KCTCS Human Research Protection Program | KCTCS

Administrative Procedures

Administrative Procedures

Human Subjects Research Protection Program

Procedure Number: 1.8.2.3.2-P

Current Effective Date: 03/20/2023

Original Effective Date: 03/20/2023

Revision Dates: 0

Revision Number: 0

Revision Summary: implementation of new procedure

Responsible Official: KCTCS President

References: Administrative Policy 1.8.2.3.2

1. Purpose

This procedure implements KCTCS Administrative Policy 1.8.2.3.2 Human Research Protection Program (HRPP), promoting adherence to foundational ethical principles and ensuring compliance with applicable federal regulations.

2. Scope

This procedure applies to all KCTCS students, faculty, and staff, as well as non-KCTCS personnel conducting research in which KCTCS students, faculty, or staff are subjects.

3. Terms and Acronyms

  1. Acceptance: The determination of the KCTCS HRPP that an existing research exemption or approval rendered by an external institution will be adopted as the primary determination of the project.

  2. Administrator: KCTCS Human Subjects Administrator.

  3. Approval: The determination of the KCTCS HRPP that the research has been reviewed and may be conducted within the constraints set forth by the HRPP, other institutional bodies, and federal requirements (45 CFR 46.102(h)).

  4. Coordinator: KCTCS Human Subjects Coordinator.

  5. Federal-wide Assurance (FWA): A document filed by an institution with the U.S. Department of Health and Human Services (HHS) stating it will comply with the requirements set forth in 45 CFR 46 and the Terms of Assurance.

  6. Institution: Any federal, state, or private entity, department, or agency (45 CFR 46.102(f)).

  7. Institutional Review Board (IRB): A KCTCS governance body established in accordance with and for the purposes expressed in 45 CFR 46.

  8. Legal Advisor: KCTCS Human Subjects Legal Advisor.

  9. Noncompliance: Conducting research in a manner that disregards or violates federal regulations, KCTCS policy, KCTCS procedure, or KCTCS IRB guidance regarding human research, or experiences unanticipated problems involving risks to human subjects.
    1. Minor Noncompliance: Administrative or technical violations that do not result in harm or risk of harm to human subjects.
    2. Serious Noncompliance: Violations resulting in either:
      1. Substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human subjects, researchers, or others.
      2. Substantive compromise to the effectiveness of KCTCS’ HRPP.
    3. Continuing Noncompliance: Persistent failure to adhere to federal regulations, KCTCS policy, KCTCS procedure, or KCTCS IRB guidance regarding human research.

  10. Principal Investigator (PI): The primary individual responsible for the preparation, conduct, and administration of research in compliance with applicable laws, regulations, and policies.

  11. Protocol: The written procedures or guidelines that provide the blueprint for the research study, as well as good and ethical practices.

  12. Reliance Agreement: A written document that provides a mechanism for an institution engaged in research to delegate IRB review to the IRB of another institution. Institutions must agree to the terms of the Reliance Agreement before the PI can begin research.

  13. Site Access: Written approval to conduct research in an organization or institution.

  14. SharePoint site: The KCTCS HRPP SharePoint site, on which all HRPP documentation is processed and archived.

4. Responsible Parties

  1. Administrator (KCTCS Human Subjects Administrator)
    1. Serves as the point of contact for human subjects research inquiries and signature authority for appropriate institutional documents (e.g., reliance agreements).
    2. Maintains and updates KCTCS’ human subjects research policies, procedures, and processes based on feedback, best practices, and new federal requirements.
    3. Appoints, oversees, and serves as an ex officio member of KCTCS’ IRB.
    4. Completes National Institute of Health-approved training on human research protection within 30 days of appointment.
    5. Recommends to the Chancellor and General Counsel research protocols that merit additional review prior to or at the time of approval by the IRB.
    6. Leads the annual evaluation of the HRPP.
    7. Supports IRB investigations of noncompliance with this policy or unanticipated problems involving risks to human subjects.

