Institutional Animal Care and Use Committee (IACUC)

Alternate Member: An individual who acts on behalf of a regular voting IACUC member in a member’s absence.  Each alternate member will have expertise similar to the regular voting member they are replacing.  An alternate member will only vote when a regular voting member is absent.
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 laboratory research animals and stipulates the procedures through which compliance will be achieved.
Authorized 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 laboratory animal research.  This person must have authority to commit funding for such research.
Conflict of Interest: An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s immediate family have any of the following:

• Involvement in the design, conduct, or reporting of the research.
• Ownership interest, stock options, or other ownership interest related to the research of any value exclusive of interests in publicly-traded, diversified mutual funds.
• Compensation related to the research of any amount in the past year or of any amount expected in the next year, including compensation for costs directly related to conducting research.
• Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.
• Any other reason for which the individual believes that he or she cannot be independent.

Continuing Non-Compliance:  A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance.
Designated Member Review: Designated member review is utilized only after all IACUC members have been provided the opportunity to call for full-committee review of a submitted study. If any member requests full committee review then that method must be used. If not, the IACUC Chairperson may appoint one or more appropriately qualified IACUC members to serve as the designated reviewer(s). Designated review may result in approval, a requirement for modifications (to secure approval), or referral to the full committee for review. Designated review may not result in withholding of approval. If a protocol is assigned more than one designated reviewer, the reviewers must be unanimous in any decision. They must all review identical versions of the protocol and if modifications are requested by any one of the reviewers then the other reviewers must be aware of and agree to the modifications. 
The specific method of review for a given protocol is documented, along with the outcome of the review.
Ex Officio/Administrative Representative: An individual who receives information, attends meetings, and participates in discussions due to their position with the university.  These individuals are non-voting and do not count toward quorum.
Expiration Date: The first date that the protocol is no longer approved i.e., the date after the end date of the approval period.
IACUC Protocol Application: The document required for all research wherein laboratory animals are purchased; housed; and/or manipulated using Rice funding or facilities.  It provides the scientific plan and purpose of the research study and addresses the 3Rs of animal research.
Modifications Required to Secure Approval:  The IACUC and/or designated reviewers require modifications to the protocol being reviewed in order to grant approval. The researcher creates a new Project Package in IRBNet to address any required modifications.
Office of Laboratory Animal Welfare (OLAW): Federal oversight agency that provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.
Principal Investigator (PI): An individual who is ultimately responsible for the design, conduct, and reporting of a project utilizing laboratory animals. Each project must have a Principal Investigator. The PI is responsible for everything that takes place in a study. A PI must be a tenured or tenure-track faculty member.  Otherwise, approval to serve as a PI must be requested from the Office of the Vice Provost for Research.
Protocol Deviation: Any departure from the approved protocol whether intentional or unintentional. Some examples include unapproved personnel manipulating animals, unapproved method of euthanasia/anesthesia/analgesia utilized; unapproved breeding; monitoring of animal’s condition not done as required in the approved protocol; housing animals in unapproved location; administration of unapproved substance
Quorum: A majority of committee members (50% plus one).
Semiannual Continuing Review: Review of animal research protocols at six-month intervals for a period not to exceed three years at which time a new application is required.
Sponsor: The organization that oversees and pay for the study or provides in-kind support.
Suspended: An action to permanently withdraw committee approval of all research procedures short of a termination of committee approval. Suspended studies remain open and are subject to continuing review.
Three Rs: Replace/Reduce/Refine i.e., researchers should make every effort to replace the animal model with another model wherever possible; if an animal model is deemed absolutely necessary to conduct the research, the number of animals should be reduced to the lowest possible number without compromising the scientific value of the research; and lastly, procedures should be refined to assure the least amount of pain, discomfort, distress, or morbidity to the research animal.

