Frequently Asked Questions (FAQs)

Frequently Asked Questions

This document includes answers to the most frequently asked questions in the following categories. If you have any additional questions or concerns, please feel free to contact us.

 

I.  General Questions About the IRB  
1. Does my project need to be submitted to the IRB?  
2. Do quality assurance projects need to be submitted to the IRB?  
3. Do I need to submit a case report?  
4. I want to create a database? Do I need to submit the proposal to the IRB?  
5.  Do I need to submit a chart review study to the IRB? 

 

 

II  General Submission Policies   
1. When are your deadlines and meetings? 
2. How do I submit to the IRB? 
3. How should I submit my documents electronically? 
4. How should I label my e-mail? 
5. Where should I deliver the hard copies and how many sets do you need? 
6. I’ve been told my submission is incomplete. What does that mean? 
7. I will be away for an extended period of time and will not be able to serve as the PI on my study during this absence. What should I do? 

 

 

III.   Initial Submissions  
1. What do I need to submit for a new study? 
2. What is a research plan? 
3. What are support letters and how do I obtain them? 
4. What should I submit for a chart review study?  
5. What is the HIPAA Waiver Authorization form for and when does it need to be submitted?  
6. I submitted my study in 2007, so why does the IRB number indicate it was submitted in 2008?  

 

 

IV.    IRB Review Processes   
1. What do the terms “exempt,” “expedite,” and “full board” mean?  
2. How do I know if my study was exempt or expedited? How does the review process work? 
3. I think my study is exempt? Can I start conducting my research?  
4. What happens if my study needs to be reviewed by the full board? 
5. What are the major contingency review conference calls and when do they occur? 
6. When can I expect to receive my approval documents?  
7. Why is the start date on consent forms different than the start date on the approval letter?  

 

 

V.  Amendments   
1. What is an amendment and when do I need to submit one?  
2. What materials should I submit for an amendment?  
3. How long will it take the IRB to review my amendment? 

 

 

VI.  Continuing Reviews  
1. When do I need to submit a continuing review?  
2. What materials need to be submitted with the continuing review?  
3. Do I have to renew my study if it is closed to enrollment?  
4. My study is completely finished. What should I do?  

 

 

VII.  Informed Consent, Assent, and Waiver Considerations  
1. Who needs to provide consent for research studies? 
2. Are there any guidelines for obtaining assent from children? 
3. Do I need to obtain assent if a child turns 12 while on study? 
4. What happens if an adolescent turns 18 while on study?  
5. How and when can I request that consent be waived? 
6. When can I consider obtaining oral consent instead of written consent? 
7. What is proxy/surrogate consent? 
8. The child and/or parents of the child I wish to enroll do not speak English. What should I do? 
9. When should I re-consent study subjects? 

 

 

VIII.  Education Guidelines  
1. I’ve been told I need to complete an education requirement. What does this mean? 
2. How do I complete the training?  
3. What is the IRB Research Personnel Form and how should I complete it? 
4. What are the timeline for education completion? 
5. Who doesn’t need to fulfill the required education component? 
6. What are the special requirements for NIH-funded projects? 

 

 

IX.  Advertisements  
1. What kind of advertisements need to be reviewed and pre-approved by the IRB? 
2. Does the IRB need to review “dear doctor” letters or review press releases? 
3. I want to advertise for my study. What information can the advertisement include? 
4. What other information do you need about the advertisement? 

 

 

X.   Adverse Events and Unanticipated Problems  
1. When do I need to submit adverse events to the IRB? 
2. What do you mean by “serious,” “possibly related,” and “unexpected” adverse event? 
3. How do I submit the adverse event report? 
4. How soon do I need to submit the adverse event reports? 
5. What should I do if my sponsor is requiring me to submit an external adverse event that does not meet our reporting requirements?  
6. Do I need to report other problems or protocol violations? 
7. How should I report problems or protocol violations that meet the reporting requirements? 
8. Do I need to submit minor deviations or administrative deviations? 
9. How does the IRB review adverse events, other unanticipated problems, and protocol violations? 

 


Answers


I. General Questions About the IRB

1. Does my project need to be submitted to the IRB? All research projects involving human subjects require IRB review and approval. To determine if your project needs to be submitted to the IRB, you will first need to consider if it qualifies as research and if it involves human subjects.

a. According to the federal regulations, research is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge.”

A “systematic investigation” involves a prospective research plan that incorporates data collection and data analysis to answer a specific research question. A study that is designed to develop or contribute to “generalizable knowledge” is one that plans to apply the knowledge gained during the study to populations outside of the specific study population, inform policy, and/or generalize findings.

Does your study fit under these definitions? Then it is research.

b. Secondly, you should consider whether your research involves human subjects. Human subjects are living individuals about whom an investigator conducting research collects data through intervention or interaction and/or through a review of identifiable private information, such as medical records, clinical databases, billing records, tissue specimens, etc.

Please note that human subjects may be individuals other than patients. For example, parents, medical students, staff members, or doctors also could be subjects in a research study.

If you have any questions about whether or not your needs to be submitted to the IRB, please contact the IRB staff before you begin the submission process.


2. Do quality assurance projects need to be submitted to the IRB?
The answer to this question is not a simple one. As previously stated, in order for a project to be considered research, it must be “a systematic investigation designed to develop or contribute to generalizable knowledge.” Many quality assurance activities involve a systematic investigation of human subjects, but they may not be developing or contributing to generalizable knowledge. Instead, they are designed only to assess effectiveness of a specific program, practice, or service at single site.

For example, a quality assurance project may ask CMH staff to answer questions about certain practices in order to determine if these practices are being done consistently throughout the Hospital. This project is not developing or contributing to generalizable knowledge – that is, the results are only being used to improve internal processes. As such, this project is not “research” and would not require IRB approval.

However, if the results from a quality assurance project may be shared with others (e.g. published or otherwise made known) so that they can benefit or learn from our experiences, then the project may require IRB review, as it is being used to contribute to or develop generalizable knowledge.

Please contact the IRB for guidance when you have questions about this type of research.


3. Do I need to submit a case report?
If you are doing a case report on one patient, you do not need to submit a full protocol application to the IRB. However, you will need to complete and submit the HIPAA Waiver Authorization form.

If the case report is on two or more patients, please contact the IRB staff for guidance.


4. I want to create a database? Do I need to submit the proposal to the IRB?
Most databases are not strictly for clinical purposes and have a research component. However, if your database is strictly for clinical purposes (e.g. to track the care of your patients), you do not need to submit it to the IRB for review. If the database may be used for research purposes, please contact the IRB and submit the project to the IRB for review.