  2. Legal Advisor (KCTCS Human Subjects Legal Advisor)
    1. Provides legal advice on human subjects research to the Human Subjects Administrator, IRB members, staff, investigators, and subjects.
    2. Maintains KCTCS’ Federal-wide Assurance (FWA) with the Department of Health and Human Services (HHS).
    3. Serves as an ex officio member of KCTCS’ IRB.
    4. Completes National Institute of Health-approved training on human research protection within 30 days of appointment.
    5. In collaboration with the Human Subjects Administrator, IRB Chair, and/or other IRB Members, determine whether proposed research is exempt from IRB approval in accordance with 45 CFR 46.104 within one week of receiving a complete submission.
    6. Assists with the annual evaluation of the HRPP.
    7. Supports IRB investigations of noncompliance with this policy or unanticipated problems involving risks to human subjects.

  3. KCTCS IRB Chair
    1. Commits to the protection of human subjects in research.
    2. Provides leadership and guidance to the IRB.
    3. Completes National Institute of Health-approved training on human research protection within 30 days of appointment.
    4. Coordinates and facilitates all IRB meetings.
    5. Selects IRB Members to conduct expedited reviews.
    6. Collaborates with IRB Members to conduct full reviews.
    7. Leads investigations of noncompliance with this policy or unanticipated problems involving risks to human subjects.
    8. Assists with the annual evaluation of the HRPP.
    9. Ensures that IRB Members with a conflict of interest are not present for any discussions and/or votes on the research with which a conflict exists.

  4. KCTCS IRB Members
    1. Commit to the protection of human subjects in research.
    2. Complete National Institute of Health-approved training on human research protection within 30 days of appointment.
    3. Notify the IRB Chair of any potential conflicts of interest.
    4. Attend and participate in all IRB meetings, unless there is a conflict of interest.
    5. Respect the confidentiality of all review materials and member discussions.
    6. Contribute to expedited reviews, when selected by the IRB Chair.
    7. Contribute to full reviews.
    8. Contribute to investigations of noncompliance with this policy or unanticipated problems involving risks to human subjects, when selected by the IRB Chair.

  5. Coordinator (KCTCS Human Subjects Coordinator)
    1. Maintains communication directly with the PI and/or the initial source of incoming requests for review.
    2. Collects all necessary information regarding research requests, including the following:
      1. KCTCS HRPP Intake Form 
      2. Proof of existing IRB Approval documentation
      3. Reliance Agreements (as needed)
      4. Research protocol
      5. Consent forms
      6. Opt-out forms and/or procedures
      7. Information on data storage, retention, and destruction protocols
      8. Survey instrumentation
    3. Maintains inventory of all HRPP requests.
    4. Maintains documentation for each project review on both the KCTCS IRB SharePoint site and established OneDrive HRPP repository.
    5. Assigns review requests to the appropriate reviewer(s) as the situation requires.
    6. Coordinates with the KCTCS Human Subjects Administrator, Human Subjects Legal Advisor, IRB Chair, and/or IRB Member/Reviewer as required.

  6. KCTCS faculty, staff, and students
    1. Submit all proposed human subjects research (45 CFR 46.102(e) and 46.102(l)) to the IRB for review prior to initiation.
    2. Conduct all human subjects research in accordance with HRPP-approved protocols.
    3. Request the HRPP’s permission to modify research prior to making changes to approved protocols
    4. Maintain records as required by all KCTCS human subjects protection policies, procedures, and approvals.

5. Procedures

Procedure A. Inter-institutional acceptance of HRPP determinations.

A KCTCS PI seeks assurance that another institution will accept our HRPP’s determination, or a PI from another institution with approval from their IRB seeks acceptance by KCTCS. (Some institutions require proof of site access before reviewing HRPP protocols. KCTCS considers this the PI’s responsibility.) Select the appropriate procedure from the following three options:

Procedure A.1. Another institution’s reliance on the KCTCS HRPP. 

A KCTCS faculty, staff, or student PI seeks assurance that another institution will accept KCTCS’ HRPP determination.

Step 1: The PI or designee submits the KCTCS HRPP Inter-Institutional Acceptance Form and supporting documents to the Coordinator.

Step 2:  The Coordinator assigns the request to the Administrator and Legal Advisor for review.

Step 3:  The Administrator and Legal Advisor review the documentation and sign the other institution’s Reliance Agreement (or similar document).

Step 4: The Coordinator provides a copy of the approved Reliance Agreement to the PI and/or designee, and files all documentation on the SharePoint site.

Procedure A.2. KCTCS' reliance on another institution's IRB.

