Research@UIC > Protocol Review > IRB > FAQs

FAQs

Engaged and Non-Engaged Research Sites

Should I consider UIC as a site engaged in my research?
Why does it matter if an external (non-UIC) site is engaged or not engaged in my research?
When is an external (non-UIC) site considered to be engaged in research?
When is an external (non-UIC) site not considered to be engaged in research?

Unanticipated Problems and Other Events Requiring Promptly Reporting to the IRB

When should unanticipated problems be reported to the IRB?
Should I report the external (i.e., from non-UIC study sites) IND safety reports or serious adverse event reports sent to me by the study sponsor to the IRB using the Event Requiring Prompt Reporting to the IRB form?
Who can I contact if I have questions or need help in completing the Event Requiring Prompt Reporting to the IRB form?
What are other types of events that need to be reported to the IRB promptly?
Are there events that require reporting to the IRB, but just not prompt reporting?

Safety and Reporting Protocol

My study sponsor is questioning whether or not I need to submit IND safety reports to the IRB. Can you clarify UIC’s policy on IND Safety Reports?
I am receiving a monthly safety statement from the study sponsor’s Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC). Do CIOMS reports need to be reported to the IRB?
Do safety results from animal studies need to be submitted to the IRB? If so, how should they be reported?

Making Changes to IRB-Approved Research Study

I want to make a change in my IRB-approved research study; what do I need to do?
My IRB-approved protocol involves a retrospective review of medical records under waivers of informed consent and HIPAA authorization. I’ve finished the review but didn’t get enough data, and I need to review more records. What am I required to do?

Engaged and Non-Engaged Research Sites

Should I consider UIC as a site engaged in my research?
Yes, if you are faculty, staff, or a student at UIC conducting research, you should consider UIC an engaged site. This would include all UIC academic and biomedical units; including training and research units, field offices, and clinics even though they may not be physically situated on the UIC campus.
Why does it matter if an external (non-UIC) site is engaged or not engaged in my research?
All sites engaged in research conducted by UIC personnel (faculty, staff, and/or students) must be evaluated to determine the level of IRB oversight necessary to include the external site in the research. If an external site does not have an IRB of its own, extra steps must be taken to determine if the UIC IRB will provide oversight of that outside site.
When is an external (non-UIC) site considered to be engaged in research?
The answer is largely determined by the research activities being performed at the outside site and by whom. If personnel (employees, staff, and/or students) of the external site are active in the research activities, then that site is engaged for research purposes. Active involvement in research can include implementing and evaluating an intervention (e.g., an exercise program, an educational curriculum, a clinical trial) and/or gathering identifiable data (e.g., information from school or medical records, biomedical samples, personal information gathered during surveys, interviews, focus groups, or observations).

It is important to remember, however, that active can be broadly interpreted. A few common examples include:
- Obtaining identifiable data or gathering samples via non-UIC personnel who have routine access to data or subjects at non-UIC sites. For example, a nurse at a non-UIC site may gather data from medical records or draw biomedical samples that will be passed on to the UIC investigator as data. Although no UIC researcher may ever go to the non-UIC site to collect the data, that non-UIC site would generally be considered engaged.
- Obtaining data or gathering samples that are “de-identified” or “coded” from an outside site may still render the site engaged. Removing obvious identifiers, such as names and addresses, is not considered sufficient for the de-identification of data. Subject data may be considered indirectly identifiable if the cumulative characteristics being gathered could render a subject identifiable. For example, if there are only a few Asian, female, 30-40 year olds in a dataset of banking administrators, then those subjects might be considered identifiable. Likewise, coding samples or data, particularly when a “master list” of identifiers exists – even if the “master list” is only at the non-UIC site, is not considered sufficient for the deidentification of data.
- Additional thought must always be taken regarding the collection of protected health information (PHI) from a site outside UIC. PHI is, by definition, considered identifiable data and guidelines regarding the collection, transmission, and use of PHI for research at UIC is governed by HIPAA.
For detailed guidance regarding the engagement of outside sites in UIC-based research, please refer to the OHRP website at www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.
When is an external (non-UIC) site not considered engaged in research?
Again, in terms of research activities, if external personnel’s participation is limited to passive research activities, then the outside site is probably not engaged. Passive involvement in research most commonly includes posting flyers or leaving contact information at an outside site or an outside site allowing UIC researchers to use its facilities (not its personnel) to interview, survey, or observe subjects.

