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Procedures for IRB Operations

Revised: November 2007

  1. Application Processes and Deadlines

    1. The IRB chair will determine a date, time and place of a regularly scheduled standing meeting. The meeting is currently set for the last Tuesday of every month.
    2. All proposals will be accepted for review if received 1 week prior to the scheduled meeting. Meetings are held the first Tuesday of each month if there are applications to review. 
    3. All research proposals shall be date-stamped upon receipt at the AHS Secretary’s Office, at the following address:

      AHS Institutional Review Board
      c/o Secretary’s Office – 4 North
      103 So. Main St
      Waterbury, Vermont 05671-0203
    4. Administrative Assistant will, within 24 hours of receipt of proposal:
      1. Assign the proposal a case tracking number
      2. Review the proposal with the Board Chair
      3. Assign a primary reviewer & secondary reviewer based on alphabetical order of last name.
    5. Members may not participate in the IRB's initial or continuing review of any project in which they are
      1. the principal investigator or project leader
      2. part of the research staff or project team
      3. a member of the sponsoring department, division, office, program or organization
    6. The primary reviewer in collaboration with the secondary reviewer will check for completeness and determine the appropriate level of review for the study within seven working days of receipt.

    The Primary reviewer is responsible for

    • Reading the full application
    • Calling the Principal investigator for any additional clarifications or questions
    • Providing a verbal summary of the project with any additional clarifications and highlighting issues for the full IRB membership
    • Making a recommendation for expedited or exemption, if applicable and presenting the rationale to the chair within seven days of receipt of the application

    The Secondary reviewer is responsible for

    • reading the full application
    • making any concerns or questions known to primary reviewer as needed
    • assuming the role of the primary reviewer in the event that the primary reviewer is absent at the full board meeting
  2. Exempt or Expedited Reviews

    1. Exempted activities as per 45 CFR 46, paragraph 46.101(b) include:
      1. Normal Educational Practices and Settings: research conducted in established educational settings involving normal educational practices such as (i) research on regular and special educational strategies, or (ii) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
      2. Anonymous Educational Tests, Surveys, Interviews, or Observations: Research involving the use of educational test (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observations of public behaviors whereby subjects cannot be identified directly or through identifiers. *Note: This exemption also applies to research involving minors when the research involves educational tests or observation of public behavior except when the investigator(s) do not participate in the activities being observed. All other research projects with minors require IRB submission.
      3. Research Involving Survey or interview procedures and observations: (including observations by participants) of public behavior, unless: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects: AND (ii) any disclosure of the human subjects’ responses outside of the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation, or deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, drug abuse, sexual behavior or the use of alcohol.
      4. All research involving survey or interview procedures is exempt, without exception, when respondents are elected or appointed public officials or candidates for public office.
      5. Collection or Study of Existing Data without Identifiers: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.
      6. Research is exempted when it is designed to study, evaluate or otherwise examine the following: public benefit or service programs, procedures for obtaining benefits or services under the programs, possible changes to the programs or procedures, or possible changes in methods or levels of payments for benefits or services under the programs, when the research is conducted by or subject to the approval of the head of the agency, department, division or office within the agency.
    2. Expedited Reviews: If there is no more than minimal risk to which the subject is exposed, expedited review by the chairperson or another of the IRB members designated by the chairperson is allowable (as per 45 CFR 46, paragraph 46.110).

      If received within 1 week prior to the next scheduled meeting, the primary reviewer will bring a recommendation for exemption or expedited review to the full board. The recommendation must include the criteria for exemption or expedited review.

      If received more than one week prior to the full board meeting, the primary reviewer will bring a recommendation for exemption or expedited review to the IRB Chair. The recommendation must include the criteria for exemption or expedited review.

      If a research proposal is not accepted under expedited review it will be considered at the next full meeting of the IRB.

  3. Full Board Reviews

    1. If a full board meeting of the IRB is required, the chairperson will place the proposal on the monthly agenda on a first-come, first-serve basis. At the chair’s discretion a special meeting can be called in order to assure a timely review of proposals. A standing agenda will be as follows:
      1. Review and approval of previous meeting minutes
      2. Review any subcommittee activity (non-compliance, adverse events) as needed
      3. Review and approval of pending or continued submissions
      4. Review and approval new submissions
      5. Other business
    2. A brief acknowledgement will be sent to the principal investigator, giving them the name of the primary and secondary reviewer, letting them know the date of the review and reserving the morning for either a phone conference or in-person presentation. A specific 30 minute time slot will be confirmed one week prior to meeting.
    3. The AHS Privacy Officer will receive all proposals to determine if HIPAA requirements apply and if so, to determine if they are met.

