Baruch Human Research Protection Program
Baruch Human Research Protection Program (HRPP) Office
45 CFR 46.118
Applications and proposals lacking definite plans for involvement of human subjects. For example certain types of grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans (i.e. research plan, data collection instrument, etc.) are not developed yet. To allow investigators access to funding to begin aspects of the project that do not involve human subjects the IRB will provide documentation that human subjects research review is not required at this stage of the research. However, once the research plan and materials have been developed and the PI wishes to conduct human subjects research they will be required to submit an application to the IRB prior to beginning research activities.
An individual's involvement in a research project can be described as anonymous if it is impossible to know whether or not an individual participated in the study. For example, participation in an online survey that cannot be linked in any way to the individual would be considered anonymous. No one, including the researcher knows the identities of research participants. Some internet venues such Amazon Mechnical Turk, Survey Monkey, and SONA Systems collect and store identifying information regarding its users. The research participation for users of such systems can not be considered anonymous as these type of systems tracks the activities of its users.
A child’s affirmative agreement to participate in research. (See CUNY’s Children Policy)
Telling the subject upfront that only parts of the study can be revealed before participation or that some parts of the study will be deceptive. See "Suggested Language for Informed Consent Documents" for recommended deception language that should be included in consent documents.
An ethical principle that requires an obligation to protect research participants from harm. (See Belmont Report)
Is an alternative to traditional study-specific informed consent. Is a consent process in which research participants consent to have their identifiable data used and stored for research purposes. The types of studies the identifiable data and/or biospecimens will be used for must be described in the broad consent document.
Persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. (See CUNY’s Children Policy for details)
Monetary (gift cards, cash, checks, etc.) or non-monetary (gifts, research credits, extra course credits, etc.) payments given to subjects for their effort or to offset the time and inconvenience of research participation. Compensation is not considered a research benefit or incentive to participate in research activities. While federal regulations do not set limits on compensation, IRBs will take into consideration the amount of compensation, the time, and proposed method of disbursement, to ensure that they are reasonable, not coercive, and do not present any undue influence. The IRB will also determine whether or not the amount or types of research compensation meet Federal Regulations, CUNY Policies & Procedures, and Ethical Guidelines.
The Common Rule are the regulations that govern human subjects research. Effective January 19, 2018 the common rule will be revised.
A research condition in which no one except the researcher(s) knows the identities of the research participants. The treatment of information that a participant has disclosed to the researcher in a relationship of trust and with the expectation that it will not be revealed to others in ways that violate the original agreement, unless permission is granted by the participant.
Projects that require the review of the full or convened board. Types of projects that may require convened review are projects that have procedures that may pose greater than minimal risk to subjects or projects that are minimal risk but do not appear in any of the expedited review categories. Additionally the convened board may also review and take action on unanticipated problems, allegations of serious or continuing non-compliance, and subject complaints.
After running a study, explaining to a participant what happened and what the study is for, explaining any deception used in the study, asking for any remaining comments or concerns, and ensuring that the participant is left with no adverse consequences from the experience. This sometimes involves providing contact information for groups that can provide support regarding a difficult issue.
The intentional withholding of information from participants, or deception about the study’s purpose and exact nature, that is deemed necessary by the researcher in order to meet the study’s goals. Deception should only be used when the researcher feels that participant knowledge about the study would alter participants’ behavior or responses in the study. Deception should not cause any adverse consequences to the participants, and participants should be debriefed after running the study. IRB guidelines on the use of deception should be reviewed. A study that cannot justify the use of deception may not receive IRB approval.
Data are considered de-identified when any direct or indirect identifiers or codes linking the data to the individual subject’s identity are destroyed.
Protocols (whether medical or social) that hold out the prospect of direct benefit to the subjects individually though such a benefit can never be assured. Types of studies that can have direct benefits to subjects are studies to improve existing methods of biomedical or behavioral therapy, or to develop new educational or training methods. Research Compensation is not considered a direct benefit of research participation.
Engagement in Research
CUNY is considered engaged in a particular human subjects research project when CUNY employees or agents (i.e. faculty, staff, students, etc.) obtain, for the purposes of the research project, (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information.
Research that follows widely held guidelines about what is ethical, moral and responsible in research settings (e.g. not plagiarizing others’ work, not misreporting sources, not submitting questionable data, not destroying or concealing sources, etc.) and that considers its role in the broader community and the effect of its findings on the community.
Ethnography is the study of people and their cultures. Ethnographic research involves observation of and interactions with the people or group being studied in the group’s own environment, often for long periods of time. (see Field Research)
The federal regulation (45 CFR 46.101(b)) that exempts certain types of human subjects research from being reviewed by the IRB. Though these projects may meet exemption criteria, CUNY requires that exempt determinations be made by the campus HRPP Coordinator. See CUNY Exempt Review Policy for details.
The federal regulation (45 CFR 46.110) for human subjects research that requires IRB review. Note that expedited review in this context does not mean quick but is a federal review category designation for minimal risk projects that don't meet exemption criteria. See CUNY Expedited Review Policy for details.
Those characteristics that disqualify prospective subjects from inclusion in the study. Exclusion Criteria must be based on those factors that most effectively and soundly address the research problem and not on the potential subjects' easy availability.
Behavioral, social, or anthropological research involving the study of people or groups in their own environment and without manipulation for research purposes. Research conducted in natural, real-life settings, outside the laboratory. This involves observation and, in many cases, interactions with the people being studied. (see Ethnographic Research)
The intent of the research is to add information to your field of study; the results can be applied beyond the subject population to other settings. It doesn’t matter if the results will be published or not, if your research activity is designed with the aim of discovering information that can be applied in other settings, it can be considered research.