5. Do I need to submit a chart review study to the IRB?
Yes. Although there usually is no patient interaction with chart reviews, most chart reviews are considered research because they involve obtaining private information about human subjects.* As such, they require IRB review and should be submitted to the IRB. The chart review most likely will qualify for expedited review. However, as we explain in the following paragraphs, it may be considered exempt, or may require full Board review in rare cases. (Please see Section IV for more information on these types of review.)

The review of existing patient records may be considered exempt if the records are collected without identifiers or a link to identifiers. The records and data must be in existence before the review begins, and the investigator must have no way to go back to the records or re-link the data to a patient. Because most CMH investigators or their research staff have access to and/or collect some patient identifiers during a chart review, it is rare for the chart review to be exempt.

If the data will be linked – that is, if Protected Health Information (PHI) will be accessed and/or collected – the chart review may qualify for expedited review (category 5), provided that the research involves data collected solely for non-research purposes, such as medical treatment or diagnosis.

In rare cases, full Board review will be required if the identification of the subjects and/or their responses (or collection of specific data) would reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing. Expedited review only can be granted in such cases if reasonable and appropriate protections are implemented to diminish the invasion of privacy and breach of confidentiality risks, thereby making the study “minimal risk.”

Please see Section III for a description of the items that should be submitted for a chart review.

*Exception: A chart review does not constitute research and does not need IRB approval if the data are collected for quality assurance purposes. Please also see the previous FAQ regarding case reports.


II. General Submission Policies

1. When are your deadlines and meetings?
Please follow these links to the regular meeting schedule and major contingency conference call schedule.


2. How do I submit to the IRB? Except for adverse event reports, all submissions should be submitted electronically and in hard copy. Please review the following guidelines for more clarification.


3. When should I submit my documents electronically? The IRB Mailbox address () should be used for the following types of submissions:

  • Initial Submissions
  • Responses to Contingencies
  • Resubmissions of Tabled Studies
  • Amendments
  • Continuing Reviews (full board and expedited)

Attach all documents available in electronic format. Please state in the email whether there are any documents that are included in the hard copy but not available electronically.

After you send your e-mail, you will receive an automatic reply message stating that your submission has been received. However, this reply message will not reference the specific submission. If you need a receipt for sponsors or study monitors that references the specific submission, please request one in your email and we will forwarded one to you.

All other correspondence, such as inquiries, other general correspondence, or replying to general direct communication from an IRB staff person, should be sent directly to the IRB staff. In addition, please note that the IRB will no longer accept adverse event reports (i.e. AE, SAE, safety reports, DSMB reports) electronically.


4. How should I label my e-mail? The subject line of the email should indicate the nature of the submission. Please use the appropriate language as follows:

  • For new studies: New Study for Initial Review (insert PI last name)
  • For Response to Contingencies and Resubmission of Tabled Studies: Please reply to the original email sent to you by the IRB staff containing the official meeting review and attach the point by point response and any revised documents in both annotated and clean versions. Do not change the subject line.
  • For Amendments: Amendment to IRB #XXXX-XXXXX (insert PI last name)
  • For Continuing Reviews: Continuing Review for IRB #XXXX-XXXXX (insert PI last name) Please attach the research plan, progress report responses to the questions on the form, and the consent forms (if applicable).


5. Where should I deliver the hard copies and how many sets do you need? Please send hard copies to Box #205, or drop them off at the front desk at the Children's Memorial Research Center (2430 N. Halsted Street). When submitting the hard copies, please have a cover letter, or a note attached with the PI and IRB number in a prominent place (even if you have spoken with one of us on the phone, please include that info again).

  • For new studies, resubmission of tabled studies, response to contingencies, amendment submissions that require review by the convened IRB board, and continuing review progress reports: please submit one (1) original set.
  • Please submit all adverse event reports (i.e. AE, SAE, safety reports, DSMB reports) in hard copy and include a cover letter bearing the original signature of the PI. Please submit one (1) original set of each adverse event report.


6. I’ve been told my submission is incomplete. What does that mean?
Upon receipt of a submission at the IRB, the staff will conduct an administrative review of all submissions prior to forwarding the submission to the Chair or Board for consideration. Incomplete submissions will be returned to the Principal Investigator so that the outstanding items may be obtained.

As such, please ensure that the submission packets contain all required protocol documents, such as the research plan, consent/assent forms, supporting documents (routing form, letters of support), required signatures and proof of human subjects training, are included. Exceptions to this policy will be made only in extraordinary cases and will be at the sole discretion of the Director of the Office of Research Integrity and Compliance.


7. I will be away for an extended period of time and will not be able to serve as the PI on my study during this absence. What should I do?

If a Principal Investigator (PI) anticipates that he/she will be not be able to serve adequately as PI on a study due to an extended absence (e.g. travel in a remote area, medical leave, etc.)*, the IRB requires the PI designate an Acting PI in his/her absence. The Acting PI is usually one of the co-investigators and is therefore extremely familiar with the study, procedures, treatments, risks, etc.

Submission Guidelines for Request: The IRB requires the PI submit a written request to temporarily transfer the PI’s responsibilities to the Acting PI. Except in emergency situations, the PI should make this request in writing, by e-mail or letter, at least five business days prior to his/her absence. If the request is made via e-mail, the PI should send the e-mail to the IRB and copy the Acting PI on this e-mail. If the request is made by letter, both the PI and Acting PI should sign the letter.

The following information is required in the letter or e-mail:

  1. Reason for the request.
  2. Name of Acting PI.
  3. Titles of the specific studies, including the CMH IRB #, for which the request applies.
  4. Assurance that the Acting PI has (1) the qualifications to accept the responsibilities of the role of PI; (2) understands and accepts those responsibilities; and (3) has an in-depth understanding and familiarity with the study, procedures, treatments (if applicable), and risks.
  5. Assurance that the acting PI will (1) be available to respond to requests for information from the IRB; and (2) will be available and accessible to the study staff for consultation, subject evaluation, and completion of required documentation on all research-related records.
  6. Duration of the primary PI’s absence.
  7. Complete contact information for the Acting PI, including phone, pager, and e-mail.
  8. A description of the measures the Acting PI and/or study staff will take to ensure that subjects are notified of the PI’s absence, as needed.

In the event that there are no co-investigators listed on the protocol, or if the co-investigator(s) who are listed are not able serve as Acting PI during the PI’s absence, the PI should clarify whether the study will be temporarily closed or how this situation will be handled. The IRB Chair or designee will determine whether this plan is appropriate.

