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HRPP Policy - IRB Meetings and Minutes
About This Policy
- Effective date:
- Last updated:
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IU Human Subjects Office
IU has seven (7) IRBs that are charged with understanding and applying their obligation to protect the rights and welfare of human research subjects recruited to participate in research activities and to ensure compliance with applicable institutional policies and federal and state regulations.
Each IRB ordinarily meets at least once per month, with the exception of IRB 07, which is an ad hoc IRB that meets only when called by the Chair. Meeting schedules are provided to IRB members well in advance of the meetings. The IRB Chair may, however, call additional meetings at any time if necessary.
Quorum must be present at the IRB meeting to conduct business, take action, or vote. Quorum is constituted of a majority of voting IRB members, or their designated alternates, present at the IRB meeting, including at least one member whose primary concerns are in nonscientific areas. ; Members who attend remotely, such as by phone or video conference, are counted toward quorum. Members who leave the meeting or are absent for discussion and voting on an item due to a conflict of interest do not count toward quorum; however, members who leave temporarily, such as to take a phone call, are counted toward quorum.
A nonaffiliated member and a member who represents the general perspective of research subjects should be present at IRB meetings. These roles can be filled by the same person. Meetings may be held without the nonaffiliated and subject representative members, if necessary; however, frequent absences are not acceptable.
Prisoner representatives attend only as needed and only affect quorum when present at a meeting.
Committee decisions are made by a majority vote of the members present at the meeting. ; Voting occurs only after there has been a full, open discussion.
An IRB may, in its discretion, invite individuals with competence in special areas (e.g., consultants) to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB or be counted toward quorum. The IRB cannot delegate to consultants its responsibility to determine whether the criteria for approval are met.
When the IRB reviews research that affects the risk to pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates; children; or individuals lacking consent capacity, at least one individual (IRB member or consultant) who is knowledgeable about or experienced in working with such subjects must be present at the meeting or provide written comments. When the IRB reviews research involving prisoners as subjects, at least one individual (IRB member) who is knowledgeable about or experienced in working with prisoners must be present at the meeting.
Any IRB member or consultant present at a meeting who has a conflicting interest in a matter cannot vote on that matter and must be absent from the meeting during the deliberation and voting. He/she can, however, be in attendance to present information or answer questions as requested by the IRB. Examples of conflicting interests include:
- Participation in the project
- Financial interest as defined by the IU Policy on Financial Conflicts of Interest in Research
- Certain non-financial interests, including having supervision over the PI of the project or participating in a project that is in direct competition with the project
- Any other real or perceived conflict
Meeting materials are made available to all members of the IRB in advance of the meeting. The following items are included at minimum, as applicable:
- Minutes from the most recent meeting for review and approval
IRB meetings are documented by the IRB minutes, which include the following:
- Attendance at the meeting
- Names of IRB members who leave the meeting due to a conflict of interest
- Reviewers submitting written comments in lieu of attendance at the meeting
- Actions taken by the IRB, including votes for, against, or abstaining, and the names of IRB members who abstain, if any
- Description of the submission/event/circumstance
- Accounting of deliberations for each item, including a summary of the discussion of controverted issues and their resolution, the basis for requiring changes in research, and the basis for disapproving research
- The approval period (for initial approval and renewals)
- Determinations required by the regulations and research-specific findings justifying determinations for waiver or alteration of the consent process or documentation
- Determinations that the study has appropriate plans for research involving special populations, including children, prisoners, pregnant women, fetuses, neonates of uncertain viability or nonviable neonates, and individuals lacking consent capacity
- For initial review submissions, determination and documentation of the level of risk
- For determinations of unanticipated problem involving risks to subjects or others, or serious and/or continuing noncompliance, or if the IRB suspends or terminates approval of research:
- Reasons for the IRBs actions
- Plans for continued investigation and/or action
IRB minutes are approved by the convened IRB at a subsequent IRB meeting. Once approved, they may not be altered by anyone, including a higher authority.
