Section VIII: Non-Compliance, Adverse Events, Unanticipated Problems, and Subject Complaints 1. Applicability and Overview The purpose of this section is to: (i) define The New School's policy regarding Non-Compliance, Adverse Events, Unanticipated Problems, and Subject Complaints in the conduct of human subjects research, (ii) describe the criteria used to assess incidents to determine appropriate actions, and (iii) describe the procedures to inform appropriate entities. Federal regulations and TNS policy require prospective HRPP exemption or IRB approval of human subjects research.50 Federal regulations and TNS policy have no mechanism for retroactive approval of human subjects research. 1.1. Authority The federal regulations require written procedures that the IRB will follow regarding certain review activities, and that ensure prompt reporting to the IRB and others regarding any unanticipated problems involving risks to subjects or others, any serious or continuing noncompliance, and suspension or termination of IRB approval.51 However, federal regulations do not specify who is responsible for determining whether an incident meets the regulatory criteria for problems that must be reported to federal regulators, funding agencies, institutional officials, and sponsors. Therefore, in accordance with The New School's HRPP Authority (as described in section I of this Manual) the responsibility of the initial assessment and regulatory determination categorizing the nature and severity of the problem is delegated to The New School's (TNS) Human Protections Administrator (HPA) on the FWA, who has expert knowledge in regulatory issues regarding human subjects. The Institutional Official (IO) on the FWA makes the final determination regarding the regulatory categorization. The HPA also manages the review process and reporting responsibilities to the IRB, institutional officials, federal regulators, funding agencies, sponsors, and others as applicable. 2. Definitions 2.1. Non-compliance: Any situation, incident, or process during the conduct of human subjects research that is inconsistent with any of the following: (i) applicable federal, state, or local regulations; (ii) TNS policies, procedures, or guidance; (iii) the ethical principles described in the Belmont Report; or (iv) any stipulations of the HRPP/IRB regarding the protocol. 50

Section IV of this Manual, describes which activities constitute human subjects research (HSR), how HSR determinations are made, and the review and oversight of HSR. 51 45 CFR 46.103(b) and OHRP Guidance on Written IRB Procedures.

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Note: All breaches of privacy/confidentiality/data security/loss of study data/destruction of study data due to noncompliance must be reported to the HRPP. 2.1.1. Serious Non-compliance: The incident of non-compliance (as defined in 2.1) significantly increases risks to subjects; or jeopardizes the safety, welfare, or rights of subjects or others; or decreases potential benefits of the study, including the scholarly integrity of the research. 2.1.2. Continuing Non-compliance: A pattern of repeated non-compliance (as defined in 2.1), which continues after initial discovery and approval of a corrective action plan; or that suggests that non-compliance will continue if there is no intervention; or if continued, could significantly increase risks to, or jeopardize the safety, welfare, and/or rights of subject(s) or others; or if continued, could decrease potential benefits (including the scientific integrity of the research). 2.1.3. Minor Non-compliance: Non-compliance that is neither "serious" nor "continuing." 2.2. Protocol Deviation: An intended or unintended divergence or non-adherence to the HRPP/IRB approved protocol. (A protocol deviation is a type of non-compliance because deviating from the approved protocol is inconsistent with the stipulations of the HRPP/IRB). Deviations include but are not limited to: over-enrollment of subjects, or changes to the study prior to HRPP exemption or IRB approval (such as changes to the procedures, research staff, recruitment, or informed consent processes or materials), to protocolforms, etc. 2.2.1. Elimination of an immediate hazard: An intentional divergence or nonadherence to the protocol that is made in order to eliminate an immediate hazard to one or more research subjects is not considered a protocol deviation. This event must be reported to the HRPP within 2 business days, for confirmation that the research team acted appropriately. (See section 3.2. below for procedure information). 2.3. Adverse Event (AE): Any physical, psychological, economic, or social harm, that may be temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Possibly related to the research: There is a reasonable possibility that the adverse event may have been caused (even partially) by the procedures involved in the research. Adverse events determined to be solely caused by an underlying disease, disorder, or condition of the subject, or other circumstances unrelated to either the research or any underlying disease, disorder, or condition of the subject, would be considered unrelated to participation in the research.