Externally Funded Studies: PIs should consult with any external sponsors to obtain acknowledgement/approval prior to submitting a request to the IRB. Documentation of this acknowledgement/approval should be included with the request. In addition, the PI should inform the Office of Sponsored Programs (OSP) of the Acting PI request.

If the request is granted by the IRB, the Acting PI will be given the authority to sign study documents and make study decisions on the PI’s behalf during this period. PIs should contact the IRB with any questions or concerns on a timely basis.

* Please note that a request for an Acting PI does not necessarily need to be submitted each time a PI is absent. For example, a PI may still be able to serve as PI if he/she is easily contactable while away. As such, PIs should consider how feasible it will be for them to monitor the study and handle problems while they are away prior to submitting such requests.
 

III. Initial Submissions

1. What do I need to submit for a new study?
Please submit the following items for all new studies. Please see Requirements for Initial Submissions of New Studies for more detailed directions. Please note that these instructions apply to all submissions except for those believed to be exempt. For exempt studies, please follow the guidance for exempt submissions.

  • OSP Protocol and Routing Form, including all signatures (Note: If your research is a collaborative effort and involves investigators from multiple Divisions and/or Departments, the OSP form should be signed by each investigator’s Department and/or Division Head.)
  • Abstract (can be separate or part of OSP form)
  • Budget  
  • IRB Research Personnel Form
  • Research Plan
  • Protocol (if clinical or industry-sponsored trial) (if applicable)
  • Consent -- Parental Permission (if applicable)
  • Consent – Adolescent Assent (if applicable)
  • Consent – Adult (if applicable)
  • HIPAA Waiver Authorization Form (if applicable)
  • Investigator’s Brochure (if applicable)
  • Applicable Support Letters, including Laboratory, Pharmacy, Medical Imaging, Nursing, Radiation Therapy and/or Other Support or IRB Approval Letter (e.g. Chicago Public Schools or lead study site)
  • Other Study-Related Material (e.g. survey, advertisements, letters to subjects, etc.)

In addition, if a study may qualify for expedited review, the investigator should include a signed cover letter requesting it and identify one or more expedited review categories under which it qualifies (see below).

If the study may be supported by the General Clinical Research Center (GCRC), your study must be submitted to the GCRC Scientific Advisory Committee. Please see the GCRC Web site for more information.

Please also see the following guidance document for tips on writing a consent or assent form: Suggestions and Guidance for Writing Consent and Assent Forms


2. What is a research plan? A research plan describes the proposed study in non-technical language that is easily understood by non-scientific members of the IRB. The research plan should be no more than 5 single-space pages, written using at least 12-point type and one-inch margins. Please see Requirements for Initial Submissions of New Studies for detailed information on the information that should be included in the research plan. Please follow the Research Plan Template.


3. What are support letters and how do I obtain them? If the Pharmacy will handle any study materials, CMRC requires a letter from the Pharmacy Director agreeing to provide the necessary services. The primary e-mail address for the Investigational Pharmacy is . The main phone number is 880-4653, and the hematology/oncology phone number is 755-4314.

If the Laboratory will handle any specimens, CMRC requires a letter from the Laboratory Services Director agreeing to provide the necessary services. Please contact Terry Nguyen at  or 880-4773.

If you will use Medical Imaging (e.g. x-rays, scans) in the project, you must attach a copy of the support letter from Medical Imaging. Please see the Medical Imaging Research site for more information.

If you will use radioisotopes in the project, you must attach a copy of the Radiation Safety Committee (RSC) approval letter. If the project uses ionizing radiation without direct clinical indication, this also requires RSC approval. Please see the Department of Radiation Safety site for more information.

All nursing research proposals involving human subjects -- those focusing primarily on the nursing profession, nursing issues, or generated by a nurse or nursing student -- must be reviewed and approved by the Nursing Research Committee prior to being submitted to the Institutional Review Board and a copy of the letter of approval attached. Please contact the Nursing Research Council Chairperson, Linda Van Roeyen, RN, MSN, CFNP at 773-880-3630, email , or Carolyn Kiolbasa, RN, BSN Nursing Research at 708-836-4876, email , for questions regarding nursing research studies.

If the study will involve radiation therapy, please contact Dr. MaryAnne Hoffman Marymont in the Radiation Oncology Dept. at Northwestern.


4. What should I submit for a chart review study?
When you submit a chart review study to the IRB, you will need to submit the following items (at a minimum):

  • OSP Form
  • Research Plan
  • Research Personnel Form
  • HIPAA Waiver Authorization or consent documents (when applicable)
  • Budget (if necessary)

Please ensure that you specify in the research plan when the data was or will be collected and how data will be kept private. In addition, please clarify what data will be collected or submit the data collection/abstraction tool.

Also, please note that the decision to grant a waiver of consent is at the IRB’s discretion. In order to grant the waiver, the IRB must agree the study meets the qualifications for a waiver. For example, the IRB may not agree to waive consent if the research involves prospective collection of data or if the investigator has ongoing contact with the patients whose data is being reviewed, as the researchers may practicably be able to obtain written consent in these cases. As such, please ensure that you include a justification for a waiver of consent in your research plan, if a waiver is being requested.

5. What is the HIPAA Waiver Authorization form for and when does it need to be submitted? For “preparatory research” (screening of patients, not requiring a consent form) or use of a database to prepare papers presenting clinical descriptions, HIPAA mandated privacy rights will require researchers to submit a HIPAA Waiver Authorization to the IRB for permission to access PHI for “preparatory research” as defined above. Once the IRB grants a waiver, informed consent is not needed. However, you must submit an Excel datasheet containing a list of patients studied and what information was accessed to the Medical Records Department (Information Management). This will permit the Medical Records Department to provide a list of who has accessed PHI for non-treatment purposes when requested by a patient or patient representative.

However, please note that chart review studies require IRB review and should be submitted to the IRB as an initial submission.


6. I submitted my study in 2007, so why does the IRB number indicate it was submitted in 2008? IRB number dates are assigned to follow fiscal year: September 1-August 31. Any new submissions that we receive after September 1 will have a prefix with the next fiscal year. If your study is resubmitted, the prefix for the year is going to change to the current fiscal year but the study number will stay the same.


IV. IRB Review Processes

1. What do the terms “exempt,” “expedite” and “full board” mean? The levels of IRB review include exempt, expedited and full board. The level of review is based on the risk level to subjects. The IRB has the final determination regarding what level of review is required for each study.

Exempt – These studies involve no or low risk and are not subject to IRB oversight. However, an exempt determination does not mean human subjects are not involved. It means that the level of risk to the subjects is low enough to not require IRB oversight. The IRB must make the final determination regarding exemption status.

