Glossary

the process of seeking eligible participants and obtaining their consent to participate in the research.

indicates receipt of a communication, document or memo that does not, according to applicable regulations or policy, require formal approval.

applicable to non-interventional studies, indicates participant is actively involved with study intervention(s) or interaction(s).

applicable to interventional study, indicates participant is actively involved with study intervention(s) (including the intervention of being tested or evaluated).

a modification to an approved application which does not require IRB or IACUC approval (as applicable).

Examples include (but are not limited to):

• Correction of typos
• Minor changes to contact information,
• Removal of a performance site,
• Changes requested by affiliated institutions,
• Changes that correct administrative errors made during previous IRB or IACUC review. 
• Translations of approved consent forms and recruitment material,
• Verification of media advertisements based on IRB approved scripts,

Addition of a substance that is used as an addition to another substance.

any untoward or unfavorable medical occurrence in a research subject (e.g., physical or psychological harm), including any abnormal sign, symptom, or disease, temporally associated with the subject's participation in the research, whether or not it is considered related to the subject's participation in the research.

any institution that relies on the HSC IRB or IACUC.

A chemical compound, drug, reagent or biologic.

used to indicate when an individual is working on behalf of the institution (i.e., performing designated activities or exercising delegated authority or responsibility) in relation to research. An agent can be an employee of the institution (e.g., faculty or staff) or a non-employee who is authorized by the institution to act on behalf of the institution (e.g., student, affiliated faculty, emeritus professors).

It is possible for a HSC employee to conduct research and not be considered an agent of the university if the research is conducted during non-official duty time, is not in connection with her/his HSC responsibilities, is not being conducted at a HSC facility and the research is not supported by a direct HHS award to the HSC (review the HSC Handbook of Operating Procedures (HOP) on Conflict of Commitment). The institution however generally reserves the right to determine for themselves whether their employee (in whole or in part) is performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility in regard to that research and the IRB will generally consider this in determining whether the institution in question is engaged in research.

an unproven assertion of noncompliance.

a formal process for changing a previously approved IRB or IACUC application.  Amendments require approval by the IRB or IACUC.

abbreviation for the USDA's Animal and Plant Health Inspection Service

• Trials of drugs and biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation.
• Trials of biomedical devices: controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.

appreciation payments are bonuses given after children's participation to thank them for their efforts. These are usually of no more than token value and may include non-cash items such as toys, event tickets, or gift certificates.

official(s) determined by each organization to be points of contact for research. This may include an individual, an office or a committee.  (This term should not be confused with another similar but distinctly different DHHS term Authorized Institutional Official).

affirmative agreement by an individual not competent to give legally valid informed consent to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

is a written document submitted by an institution that is engaged in non-exempt human subjects research conducted or supported by a federal agency.

an institution holding an approved assurance from the applicable federal agency.

both physical attendance and attendance via teleconference so long as all members are connected simultaneously.

an individual's written permission to allow a covered entity to use or disclose specified PHI for a particular purpose.

within an institution, the point of responsibility for the oversight of research and IRB functions.

persons who are authorized under Texas state law to make health care decisions on behalf of other individuals will also be personal representatives under HIPAA.

the ability of a person to consider alternatives, make choices, and act without undue influence or interference from others.  

Examples of individuals with diminished autonomy may include: students or employees under the supervision of any investigator, prisoners, children, or patients under the care of a clinician who is the investigator.