When interpreting the meaning of passive activities at outside sites, it will be important to keep in mind the following:
- Recruiting subjects at outside sites should not involve personnel at outside sites in obtaining consent from subjects or disclosing identifiable information about subjects (such as contact information). The recommended approach to recruiting subjects at a non-engaged outside site is to provide contact information for the UIC investigator via a flyer or information sheet posted at the outside site and to have potential subjects at the outside site contact the UIC researcher, not vice versa.
- A “third party” outside site (with no ties to UIC or to the site where the data was originally collected) may gather de-identified and un-coded data or samples and transmit them to the UIC investigator, and remain a nonengaged site, only if the “third party” outside site has no access to the coded “master list” and/or is a commercial or professional entity (such as ICPSR or the US Census Bureau) that abides by recognized standards for maintaining privacy and confidentiality. Thus, for example, a “third party” laboratory, databank, or government entity may gather and send deidentified, un-coded data to the UIC investigator without being an engaged site.
For detailed guidance regarding when outside sites are not engaged in UIC based
research, please refer to the OHRP website at www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.

As always, each protocol is different and the UIC OPRS encourages you to seek out specific guidance regarding your protocol after consulting these FAQs and the OHRP website.

Unanticipated Problems and Other Events Requiring Promptly Reporting to the IRB

When should unanticipated problems be reported to the IRB?
Federal Regulations require that all unanticipated problems involving risks to subjects or others be promptly reported to the IRB. Unanticipated problems involving risks to subjects or others (UPIRSOs) are research related incidents that may impact the rights, safety, or welfare of subjects or others. The three criteria which must be present for an adverse event or other problem to be an UPIRSO include: 1) it is not expected in terms of either its nature, severity or frequency; 2) it is related or possibly related to participation in the research; and 3) it suggests that the research places subjects or others at greater risk of harm than was previously known or recognized.

An unanticipated problem requiring promptly reporting may occur in both biomedical and social/behavioral research, and may impact the overall risk or harm associated with the research by affecting the physical, financial, legal, social, emotional or psychological well being of the subject.

Examples of an unanticipated problem requiring prompt reporting to the IRB include a breach of confidentiality due to the loss of a laptop with individually identifiable subject data, identification of a unique adverse effect in a clinical trial, occurrence of a known side effect at a higher than expected frequency, a subject complaint when the complaint indicates unexpected risks or cannot be resolved by the investigators, and a research team member experiences harm in the conduct of the study.

UIC policy requires that all internal (happening at a UIC site), serious (e.g., death, life threatening, persistent or significant disability) )unanticipated problems and adverse events be reported within 5 working days of discovery of the incident using the “Prompt Reporting to the IRB” form. Other events must be reported within 10 working days of discovery.
Should I report the external (i.e., from non-UIC study sites) IND safety reports or serious adverse event reports sent to me by the study sponsor to the IRB using the Event Requiring Prompt Reporting to the IRB form?
Generally, no. Under the UIC policy, IND safety reports and external serious adverse event reports do not require prompt reporting to the IRB, unless the investigator, sponsor or monitoring entity (DSMB, DMC Medical Monitor) has determined that the individual event meets the criteria for an UPIRSO (unanticipated, related and increased risk of harm) and provides written documentation to support that determination. However, per the Federal regulations, you should retain the information in your study files.

On the other hand, adverse events occurring internally (i.e., UIC sites) require reporting when determined by the investigator to be unanticipated and related to the research.
Who can I contact if I have questions or need help in completing the Event Requiring Prompt Reporting to the IRB form?
Contact OPRS at 312-996-1711 for assistance when reporting any events requiring prompt reporting that occur in your research.
What are other types of events that need to be reported to the IRB promptly?
In addition to UPIRSOs (local or from non UIC sites), events that should be reported promptly include unanticipated adverse device effects, protocol violations (i.e., those that impact subject safety, compromise integrity of study data, or affect subject’s willingness to participate), protocol deviations made to eliminate an apparent immediate hazard to a research participant, breach of confidentiality, complaints made by research participants indicating an unanticipated risk or that cannot be resolved by the research staff, VA reportable events, new information indicating an unexpected change to the risks or benefits of the research, withdrawal of a FDA marketed agent, incarceration of a research subject, and non-compliance.
Are there events that require reporting to the IRB, but just not prompt reporting?
Yes. Local (internal) serious adverse events that are anticipated and/or not related to the research do not require prompt reporting, but are reported at the time of continuing review. Additionally, DSMB reports and adverse event summary reports for NIH funded multicenter clinical trials that do not require a change to the research should be submitted with the continuing review applications, but do not require prompt reporting.

