Appendix H Definitions Provided by The Common Rule, the IRB Guidebook (OHRP, 2001), the previous editions of this policy (1996, 1999), or were created for this edition. The definitions are divided into five categories: Human Subject Research and Research Activities, Researchers and Officials, Research Subjects, Review Process and Considerations, and Policies. 1. Human Subject Research and Research Activities Research: A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Common Rule, 46 CFR 45.102(d)]. Human Subject Research: In clinical or educational institutions, the boundary between research and experimental and innovative care and teaching is a complex and controversial issue. However, for the purposes of this policy, human research is any activity which has the intent of securing information from humans for the purpose of advancing generalizable knowledge. Such activity may or may not differ from customary professional or medical practice [Common Rule, 46 CFR 45.102(f)]. Classroom-based Research: Demonstrations, exercises, and/or experiments designed for the exclusive purpose of student education, e.g. teaching, interviewing by having students interview each other and derive Afindings@, with no intent to generate data whose main purpose is the advancement and dissemination of generalizable knowledge beyond the classroom setting is not considered a research activity. However, some research conducted by students for course assignments may constitute human subject research when it exceeds the bounds of the classroom and includes significant contact with subjects outside the confines of the classroom. [WPU-IRB Policy, 1996.] Research Activities: The activities or procedures involved in research may be invasive or noninvasive and include placing subjects in various therapeutic or research situations; removal of body tissues or fluids; administration or application of chemical substances or forms of energy; modification of diet, daily routine or service delivery; alteration of environment; observation; administration of questionnaires or tests; interviews; randomization of subjects; review of records, or surgical interventions. [Guidebook, 2001.] Intervention: Physical procedures by which data are gathered (for example, venipuncture) or manipulations of the subject or subject's environment are performed for research purposes. [WPU-IRB Policy, 1996.] Interaction: Communication or interpersonal contact between investigator and subject. [WPU-IRB Policy, 1996.] Surveys: Studies designed to obtain information from a large number of respondents through written questionnaires, in-person interviews, telephone interviews, door-to-door canvassing, or similar procedures. [Guidebook, 2001.] Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk." [Guidebook, 2001.] Minimal Risk: 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 [Common Rule, 46 CFR 45.102(i)]. Examples: The risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. [Guidebook, 2001.] The risk of asking questions concerning a persons life history or experience purposes no greater risk than having a conversation on the same topic. Adverse Effect: An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). [Guidebook, 2001.] 2. Researchers and Officials Principal Investigator: The scientist or scholar with primary responsibility for the design and conduct of a research project. [Guidebook, 2001.] Investigator or Researcher: An individual who actually conducts an investigation or study [21 CFR 312.3;. Guidebook, 2001.] Research Project Staff: Other project staff involved in the conduct of a research project. Unlike an Investigator or the Principal Investigator, project staff have little direct contact with subjects but may have extensive contact with the data generated through the research. [Guidebook, 2001.] Legally Authorized Representative: A person authorized either by statute or by court appointment to make decisions on behalf of another person; a guardian. In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research [Common Rule, 46 CFR 45.102(c)]. Authorized Institutional Official or Responsible Institutional Official: An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research. [Guidebook, 2001.] Institutional Review Board or IRB: A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research [Common Rule, 46 CFR 45.102(g), ___.108, ___.109]. IRB Chair: The person elected by the IRB Committee to work with the Authorized Institutional Official and the IRB Administrator to achieve the effective implementation of IRB-related policies and regulations. IRB Administrator: An official of an institution with the responsibility to (a) insure the effective implementation of IRB-related policies and regulations, (b) support the activities of the Authorized Institutional Official, the IRB Committee and the IRB Chair, (c) maintain well organized and accessible records on IRB Committee activities and meetings, reviewed protocols, and related information, and (d) distribute information to the local community to improve and ensure compliance with all appropriate policies and regulations. 3. Research Subjects Human Subjects: Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects 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 [Common Rule, 46 CFR 45.102(f)]. Classes of Subjects Normal Volunteers: Volunteer subjects used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with subjects who do have the condition. "Normal" may not mean normal in all respects. Example, patients with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism and patients with heart disease but without diabetes may be "normal" for a study of diabetes complicated by heart disease. [Guidebook, 2001.] Patient: A sick individual, especially when awaiting or under the care and treatment of a health care professional, a hospital, clinic, nursing home or other medical facility, or a client of a health care professional, hospital, clinic or health care provider, or a resident of hospital, nursing home or other medical facility. See also Cognitively Impaired Person. [Guidebook, 2001.] Cognitively Impaired Person: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or 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 interests. [Guidebook, 2001.] Institutionalized Cognitively Impaired: Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded). [Guidebook, 2001.] Elderly/Aged Person: An individual who is at least 65 years old. [Guidebook, 2001.] Minority: An individual of African, Asian, Hispanic, Native American or other ancestry as designed by William Paterson University, other cognizant agencies, or a prospective funding agency. Students: Individuals who are enrolled in an educational institution, including William Paterson University, regardless of their age, course of study, level of enrollment (e.g: full or part time) or other factor. Employees: An individual paid by a company or entity for work they do on behalf of that company or entity, including William Paterson University, and regardless of their age, work assignment, level of employment (e.g: full or part time) or other factor. For the purposes of this policy, includes consultants. Federally identified AVulnerable Populations.