    1 week prior to the IRB meeting

    The final agenda will be confirmed.

    • Each primary reviewer lets Chair and Administrative staff know if project is applicable/ready for meeting review;
    • Administrative staff with the Chair will assign a time slot for each project on the agenda;
    • If needed, administrative staff will notify researchers whose proposals are to be considered of the time on the agenda and determines whether the researcher will be present in person or by phone If by phone, staff confirms phone number;
    • All committee members will receive a copy any proposal to be reviewed at full board meetings.

    Meeting Procedures

    Meetings will be facilitated by the Chair, unless another member has been designated to do so.

    • A recorder/note taker may be determined at the start of each meeting as needed;
    • At the IRB meeting, members may approve, disapprove, or require changes in a proposal by a majority vote. For approval, the following criteria must be met:
      1. Risks to subjects are minimized.
      2. Risks to subjects are reasonable in relation to anticipated benefits.
      3. Selection of subjects is equitable.
      4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
      5. Informed consent will be appropriately documented.
      6. The research plan makes adequate provision for monitoring the data collected to insure the safety of subjects.
      7. There are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data.
      8. Appropriate additional safeguards have been included to protect the rights and welfare of subjects belonging to a vulnerable population (e.g., fetuses, pregnant women children, prisoners, persons who are institutionalized, individuals with disabilities).

    Possible Determinations/Voting Options

    1. Abstain: conflict of interest; and/or did not have enough information to vote due to absence from any previous discussions or reviews of associated materials
    2. Approved as submitted: Approved with no further information needed
    3. Conditionally Approved: The protocol will be approved, if specific, clearly identifiable changes can be communicated to the researcher and the researcher reports that changes are made and/or resubmits to the IRB.
    4. Not approved or Disapproved: The IRB is not able to identify conditions under which it would approval the protocol.
    5. Tabled Pending More Information: The committee needs to requests further information from the researcher in order to reach a decision.

    Written Notifications

    The researcher shall be notified in writing of the decision of the IRB within seven working days.

    • If modifications are required, the researcher must provide the chairperson with written acceptance of the changes before continuing.
    • If a proposal is disapproved, the researcher is to be notified of the reason for disapproval and will be allowed to resubmit a proposal with modification for future consideration by the IRB.
    • If a proposal is tabled the specific information needed in order for the IRB to proceed must be outlined for the researcher

    Tracking

    Following the final decision, chair will assure that AHS tracking information is completed in the original application final section and returned to administrative staff. Staff will enter relevant information into IRB tracking database.

    Review of Protocol Changes

    A. Researchers are responsible for the submission of any changes or amendments to an approved protocol.

    1. Amendments that potentially create risks not previously identified or substantially increased known risks will be assigned to the original primary reviewer and must be brought for review through the full IRB.
    2. Minor modifications not affecting the risk to subjects may be reviewed through the expedited review process.

    B. Amendments that impact the safety of subjects previously enrolled who continue in the study may require an addendum to the existing consent form, use of new form, or the provision of an informational sheet with the updates.

    C. Considerations for review of amendments includes

    1. What part of the research study is being revised?
    2. Does the revision affect the risk to the subjects?
    3. Does the currently approved consent form require revision to convey the potential risks?
  4. Continuing Review

    All research approved by the IRB will be reviewed at least once every twelve months to insure that human subjects are being protected. This review will be conducted by the members of the IRB or subcommittee as designated by the chairperson. The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements.

    1. Frequency of the continuing review will be decided for each protocol at the time of the initial review and under recommendation from the primary reviewer.