Safety and Reporting Protocol

My study sponsor is questioning whether or not I need to submit IND safety reports to the IRB. Can you clarify UIC’s policy on IND Safety Reports?
UIC’s reporting policy has been revised to reflect the new federal guidelines on this matter, which state that only unanticipated problems involving risks to subjects or others (UPIRSOs) need be reported to the IRB. IND Safety Reports do not need to be submitted to the IRB if they do not clearly meet the definition of an UPIRSO. If the investigator, sponsor or monitoring entity has determined that the individual safety report represents an UPIRSO, then the report must be submitted and include sufficient information about the event for the IRB to evaluate the event in the context of the local study (e.g., detailed description of the event, incident and the outcome, the basis for determining the event is an UPIRSO, and a description of any changes to the protocol or consent or corrective actions that may need to be taken).

The policy regarding events require prompt reporting, reporting form and a letter to send to your study sponsor describing UIC’s policy are available on the OPRS website.
I am receiving a monthly safety statement from the study sponsor’s Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC). Do CIOMS reports need to be reported to the IRB?
CIOMS reports or monthly safety statements do not need to be reported to the IRB if they provide no new information about the research, and/or no additional or increased risks are discovered. DSMB/DMC updates received from the sponsor should be reported using the Prompt Reporting Form only if the DSMB requests a change in the research protocol and/or consent document. If the report shows no changes to the research and/or reports no adverse information, the report should be retained in your study files and reported in summary at the time of continuing review.
Do safety results from animal studies need to be submitted to the IRB? If so, how should they be reported?
Generally, individual IND safety reports reflecting data derived from animal testing do not represent UPIRSOs and would not need to be submitted to the IRB promptly. Results obtained from tests in laboratory animals only need to be reported if the data provides new information or describes new risks that human research subjects and the IRB should be aware of and that is not currently present in the protocol, Investigator’s Brochure and/or the informed consent document. If there is new risk information then you may also need to submit an amendment to revise the research protocol, Investigator’s Brochure, and/or consent documents. Currently and/or previously enrolled subjects may also need to be informed of this new information.

Making Changes to IRB-Approved Research Study

I want to make a change in my IRB-approved research study; what do I need to do?
Complete an amendment form: All changes in IRB approved research require the submission of an amendment form. The amendment form should not only list all proposed changes, but should provide the reason or justification for the changes.

Revise study documents: In addition to completing an amendment form, you should also modify all applicable study documents (research protocol, research application form, recruitment materials, consent and/or authorization forms as necessary) to reflect the changes being proposed in the amendment. When revising study documents, please follow the Instructions for Amendments to Previously Approved Research, available on the OPRS website at http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/forms/index.shtml.

Include sponsor’s documents: For sponsor-initiated amendments, you should also include any communication from the sponsor regarding the amendment, and a copy of the sponsor’s amendment documents.

Please note that a common cause of delay in approval of amendments is failure to include revised documents or sponsor’s documents with the amendment form.
My IRB-approved protocol involves a retrospective review of medical records under waivers of informed consent and HIPAA authorization. I’ve finished the review but didn’t get enough data, and I need to review more records. What am I required to do?
You are required to submit an amendment to the IRB explaining why you need to review more records and how you intend to expand your review. Be advised, however, that the waivers of consent and authorization granted for the initial retrospective review apply only to review of data that were already in existence on the date that you first proposed the research. Review of records for data produced after the date of your initial research proposal would be considered prospective, and normally require informed consent and HIPPA authorization be obtained from subjects unless the criteria for a waiver are shown to be met [45 CFR 46.116(d) and 45 CFR 164.512(i)]. The ability to demonstrate that the research could not practicably be carried out without a waiver or alteration is more difficult for the prospective than the retrospective collection of data. Therefore, unless the amendment includes provision for obtaining the subjects’ consent and authorization, the IRB may be unable to approve the expansion of the research to include information that has been collected since the research was originally proposed.

Example:
1. Your research proposal dated 6/1/07 is initially approved with waivers of consent and authorization for a retrospective review of records for procedures performed at UIC clinics between 1/1/01 and 12/31/05. (Retrospective review – data already in existence on 6/1/07, the date your research was proposed.)
2. You propose expanding the review to include procedures performed between 1/1/06 and 12/31/06. (Still retrospective review – these data were also in existence on 6/1/07 – waivers may be extended by the IRB to include collection of this data.)
3. You propose expanding the review to include procedures performed after 6/1/07, for example between 6/2/07 and 12/31/07. This review would not qualify as “retrospective,” because these data were not in existence at the time that your research was initially proposed. This record review would be considered “prospective” and would typically require subjects’ written consent and authorization.
4. Please keep in mind that the date of reference for the IRB is the date on the research application form initially submitted to the IRB, and not the date of the amendment to expand the record review.