Please see section §46.101.b for a list of categories of exempt research activities. Please submit all exempt research submissions using the exempt application.

Please note that most FDA-regulated research (e.g. involving a drug, medical device, food, or other product regulated by the FDA) cannot be exempt. Please see our Policy and Procedures Manual for more information.

Expedite – These studies involve no more than minimal risk and involve procedures listed in one or more federally defined categories. The expedited review procedure consists of a review by the IRB Chair or by one or more experienced reviewers designated by the Chair. The rigor of review is the same as for full IRB review and “expedited” does not necessarily mean a fast review.

Please see the OHRP Web site for a list of expedited review categories for initial studies and continuing reviews.

Full Board – Studies that are not exempt or expedited must be reviewed by the full IRB committee at a scheduled meeting. These meetings take place once per month, typically on the third Monday.


2. How will I know if my study was exempt or expedited? How does the review process work? After you submit your study to the IRB, the staff first will assess the protocol to determine if it may qualify for exemption or expedited review. The IRB Coordinator then will conduct an administrative review and notify you if there are any administrative issues that need to be addressed, including if the submission is incomplete (see above).

After the administrative review is complete, the Chair or designated reviewer will look over the submission. The Chair or designated reviewer will confirm that the research protocol meets the criteria for exemption or expedited review. In addition, the Chair or designated reviewer will notify you via e-mail if there are any issues that need to be resolved before the protocol can be exempted or approved via expedited review.

All outstanding issues (including issues identified during the administrative review) must be satisfactorily addressed within four months of the date of the Chair's or designated reviewer's e-mail. If they are not addressed, the protocol will be withdrawn and the PI must resubmit the study after the issues are resolved.

After any outstanding issues are resolved, an exemption notice or expedited approval notice will issued electronically.


3. I think my study is exempt? Can I start conducting my research?
No, an investigator may not make an exempt determination for his or her own research. The IRB must make the final determination regarding exemption status. If you believe your study is exempt, please complete the new Application for Exemption from IRB Review form.

The research plan should be pasted directly into the document in the Research Plan section and not submitted as a separate document. The IRB Personnel Form and any other supplemental materials are required for submission and can be attached as separate documents; however, you no longer have to complete the OSP form for exempt submissions as an IRB requirement. The Division/Program Leader and Department Head signatures will now be obtained on this exemption form. Funded projects will still require the submission of the OSP form to OSP as per their requirements. After the Chair or a designee reviews your study, you will be notified if your study is exempt.

For exempt applications only:

1. A complete submission consists of the completed application, the IRB Personnel Form listing all current, certified research staff and any supplemental materials (such as anonymous surveys) submitted both electronically to the IRB Mailbox and in hard copy (hard copy must be signed) to the IRB.

2. Only the PI and his/her Division Head/Program Leader, and Department Head will need to sign the form. All research personnel including Co-PI’s and other study personnel should continue to be included on the personnel form. Their signatures will not be required.

3. You will not have to submit a separate research plan. The form will allow the user to type or paste in the entire research plan directly into the form. This information should not be summarized but included in full detail to allow the IRB to make an adequate assessment of the research procedures.

4. Once you download and complete the form, you should change the name of the document specific to your application.

5. If the research is externally funded, please follow OSP’s requirements for submission of any associated grants or contracts including completing the OSP form for their review. The IRB will not require the submission of the OSP form as part of the exempt application.

Per regulation and IRB policy, the IRB will make the final exempt determination. Any research not meeting the requirements for exemption will be reviewed at the appropriate level of review (expedited review or full board) after notification of the PI and/or Study Contact. For research not meeting the requirements for exemption, the OSP form will be required as per the IRB Complete Submission Policy and review will take place upon receipt of the OSP form.
Please note that continuing review reports do not need to be submitted for exempt protocols. However, any proposed changes to exempt research must be submitted to the IRB, prior to implementation, in order to determine if the research still qualifies for exempt status. If the IRB finds that the research is no longer eligible for exemption, you will be notified whether the study needs to be submitted for either expedited or full board review.


4. What happens if my study needs to be reviewed by the full board?
If your study needs to go for full board review, the IRB will notify you of the Committee’s decision within approximately 7-10 days after the meeting. This notification will be sent via e-mail with one of the following determinations. These determinations also apply to amendments and continuing reviews.

Approval without contingencies – Enrollment may begin after the approval documents are sent to the PI.

Approval with minor or major contingencies – In many instances, approval is given with the contingency that the investigator needs to respond to IRB questions and/or make changes to the research plan and/or consent form. These contingencies may be major or minor.

If there are minor contingencies, review and approval of the PI’s response to the IRB can typically be performed by the IRB Chair, or his/her designee, via an expedited procedure. However, if there are major contingencies, the response must come back to the full board. This may be done via conference call (see below).

Enrollment cannot begin until the investigator provides the IRB with the required information and materials, and the IRB approves of them. Once this final approval is received, the contingency is lifted and subject enrollment is allowed. The PI will have four months from the date of original review to respond to all contingencies and have the responses approved by the IRB. Failure to meet the four-month deadline will require a complete resubmission of the protocol to the IRB for review.

Tabling of the protocol – In this case, the IRB feels that sufficient problems exist that the PI must address the committees concerns and/or make substantial revisions. The IRB will provide the investigator with its critique. The PI should resubmit the entire proposal with a point by point response to each question. The protocol will be reviewed at a meeting based on the deadline schedule. Unlike contingent approvals, there is no time limit for responding to issues relating to a tabled study.

Rejection/Disapproval – In this case, the IRB feels the protocol is inadequate and may be lacking scientific and/or ethical justification to be implemented in the protected population (infants, children, and adolescents). A protocol may also be rejected due to the extreme risk (safety, psychological) placed on participating subjects. When a research protocol has been rejected, the IRB will provide the research investigator(s) with the reasons for the decision, which may be appealed. However, the PI first must address all outstanding issues and resubmit the entire protocol.


5. What are the major contingency review conference calls and when do they occur? When a protocol is “approved with major contingencies, the response to which requires review by the convened IRB,” may be allowed the PI to submit the requested revisions to the IRB Major Contingency Review Conference Call Meeting (“IRB MC meeting”) at the discretion of the IRB. The IRB MC meeting occurs between the monthly board meetings. The goal the IRB MC meeting is to give PIs the opportunity to submit responses to the major contingencies and have these responses reviewed sooner, so that if appropriate, they may obtain approval for the protocol without having to wait a full month.

