for the adverse event.
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.
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.
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.
An allowance in the Federal Policy for the Protection of Human Research Subjects (45 CFR Part 46) for an IRB to waive the requirement for the investigator obtain a signed consent document from participants when specific conditions are met.
Association for the Accreditation of Human Research Protection Programs, Inc. - Brown University's HRPP/IRB is not AAHRPP accredited
Adverse Device Effect
Certificate of Confidentiality
Conflict of Interest
U.S. Department of Health and Human Services
Data Safety Monitoring Board or Committee
Data Safety Monitoring Plan
Data Use Agreement
Embryonic Stem Cell Research Oversight Committee
Food and Drug Administration
The Family Education Rights and Privacy Act
Good Clinical Practice
Health Insurance Portability and Accountability Act
Human Research Protection Program (formerly known as the Research Protection Office, or RPO)
Institutional Authorization Agreement
Institutional Biosafety Committee
Investigational Device Exception
Investigational New Drug
Institutional Review Board
Memorandum of Understanding
New Drug Application
National Institute of Health
National Science Foundation
Office for Human Research Protections (under DHHS)
Office of Research Integrity
Protected Health Information
Quality Assurance/Quality Improvement
Significant Financial Interest
Single Institutional Review Board
SMART IRB is an online reliance system used by Brown to facilitate sIRB review
Unexpected Adverse Event
Unanticipated Problem Involving Risk to Participants or Others