Tutorial: Glossary

Approved

Approved means “formal, written approval from the UCAIHS for proposed work.”

Assent

Verbal agreement by an individual not regarded as able to give legally valid written informed consent (e.g., a minor under age 12) to participate in research.

Assurance

The formal, written, binding commitment that is negotiated with the Federal Government in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.

Belmont Report

A statement of the basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.

Beneficence

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: 1) do not harm; and 2) protect from harm by maximizing possible benefits and minimizing risk.

Coercion

Coercion is defined as pressure, or undue enticement or influence. In research involving human subjects, the principle of voluntariness is a cornerstone of the informed consent process. This means that consent should be obtained without exercising coercion. Examples of coercive situations include an investigator using his or her own patients or students as subjects, or an employer acting as a subject recruitment agent for an investigator from among its own employees. It could also include such things as excessive monetary compensation, a promise of special consideration for participation or withholding of services that would otherwise be available.

Covered entity

The Privacy Rule under HIPAA defines a covered entity as the following: a health plan, health care clearinghouse, or health care provider that transmits any health information in electronic form in connection with any of the HIPAA standard transactions, which include billing and claims verification.

Deception

Deception is the deliberate withholding of information from the subject by the researcher in order to achieve the scientific goals of the study. Deception is not permitted in studies with more than minimal risk. A debriefing for subjects is required for all studies involving deception and must include an explanation of what the deception was and why it was scientifically necessary.

Exempt Status

Certain categories of research deemed very low risk under Federal regulations may be granted Exempt Status once the appropriate review has been conducted by the UCAIHS.

If Exempt Status is granted, the study will no longer be under continuing review by the UCAIHS, unless procedures are revised which deviate from those originally reviewed by the UCAIHS.

Only the UCAIHS may grant Exempt Status and thus all requests for such status must be reviewed by the UCAIHS.

Full Review

Full review refers to projects which are reviewed by the full UCAIHS in a convened meeting. All Applications which are not granted Exempt Status must receive full review.

Generalizable knowledge

Generalizable knowledge means that the information derived from the activity will be applicable to similar studies.

Guardian

An individual who is authorized under applicable state or local law to make decisions on behalf of an individual.

HIPPA

The Health Insurance Portability and Accountability Act (HIPAA) is the Federal legislation that authorized the Secretary of the Department of Health and Human Services to write the medical privacy regulations known as the “Privacy Rule.” The Privacy Rule governs all uses and disclosures of Protected Health Information (PHI) by persons and entities subject to these regulations.

Human subject

A human subject is a living individual about whom an investigator obtains either:

  • data through intervention with the individual
  • identifiable private information.

Data pertaining to the person may be obtained by:

  • Interaction — talking with someone or eliciting information through a questionnaire, interview, or focus group
  • Intervention — drawing a blood sample or taking a DNA swab
  • Records review — collecting or renewing information from medical, school, or other records.

Human subjects research

Human subjects research means any activity intended to obtain and record information from or about individuals for research purposes. Examples of human subjects research include:

  • Questionnaires
  • In person and telephone surveys
  • Educational tests
  • Observation of public or private behavior, including classroom observation
  • Interviews and focus groups
  • Evaluation and research components of demonstration and training programs
  • Collectiion or study of existing data (for example, medical, school, or other records).

Informed consent

Informed consent is a person’s voluntary agreement, based upon adequate knowledge and understanding of the relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. The informed consent process ensures the voluntary nature of a subject’s participation and reflects respect for people and individual autonomy fundamental to the protection of human subjects.

Institutional Review Board (IRB)

An Institutional Review Board (IRB), in accordance with federal regulations, is the specially constituted committee established by an organization to protect the welfare of the human subjects recruited to participate in research. Two IRBs have been established by New York University's Washington Square campus in accordance with these regulations. These boards review all proposed research with human subjects to ensure that the subjects’ rights and welfare are adequately protected.

Known as the University Committee on Activities Involving Human Subjects (UCAIHS), New York University’s IRBs are composed primarily of faculty members from disciplines in which research involving human subjects is integral to the discipline’s work (for example, psychology, sociology, anthropology, education, nursing, social work, dentistry).

Investigator (Principal Investigator)

The scientist or scholar with primary responsibility for the design and conduct of a research project.

Justice

An ethical principal discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances similarly.

Legally Authorized Representative

A person authorized by either by statute or by court appointment to make decisions on behalf of another person.

Minimal risk

Minimal risk is the probability and magnitude of physical or psychological harm that is no greater than that normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy people.

Minor

Persons who have not attained the legal age for consent to participate in research, as determined under the applicable law of the jurisdiction in which the research will be carried out. In New York State, and as standardly used by the UCAIHS, a minor is defined as a person under 18 years of age. Special protections are in place to protect minors involved in research activities.

Nuremberg Code

A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950’s and 1960s for protecting human subjects.

Office of Sponsored Programs (OSP)

The Office of Sponsored Programs (OSP) administers the human subjects review process on behalf of the University Committee for Activities Involving Human Subjects for all university divisions, except the School of Medicine.

Privacy Rule

The Privacy Rule governs all uses and disclosures of Protected Health Information (PHI) by persons and entities subject to these regulations. The Department of Health and Human Services Secretary was authorized by the Federal regulation, the Health Insurance Portability and Accountability Act (HIPAA), to write the Federal medical privacy regulations known as the Privacy Rule.

Protected Health Information (PHI)

All uses and disclosures of Protected Health Information (PHI) by persons and entities governed by HIPPA (the Health Insurance Portability and Accountability Act) (HIPAA) are protected by the Privacy Rule, the Federal medical privacy regulations written by the Department of Health and Human Services Secretary.

Protected population

A protected population is a group of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons for whom special consideration needs to be given. The Federal government has specific regulations on research involving protected populations.

Protocol

The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and/or to an agency for research support.

Research

Research means a systematic investigation designed to produce generalizable knowledge.

Respect for Persons

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

Risk

Risk is the possibility of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study.

Secondary Data

Secondary data is information that was collected in the course of another study or is part of a publically available set of data.

Investigators wishing to use secondary data not publically available must have authorization from the owner of that data, usually the Principal Investigator of the original study, to make use of the data. Should the data include Protected Health Information, the investigator may also need a HIPAA authorization or other HIPAA approval since the HIPAA Privacy Act does not allow for the secondary use of data in the same manner as does the Common Rule.

Standard Educational Practice

Standard Educational Practices are normal educational practices in commonly accepted educational settings. Many research activities involving standard educational practices may be granted Exempt Status. Activities that are introduced for the purposes of the study do not constitute normal educational practice.

Surveys

Studies designed to obtain information from a number of respondents through written questionnaires, telephone or in-person interviews, door to door solicitation, or similar procedures.

Systematic investigation

A systematic investigation means that the research information is designed so that conclusions may be drawn and others can review these conclusions.

Therapy

Treatment intended to alleviate a disease or disorder.

University Committee on Activities Involving Human Subjects (UCAIHS or the Committee)

University Committee on Activities Involving Human Subjects (UCAIHS or the Committee) is the University’s 2 federally authorized Institutional Review Boards whose responsibility it is to protect the rights and welfare of human subjects in research.

The Committee’s membership, policies, and procedures, including the decision making process, are governed by the Federal Wide Assurance. Each IRB meets monthly (except in August) and is chaired by a senior faculty member. No research involving human subjects may be initiated without prior review and approval by the UCAIHS.

Voluntary

Free of coercion, duress, or undue inducement or influence. Used in the research context to refer to a subject’s uncoerced decision to participate or to continue to participate in a research activity.

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Take the Certification Exam!
  • Glossary
  • References