A PI seeks assurance that KCTCS will accept another institution’s IRB determination.

Step 1: The PI or designee completes and submits the KCTCS HRPP Inter-Institutional Acceptance Form to the Coordinator.

Step 2: The Coordinator assigns the request to the Administrator and Legal Advisor for review.

Step 3: The Administrator and Legal Advisor review the documentation and sign both forms or request clarification/changes.

Step 4: The Coordinator provides signed copies of both forms to the PI and/or designee, and files all documentation on the SharePoint site.

Procedure A.3. KCTCS' review of another institution’s IRB approval.

A PI from another institution seeks KCTCS acceptance of an external institution’s IRB approval when no Reliance Agreement exists.

Step 1: The PI or designee completes and submits the KCTCS HRPP Inter-Institutional Acceptance Form to the Coordinator.

Step 2: The Coordinator assigns the request to the Administrator and Legal Advisor for review.

Step 3: The Administrator and the Legal Advisor make a determination from the following categories:

  1. Acceptance. KCTCS accepts the other institution’s IRB approval for a period of one year, or until it expires, whichever occurs first.
    1. The Coordinator drafts an approval letter, which is then signed by the Administrator and returned to the PI and/or designee.
    2. The Coordinator files all documentation on the SharePoint site.

  2. Modification. KCTCS requests additional modification of the protocol to be considered for acceptance.
    1. The Coordinator requests additional information from the PI and/or designee.
    2. Upon receipt, the request may reach Acceptance or Rejection as described in Step 3(a) and 3(c), respectively.

  3. Rejection. KCTCS determines the other institution’s IRB approval is unfit for acceptance.
    1. The Coordinator drafts a rejection letter, which is then signed by the Administrator and returned to the PI and/or designee.
    2. The Coordinator files all documentation on the SharePoint site.

  4. Referral. KCTCS determines the other institution’s IRB approval requires additional review. The research request is referred to the IRB Chair and all IRB Members to conduct a full review in accordance with Procedure B.2.

Step 4: The Coordinator notifies the PI and/or designee, and files all documentation on the SharePoint site.

Procedure B. Initial Approval by KCTCS.

A KCTCS faculty, staff, or student investigator seeks initial approval. All proposals undergo Screening (Procedure B.1), which concludes with a determination of whether the research is exempt, Expedited Review (Procedure B.2) will be conducted, or Full Review (Procedure B.3) is required.

Procedure B.1 Screening

All submissions seeking initial approval will be reviewed as follows.

Step 1: The PI or designee submits the completed KCTCS HRPP Intake Form and supporting documentation to the Coordinator.

Step 2: The Coordinator reviews for eligibility based on meeting federal definitions of “research” (45 CFR 46.102(l)) and “human subjects” (45 CFR 46.102(e)).

Step 3: The Coordinator assigns the request to the Administrator and Legal Advisor to review for exemption.

  1. If the research meets the standard of exemption set forth in 45 CFR 46.104 and subjects are not members of vulnerable populations (45 CFR 46.111(b)), the request is returned to the Coordinator.
    1. The Coordinator drafts an approval letter, which is then signed by the Administrator and returned to the PI and/or designee.
    2. The Coordinator files all documentation on the SharePoint site.

  2. If the request does not meet the standard of exemption (45 CFR 46.104), continue to Step 4.

Step 4:  The Administrator and Legal Advisor determine if an expedited or full review is required:

  1. Expedited Review (Procedure B.2) will be conducted if risk meets the definition of “minimal risk” (45 CFR 46.102(j)) and no additional concerns are identified.

  2. Full Review (Procedure B.3) will be employed if risk is greater than “minimal risk” (45 CFR 46.102(j)) or additional concerns are identified.
Procedure B.2. Expedited Review

For protocols that meet the definition of “minimal risk” and do not include vulnerable populations.

Step 1: Upon determination by the Administrator and Legal Advisor that an expedited review is warranted, the Coordinator assigns the request to the IRB Chair and one IRB Member to conduct the review within two weeks of assignment.

Step 2: The review will consider that: 

  1. Risks to subjects are minimized as described in 45 CFR 46.111(a)(1)(i) and 46.111(a)(1)(ii).

  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result (see 45 CFR 46.111(a)(2)).