Monthly IRB meetings take place on a Monday afternoon. By Thursday of that week (3 days later), PIs whose protocols were “approved pending major contingencies” will have received the meeting review and the administrative review electronically to the e-mail address provided with the original submission. The PI has until the following Wednesday at 4 p.m. (7 calendar days) to respond to all the contingencies. Partial responses will not be accepted. Only responses related to protocols reviewed at the preceding Monday meeting will be considered.

Following the deadline, the IRB staff will determine which responses meet the criteria and will be placed on the IRB MC meeting agenda. The IRB MC meeting will take place the Monday following this deadline. At this meeting the IRB members will vote that the protocol is “approved,” or that it is “approved with minor contingencies the response to which may be approved by expedited review by the Chair” or “approved with major contingencies to come back to the full board”. In this last instance, the response will need to come back to the full convened monthly meeting. The PI will be informed of the IRB’s decision in writing.


6. When can I expect to receive my approval documents?
You may expect to receive the approval documents within five to 10 business days of the approval. If you have not received your approval documents after 10 business days, please contact the IRB staff.


7. Why is the start date on consent forms different than the start date on the approval letter? The dates on the approval letter follow the date of the IRB Meeting when the initial was presented and approved (even if there were contingencies to be met): they are the start and ending dates of the first full year approval period.

When the first date is different on the consent form(s), the first date indicates the date that any contingencies were removed, and the second date will be the same as on the approval letter, i.e., the end of the approval term.

V. Amendments

1. What is an amendment and when do I need to submit one? Investigators are responsible for reporting promptly to the IRB any proposed changes in a previously approved research study. The IRB must approve the change before it is implemented, unless the change must be implemented immediately to eliminate apparent immediate hazards to the subject(s). Both major and minor changes should be submitting, including the addition of co-investigators or research personnel.


2. What materials should I submit for an amendment?
For all amendments, you should submit the following items:
 

  • A completed Amendment Form 
  • If the proposed change(s) affect any previously approved study materials or if the new study materials are being submitted, all documents should be submitted to the IRB. Examples of such study materials include the protocol, consent form, advertisements, etc.
  • One hard copy and one electronic copy of all materials included in amendment


3. How long will it take the IRB to review my amendment?
The length of time to review an amendment depends on the complexity of changes requested. Minor changes can undergo expedited review. However, if the proposed change is “more than a minor change” (as determined by the IRB) and if the initial submission required full board review, the amendment may require full board review. If the initial research was approved by expedited review, a “more than minor change” could still be approved by expedited review if it did not change the overall risk determination from minimal.

Expedited amendments are processed, and reviewed within two to three weeks of submission.. The IRB will notify you upon receipt and administrative review of the submission if there are any issues that need to be addressed before the amendment can be forwarded for Chair or full committee review.

If the amendment requires full board review, the IRB will notify you in writing of the status (approval or contingencies) of the amendment within 7 to 10 days following the monthly meeting.

 

 

 

 

VI. Continuing Reviews

1. When do I need to submit my continuing review?
Federal regulations require that the IRB review each research study not less than once per year. Your approval letter will tell you on what date your study expires. Due to the large volume of continuing reviews that the IRB must review, you should submit the renewal materials no later than 3 months prior to the expiration date.

It is ultimately the investigator’s responsibility to keep track of each protocol’s expiration date and submit the continuing review to the IRB in a timely fashion. However, as a courtesy, the IRB will attempt to remind each PI of the expiration date. If the IRB is unable to process the continuing review prior to the expiration date, the protocol will expire.

If your protocol inadvertently expires and you still wish to continue the study, all research must stop until after the complete protocol is resubmitted and approved by the IRB. Please contact the IRB for additional guidance, particularly if there are any subjects on the study at the time it expires.


2. What materials need to be submitted with the continuing review?
Please include all of the applicable materials. As previously noted, please submit one electronic copy and one hard copy.

  • Continuing Review Form 
  • Protocol Abstract (focusing on the research plan)
  • Status Report on the Progress of the Research (Including but not limited to the number of subjects accrued; a description of any adverse events or unanticipated problems involving risks to subjects or others, and an explanation of the withdrawal of any subjects from the research and/or complaints about the research)
  • Investigator-Held IND/IDE with FDA (If there is an investigator-held IND/IDE associated with this study, provide the IND/IDE #, the date of issuance and a copy of the current annual progress report submitted to the FDA)
  • Summary of Recent Literature Relevant to the Study (published since the IRB last reviewed the protocol)
  • Findings Obtained Since the Last IRB Review  
  • Amendments and Modifications to the Research Since the Last IRB Review  
  • For Multi-Center Trials, relevant information from other sites (especially about risks associated with the research)
  • Current Consent form(s) (with the IRB approval stamp) and, if you are still enrolling study subjects, an unstamped original (to be stamped with the continuation approval date)
  • Current Protocol or Research Plan that should include ALL IRB-approved amendments to date (can be either an up-to-date protocol with the amendments incorporated into the body of the protocol OR the past IRB correspondence for each amendment can be attached to a copy of the old protocol).
  • Current Personnel Form (see “Education Guidelines” section for more information)


3. Do I have to renew my study if it is closed to enrollment? You must submit a continuing review if any study procedures are ongoing, including any data collection or analysis. If all subjects have completed protocol-specified therapy or interventions (including follow-up) and data analysis is complete, please submit a final report to the IRB to close (inactivate) the study.


4. My study is completely finished. What should I do?
Studies may be closed once all research activities have been completed, including data analysis. If the study is part of a large multi-center trial, the study may be inactivated once all enrolled subjects have completed all research interventions and data is no longer being submitted to the sponsor.

Inactivations may be requested at the time of the continuing review or may be submitted at any time during the year of approval. The IRB strongly encourages the submission of a final report rather than allowing the study to expire.  


VII. Informed Consent, Assent, and Waiver Considerations

1. Who needs to provide consent for research studies? Because most studies conducted by CMH investigators enroll children, one or both parents usually must sign a consent form to allow the child to participate in a research study. According to the federal regulations, the number of parents who must sign the consent form is based on the level of risk of the study and the potential benefits of the study. However, the IRB considers each study individually and may require additional parent signatures when the IRB agrees that is appropriate.

If the study is minimal risk or if the study is more than minimal risk with the prospect of direct benefit, the regulations state that only one parent needs to sign the consent form.

If the study is greater than minimal risk and provides no potential direct benefit to individual subjects, two parents will need to sign the consent form. This requirement may be waived if one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

If you plan to enroll healthy children on a study that is greater than minimal risk with no potential for direct benefit, please contact the IRB office before you submit the study. Such studies require additional review by the Office of Human Research Protections (OHRP).