      If the research did not qualify for expedited review at the time of the initial review, then it does not qualify for expedited continuing review unless:

      1. The research is permanently closed to the enrollment of new subjects
      2. All subjects have completed all research-related interventions; and the research remains active only for long term follow-up of subjects OR
      3. No subjects have been enrolled and no additional risks have been identified OR
      4. The remaining research active are limited to data analysis
    2. Researchers must supply a status report on the progress of the research, including but not limited to:
      • The number of subjects accrued;
      • A summary of adverse events and any unanticipated problems involving risks to subjects or others and any relevant recent literature, interim findings and amendments or modifications to the research since the last review;
      • Any relevant multi-center trial reports;
      • Any other relevant information, especially information about risks associated with the research and
      • A copy of the current informed consent document and any newly proposed consent document.
    3. Continued Reviews will ensure that
      • The currently approved consent document is still accurate and complete;
      • Any significant new findings that may related to the subjects willingness to continue participation are provided to the subject .

      Additionally, continuing reviews address the following considerations:

      • Risks to the subjects are still minimized;
      • Risks to the subjects are still reasonable in relation to the anticipated benefits;
      • The number of subjects initially requested and approved has not been exceeded;
      • Protocol revisions approved by the IRB since the last review are in place;
      • That the study is progressing as planned;
      • That unexpected events or complications which may have occurred are reviewed to determine if they warrant a change in protocol or consent;
      • If there are any complaints registered by the subjects about the study;
      • An assurance that data monitoring is occurring by the research team to assure that study events are being evaluated relative to making appropriate decisions regarding termination or modifications of protocols.
  5. Issues of Research Non-Compliance

    The IRB has responsibility to review complaints and allegations of noncompliance with IRB guidelines and/or federal regulations. This includes unintended or accidental deviations in protocols previously approved by the IRB, by the researcher or a member of the researcher team.

    Potential occurrences of regulatory noncompliance in research may be revealed to the IRB chair or any member of the IRB by the researcher, a concerned individual or through the IRB’s formal or informal monitoring activities.

    At any time during any phase of the review of an inquiry or investigative process, the IRB or its sub-committee may choose to suspend a research activity if it is determined that suspension is necessary for the protection of human research participants. If a research activity is suspended, all appropriate federal regulatory and sponsoring entities will be notified as required. If a researcher voluntarily suspends a research activity during an inquiry or investigative process, reporting may not be indicated.

    Generally, the researcher under review should have access to the identity of complainant(s) and others who provide information. However, if such individuals are in a status subordinate to the researcher and wish to maintain their anonymity, the IRB will make every effort to protect their identities while at the same time affording the researcher access to the substance of the allegations and information presented against him/her.

    Reviewing complaints and allegations of noncompliance is critical to the IRB's ability to protect human subjects. A climate free of fear of sanction is required to foster appropriate reports and ensure a fair review of allegations. Retaliation against good faith "whistle blowers" is illegal and will not be tolerated. Whistle blowers who report IRB- related concerns may utilize other state and federal mechanisms for protection from retaliation.

    Inquiry Process

    1. Whenever a potential occurrence of noncompliance is presented, the IRB chair will assign an ad hoc committee to review the initial information and determine what additional facts are required to ascertain whether the matter will merit further review. If the researcher was not the source of the report, the researcher will be notified early in this phase, and may be asked to provide additional information.
    2. An initial assessment to determine if current or future subjects are at risk if the protocol is allowed to remain open will be made as quickly as possible to prevent additional risk. If it is felt subjects are potentially at risk, the chair will either:
      1. Request that the Principal Investigator voluntarily suspend some or all research activities pending investigation and resolution of the matter;
      2. Suspend all research activities immediately, with notification to all appropriate federal regulatory and sponsoring entities; or
      3. Determine other appropriate procedures to protect subjects based upon the specific circumstances.  
    3. Determination of Level of Seriousness (serious vs. not serious noncompliance):

      The following are the factors that the committee uses as a framework for discussion in making determinations in these matters:

      • Level of risk or potential risk to subjects
      • Severity of violation to the process
      • Frequency of repeated minor violations or errors
      • Intent

      After sufficient information has been obtained, the Sub-Committee may determine that the allegation or report:

      1. is unjustified or without merit and no further action is required;
      2. is not serious and minor corrective actions are indicated to achieve compliance;
      3. is potentially serious or continuing noncompliance and further review by the full Committee is required;
      4. has other institutional implications and forward information to appropriate institutional officials;
      5. is possible scientific misconduct and is handled within the appropriate institutional mechanism.