  3. Selection of subjects is equitable, as described in 45 CFR 46.111(a)(3).

  4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, 45 CFR 46.116 and 45 CFR 46.117.

  5. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

  6. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Step 3: A determination is made based on one of the following categories:

  1. Approval. The Coordinator drafts a letter, indicating the proposal is approved for no more than one year, which is then signed by the Administrator and returned to the PI and/or designee.

  2. Modification. The request requires additional documentation and/or information to be considered for approval. The Coordinator requests additional information from the PI and/or designee. Upon receipt, the protocol will be reconsidered.

  3. Referral. The research request is referred to the IRB Chair and all IRB Members to conduct a Full Review (Procedure B.3).

Step 4: The Coordinator notifies the PI and/or designee, and files all documentation on the SharePoint site.

Procedure B.3. Full Review

For protocols that pose more than “minimal risk” or include vulnerable populations.

Step 1: Upon determination by the Administrator and Legal Advisor that a full review is required, the Coordinator assigns the request to the IRB Chair and all IRB Members to conduct the review during a meeting of the Board, within four weeks of assignment.

Step 2: The review will consider that:

  1. Risks to subjects are minimized as described in 45 CFR 46.111(a)(1)(i) and 46.111(a)(1)(ii).

  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result (45 CFR 46.111(a)(2)).

  3. Selection of subjects is equitable (45 CFR 46.111(a)(3)).

  4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, 45 CFR 46.116 and 45 CFR 46.117.

  5. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

  6. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Step 3: A determination is made based on one of the following categories:

  1. Approval. The Coordinator drafts a letter, indicating the proposal is approved for no more than one year, which is then signed by the Administrator and returned to the PI and/or designee.

  2. Modification. The request requires additional documentation and/or information to be considered for approval. The Coordinator requests additional information from the PI and/or designee. Upon receipt, the request may reach Approval or Rejection as described in Step 3(a) and 3(c), respectively.

  3. Rejection. The Coordinator drafts a rejection letter, which is then signed by the Administrator and returned to the PI and/or designee, noting they may resubmit the request (Procedure B).

Step 4: The Coordinator notifies the PI and/or designee, and files all documentation on the SharePoint site.

Procedure C. Modification of Research Approvals

Proposals previously exempted by KCTCS follow Procedure C.1, protocols previously approved by KCTCS follow Procedure C.2, and Protocols approved by another institution then accepted by KCTCS follow Procedure C.3. 

Procedure C.1. Modification of a proposal previously exempted by KCTCS’s HRPP

A research protocol may not be modified until approved by KCTCS’ HRPP.

Step 1: The PI or designee submits the completed KCTCS HRPP Research Modification Form and supporting documentation to the Coordinator.

Step 2: The Coordinator assigns the request to the Administrator and Legal Advisor for review.

Step 3: The Administrator and Legal Advisor review to determine if the modified protocol still meets eligibility for exemption.

  1. If the modified protocol still meets eligibility for exemption (45 CFR 46.104), the Coordinator drafts an exemption approval letter, which is then signed by the Administrator and returned to the PI and/or designee.

  2. If the modified protocol no longer meets eligibility for exemption (45 CFR 46.104), the Coordinator informs the PI and/or designee of the reasoning and that the PI or designee may resubmit the request (Procedure B).

Step 4: The Coordinator files all documentation on the SharePoint site.

Procedure C.2. Modification of a protocol previously approved by KCTCS’s IRB

Step 1: The PI or designee submits the completed KCTCS HRPP Research Modification Form and supporting documentation to the Coordinator.

Step 2: The Coordinator assigns the request to the Administrator and Legal Advisor.

Step 3: The Administrator and Legal Advisor determine the scope of proposed modifications to the previously approved research protocols based on the following categories:

  1. Minor modifications. Proposed modifications resulting in little to no additional risk to human subjects may be addressed according to one of the following:
    1. If approved, the Coordinator drafts an approval letter, which is then signed by the Administrator and returned to the PI and/or designee.
    2. The Administrator may refer the request to the IRB Chair and one IRB Member to conduct an expedited review (Procedure B.2).
    3. The Administrator may refer the request to the IRB Chair and all IRB Members to conduct a full review (Procedure B.3).

  2. Significant modifications. Proposed modifications resulting in more than minimal additional risk to human subjects will be referred to the IRB Chair and all IRB Members to conduct a full review (Procedure B.3).

