General

Acknowledged: the committee has received your protocol and it will now be sent out for review to Board members.

Administrative Hold: An action to temporarily stop data collection and analysis on a project. This is a voluntary action by the Principal Investigator.

Amendments: Amendments are changes that the researcher wishes to make after a study is approved by the Committee. The researcher must submit an Amendment/Modification Package for Committee approval.

Co-Principal Investigator (Co-PI): The other primary scholar or researcher involved in conducting the research; if the project is for a thesis or dissertation, the student is the Co-PI.

Designated Reviewer: The committee chair or an experienced committee member designated by the committee chair to conduct Non-Committee Reviews.

Experienced Member: A compliance committee member is considered experienced if the respective compliance committee chair considers the member to have sufficient experience in and knowledge of conducting research compliance reviews.

Full Board Review: Review of proposed research at a convened meeting at which a majority of the membership of the compliance committee 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.

Institutional Animal Care and Use Committee (IACUC): A body specifically constituted as required in 9 CFR 2.31 which provides review and approval of animal use activities, and inspection of animal facilities. The principal investigator (PI) or instructor, and their staff, are responsible for understanding and following the regulations, as well as institutional policies, governing animal care and use.

Institutional Biosafety Committee (IBC): A body specifically constituted as required in 49 CFR 171 which conducts (1) the initial review and approval and (2) the continuing review of research involving recombinant DNA. These reviews are conducted in accordance with the provisions of the NIH Guidelines for Research Involving Recombinant DNA.

Modification: Any change to a committee approved study protocol, regardless of the level of review it receives initially.

Non-Affiliated Member: An compliance committee member who is not, and whose immediate family members are not, affiliated with the university appointment on the respective compliance committee.

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.

Sponsor: The organization that oversees and pays for the study or provides in-kind support (like medications). This can be a single person, a charitable foundation, a medical institution, a drug-making company, or a federal agency like the National Institutes of Health or Department of Defense.

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: https://osp.od.nih.gov/biotechnology/nih-guidelines/, 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.