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Note: All AEs resulting from a breach of privacy/confidentiality/data security/loss of study data/destruction of study data must be reported to the HRPP. 2.3.1. Serious Adverse Event (SAE): Any adverse event (as defined in 2.3) that: (a) results in death; (b) is life-threatening (places the subject at immediate risk of death from the event as it occurred); (c) results in inpatient hospitalization or prolongation of existing hospitalization; (d) results in a persistent or significant disability/incapacity; (e) results in a congenital anomaly/birth defect; or (f) based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. 2.4. Unanticipated problem (UP) involving risks to subjects or others: Any unexpected incident, experience, or outcome, that is or may be related to the research, and suggests that the research places subjects or others at a greater risk of physical, psychological, economic, or social harm than was previously known or recognized. Unexpected in terms of the nature, severity, or frequency of the incident given (i) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (ii) the characteristics of the subject population being studied. Possibly related means a reasonable possibility that the event may have been caused (even partially) by the procedures involved in the research. 2.5. Suspension: Temporary withdrawal of IRB approval. Approval may be suspended to the entire human subject research, or aspects of the study, such as suspending subject recruitment. 2.6. Termination: Permanent withdrawal of IRB approval of the human subject research study/protocol.

3. Investigator Procedures A. Whether their protocol is exempt from IRB review or requires IRB review (expedited or convened), investigators conducting human subjects research must take necessary steps to ensure the safety of subjects participating in research. This may include removing a source of harm and/or providing care after a subject has been harmed. All adverse events and unanticipated problems must be reported to the HRPP. B. Investigator(s) must also report to the HRPP: non-compliance, protocol deviations, and subject complaints (as defined in section 2, above). In accordance with TNS Policy and federal regulations, investigators must prospectively receive HRPP exemption or IRB approval, prior to any human subjects research activities. Relatedly, investigators must prospectively receive HRPP exemption or IRB approval of any change to an existing

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protocol, prior to implementing the change, except when necessary to eliminate apparent immediate hazards to the subject (as described above). C. Investigators should contact the HRPP with any questions. 3.1. Incidents of non-compliance, protocol deviation, adverse events (AEs), and unanticipated problems (UPs): 3.1.1. Investigators must inform the HRPP of any of the above-described incidents within 4 business days of investigators' becoming aware of the incident(s). 3.1.2. Investigators must communicate the incident(s) to the HRPP in writing, using either: the "Form: report of incidents and problems," or sending an email with all pertinent information describing the incident (as found in the report Form).  Since agencies generally focus on the adequacy of the actions taken to resolve the problem/incident, including prevention of a similar incident in the future, the PI should clearly describe both (i) the corrective actions taken to resolve the incident, as well as (ii) actions that will help to prevent the incident from happening again. 3.1.3. Depending on the nature or severity of the incident, investigators may need to provide a revised protocol for review. The protocol revisions may be to: the assessment of the risks/harms to subjects, assessment of the research benefits, the process to inform subjects and obtain their consent, the research procedures, the protection of subject privacy, and the measures to protect research data.  Depending on the nature or severity of the incident, investigators may also need to inform subjects who have completed their participation in the research. 3.2. Eliminating an immediate hazard to one or more research subjects: 3.1.4. An investigator may intentionally diverge from the approved protocol in order to eliminate an immediate hazard to one or more research subjects, without prospective HRPP/IRB approval. 3.1.5. This protocol divergence must be reported to the HRPP within 2 business days, for confirmation that: the hazard to subject(s) required immediate action from the investigator, and the research team took appropriate actions to eliminate the immediate hazard. 3.1.6. Investigators must communicate in writing to the HRPP describing: (i) the hazard to one or more research subjects requiring immediate action by the investigator, (ii) the actions taken to eliminate/remove the immediate hazard, and (iii) changes needed to the protocol, if any, to avoid similar occurrences in the future. Investigators provide this information either: using the "Form: report of elimination of an immediate hazard to subjects," or sending an email with all pertinent information describing the incident. 3.1.7. Depending on the nature or severity of the hazard, investigators may need to provide a revised protocol for review. The protocol revisions may be to: the assessment of the risks/harms to subjects, assessment of the research benefits, the

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process to inform subjects and obtain their consent, the research procedures, the protection of subject privacy, and the measures to protect research data.