IRB minutes and decisions may be made available, upon request, to relevant individuals or institutional officials at IU and/or its affiliates.
A primary reviewer system is used for items requiring review by the convened IRB. This includes amendments, renewals, and general information, including reportable events. For new studies which are greater than minimal risk requiring review by the convened IRB, a secondary reviewer is also assigned. Human Subjects Office (HSO) staff evaluate each study and assign a primary and/or secondary reviewer with appropriate scientific expertise to conduct the in-depth review. Additionally, for these same submissions, a nonscientist or nonaffiliated member may be assigned as a tertiary reviewer.
If an IRB member feels the item they have been assigned to review is outside of their area of expertise and/or if they have, or believe they have, a conflict with the item, the IRB member should contact the HSO as soon as possible so the item may be reassigned to another IRB member to review and/or an additional reviewer can be identified.
Complete submission information is made available for review by any IRB member at the meeting, and any member may, upon request, review the full research study.
A minimum of the following items, as applicable, are provided to all IRB members:
- Applicable forms, questionnaires, and protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval;
- Proposed consent/assent document(s);
- Recruitment materials;
- Protocol and investigator's brochure;
Except for life-threatening emergencies that meet very specific requirements as outlined in the IU HRPP Policy on Emergency Use of Investigational Test Articles, review of all research that qualifies for full IRB review is performed at a convened IRB meeting.
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Element II.1.D
- Element II.1.E
- Element II.2.C
- Element II.2.D
- Element II.5.B
- 21 CFR 56
- 45 CFR 46
- Memorandum of Understanding Between Richard L. Roudebush Veterans Affairs Medical Center and Indiana University Concerning Utilization of Indiana University's Institutional Review Boards
- OHRP/FDA Guidance:
- VHA Directive 1200.05 - Requirements for the Protection of Human Subjects in Research, especially section 8
assent An individual's affirmative agreement to participate in research obtained in conjunction with permission of the individual's parents, guardian, or legally authorized representative. Mere failure to object should not, absent affirmative agreement, be construed as assent.
continuing noncompliance (see also noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) A pattern of the same or similar instances of noncompliance, occurring in reasonably close proximity, which continues to occur after discovery of noncompliance and implementation of a preventive action plan, or results from failure to implement a preventive action plan approved by the IRB.
federally-funded Supported, either directly or indirectly, by funds provided by the federal government. This includes federal pass-through funding (i.e., received as a subrecipient through subcontracts). Use of administrative services funded by a federal grant, alone, is not sufficient to consider research federally-funded.
fetus The product of conception from implantation until delivery.
life threatening Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of the clinical trial analysis is survival. Also includes severely debilitating, meaning diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of arm, leg, hand, or foot).
minimal risk The probability and magnitude of harm or discomfort anticipated in the 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.
neonate A newborn child less than four weeks old. A Bold-nonviable neonate-Bold is an expelled or delivered fetus who, although living, cannot sustain life independently, even with medical intervention.
noncompliance (see also continuing noncompliance, minor noncompliance, observed or apparent noncompliance, serious noncompliance) Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, requirements of VHA Handbook 1200.05, or institutional policies governing human subjects research or the requirements or determinations of the IRB.
nonscientist For the purposes of IRB membership, refers to a member whose primary concerns are in nonscientific areas; specifically, little to no scientific or medical training or experience such that the individual would be considered unambiguously nonscientific.
prisoner Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute; individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples of individuals considered prisoners are available in the OHRP Prisoner Research FAQs.
recruitment Initial identification and contact with potential subjects, which may include both direct interactions with individuals and/or accessing identifiable data or specimens for the purpose of determining whether an individual or their data or specimen may participate or be included in a study.
reportable event An event which may represent noncompliance or an unanticipated problem involving risks to subjects or others. Reportable events are reported to the IRB in accordance with the IU HRPP Policy on Reportable Events.
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
serious adverse event (SAE) Any adverse event that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability/incapacity, congenital anomaly, or birth defect, or that requires medical or surgical intervention to prevent such an outcome.