      The full Committee will be routinely briefed on the results of the review by the ad hoc committee of all serious or continuing noncompliance matters.

    4. Establishment of Corrective Actions

      The Committee will base its decisions on all the information gathering and input from the researcher. Actions which the Committee may take include, but are not limited to:

      1. no further action is required;
      2. minor corrective actions are indicated and initiated to achieve compliance;
      3. Institute limitations on the use of data;
      4. Find that additional education would be appropriate for the researcher and/or other members of the research team;
      5. Require Principal Investigator to address how to prevent situation from happening in the future;
      6. Review internal departmental or institutional mechanisms and systems for opportunities to prevent reoccurrence;
      7. Require additional oversight (e.g., Co-Principal Investigator);
      8. Require more frequent IRB reviews;
      9. Require internal monitoring visits;
      10. Suspend or terminate individual protocols;
      11. Probation, suspension or termination of research privileges or embargo of publications.

      The IRB will issue the final report of its findings and send it to the researcher. The decision becomes final within five working days of release unless the researcher files a written statement of appeal within that time frame.

      A determination of “Serious Noncompliance” is reportable to OHRP, Institutional Officials, AHS affiliated department(s) and/or the Secretary’s Office, and, if applicable, federal funding source and FDA for covered drug or device research.

      A determination of “Continuing Noncompliance” is reportable to OHRP, Institutional Officials, AHS affiliated department(s) and/or the Secretary’s Office and, if applicable, federal funding source and FDA for covered drug or device research.

    5. Appeals

      The purpose of an appeal is to give the researcher an opportunity to request reconsideration of the decision under certain limited circumstances. Grounds for appeal are limited to: 1) new information not reasonably available during the investigation; 2) material failure by the IRB to follow its policies and procedures; and 3) action taken exceeds the severity of the violations. No other grounds will be considered.

      The Appeals Panel will be comprised of three IRB members who have not been directly involved in the investigation. The Appeals Panel will review a written statement of appeal by the researcher and make a recommendation as to whether the Committee should reconsider any aspect of its decisions based on the grounds outlined above. In reaching this recommendation, the Appeals Panel may seek a response from the IRB members involved in the initial review. The decision whether to forward a request for reconsideration back to the IRB Chair should be made within 10 working days from receipt of the request.

      If the Appeals Panel denies the appeal, the Committee’s prior decision becomes final. If the Appeals Panel recommends reconsideration, the IRB will re-open the case. When the case is re-opened, the IRB Chair may choose to reconvene the same members involved in the initial review or set up another process. The researcher will be provided the opportunity to appear personally to present the appeal.

      Upon reconsideration, the IRB will determine whether to modify or uphold its original decision. This action is final. Consistent with the IRB’s regulatory authority, no other entity within the AHS may override an IRB decision that limits, imposes conditions or in any way restricts a researcher’s privileges. The reconsideration phase will be completed within 30 working days.

  6. Adverse Events

    Occurrences of adverse events may be revealed to the IRB chair or any member of the IRB by the researcher, a concerned individual or through the IRB’s formal or informal monitoring activities.

    At any time during any phase of the review of an inquiry or investigative process, the IRB or its sub-committee, may choose to suspend a research activity if it is determined that this is necessary for the protection of human research participants. If a research activity is suspended, all appropriate federal regulatory and sponsoring entities will be notified as required. If a researcher voluntarily suspends a research activity during an inquiry or investigative process, reporting may not be indicated.

    Review Process

    1. The IRB chair will appoint an ad hoc IRB sub-committee to assess:
      • Seriousness of the event
      • Whether the event was expected or unexpected
      • Possible relationship of the event to the research
      • Whether the currently approved consent form addresses the reported event.
    2. The IRB may request additional information such as other concomitant treatment, the number of subjects treated with similar events, etc. from the researchers. If the IRB finds that the serious adverse event does not potentially affect risk to the subjects or, there is insufficient information to determine this, a report will be filed with no further action required. It will be reported via minutes to the full IRB.

      If further action is required the IRB will determine the proper course such as, but not limited to:

      1. A request to notify the subjects either with an informational sheet or a change to the consent document to include the reported risk
      2. A request to amend the protocol
      3. A request to stop protocol activities.

    Requested actions must be confirmed and completed by the researcher in writing.