4. HRPP Procedures 4.1. HPA regulatory categorization and processing TNS Human Protections Administrator (HPA) on the FWA must prioritize the processing of incidents to ensure the protection of human subjects, and to comply with federal and funding agency reporting requirements. 4.1.1. The Human Protections Administrator (HPA) on the FWA will evaluate all pertinent information regarding the incident and the protocol, to perform an initial assessment and regulatory categorization. 4.1.1.1. For all incidents, including the elimination of an immediate hazard to one or more research subjects or allegations of non-compliance, the HPA will use the "Checklist for determining NC, AE, UP, Complaints" to make an initial regulatory categorization (based on definitions in section 2 of this policy). 4.1.1.2. For either exempt or IRB reviewed human subjects research, the HPA may solicit additional expertise as needed to evaluate the incident. This includes but is not limited to, the Institutional Official (IO) on the FWA, the IRB Chair or members, other TNS investigators, staff, or university officials, as well as external sources such as OHRP, funders, government agencies, etc. 4.1.1.3. For either exempt or IRB reviewed human subjects research, the HPA may refer the incident to the IRB for regulatory categorization. 4.1.2. Depending on the initial regulatory categorization, further processing will occur as follows:  See section 4.1.3. for a Determination that the incident does NOT meet the criteria of: non-compliance per 2.1.; protocol violation per 2.2.; adverse event (AE) per 2.3.; unanticipated problem (UP) 2.4.  See section 4.1.4. for Allegations of non-compliance.  See section 4.1.5. for Determination of non-compliance or protocol violation.  See section 4.1.6. for Determination of adverse event (AE).  See section 4.1.7. for Determination of unanticipated problem (UP). 4.1.3. Determination that the incident does NOT meet the criteria of: noncompliance per 2.1.; protocol violation per 2.2.; adverse event (AE) per 2.3.; unanticipated problem (UP) 2.4. (a) The HPA will document the basis for the determination and file within the protocol records.

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(b) The HPA will provide documentation of the determination to the investigator. (c) When applicable, the HPA will inform the IO, IRB, and/or others. See section 5 below, for reporting procedures. 4.1.4. Allegations of non-compliance 4.1.4.1. An "allegation of non-compliance" is a claim of non-compliance (as defined in 2.1) that has not been substantiated. 4.1.4.2. Allegations may come from the investigator(s) working on the protocol, human subjects, TNS staff, or the general public. 4.1.4.3. Allegations/claims of non-compliance will undergo an inquiry relative to the nature and severity of the allegation: (a) When necessary, the HPA will consult with the Institutional Official (IO), IRB Chair, and/or other individuals or entities as appropriate, during the conduct of the inquiry. (b) A report of the inquiry findings will be used in the assessment and regulatory categorization (disposition) of the incident. 4.1.4.4. The HPA may refer an incident directly to the Institutional Official (IO) identified on the FWA; the IO may suspend or terminate a human subjects research protocol if not conducted in accordance with the Terms of Assurance. (See section 4.6.2. below, for more information). 4.1.5. Categorization of non-compliance per 2.1, or protocol violation per 2.2. (a) After categorizing an incident as meeting the criteria of non-compliance, the HPA will review pertinent materials to determine whether or not the incident meets the criteria of: (i) "serious" non-compliance per 2.1.1, and/or (ii) "continuing" non-compliance per 2.1.2. (b) The HPA may solicit additional expertise as needed for assessment and regulatory categorization (disposition) of the incident. 4.1.5.1.