If only adults (age 18+) are being enrolled on a study, parental consent is not needed unless the potential subject is unable to consent for him/herself due to medical circumstances. Please see the section on proxy consent for more information on how to proceed in those situations.

The IRB wishes to remind you that only approved (stamped) consent and assent forms should be used.

Please also see the following guidance document for helpful tips on writing a patient-friendly consent or assent form: Suggestions and Guidance for Writing Consent and Assent Forms.


2. Are there any guidelines for obtaining assent from children? The federal regulations repeatedly refer to “adequate provisions…for the assent of the children.” However, the regulations leave it up to IRBs to determine what constitutes adequate provisions, and IRBs vary greatly in how they address the issue. However, there does seem to be broad agreement on two matters. First, investigators have a moral obligation to take a child’s refusal to become a research subject very seriously. Second, the age at which the child should have an opportunity to accept or refuse participation varies with a) the child’s maturity / intelligence / understanding of the situation (rather than an arbitrary age) and b) the circumstances of the research.

Children younger than eight years usually cannot meaningfully reason about the benefits and consequences of participation in research. However, they may well understand concrete aspects of what an investigator will ask of them, such as cooperation with procedures. Also, chronically ill children often have an appreciation of their situation well beyond that expected of a well child of similar age. Adolescents typically have a relatively good understanding of the consequences and benefits of par­ticipation in research.

The CMH IRB expects investigators (or their designees) to discuss the proposed research project with all children over age four years in developmentally appropriate language. The IRB encourages the use of drawings and other visual aids to augment this process. For children ages 4 through 11, the oral explanation of the purpose of the study, the procedures to be used, and possible risks should suffice. For minors ages 12 and above, a complete explanation of all required basic elements of informed consent is necessary; adolescents must sign a form noting their assent. Please utilize the CMH assent form template.

An investigator may request a waiver of child assent for consciousness impaired or mentally incapacitated children at the time the protocol is initially submitted or as an amendment at any time thereafter.

Please ensure that you provide adequate information in your research plan regarding from whom and how you will obtain and document assent.


3. Do I need to obtain assent if a child turns 12 while on study?
Yes. The CMH IRB requests that investigators obtain written assent from children if they turn 12 while participating in the study. If you do not have an approved assent form, please submit one to the IRB for approval before the child in question turns 12.


4. What happens if an adolescent turns 18 while on study?
Subjects reaching the age of majority (18 years of age) must re-consent to continue participating in research if they were initially enrolled to the study by their parent/guardian when they were minors.


5. How and when can I request that consent be waived? The IRB can approve a waiver of consent if all of the following points are true:

a. The research is no more than minimal risk.
b. The rights and welfare of subject are not adversely affected.
c. Research could not be practicably conducted without the waiver.
d. Subjects provided with pertinent information after participation.

To request a waiver of consent, please request and provide justification for the waiver based on the above criteria in the research plan. Please also note that the IRB has the ultimate authority when deciding whether a waiver of informed consent can be granted.


6. When can I consider obtaining oral consent instead of written consent? The IRB can waive the requirement for the investigator to obtain a signed consent form and approve another method of consent, such as oral consent. However, the IRB must agree that for some or all subjects, one of the following is true:
a. that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

b. that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

Using one of these criteria, please provide justification for oral consent in your research plan. In addition, please submit a copy of the oral script that will be used to consent subjects.

Please also note that the IRB has the ultimate authority when deciding whether oral consent is appropriate for a specific study.


7. What is proxy/surrogate consent?
Occasionally, studies may wish to enroll adult subjects who are unable to consent for themselves due to medical circumstances. In such cases, proxy/surrogate consent would be required. Please contact the IRB for more information.


8. The child and/or parents of the child I wish to enroll do not speak English. What should I do?
Whenever possible, you should have the complete assent and/or consent form translated into the native language of the child, parent, and/or adult subject and approved by the IRB before the subject is consented on a study. For example, if you anticipate that your study will enroll non-English speaking subjects, please arrange to have the consent documents translated. Please also translate any other study documents that will be read by subjects (such as surveys, advertisements, etc.). The translated documents and proof of certification from the translator should be provided to the IRB. It is advised that you wait to have the consent documents translated until the English versions are finalized and approved by the IRB.

If you unexpectedly wish to consent a non-English speaking individual, the IRB has a policy in place that will allow you to provide the individual(s) with an oral translation of the contents of the IRB-approved English-language consent document. The individual should then sign a short form consent document in their native language. Please refer to the “Studies Involving Non-English Speaking Subjects” section in our Policy and Procedures Manual (P&P Manual) for more detailed information. In addition, the IRB has posted copies of frequently used short form consent documents, including the English, Spanish, Bosnian, Vietnamese, Polish, Arabic, and Russian versions (copies also are available in the P&P Manual).  Also available on the website are instructions for use of the short forms.  Please contact the IRB staff with any questions.

In all cases, please make use of translation services available through the hospital.


9. When should I re-consent study subjects? Federal rules require that the consent form state (where appropriate) that the investigator will inform subjects if “significant new findings” come to light during the study that might affect the subjects’ “willingness to continue participation” in the research. Examples of significant new findings may include new study drug risks/warnings or major changes in the study procedures.

The CMH IRB does not have a standard requirement that patients be re-consented by having the subject sign a new consent form every time an amendment to the study is approved. There are some sponsors who do require this though. However, in light of the requirement to inform subjects of “significant new findings” that may affect their “willingness to continue participation,” any new information must be given to the subjects. Unless directed to re-consent by the IRB at the time of amendment approval, investigators may provide this information to the subjects in letter form (letter to subject must be IRB-approved). If there is a specific sponsor’s requirement to re-consent, the sponsor’s requirement will prevail.


VIII. Education Guidelines

1. I’ve been told I need to complete an education requirement. What does this mean? Education and training in the protection of human research participants for investigators, IRB members and staff, and other relevant personnel is a key element in CMH’s efforts to achieve and maintain excellence in human subject research. CMH investigators and personnel must conduct human subject research in an ethical manner and in compliance with federal regulations, IRB and institutional policies, and state and local law.

As such, all Principal Investigators, Co-Investigators, and Personnel conducting research involving the use of human subjects submitted to the IRB must fulfill the education requirement (i.e., become “certified”). This requirement applies to all human subject research, regardless of whether it was given full board or expedited IRB approval or is determined by the IRB to be exempt from the federal regulations governing human subject research.