Institutional Biosafety Committee (IBC)

Alternate Member: An individual who acts on behalf of a regular voting IBC member in a member’s absence.  Each alternate member will have expertise similar to the regular voting member they are replacing.  An alternate member will only vote when a regular voting member is absent.
Appeal of an IBC Decision: If an investigator wishes to appeal a decision of the IBC, the appeal must be made in writing and submitted to the Compliance Administrator.  The appeal will be considered at the next meeting of the IBC.
Approved: If the study is approved, the Compliance Administrator will notify the PI and provide an electronic copy of the approved registration.
Approval Contingent: The IBC may approve a study contingent upon minor and specific changes or modifications being made to the registration form.  Once the appropriate changes have been made, the investigator must forward the documents to the Compliance Administrator who will forward them to the Chair for approval.  Once approval is given, the Compliance Administrator will provide electronic approval and an electronic copy of the registration.
Approval Deferred:  If the IBC requires additional information to make an appropriate decision regarding the study, the Compliance Administrator will so inform the investigator identifying the specific documentation required.  This documentation, along with the initial submittal, will be reviewed at the next meeting of the IBC following receipt of such documents or designated reviewers may be assigned to review and approve the revisions. The investigator may be invited to present the additional information to the IBC in person.
Authorized 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 laboratory safety for the use of recombinant DNA.
Biosafety Level (BL): A description of the degree of physical containment being employed to confine organisms containing recombinant DNA molecules and to reduce the potential for exposure of laboratory workers, persons outside of the laboratory, and the environment.  In Appendix G of the NIH Guidelines, these are graded from BL1 (the least stringent) to BL4 (the most stringent).
Biological Safety Officer (BSO): An individual appointed by an institution to oversee management of biosafety risks.
Conflict of Interest: An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s immediate family have any of the following:

• Involvement in the design, conduct, or reporting of the research.
• Ownership interest, stock options, or other ownership interest related to the research of any value exclusive of interests in publicly-traded, diversified mutual funds.
• Compensation related to the research of any amount in the past year or of any amount expected in the next year, including compensation for costs directly related to conducting research.
• Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.
• Any other reason for which the individual believes that he or she cannot be independent.

Continuing Non-Compliance:  A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance.
Continuing IBC Review: For all approved research, including that granted exempt status, a review is required at least once per year.
Declaration of Refusal: A safe and effective vaccine is available for protection from Hepatitis B.  While Rice University strongly encourages employees to be vaccinated, accepting vaccination is not a condition of employment.  If the employee choose not to be vaccinated, the Declaration of Refusal form must be submitted
Disapproved: If a research study is disapproved by the IBC, a written statement including the reason(s) for the disapproval shall be sent to the investigator.  The investigator will be given an opportunity to respond to this statement.  His/her response may be given either in person or in writing.
Ex Officio/Administrative Representative: An individual who receives information, attends meetings, and participates in discussions due to their position with the university.  These individuals are non-voting and do not count toward quorum.
Exempt from further IBC Review: Certain categories of research are exempt from the NIH Guidelines, as provided in Section III-F.  However, the IBC Chair makes such determination or a member designated by the IBC Chair, not the researcher. Exempt registrations for new or renewing studies or modifications to existing approved studies may be reviewed and approved by the Chair or his/her designate and reported to the Committee.
Expedited Review: Minor changes i.e., anything other than changes to the approved host/vector systems or a change in principal investigator, may be approved by the Chair or his/her designate and reported to the IBC.
Expiration Date: The first date that the protocol is no longer approved i.e., the date after the end date of the approval period.
NIH Guidelines: Registration reviews are conducted in accordance with the provisions of the NIH Guidelines for Research Involving Recombinant DNA.  The NIH Guidelines are available at the website of the Office of Biotechnology Activities: http://www4.od.nih.gov/oba, and apply to all recombinant DNA research performed at Rice University, regardless of the funding source.
Office of Biotechnology Activities (OBA): The NIH office responsible for developing, implementing, and monitoring NIH policies and procedures for the safe conduct of recombinant DNA activities, including human gene transfer.
Recombinant DNA:  In accordance with the NIH Guidelines, Section 1-B, recombinant DNA molecules are defined as either: “(i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.”
Risk Group 1 (RG1):  Classification for agents that are not associated with disease in healthy adult humans.
Risk Group 2 (RG2):  Classification for agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
Risk Group 3 (RG3):  Classification for agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk, but low community risk).
Risk Group 4 (RG4):  Classification for agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk).
SOP: Standard Operation Procedures of the IBC.