For human subjects research that is exempt from IRB review: (a) The HPA will determine if the corrective actions are sufficient. The HPA may require additional corrective actions, including but not limited to revisions to the protocol. (b) The HPA will document the basis for the determination and file within the protocol records. (c) The HPA will provide documentation of the determination to the investigator. (d) The HPA will provide a report to the IO and others as necessary. See section 5 below, for reporting procedures.

4.1.5.2.

For human subjects research that requires IRB review:

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(a) The HPA will provide to the IRB the regulatory categorization and the basis for the determination. When applicable, the report of the inquiry findings will also be provided. (b) The HPA will provide to the IRB all relevant materials needed for the review of the corrective actions, including but not limited to protocol revisions. 4.1.6. Categorization of adverse event (AE) per 2.3. 4.1.6.1. After categorizing an incident as meeting the criteria of adverse event (AE), pertinent materials will be reviewed to determine whether or not the incident meets the criteria of a serious adverse event (SAE) per 2.3.1. 4.1.6.1.1. All SAE categorizations will be referred to the convened IRB, regardless of whether the human subjects research is exempt from IRB review. 4.1.6.2. If the AE does not meet the criteria of "serious" then processing will occur as follows: 4.1.6.2.1. For human subjects research that is exempt from IRB review: (a) The HPA will determine if the corrective actions are sufficient. The HPA may require additional corrective actions, including but not limited to revisions to the protocol. (b) The HPA will document the basis for the determination and file within the protocol records. (c) The HPA will provide documentation of the determination to the investigator. (d) The HPA will provide a report to the IO and others as necessary. See section 5 below, for reporting procedures. 4.1.6.2.2. For human subjects research that requires IRB review: (a) The HPA will provide to the IRB, the regulatory categorization and the basis for the determination. (b) The HPA will provide to the IRB, all relevant materials needed for the review of the corrective actions, including but not limited to protocol revisions. 4.1.7. Categorization of unanticipated problem per 2.4. 4.1.7.1. Any incident meeting the criteria of an unanticipated problem will be referred to the convened IRB, regardless of whether the human subjects research is exempt from IRB review.

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4.2. Referral to the IRB for review of the incident 4.2.1. Based on the initial assessment and regulatory categorization, the Human Protections Administrator (HPA) may refer incidents to the IRB for further review and final disposition. 4.2.2. Depending on the nature and severity of the incident, the incident will be referred to either: (a) the IRB chair, or (b) a subcommittee of the IRB, or (c) the convened IRB. 4.3. IRB incident review procedures 4.3.1. The Chair, subcommittee of the IRB, or convened IRB will review the information provided by the investigator, the initial assessment and regulatory categorization of the HPA, the protocol, and all other materials pertinent to the incident. 4.3.2. The Chair, subcommittee of the IRB, or convened IRB may solicit additional expertise as needed to evaluate the incident and determine appropriate corrective actions. 4.3.3. See the following sections for IRB review of: Determination of non-compliance or protocol deviation (section 4.4.), and Unanticipated problem involving risks to subjects or others (section 4.5.). 4.3.4. After assessing the incident, the IRB must determine appropriate corrective actions, to reduce the possibility of a repetition of the incident. This may include, but is not limited to, revision of the protocol, investigator training, or other actions. 4.3.5. Depending on the nature, severity, or frequency of the incident, the IRB may suspend or terminate the study; see section 4.6. below. 4.4. Determination of non-compliance or protocol deviation A determination of non-compliance is based on the criteria described in this Policy; the criteria come from federal regulations and guidance documents. As described in section 4.1 above, this regulatory categorization is made by the HPA, who may solicit additional expertise as needed to evaluate the incident. 4.4.1. The review by the IRB pertains to the human subject research protocol, particularly the evaluation of risks and benefits, and changes to the protocol that may be required. 4.4.1.1. Depending on the nature, severity, or frequency of the non-compliance, the IRB should consider whether the protocol still satisfies the requirements for IRB approval per TNS policy, or when applicable, HHS regulations at 45 CFR 46.111. 4.4.2. After assessing the incident, the IRB must determine appropriate corrective actions, to reduce the possibility of a repetition of the incident. This may include, but is not limited to, revision of the protocol, investigator training, or other actions. 4.4.2.1. The protocol revisions may be to: the assessment of the risks/harms to subjects, assessment of the research benefits, the process to inform subjects