Step 4: The Coordinator files all documentation on the SharePoint site.

Procedure C.3. Modification of a protocol approved by another institution’s IRB and accepted by KCTCS

Step 1: The PI or designee shall follow all requirements for research modification as established by the governing IRB from which approval has been accepted by KCTCS.

Step 2: If a modification has been approved by the governing IRB, the PI or designee will notify the Coordinator of the approved modification electronically at the time of approval.

Step 3: The Coordinator assigns the request to the Administrator and Legal Advisor for review:

  1. If approved, the Coordinator drafts an approval letter, which is then signed by the Administrator and returned to the PI and/or designee.

  2. In the event the request is denied, the Administrator informs the PI and/or designee of the reasoning and the PI may resubmit the request (Procedure A).

Step 4: The Coordinator files all documentation on the SharePoint site.

Procedure D. Renewal of HRPP approval

A PI or designee must renew KCTCS approval before it expires or cease conducting research. If approval is not renewed prior to expiration, the PI or designee must submit a new request (Procedure B) prior to reinitiating research.

Procedure D.1. Renewal of an approval from KCTCS’ HRPP

Step 1: The Coordinator electronically informs the PI and/or designee their approval will expire at least 30 days prior to the expiration date.

Step 2: If the PI or designee wishes to renew the approval:

  1. If there will be no changes to the research protocol:
    1. The PI or designee submits the completed KCTCS HRPP Research Renewal Form, along with all originally approved documentation and KCTCS HRPP Approval Letter.
    2. The Coordinator assigns the request to the Administrator and Legal Advisor for approval.
    3. If the renewal request is approved, the Coordinator drafts a letter, indicating the renewal is approved for no more than one year, which is signed by the Administrator and provided to the PI and/or designee.
    4. If the renewal request is denied, the Coordinator drafts a denial letter informing the PI and/or designee of the reasoning and that the PI or designee may resubmit the request (Procedure B), which is signed by the Administrator and provided to the PI and/or designee.

  2. If the research protocol is expected to change, the Coordinator informs the PI and/or designee that s/he may submit a modification (Procedure C).

  3. If the renewal request is submitted after the original approval has expired, the Coordinator informs the PI and/or designee that s/he may resubmit the request (Procedure B).

Step 3: If the PI or designee does not wish to renew the approval, the research project will be marked as “Complete.”

Step 4: The Coordinator files all documentation on the SharePoint site.

Procedure D.2. Acceptance of a renewal by another institution’s IRB

Step 1: The PI or designee shall follow all requirements for research renewal as established by the governing IRB from which approval has been accepted by KCTCS.

Step 2: If a renewal has been approved by the governing IRB, the PI or designee will notify the Coordinator of the approved renewal electronically at the time of approval.

Step 3: The Coordinator assigns the request to the Administrator and Legal Advisor for review.

  1. If approved, the Coordinator drafts a letter, indicating the proposal is approved for no more than one year, which is then signed by the Administrator and returned to the PI and/or designee.

  2. In the event a renewal request is denied, the Administrator informs the PI and/or designee of the reasoning and that the PI may resubmit the request (Procedure A).

Step 4: The Coordinator files all documentation on the SharePoint site.

Procedure E. Investigations of Noncompliance and Corrective Actions

When a PI is alleged to have conducted research in a manner that disregards or violates federal regulations, KCTCS policy, KCTCS procedure, or KCTCS IRB guidance regarding human research, or experienced unanticipated problems involving risks to human subjects, the following procedures shall be followed in accordance with 45 CFR 46.108(a)(4)(i).

Procedure E.1 Submission and assessment of allegations

Step 1: Anyone may submit allegations of noncompliance to KCTCS’ HRPP verbally or in writing. HRPP staff or IRB members may also identify instances of noncompliance during reviews. HRPP staff and IRB members will respect the confidentiality of individuals submitting allegations to the extent possible.

Step 2: The Coordinator is informed of allegations of noncompliance and collects the relevant information.

Step 3: The Coordinator assigns the case to the Administrator and Legal Advisor for assessment.

Step 4: The Administrator and Legal Advisor assess the allegations to determine whether they are:

  1. Not credible (i.e., no supporting documents, statements, and/or evidence can be identified), in which case they may decide no additional action is needed, the case is marked closed, the individual who made the allegation is advised (if their identity is known), and the Coordinator files all documentation on the SharePoint site.