2. How do I complete the training?
Initial Certification – For your initial certification, you should complete one of the two following education courses:

  • NIH Course: Protecting Human Research Participants
  • CITI Program: Human Subjects Protection Course (Please select “Northwestern University” as your affiliate institution.)

Continuing Education Certification – Proof of continuing education in human subject protections must be documented every two years. Continuing education credit may be obtained by completing any one of the following options within the two-year period:  

  • Attend an CMH IRB outreach session
  • Contact the IRB staff for a copy of the continuing education articles
  • Contact the staff for additional options

Please e-mail or fax proof of certification to the IRB. If you have been certified at another institution and would like to request that that certification satisfy CMH’s certification requirements, please contact the IRB staff, who will ask you to provide a course description and the completion certificate to the IRB. The IRB Chair will review the course description and tell you whether it is acceptable.

To see when your education certification expires, please check the Current Certifications List, which is updated periodically.


3. What is the IRB Research Personnel Form and how should I complete it? The Research Personnel Form is designed to help the IRB better document and track personnel working on our research projects. On this form, you should list all individuals who will have a significant role in the research. Please do not list Pharmacy or GCRC staff.

This form also will give the IRB a list of personnel who will have the additional responsibility of interacting with subjects directly, including obtaining informed consent. Only personnel who have been identified as having the responsibility of obtaining consent will be allowed to consent subjects and sign the consent/assent documents.

Please note the following points regarding this form:

  • If not already on file, please also submit proof of current training completion (e.g. training certificate) when submitting this form.
  • The inclusion of this form is a requirement under the IRB’s Complete Submission Policy. It must be included with all initial reviews and continuing reviews as part of the electronic and hard copy submission. If this form is not included with the submission, the submission will be considered incomplete and, as per the policy, may be returned to the investigator.
  • All personnel listed on the form must be current in their Human Subject’s Education certification. Those who have not completed an initial certification, have a certification due to expire within 3 months, or have an expired certification will need to complete this requirement before they can be included as personnel on the Personnel Form and be involved in the protocol.
  • At the time of continuing review, the submitted Personnel Form should reflect the current research staff working on the study.
  • When personnel are added or removed from a protocol, please submit an amendment that includes a) an updated Personnel Form and b) proof of certification (if not already on file).
  • Signatures of research staff are not required on the Personnel Form.


4. What are the timelines for education completion?
Initial Reviews of Research – Initial or continuing education certification of the PI and all persons involved with the human subject research as listed on the IRB Research Personnel Form is a contingency for final IRB approval (i.e., final approval letter and approved stamped consent forms will not be issued until these persons are certified). If the requirement is not fulfilled within the given amount of time to address approval contingencies, contingent approval will expire and the study will have to be resubmitted as a new submission. However, the study will not be reviewed again prior to all persons fulfilling the education requirement.

Amendments – If the PI wishes to add a person to the protocol to conduct human subject research, please submit an amendment to the IRB along with that person’s proof of certification.

Continuing Reviews of Previously Approved Research – Initial or continuing education certification of the PI and all persons involved with the human subject research as listed on the IRB Research Personnel Form is a contingency for continuing IRB approval (i.e., approval letter and approved stamped consent forms will not be issued until these persons are certified). If these persons have not become certified by the expiration date of current IRB approval, IRB approval will be suspended. All work on the study must cease, except when needed for patient safety. This suspension will be for a maximum of 30 days. If by 30 days all persons have not fulfilled either the initial or continuing education requirements, the IRB approval will be terminated. All work must end and the study will have to be resubmitted as new for re-review and approval. However, this new initial review will not occur until these persons have first fulfilled the education requirement.


5. Who doesn’t need to fulfill the required education component? Individuals who will not be involved with the human subject research as indicted on the form (e.g., a computer technical consultant) do not have to complete the education requirement. Please note that this exemption from certification means that the person not only has no direct subject involvement, but also has no involvement with coded/identifiable data and specimens.

Persons listed on a subcontract to another institution are subject to the subcontracted institution’s education policies and should not be listed on the Personnel Form. In most cases, you also do not need to list supporting individuals from the Pharmacy, General Hospital Laboratory, or the GCRC.

If you will be utilizing a consultant, please contact and provide the IRB with information on the role they are playing in the research so that the IRB can determine whether they need to complete the education component.


6. What are the special requirements for NIH-funded projects?
New Grant Submissions or Continuing Renewals – Initial education requirement must be met within 60 days after the NIH grant submission date.

Non-Competing Renewals – Initial education or continuing education requirement must be met by the NIH renewal submission date.

IX. Advertisement

1. What kind of advertisements need to be reviewed and pre-approved by the IRB? The IRB must review any direct advertising for research subjects, or advertising that is intended to be viewed or heard by prospective subjects to solicit their participation in a study. Direct advertising can include (but is not limited to): newspaper, radio, TV, bulletin boards, contact letters, posters, and flyers that are intended for prospective subjects. Please contact the IRB if you are unsure if your advertisement requires IRB review.

Please note that with the exception of the items listed in #2, all advertisements need IRB pre-approval before they can be used to recruit CMH study subjects. Pre-approval is necessary so that the IRB can confirm that the advertisements comply with all policies, are not coercive, and truthfully relay the goals and benefits of the study.


2. Does the IRB need to review “dear doctor” letters or review press releases?
“Dear Doctor” or doctor-to-doctor letters (even when soliciting for study subjects) are not considered advertising that has to be approved by the IRB, because it is not intended to be directly seen or heard by prospective subjects. News stories and publicity intended for other audiences are not considered advertising.


3. I want to advertise for my study. What information can the advertisement include? The IRB reviews advertisements to determine that they are neither misleading nor coercive to potential subjects. In addition, for treatment protocols, no claims should be made either explicitly or implicitly that the drug or device is safe and/or effective for the purposes under investigation, or that the drug or device is in any way equivalent or superior to any other drug or device.

Advertisements should be limited to the following information:

  • the name and address of the investigator and/or research facility;
  • the condition under study and/or the purpose of the research;
  • a summary of the eligibility criteria;
  • a straightforward, truthful brief list of the benefits, if any (e.g. no cost health examination);
  • the time or other commitment required of the subject; and
  • the location of the research and the person to contact for further information.

Advertisements should not:

  • Use terms such as “new treatment," "new medication" or "new drug" to describe into investigational drugs, biologics, or devices without explaining that the test article is investigational. Such terms leads study subjects to believe they will be receiving newly improved products of proven worth.
  • Promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation.
  • Emphasize the payment or the amount to be paid by larger or bold type.