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and obtain their consent, the research procedures, the protection of subject privacy, and the measures to protect research data. 4.4.2.2. Depending on the nature, severity, or frequency of the incident, the IRB may determine that one or more investigators do not have the appropriate expertise to conduct the protocol. In such cases, the IRB may temporarily or permanently disallow the investigator(s) from conducting the current protocol, or similar future research. 4.4.2.2.1. The IRB may determine the training necessary for the investigator(s) to be allowed to conduct the research procedures. Reinstatement of study staff to conduct the research must be reviewed and approved by the IRB via expedited or convened procedures. 4.4.3. Data gathered using procedures determined to be non-compliant 4.4.3.1. Federal regulations and TNS policy require prospective HRPP exemption or IRB approval of human subjects research. Federal regulations and TNS policy have no mechanism for retroactive approval of human subjects research. 4.4.3.1.1. Also note that any activities conducted on an expired protocol (lapse of IRB approval) are considered conduct of human subjects research prior to IRB approval. 4.4.3.2. While the IRB will not require any investigator to destroy data, or place restrictions on the presentation or publication of data, investigator(s) must understand that: 4.4.3.2.1. Any use of data (a thesis, presentation, or publication) gathered prior to either HRPP exemption or IRB approval may not be represented to any entity* as having IRB approval, or as having been collected in accordance with IRB approved procedures. 4.4.3.2.2. Any use of data (a thesis, presentation, or publication) gathered using procedures determined to be non-compliant, may not be represented to any entity* as having IRB approval, or as having been collected in accordance with IRB approved procedures. *Entities include but are not limited to: editors of journals/publications, future grant proposals, university departments or committees, etc. 4.5. Unanticipated problems involving risks to subjects or others (UP) 4.5.1. Any unanticipated incident, experience, or outcome that places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized must be reviewed by the convened IRB. 4.5.2. During the review of an adverse event, the IRB must also consider if the incident is an unanticipated problem involving risks to subjects or others (UP). 4.5.2.1. Is the adverse event unexpected?

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Unexpected adverse event: Any adverse event occurring for one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either: (1) the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; OR (2) the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event. 4.5.2.2. Is the adverse event related or possibly related to participation in the research? Possibly related to the research means there is a reasonable possibility that the adverse event, incident, experience, or outcome may have been caused by the procedures involved in the research. 4.5.2.3. Does the adverse event suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized? Determine if the adverse event is serious, per definition 2.3.1. Serious Adverse Event (SAE). 4.5.3. IRB determination that the incident, experience, or outcome is an unanticipated problem involving risks to subjects or others (UP): 4.5.3.1. The IRB must consider if substantive changes are required (i) to the research protocol, or (ii) to the informed consent process/document, or (iii) if other corrective actions are needed. 4.5.3.2. Examples of corrective actions or substantive changes that might need to be considered in response to an unanticipated problem include: (a) changes to the research protocol initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects; (b) modification of inclusion or exclusion criteria to mitigate the newly identified risks; (c) implementation of additional procedures for monitoring subjects during and after the research; (d) suspension of enrollment of new subjects; (e) suspension of research procedures in currently enrolled subjects; (f) modification of informed consent documents to include a description of newly recognized risks; (g) provision of additional information about newly recognized risks to previously enrolled subjects;

