North Shore-Long Island Jewish Health System Institutional Review Board s1

North Shore-Long Island Jewish Health System Institutional Review Board

Reportable Event Form

THIS FORM MUST BE TYPED. THE IRB WILL NOT ACCEPT HANDWRITTEN FORMS.

How to Use this Form: Please read this background information before completing this form

IRB’s are required by federal law to notify federal agencies when a certain type of event occurs in a research study at their institution. These events are called “reportable events.” This form is designed for researchers to submit a potential reportable event to the IRB for review.

There are three categories of reportable events, and each category is described below. Events can fall into more than one category.

1.  Unanticipated problems involving risks to subjects or others (UPIRTSO). A UPIRTSO is an event that meets all of the following three criteria:

A.  Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

AND

B.  Related or possibly related to participation in the research [i.e., there is a reasonable possibility (more likely than not) that the incident, experience, or outcome may have been caused by the procedures involved in the research];

AND

C.  Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

In general, a UPIRTSO warrants consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others.

2.  Serious noncompliance (SNC). Serious noncompliance occurs when an incidence of non-compliance creates any of the following three conditions:

A.  Creates an increase in risks to subjects

OR

B.  Adversely affects the rights, welfare or safety of the research subjects

OR

C.  Adversely affects the scientific integrity of the study.

Willful violation of policies and/or federal regulations may also constitute serious noncompliance.

3.  Continuing noncompliance (CNC). Continuing noncompliance occurs when there exists a pattern of non-compliance that if allowed to continue is likely to increase risk to subjects, adversely affect the rights, welfare and safety of research subjects, or adversely affect the scientific integrity of the study.

There are a wide variety of events that may qualify as a reportable event. For instance a major protocol violation that increases risks to subjects could be serious noncompliance. Another example would be a lost study laptop that contains study information; this may qualify as an unanticipated problem involving risks to subjects are others, but it may also qualify as serious noncompliance if the laptop was not encrypted as institutional policy requires. A serious adverse event that meets all the criteria of a UPIRTSO would also qualify as a reportable event. It is important to note regarding serious adverse events, however, that most SAEs do not qualify as reportable events because they are expected by the investigator’s brochure or consent form. So adverse events should only be reported to the IRB when they meet all the criteria of a UPIRTSO.

How to Use this Form (cont’d)

The following pages of this form contain the most common types of reportable events. If you believe your event does not fall into any of the types listed, but that it meets one of the three categories on page 1 of this form, then described the event in Section A, #9 “Other.”

Use this form to help you decide if your event is reportable, and if you should submit this form to the IRB. If you have any questions, contact your IRB office and we can help you decide.

Below are definitions that may be helpful in completing the form, as well as instructions on how to submit the form

Definitions

Unanticipated

An event is unanticipated when its specificity or severity is not consistent with the current investigator brochure, protocol, consent form, package insert or label or unanticipated in its frequency, severity, or specificity* and the characteristics of the subject population being studied.

*Note: If an anticipated event has changed in specificity or severity and is no longer consistent with the current investigator’s brochure, protocol or consent form it is now an UNANTICIPATED EVENT.

Related

An event is related to a research procedures if in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures or if it is more likely that not that the event affects the rights and welfare of current participants.

Harmful

Caused harm to participants or others, or placed them at increased risk of harm (including physical, psychological, economic or social harm). The harm does not have to be a direct harm to be reportable. The harm, as assessed by the PI has presented increased risk (e.g., losing a laptop with subject data). Additionally the harm doesn't have to be the harm to subjects it could involve risk to others (researchers, technicians, bystanders, the public, etc.).

Note: non-medical events (e.g., breach of confidentiality, emotional breakdown, loss of insurance, imprisonment etc.). if unanticipated - would also be reportable to the IRB.

Adverse Event

Any physical, psychological or social harm to subjects during the course of research.

Submission Instructions for NSLIJ IRB

This form may be submitted through email to the IRB at: . Please contact the IRB at 516-321-2100 with any questions.

Date of Submission:

Principal Investigator

Fax #:

PROTOCOL TITLE:

IRB Number:

1.  Major Protocol Deviation that meets one or more of the following criteria

·  The deviation could have potentially affected the subject’s safety or potentially put the subject at increased risk; AND/OR

·  Affects the integrity of study data; AND/OR

·  May affect a subject’s willingness to participate in the study.

Please cite the protocol page or section that was deviated from:

Examples: Enrollment of a subject who did not meet all inclusion/ exclusion criteria; performing a study procedure not approved by the IRB; drug/study medication dispensing or dosing error; or failure to perform a required lab test or conducting a study visit outside the required timeframe, if, in the opinion of the investigator, may affect subject safety and/or data integrity). Only internal major protocol deviations should be reported to the IRB.