Institutional Review Board (IRB)

Adverse Event: Any untoward occurrence in a research participant. Complications or drug side effects that may occur during the research study. The occurrence need not have a clear causal relationship with the individual’s participation in the research. An anticipated adverse event is known to occur from past experience with the treatment. An unanticipated adverse event is an unexpected complication and should be reported to the committee as soon as possible after it is identified. These events may or may not be related to your participation in the research study, and will be closely monitored and recorded by the Principal Investigator.
Allegation of Non-Compliance: An unproved assertion of Non-Compliance.
Alternate Member: An individual who acts on behalf of a regular voting IRB member in a member’s absence.  Each alternate member will have expertise similar to the regular voting member they are replacing.  An alternate member will only vote when a regular voting member is absent.
Anonymous Data: Information that was previously recorded without any HIPAA identifiers and no code and key that would allow identification of individual subjects.
Assent: agreement by an individual not competent to give legally valid informed consent to participate in research Assent is obtained from children older than 7 years of age (where possible) and permission is obtained from the child’s parent(s) or legal guardian(s), together they comprise the informed consent to participate.
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.
Authorized 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.
Benefit: A valued or desired outcome; an advantage.
Bias: Factors, such as human choice or opinion, that may affect the results of the study when, in reality, these factors are not related to the treatment under study.
Blinded: An approach to avoid bias, when a researcher and/or study participant is not aware of whether the study participant is on the drug being studied or a placebo.
Certificate of Confidentiality: a certificate issued by the National Institutes of Health that protects identifiable research information of a sensitive nature from forced disclosure. It is typically requested when the researcher believes his/her research objectives could not be met without this form of protection. For additional information, please see the NIH Certificates of Confidentiality website.
Children: Persons who have not attained the legal age for consent to research; individuals under the age of 18 in Texas are considered children for most research situations.
Clinical Research: Medical research that may involve patients and sometimes healthy volunteers. These research studies are designed to uncover better ways to treat, prevent, diagnose, and understand human disease. Sometimes they help patients feel or get better but sometimes they don’t. In rare cases, the studies can make patients worse.
Clinical Trial: A biomedical or behavioral research study of human subjects designed to answer specific questions about diagnostic procedures or therapeutic interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new diagnostic procedures or therapeutic interventions are safe, efficacious, and effective.
Coded information/data/specimens: Information that has been de-identified but given a code.  A key exists that would allow deciphering of this coded data and identifying the private information or specimens.
Coercion: The act of forcing or compelling one to take action against one’s will. Coercion can be overt or perceived, and it can occur when the researcher is in a position of authority or power over the subject (for example, teachers over students or physicians over patients). It can also occur when incentives become so great that the participant will only participate to attain the incentive.
Cognitively Impaired: 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.
Compensation: Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
Competence: A legal term, 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.
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.
Conflict of Interest: An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s Immediate Family have any of the following:

• Involvement in the design, conduct, or reporting of the research.
• Ownership interest, stock options, or other ownership interest Related to the Research of any value exclusive of interests in publicly-traded, diversified mutual funds.
• Compensation Related to the Research of any amount in the past year or of any amount expected in the next year, including compensation for costs directly related to conducting research.
• Proprietary interest Related to the Research including, but not limited to, a patent, trademark, copyright or licensing agreement.
• Any other reason for which the individual believes that he or she cannot be independent.