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(h) temporarily or permanently disallowing the investigator(s) from conducting the current protocol, or similar future research; (i) other actions, as appropriate to the incident. 4.5.4. While reviewing the UP, the IRB should consider whether the affected research protocol still satisfies the requirements for IRB approval per TNS policy, or when applicable, HHS regulations at 45 CFR 46.111. 4.5.4.1. In particular, the IRB should consider (i) whether risks to subjects are still minimized and reasonable in relation to the anticipated benefits, if any, to the subjects and (ii) the importance of the knowledge that may reasonably be expected to result. 4.5.5. In accordance with federal regulations, the IRB has authority to require as a condition of continued approval, submission of more detailed information by the investigator(s), sponsor, the study-coordinating center, or Data Safety Monitoring Board (DSMB), about any adverse event or unanticipated problem occurring in a research protocol. See HHS regulations at 45 CFR 46.109(a). 4.6. Suspension or Termination of a human subject research study 4.6.1. In addition to the determinations described in Section 4.3.3, the IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with federal regulations, the IRB’s requirements, or that is associated with unexpected serious harm to subjects.52 4.6.1.1. The IRB Chair, Subcommittee of the IRB, or the Institutional Official (IO), may refer a human subjects research protocol to the convened IRB, for consideration of suspension (per 2.5.) or termination (per 2.6.). 4.6.1.2. Determinations to suspend or terminate approval of research will be made by the IRB during a convened meeting (in accordance with convened IRB meeting procedures). 4.6.1.2.1. The lifting of a suspension will be made by the IRB during a convened meeting (in accordance with convened IRB meeting procedures). 4.6.2. The Institutional Official (IO) identified on the FWA is authorized to represent the institution, and must assure that human subjects research to which the FWA applies is conducted in accordance with the Terms of Assurance. As such, the IO may suspend or terminate a human subjects research protocol if it is not conducted in accordance with the Terms of Assurance. 4.6.2.1. Examples for IO suspension/termination include (but are not limited to): removing immediate hazards to research subjects during an investigation of non-compliance, or determination of investigator misconduct. 4.6.2.2. Any suspension or termination by the IO will be promptly reported to the IRB. 52

45 CFR 46.113

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4.6.2.3. In accordance with the Terms of Assurance and federal regulations, the IO may not approve a protocol that the IRB has suspended or terminated. 4.6.3. A suspension or termination of IRB approval may occur at any time during the period for which IRB approval had already been given.53 4.6.4. The basis for the determination will be documented and filed within the protocol records, and when applicable, in the IRB meeting minutes. 4.7. Documenting and communicating the disposition of the incident review 4.7.1. The Human Protections Administrator (HPA) will ensure that the final disposition, and the basis of the determination, are appropriately documented in the protocol record, and when applicable, in the IRB meeting minutes. 4.7.2. The HPA will provide documentation of the final disposition and the basis of the determination to the PI/research team. 4.7.3. The HPA will report the disposition of incident review determinations to the appropriate institutional officials, federal regulators, funding agencies, and sponsors, as applicable. See Section 5 (below) for reporting procedures.

5. Reporting to External and Internal Entities TNS Human Protections Administrator (HPA) on the FWA will report and respond to all external agencies in accordance with applicable regulations, laws, funding agency and sponsor policies. 5.1. Federally funded, conducted, or supported non-exempt human subjects research 5.1.1. In accordance with 45 CFR 46.103(a) and (b)(5), incidents that have been determined to meet the following criteria will be promptly reported to the HHS Office for Human Research Protections (OHRP), Division of Compliance Oversight:  Any unanticipated problems involving risks to subjects or others; or  Any serious or continuing noncompliance with federal policy or the requirements or determinations of the IRB; or  Any suspension or termination of IRB approval. 5.1.1.1. In consultation with the Institutional Official (IO) identified on the FWA, the Human Protections Administrator (HPA) on the FWA will report these incidents to OHRP on behalf of The New School. 5.1.1.2. In addition to OHRP, other regulatory agencies, funding agencies, sponsors, external collaborators, other institutional officials, or other individuals/entities will be included in the communication, as applicable. 5.1.2. In accordance with OHRP guidance, determinations of (i) Unanticipated problems involving risks to subjects or others, or (ii) Serious or continuing

53

2010 OHRP Guidance on IRB Continuing Review of Research, Section D.

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noncompliance with federal policy or the requirements or determinations of the IRB, or (iii) Suspension or termination of IRB approval will be reported within 30 days, or sooner when possible. 5.1.2.1. For a more serious incident, a prompt report to OHRP may need to occur within days. In such circumstances, the HPA may send an initial report and indicate that a follow-up or final report will be followed by the earlier of: a specific date, or when an investigation has been completed or a corrective action plan has been implemented. 5.1.3. In accordance with OHRP guidance, the following information will be provided in the report to OHRP: 5.1.3.1.