Greater than Minimal Risk
Research procedures that may include risks beyond that ordinarily encountered by subjects. Greater than minimal risk studies required Convened/Full Board Review.
Human Subjects or Participants
Individuals whose physiological or behavioral characteristics and responses are the object of study in a research project. Under federal regulations, human participants are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
The on-line program used by CUNY-Affiliated Researchers to submit new, continuing, and amended IRB Applications. For access to IDEATE click here.
Are biospecimens for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Identifiable Private Information
For information to be considered “identifiable private information” two criteria must be true. First, the information must be private, meaning it is either about behavior that occurs in a context where the individual reasonably expects no observation is taking place or the individual has provided the information for a specific purpose and reasonably expects the information will not be made public. Second, the information must be individually identifiable, meaning the identity of the person is or may be readily ascertained by the investigator or the identity of the person is or may readily be associated with the information.
Characteristics that the prospective subjects must have if they are to be included in the study. Inclusion Criteria must be based on those factors that most effectively and soundly address the research problem and not on the potential subjects' easy availability.
The principle that potential participants are given adequate and accurate information about a study before they are asked to agree to participate, and that they do in fact agree (consent) to participate. In giving informed consent, participants many not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
Includes communication or interpersonal contact between investigator and subject.
Includes both physical procedures by which data are gathered and manipulations of the participant or the participant's environment that are performed for research purposes. Intervention includes communication or interpersonal contact between investigator and participant.
An ethical principle that requires fairness in the distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly. (See Belmont Report)
Includes activities focused on the collection, verification, and reporting of information or facts on current events, trends, newsworthy issues or stories about people or events, with no intent to develop or test a hypothesis. In revised Common Rule this type of research activitity has been deemed not to be research.
Key personnel are defined as the Principal Investigator, co-investigators and research personnel who interact directly with human subjects or who have access to private information related to human subjects during the course of a research project. Key personnel also include faculty sponsors/advisors who provide direct oversight of research with human subjects or research using private information about human subjects.
A brief summary of a research project that is used to explain complex ideas and technical and scientific terms to people who do not have prior knowledge about the subject matter.
Limited IRB Review
Under the new revised Common Rule, Exempt Categories 2, 3,7 & 8 now include a provision for Limited IRB Review. Limited IRB Review must be performed by the IRB using expedited review procedures. Limited IRB Review is limited in scope and the review criteria differs based on the specific exemption category. For example Limited IRB Review for Exempt Categories 2 & 3 would only occur if research is obtaining sensitive and identifiable information. Limited IRB Review for categories 2 & 3 would consist of ensuring that privacy and confidentiality procedures are sufficient. Limited IRB Review is always required for Exempt Categories 7 & 8 and requires that broad consent be obtained in accordance with 45 CFR 46.116 and appropriately documented. Additionally identifiable private information must be adequately stored and maintained .
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are 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.
Oral history is a recorded conversation about the past with named individuals in which knowledge about specific events or the experiences of individuals is discussed. Biographical in nature and historical in scope, the scholarly oral history interview is rooted in particular recollections about history based on the individual perspective of the narrator. There is no intent to draw conclusions or generalize findings as defined by HHS regulations 45 CFR 46. For additional information regarding Oral History see FAQ's. In revised Common Rule this type of research activitity has been deemed not to be research.
A child’s biological or adoptive parent or court-ordered person responsible for child or ward. Unless consent is waived/altered parental permission/agreement of 1 or both parent(s) or guardian(s) are required for the participation of their child or ward in research.
Principal Investigator (Protocol)
The scientist or scholar with primary responsibility for the design and conduct of a research project.
A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.
CUNY defines a researcher as anyone who serves as either the PI or co-investigator, ii) interacts directly with research subjects for research purposes; or iii) has access to identifiable private information about the human subjects for research purposes.
Respect for Persons
An ethical principle requiring that individual autonomy be respected and that persons with diminished autonomy be protected. (See Belmont Report)
Restricted Use or Limited Data Set
Files that have restrictions imposed regarding their use in research and contain data fields such as social security numbers, names, protected health information or other life history markers that might enable an unauthorized user to identify a participant.
Retrospective Data Review
The collection and review of data from past records (i.e. records already in existence prior to IRB submission) with no follow up procedures with patients/participants. Some examples of the data used in such reviews are electronic databases, medical records, and census data.
A detailed plan for a scientific experiment that explains the scientific procedures or protocols that will be followed.
Secondary Data Set
Data that can be used in research and comes from public or private documents, including medical records, police reports, vital statistic records, student records.
This type of research benefit refers to the benefit to society at large. For most social behavioral studies, the research benefit being referred to is how the study results will add to the researcher's field of study, professional organization, or institution where the research is being conducted.
Procedures normally conducted prior to main study to assess whether prospective subjects are appropriate candidates for inclusion in studies. Screening can be done in various ways (by phone, internet, medical records review, etc.). Screening procedures for research eligibility are considered part of the subject selection and recrutiment process and therefore requires IRB oversight.
When a study treatment or intervention has some sort of therapy benefit to subjects. Therapeutic Benefit refers mainly to medical/scientific studies.
The principle that study participants choose to participate of their own free will, rather than being coerced or forced to participate. For IRB purposes, this is a key part of your study proposal; you must demonstrate that participants will be participating voluntarily for a study to be approved by the IRB.