Please note: If the deviation does not affect subject safety, the integrity of study data, or a subject’s willingness to participate, it should be reported as a minor deviation at the time of continuing review, on the Protocol Deviation Log. This log is available for download on the IRB forms page.

2.  Change to the IRB approved protocol – taken without prior IRB review to eliminate apparent hazard to a research subject(s) (e.g. purposeful and for subject safety). Only internal protocol changes should be reported to the IRB.

3.  Publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected change to the risks or potential benefits of the research, in terms of severity or frequency.

4.  Investigator- or Sponsor-initiated study suspension or hold

5.  Adverse Event that meets the criteria of being a UPIRTSO (Unanticipated Problem Involving Risk to Subjects or Others) as defined on page 1 of this form.

Please note: If the adverse event does not meet all 3 criteria of the UPIRTSO definition on page 1 of this form, the event should not be reported to the IRB. However the study team may need to report the event to a DSMB or Study Sponsor.

6.  Unanticipated Adverse Device Effect (Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects).

7.  Complaint of a subject that indicates unexpected risks or that cannot be resolved by the research team. Only internal subject complaints should be reported to the IRB.

8.  Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research study.

9.  Other event that may qualify as an Unanticipated Problem Involving Risks to Subjects or Others (as defined on page 1 of this form): Please explain:

1.  Indicate where this study is taking place:

Single site

Multi-site;

If Multi-site

Event occurred here

Event occurred off-site

2.  This is a follow-up report:

Yes; original report date was:

No; Date Event occurred:

3.  Protocol involves:

Investigational Drug, IND #

Investigational Device, IDE#

Investigator Initiated

None

4.  What is the status of study and recruitment?

Open to accrual

Closed to accrual, but subjects are still receiving a required research intervention (drug, device, or biologic)

Closed to accrual, no subjects receiving a required research intervention (drug, device, or biologic), but subjects are still undergoing follow-up

Closed to accrual and no subjects receiving required research intervention (drug, device, or biologic) or follow-up; data analysis is ongoing

Other (please explain):

5.  Number of Active Subjects or N/A

1.  Date of Event: Date Notified:

2.  Site: On-site. Site where event occurred: Subject ID (if applicable):

External Site

3.  Report: Initial Report

Follow-up Report

4.  Provide a description of the event and include information as to whether or not the event has resolved:

5.  Could the event have affected a subject’s willingness to participate in the study?

Yes à Please explain:

No à Please explain:

6.  Did the event compromise the validity of the data, for the study as a whole?

Yes à Please explain why it compromised the validity of the data:

No à Please explain why it DID NOT compromise the validity of the data:

7.  Did the event have the potential to negatively affect the subject’s safety OR potentially put the subject at increased risk?

Yes à Please explain why the event had the potential to negatively affect the subject’s safety OR potentially put the subject at increased risk:

No à Please explain why the event DID NOT have the potential to negatively affect the subject’s safety and DID NOT potentially put the subject at increased risk:

8.  Is this an unanticipated problem involving risks to subject’s or others (UPIRTSO)? See page 1 for guidance.

Yes à Please explain why it meets the definition of an UPIRTSO:

No à Please explain why it does not meet the definition of an UPIRTSO:

9.  Explain the corrective measures taken as a result and the preventive measures to be taken to prevent recurrence in the future (if possible), how this was (or will be) resolved, and whether the sponsor was notified of this (if applicable):

Please indicate any actions that will be taken as a result of this report (check all that apply):

1.  Will the consent form be revised? Please note: This is required for an adverse event that is not consistent with the current informed consent document and/or available literature (e.g. drug/investigational brochure, protocol, publications), including any change in its severity and/or frequency.

Yes à Please submit an Application for Requested Modifications, requesting the revisions. If the amendment cannot be submitted at this time (e.g. requires sponsor approval first), please explain:

No à Please explain why it is not appropriate to revise the consent:

2.  Will currently enrolled subjects be notified or re-consented?

Yes

a.  Please attach a copy of the notification

b.  Please explain when and how subjects will be notified: .

c.  Please explain how such notification will be documented: .

No à Please explain why it is not appropriate to notify currently enrolled subjects:

3.  Will the protocol be revised?

Yes à Please submit an Application for Requested Modifications, requesting revisions to the protocol. If the modification cannot be submitted at this time (e.g. requires sponsor approval first), please explain:

No à Please explain why it is not appropriate to revise the protocol:

4.  Will other corrective and/or preventive action be taken?

Yes à Please explain what other corrective and/or preventative action will be taken:

No

PI Signature

I attest the information provided on this form is true and accurate.

______

PI Printed Name PI Signature Date

FOR IRB USE ONLY

Action: No actions required – event report acknowledged, as is; this does not constitute an unanticipated problem involving risk to subjects or others, serious non-compliance or continuing non-compliance.

______

Reviewer Name Reviewer Signature Review Date

Version: 10/31/14 Page 5 of 5