For unanticipated problems involving risks to subjects or others (UP):  Name of the institution (e.g., university, hospital, foundation, school, etc.) conducting the research;  Title of the research project and/or grant proposal in which the problem occurred;  Name of the principal investigator on the protocol;  Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);  A detailed description of the problem; and  Actions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, etc.).

5.1.3.2.

For serious or continuing noncompliance:  Name of the institution (e.g., university, hospital, foundation, school, etc.) conducting the research;  Title of the research project and/or grant proposal in which the noncompliance occurred, or, for IRB or institutional noncompliance, the IRB or institution involved;  Name of the principal investigator on the protocol, if applicable;  Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);  A detailed description of the noncompliance; and

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5.1.3.3.

Actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator, educate all research staff, educate the IRB or institutional official, develop or revise IRB written procedures, suspend the protocol, suspend the investigator, conduct random audits of the investigator or all investigators, etc.).

For suspension or termination:  Name of the institution (e.g., university, hospital, foundation, school, etc.) conducting the research;  Title of the research project and/or grant proposal that was suspended or terminated;  Name of the principal investigator on the protocol;  Number of the research project assigned by the IRB that was suspended or terminated and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);  A detailed description of the reason for the suspension or termination; and  The actions the institution is taking or plans to take to address the suspension or termination (e.g., investigate alleged noncompliance, educate the investigator, educate all research staff, require monitoring of the investigator or the research project, etc.).

5.2. For all TNS human subjects research (Including non-Federally funded, conducted, or supported research) 5.2.1. For all regulatory categorizations (of non-compliance per 2.1.; protocol violation per 2.2.; adverse event (AE) per 2.3.; unanticipated problem (UP) 2.4.):  The HPA will send an email to inform the IO of all regulatory categorizations made using this policy.  For non-exempt studies, the IRB Chair will be included on the communication.  For protocols under the direction of a Faculty Advisor (FA), the FA will be included on the communication.  For funded protocols, the funding agency will be included on the communication in accordance with the terms of the award.  For collaborative studies with sites other than The New School, the responsible individual(s) at the collaborative site(s) will be included on the communication. 5.2.2. Additional reporting:

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  

For dispositions of non-compliance, the Divisional/Department lead will be included on the communication. For studies that are suspended or terminated, by either the IRB or the IO, the Divisional/Department lead will be included on the communication. For other federal, state, institutional, or other entities or authorities as necessary, will be included on the communication when applicable.

6. Subject Complaints Subjects have the right to complain if they believe that they were treated unfairly, were placed at more risk than was agreed upon at the beginning of the research, or if they believe the research was conducted contrary to ethical and regulatory requirements.  Complaints may come from many different sources, including but not limited to the subjects participating in the research or their family members, the research team, IRB members, employees of The New School, the media, the general public, or anonymous sources.  Complaints are most often received via email, via telephone, or in-person. 6.1. Notifying the HRPP/IRB of a Complaint 6.1.1. The recipient of a complaint contacted via telephone or in-person should gather and document as much information as possible, to be able to inform the HRPP. 6.1.2. The recipient of a complaint should notify the HRPP within 1 business day of being informed of a subject complaint. 6.2. HRPP Review Process 6.2.1. All subject complaints forwarded to the HRPP will undergo an inquiry by the HRPP. 6.2.2. Each inquiry will be conducted on a case-by-case basis, appropriate to the complaint. 6.2.3. The inquiry will be conducted in consultation with the Institutional Official (IO). The HPA will provide pertinent information about the complaint, including the research protocol. 6.2.4. When appropriate, the inquiry will be conducted in consultation with other individuals/entities (for example, a complaint about a data-security breach may involve IT). 6.2.5. The results of the inquiry will determine further actions to be taken, which may or may not involve other sections of this policy (for example, allegations of noncompliance). 6.2.6. In accordance with other sections of this policy, the HPA will document the basis for any determination(s), provide documentation to the investigator, and inform internal and external entities, as appropriate.