@ Fetus: The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. [Guidebook, 2001.] A Dead Fetus is an expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached) [45 CFR 46.203(f)]. Fetal Material or Tissue: The placenta, amniotic fluid, fetal membranes, and umbilical cord [Guidebook, 2001.] A Nonviable Fetus is an expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Neonate: Neonate means a newborn [45 CFR 46.102(d)]. A nonviable neonate means a neonate after delivery that, although living, is not viable [45 CFR 46.102(e)]. A Viable Infant is a delivered or expelled fetus, the term "viable infant" means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy [45 CFR 46.202(d)]. Woman: An individual who, as it pertains to The Common Rule=s concerns for fetuses and neonates, bears young or produces eggs as distinguished from one that produces sperm. Pregnancy: For women, the period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. This "confirmation" may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary. [Guidebook, 2001.] Children: Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)]. The age of consent or majority in New Jersey is 16. Mature Minor: Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. [Guidebook, 2001.] Prisoner: An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)]. 4. Review Process and Considerations Assent: Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. [Guidebook, 2001.] Assurance: A formal written, binding commitment that is submitted to a federal agency 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 [Common Rule, 46 CFR 45.103]. Confidentiality: Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. [Guidebook, 2001.] Consent, See: Informed Consent. Informed Consent: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may 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 [Federal Policy 116; 21 CFR 50.20 and 50.25]. Permission: The agreement of parent(s) or legally authorized representative(s) (i.e.: guardian) to the participation of their child or ward in research [45 CFR 46.402(c)]. Private information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects (i.e., the identity of the subject or his or her membership in an identifiable group that may be isolated by the information collected may readily be ascertained by the investigator, the subject or other individuals). [WPU-IRB Policy, 1996.] Protocol: The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. The protocol may include therapeutic or other activities intended to benefit the subjects and procedures, as well as procedures to evaluate such activities. [Guidebook, 2001.] Review (of Research): The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis [Common Rule, 46 CFR 45.108(e)]. Voluntary: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity. [Guidebook, 2001.] Types of Reviews Initial Review: The first time an Institutional Review Board reviews and takes an action on a research protocol. The initial review period continues until the protocol is approved. The three types of initial reviews include Exempted Review (the review of certain kinds of research involving no risk and for minor changes in approved research [Common Rule, 46 CFR 45.110]), Expedited Review (the review of certain kinds of research involving no more than minimal risk and for minor changes in approved research [Common Rule, 46 CFR 45.110]), and Full Board Review (the review of all research that is not otherwise exempted or expedited [Common Rule, 46 CFR 45.108]). Continuing Review: All reviews subsequent to a protocol=s approval. Includes the the reevaluation of research projects at intervals appropriate to the degree of risk but not less than once a year [Common Rule, 46 CFR 45.108(e)], substantive changes to the approved protocol, the reporting of adverse reactions or unanticipated findings [Guidebook, 2001], and the termination of the study. Student Protocol Review: The review of proposed research by a WPU undergraduate or graduate student that includes one of four key factors (the study involves a vulnerable population, collection of sensitive information, poses more than minimal physical or psychological risk to subject or student investigator, or collects identifying information on subjects) or is required by the academic department or instructor for completion of the course.[WPU-IRB Policy, 1999 revision.] 5. Policies The Nuremburg Code: A code of conduct concerning the use of human subjects in research that resulted from the war crime trials following World War II. The Declaration of Helsinki: Published by the World Medical Association defines how the principals of AThe health of a patient is a doctor=s first consideration@ are applied to research involving human subjects. The Belmont Report: A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. [Guidebook, 2001.] The three guiding principals defined in the Belmont Report are: 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 possible risks of harm. JUSTICE 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. RESPECT FOR PERSONS An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected. The Common Rule or 45 CFR Part 46, the Federal Regulations that govern research conducted in the United States that is funded or supported through the Department of Health & Human Services and 17 other Federal Agencies and Departments. 21 CFR Part 50: Regulations governing research involving human subjects funded, supported or applying to the Food and Drug Administration. Very similar to The Common Rule but differing in several important ways concerning clinical trials and the introduction of new drugs and devices.