In addition to complying with university policies and procedures related to human subjects, investigators with conflicting interests may need to comply with university policies.
Consultant: A non-IRB member who, at the request of the IRB, provides advice or serves as an ad hoc reviewer of  IRB applications. Consultants may have access to all project related documents and participate in IRB discussions but may not vote and are not counted towards quorum.
Continuing Non-Compliance:  A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance.
Continuing Review:  Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year.
Control (Subjects) or Controls: Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.
Debriefing: Giving subjects previously undisclosed information about the research project following completion of their participation in research.
De-Identified Data: Data that has been stripped of all identifiers, as defined by HIPPA, so that information may not be traced back to an individual.
Descriptive Study: Any study that is not truly experimental (e.g., quasi-experimental studies, correlational, studies, record reviews, case histories, and observational studies).
Designated Reviewer: The IRB chair or an Experienced IRB Member designated by the IRB chair to conduct Non-Committee Reviews.
Deviation: Any departure from the IRB approved study design and procedures, forms, or other approved materials.  Protocol deviations must be reported to the Office of Research Integrity & Assurance within 10 business days of occurrence or identification using the amendment form.
Emancipated Minor: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation.
Equitable: Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
Engagement: Rice University is considered engaged in research when its employees or agents, for the purposes of non-exempt research project obtain (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; or (4) when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor.
Ex Officio/Administrative Representative: An individual who receives all IRB information, attends meetings, and participates in discussions due to their position with the university.  These individuals are non-voting and do not count toward quorum.
Exempt Review: GMU has identified several categories of research available for exempt review. This determination must not be made by the PI, but by the IRB or someone appointed by the IRB.
Expedited Review: 45 CFR 46.110 and 21 CFR 56.110 identifies several categories of minimal risk research that may be reviewed through an expedited review process. For more information, please see OHRP’s “Categories of Research that may be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure.”
Experienced IRB Member: An IRB member is considered experienced if the IRB chair considers the IRB member to have sufficient experience in and knowledge of conducting IRB reviews.
Expiration Date: The first date that the protocol is no longer approved. The date after the end date of the approval period.
Family Educational Rights and Privacy Act (FERPA): This act defines the rights of students and parents concerning reviewing, amending, and disclosing educational records and requires written permission to disclose personally identifiable information from a student’s education record, except under certain circumstances such as an order of subpoena.
Federalwide Assurance (FWA): A formal written, binding assurance filed with and accepted by the federal Department of Health and Human Services committing Rice University to compliance with 45 CFR 46.
Finding of Non-Compliance: Non-Compliance in fact.
Full Board Review: Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. Generally, studies that undergo full board review are studies involving greater than minimal risk, risky, novel procedures, or vulnerable populations.
Generalizable Knowledge: Information obtained from research that can be applied outside of the population involved in the research (i.e.) Findings are analyzed and disseminated in a way so that findings may be presented as new or beneficial to groups outside of the original research study.)
Guardian: An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.
Health Insurance Portability and Accountability Act (HIPAA): The rule which protects the privacy of individually identifiable health information. The privacy rule provides federal protections for personal health information held by covered entities and gives patients specific rights with respect to that information.
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.
Human Subject Research: Any activity that either:
Is Research as Defined by DHHS and involves Human Subjects as Defined by DHHS; or
Is Research as Defined by FDA and involves Human Subjects as Defined by FDA.
Identifiable Information: Information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) including: name, birth date, Social Security number, address, telephone number, email address, computer ID, and others.
Immediate Family: Spouse, domestic partner; and dependent children.
Incapacity: 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. Often used as a synonym for incompetence.
Incentive: A small gift provided to research subjects to reimburse for costs realized by the subject (e.g. Parking fees) and/or thank them for their time.
Incompetence: A legal term meaning inability to manage one’s own affairs, and often used as a synonym for incapacity.
Inclusion/Exclusion Criteria: The predetermined criteria that are used to select the correct participants for the study. These include the presence or absence of certain conditions, medications, or physical characteristics. Individually Identifiable Information: Any information collected from an individual (including demographics) that there is a reasonable basis to believe could lead to identification of the individual.
Informed Consent: An individual’s voluntary agreement, based on adequate knowledge and understanding of relevant information, to participate in research. 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.
Informed Consent Form (ICF): The form participants sign to agree to be in the study. The ICF includes details about the study, such as its purpose, duration, required procedures, risk, benefits, and who to contact for further information. Sometimes, a signature is not needed, but participants may still keep a copy of the ICF. In these cases it may be called an Information Sheet instead, but the contents are the same. The ICF is not a contract. Participants do not give up any legal rights by signing an ICF. Participants are free to withdraw at any time.
Institutional Official: The signatory on the federal-wide assurance. A high-level official who has the authority to represent the institution in matters related to the human subjects protection program.
Institutional Review Board (IRB): A body specifically constituted as required in 45 CFR 46 which provides review and oversight of all human subjects research at Rice University.  This board is charged with protecting the rights and welfare of human subjects recruited to participate in research in which the university is engaged.
Interaction: Communication or interpersonal contact between an investigator and a research subject.
Intervention: Physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Investigator: A scientist who is working on a research study to answer certain questions, test a theory, or explore a new area in hopes of designing a future study. Also called a researcher.
IRB Approval: An official determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and other institutional and federal requirements.
Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research that 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. For research involving prisoners Minimal Risk is 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.
Modification: Any change to an IRB-approved study protocol, regardless of the level of review it receives initially.
Modifications Letter: Lists all of the changes that the reviewers want made before approval can be granted.
Non-Affiliated Member: an IRB member who is not, and whose immediate family members are not, affiliated with the university appointment on the IRB.
Non-Committee Review: Any of the following:

• Determination of whether an activity is Human Research.
• Determination of whether Human Research is exempt from regulation.
• Reviews of non-exempt research using the expedited procedure.
• Determinations of which subjects can continue in expired research.

Non-Compliance: Failure to follow the regulations, or the requirements or determinations of the IRB.
Office for Human Research Protections (OHRP): The office within the Department of Health and Human Services that is responsible for implementing 45 CFR 46.
Oral Consent: Written information that describes what will be told to research participants who cannot read or feel uncomfortable signing forms for cultural reasons.
Parent/Guardian Permission: This form is signed by parents/legal guardians in order to allow children to participate in a study. For children 7 and older, an assent form is also provided to the child.
Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research.
Prisoner: Any individual involuntarily confined or detained in a penal institution. This term encompasses individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Privacy: Control over the extent, timing, and circumstances of disclosing personal information (physical, behavioral, or intellectual) with others.
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. It also includes information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for the acquisition of the information to constitute research involving human subjects.
Prospective Studies: Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
Protected Health Information (PHI): Health information that can identify an individual, including: name, birth date, Social Security number, address, telephone number, email address, computer ID, medical record number, and others.
Protocol: The scientific plan of the research study. A protocol describes the purpose of the study, who is eligible to participate, details about the research procedures, the length and steps of the study, and what information will be gathered.
Quorum: A majority of IRB members (50% plus one).
Recruitment: An activity that seeks to enroll prospective subjects into a research study by presenting information about the research including a summary of eligibility requirements.  All recruitment materials must be consistent with application and informed consent documents.
Research: An organized or systematic investigation. Most scientists conduct research, but not all research involves human volunteers. Most research is done with the hope of learning something valuable enough to share with others by publishing articles in scientific journals. Research can turn up both expected and unexpected results. Research usually involves some sort of risk-taking, whether small or great.
Research Study: This is a kind of study that is developed to answer a basic question on any subject, such as testing a new drug or treatment or comparing commonly used interventions.
Research Participants (or Research Subjects): The participants in a research study. These individuals voluntarily agree to participate in the study.
Restricted: Applies to investigators who are delinquent in meeting IRB requirements.
Risk: The probability and magnitude 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. Risks include immediate risks of study participation as well as risks of long-term effects.
Scientific Member: A committee member who has a terminal degree in a medical or scientific field.
Serious Non-Compliance: Non-Compliance that adversely affects the rights or welfare of subjects.
Site Visit: A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of the protection of human subjects, animal subjects or the capability of personnel to conduct the research.
Social-Behavioral: Involving the social sciences, the formal study of societies and human behavior. The areas of anthropology, sociology, psychology, religion, and political science are examples of disciplines that may conduct research of this kind. Common ways of collecting information include surveys, focus groups, interviews, and observing behavior in a specially designed setting.