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7. Conduct of HS Research Prior to HRPP Exemption or IRB Approval Federal regulations and The New School (TNS) Policy require prospective HRPP exemption or IRB approval of human subjects research.54 The regulations do not allow any retrospective approval of human subjects research. Therefore, any activities conducted prior to receipt of either HRPP exemption or IRB approval constitute non-compliance with federal regulations and TNS policy. 7.1. PI Procedures 7.1.1. In accordance with Federal regulations and TNS Policy, investigators at The New School (TNS) must receive either HRPP exemption or IRB approval prior to initiating any human subjects research55 (including any subject recruitment). See the Review Procedures of the HRPP Manual, for information regarding the review of human subjects research by the HRPP/IRB. 7.1.2. Also note that any activities conducted on an expired protocol (lapse of IRB approval) are considered conduct of human subjects research prior to IRB approval. 7.1.3. In accordance with Federal regulations and TNS Policy, investigator(s) must report non-compliance to the HRPP (see section 3.B. of this Policy). 7.2. HRPP Procedures 7.2.1. Any conduct of human subjects research prior to HRPP exemption or IRB approval must be reported to the HRPP. This report may come from the PI/research team, IRB members, or other individuals. In cases where HRPP staff are not notified, but discover the initiation of human subjects research prior to HRPP exemption or IRB approval, the HRPP will follow the same procedures. 7.2.2. The HRPP will conduct an inquiry in accordance with section 4.1.4. Allegations of non-compliance. Each inquiry will be conducted on a case-by-case basis appropriate to the situation. 7.2.3. The inquiry report will be provided to the Institutional Official (IO), and when applicable, to the IRB Chair, within 5 business days. 7.2.4. The HRPP will provide a summary of what has occurred to the IO, and when applicable, to the IRB Chair, within 5 business days. 7.2.5. The Human Protections Administrator (HPA) will ensure that the incident is documented and communicated in accordance with section 4.7. of this policy, and reported accordingly.

54

See the Section B: Review Procedures of this HRPP Manual, for information regarding the review of human subjects research by the HRPP/IRB. 55 To determine whether an activity constitutes human subjects research, please refer to the section titled "Determining which activities are subject to review and oversight by The New School Human Research Protection Program (HRPP)."

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7.2.6. The review of the inquiry report and all pertinent materials by the IO (and when applicable, to the IRB Chair), will determine further actions, (including but not limited to sections 4.3. of this policy). 7.3. Use of data gathered prior to either HRPP exemption or IRB approval 7.3.1. While the IRB will not require any investigator to destroy data, or place restrictions on the presentation or publication of data, investigator(s) must understand that: 7.3.1.1. Any use of data (in a thesis, presentation, or publication) gathered prior to either HRPP exemption or IRB approval may not be represented to any entity as having IRB approval, or as having been collected in accordance with IRB approved procedures. Entities include but are not limited to: editors of journals/publications, future grant proposals, university departments or committees, etc. 7.4. Reporting conduct of HS research prior to HRPP Exemption or IRB approval 7.4.1. TNS Human Protections Administrator (HPA) on the FWA will report to External and Internal entities, in accordance with section 5. of this policy.

References:  Code of Federal Regulations, 45 CFR Part 46, Protection of Human Subjects  The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research  Federal Policy for the Protection of Human Subjects ('Common Rule')  OHRP 2007 Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events  OHRP 2011 Guidance on Reporting Incidents to OHRP  OHRP 2010 Guidance on IRB Continuing Review of Research  OHRP IRBs and Assurances  OHRP Assurance Process - FAQs  OHRP Investigator Responsibilities - FAQs

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