4. What other information do you need about the advertisement? Please give the IRB the following information:

  • the method(s) of advertisement (e.g. newspaper advertisement, Web ad, etc.);
  • if bulletin board notices will be used, a final copy of the notice must be submitted to the IRB for approval prior to posting. If the advertisement is approved, the IRB will return the notice with a dated IRB approval stamp;
  • if the advertisement will appear in a newspaper or other media, the final version of the advertisement must be submitted for IRB approval prior to sending it to the press or other media. When advertisements are to be taped for broadcast, investigators are encouraged to submit the message text for approval prior to taping to avoid re-taping because of inappropriate wording. The IRB should then be supplied with a final audio/video tape for review and approval prior to distribution.

Please note that any changes in the content of any advertisement must be approved by the IRB before being used.  


X. Adverse Events and Unanticipated Problems

1. When do I need to submit adverse events to the IRB? Internal Adverse Event – An internal adverse event is an untoward or unfavorable medical occurrence that is experienced by a subject enrolled on study at our site. An internal adverse event must be reported if it is serious, possibly related, and unexpected (see definitions below).

In addition, all deaths of CMH should be reported. However, investigators do not need to report deaths for patients on observational, database, or registry studies. Exceptions only should be made if the investigator determines that death is related to the research (extremely rare).

External Adverse Event -- External adverse events are those adverse events experienced by subjects enrolled at other institutions participating in the clinical trial. An external adverse event only should be reported if a) the event occurred on a study where CMH is a participating study site and b) it is are serious, possibly related, and unexpected.

Please use the following flowchart to help you determine when you need to submit adverse events to the IRB:

[insert new link here]

2. What do you mean by “serious,” “possibly related,” and “unexpected” adverse event? A serious adverse event is any adverse event is one that:

  • results in death;
  • is life-threatening (places the subject at immediate risk of death from the event as it occurred);
  • results in inpatient hospitalization or prolongation of existing hospitalization;
  • results in a persistent or significant disability/incapacity;
  • results in a congenital anomaly/birth defect; or
  • 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 (examples of such events include allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse).

An unexpected adverse event is any adverse event occurring in one+ research subject for which the nature, severity, or frequency is not consistent with either:

i. the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the study-related documents, such as the protocol, investigator’s brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; or

ii. the expected natural progression of any underlying disease, disorder, or condition of the subject in question and the subject’s predisposing risk factor profile for the adverse event.

Possibly related means there is a reasonable possibility that the incident, experience, or outcome (including adverse event) may have been caused by the procedures involved in the research.


3. How do I submit the adverse event report?
The IRB has created two forms for reporting adverse events: 

INSERT NEW LINKS

The use of each form is MANDATORY. Only one subject’s event(s) should be reported per form. Hard copies should be sent or delivered to the IRB – electronic copies do not need to be submitted.


4. How soon do I need to submit the adverse event reports?
Internal Adverse Events 

  • For deaths of CMH subjects, please submit the report within two business days of the investigator’s knowledge of the event.
  • For all other adverse events for CMH subjects that meet reporting requirements, please submit the report within 7 business days of the investigator’s knowledge of the event.

External Adverse Events  

  • Please submit each report within 15 working days of the investigator’s knowledge of the event.


5. What should I do if my sponsor is requiring me to submit an external adverse event that does not meet our reporting requirements? First, please refer the sponsor again to our Policy and Procedures Manual to remind them that the adverse event in question does not meet our reporting requirements. Please also show the sponsor a copy of our External Adverse Event Report form, which provides detailed instructions regarding when external adverse events should be submitted. If the report is submitted anyway, it will be returned to you.


6. Do I need to report other problems or protocol violations? Yes. The IRB is asked to ensure prompt reporting of serious or continuing noncompliance with the federal regulations or the requirements and determinations of the IRB. This includes protocol violations, which occur when the study departs from the IRB-approved protocol in any way without the investigator first obtaining IRB approval.

In addition, the IRB must review any unanticipated problems, or incidents, experiences, or outcomes that are unexpected, related or possibly related to the research, and may place the research subject or others at a greater risk of harm (including physical, psychological, economic, or social harm). Oftentimes, in medical research, the unanticipated problem is an “adverse event,” or an untoward or unfavorable medical event that puts the subject at a greater risk of physical harm. However, some unanticipated problems (such as confidentiality breaches) do not fit the definition of an adverse event, but still need to be reported to the IRB.

Investigators should report unanticipated problems or protocol violations that affect: a) the rights, safety, and/or welfare of subjects or others; b) integrity of the research data; or c) the willingness of subjects to continue in study.

Examples of unanticipated problems or major violations that would need to be reported include (but are not limited to):

  • failure to obtain informed consent (including lack of appropriate documentation of informed consent), or obtaining informed consent after the study procedures have begun;
  • enrollment of subjects after the study has expired or before IRB approval is granted;
  • use of an incorrect version of the consent form;
  • study visits conducted out of the required timeframe that may affect safety or data integrity;
  • inclusion of a subject not meeting eligibility criteria;
  • enrollment of a subject from a federally defined “vulnerable population” – children, prisoners, pregnant women, fetuses, and some neonates – without prior approval for including that group;
  • confidentiality breaches;
  • complaint from a subject that suggests unanticipated risk or cannot be resolved; or
  • drug dispensing/dosing errors that may affect subject safety or data integrity.

7. How should I report problems or violations that meet the reporting requirements? Please report the problem or violation using the Other Unanticipated Problems and Protocol Violation Report form. This form should be submitted to the IRB within 7 business days of the investigator’s knowledge of the problem or violation.


8. Do I need to submit minor deviations or administrative deviations? If a deviation does not affect the rights, safety, or welfare of subjects or integrity of the research data, it does not need to be reported on the Unanticipated Problem and Protocol Violation Reporting form. Instead, they should be summarized at the time of continuing review. Investigators should contact the IRB if they are unsure whether the event in question needs to be reported using this form, or if it can be summarized during the renewal.

9. How does the IRB review adverse events, other unanticipated problems, and protocol violations? First, the Chair or designated reviewer will determine if the event meets the requirements for reporting. If the event does not meet the requirement for reporting, this finding will be noted on the report and it will be sent back to the PI.

If the Chair determines the events meets the requirement for reporting to the IRB, the Chair or his/her designee will review the event report and decide what further IRB related action/review is indicated. The Chair or his/her designee will summarize his/her review directly on the form and return a copy of the form to the PI.

For all events submitted, the IRB Chair reserves the right to request additional information to assist in making a determination or decision regarding the event and any revisions to the approved consent form(s). In addition, the Chair may ask the Committee to review the adverse event at a convened IRB meeting.

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