  2. Credible (i.e., supporting documents, statements, and/or evidence can be identified), in which case they will initiate an investigation (Procedure E.2).
Procedure E.2. Investigation by the KCTCS IRB 

Step 1: The Administrator and Legal Advisor notify the Chancellor and General Counsel.

Step 2: The Administrator and IRB Chair establish an Investigation Committee of IRB Members, led by the Chair and charged by the Administrator.

Step 3: The Investigation Committee, supported by the Administrator and Legal Advisor, conduct fact finding regarding the allegations of noncompliance and/or unanticipated risks to human subjects.

Step 4: The Investigation Committee documents the facts of the case, whether noncompliance was confirmed, and if so, recommends corrective actions in a report that is submitted to the Administrator. Corrective actions will consider the severity of noncompliance, whether/how approval was granted, and the institutional affiliation(s) of the PI and/or collaborating investigators. Recommendations may include, but are not limited to:

  1. Require the PI and/or collaborating investigators complete remedial and/or additional professional development on human subjects protection;
  2. Require changes to the research protocol and/or consent process;
  3. Establish a continuing review schedule;
  4. Require monitoring of research and/or consent process;
  5. Suspend or terminate approval of research;
  6. Disapprove continuation, modification, or renewal of research;
  7. Require investigations of the PI’s and/or collaborating investigators’ other active KCTCS research protocols;
  8. Disqualify the PI and/or collaborating investigators from conducting research involving human subjects at KCTCS;
  9. Require the PI contact subjects previously enrolled in the study and provide them with additional information and/or obtain new consent from them;
  10. Prohibit the PI and/or collaborating investigators from using data collected for publication;
  11. Require the PI and/or collaborating investigators to inform publishers and editors if he/she has submitted or published manuscripts emanating from the research.

Step 5: The Administrator and Legal Advisor review the report and request any clarifications or additions that may be necessary.

Step 6. The Administrator and Legal Advisor assess the report to determine whether the allegations of noncompliance are:

  1. Unsubstantiated and corrective actions are not warranted, in which case the case is marked closed, the individual who made the allegation is advised (if their identity is known), and the Coordinator files all documentation on the SharePoint site.

  2. Substantiated and/or corrective actions are warranted, in which case the Administrator and Legal Advisor transmit the report to the General Counsel and Chancellor for determination of corrective action (Procedure E.3).
Procedure E.3. Determination of corrective actions

Step 1: The Chancellor and General Counsel ensure proposed corrective actions correspond to the severity of noncompliance and whether/how approval was granted, endorsing, modifying, or rejecting the corrective actions.

  1. If the corrective actions are rejected, the Chancellor and General Counsel may:
    1. Request additional investigation by the KCTCS IRB, or
    2. Mark the case as closed, inform the PI, and advise the individual who made the allegation (if their identity is known).

  2. If the corrective actions are endorsed or modified, the Chancellor and General Counsel inform the PI (with copies to the Administrator, Legal Advisor, IRB Chair, and Coordinator) of the investigation’s findings, corrective actions, and the PI’s right to appeal within 30 calendar days. The individual who made the allegation is then advised (if their identity is known).

Step 2: The Coordinator files all documentation on the SharePoint site.

Procedure E.4. Appeal by PI

Step 1: The PI submits an appeal to the Coordinator within 30 calendar days of receiving notice of corrective actions.

Step 2: The Coordinator transmits the appeal to the KCTCS President (with copies to the Chancellor, General Counsel, Administrator, Legal Advisor, and IRB Chair) for review and determination.

Step 3: The KCTCS President informs the Chancellor and General Counsel whether she/he upholds, modifies, or rescinds the corrective actions.

Step 4: The Chancellor and General Counsel relay the President’s determination regarding the appeal to the PI (with copies to the Administrator, Legal Advisor, IRB Chair, and Coordinator).

Step 5: The Coordinator files all documentation on the SharePoint site.

Procedure E.5. Implementation of corrective actions

Step 1: The Administrator, Legal Advisor, and/or IRB Chair ensure the PI completes the corrective actions.

Step 2: The Coordinator files all documentation on the SharePoint site.