Institutional Review Board
Frequently Asked Questions
- IRB review/General submission requirements
- IRB process (timeline, types of reviews, etc)
- Other universities/sites and external investigators
- Special requirements for subject compensation
- Special requirements for clinical trials or studies involving Protected Health Information (PHI)
- New requirements related to January 2019 Common Rule changes
- Reporting once a study is approved
- Human protections activities that occur in the HRPP in addition to the IRB review
IRB review/General submission requirements
Q: What’s the difference between a Quality Improvement (QI) project and research? How do I determine if my study is QI or research?
A: Quality improvement projects are conducted for the purpose of benefitting an organization, activity, or population of people within an entity, and not to expand the knowledge base of a scientific discipline or scholarly field of study.
In general, the following are related to QI activities:
- The purpose is to measure performance or determine the effect of a process change.
- Data are being gathered solely for administrative purposes within the context of normal efforts to examine or improve services, or operations.
- The data is intended to be used by and in the entity where the project is taking place.
- The project will involve a sample of the population ordinarily seen/present in the institution where the project is taking place.
- The risks to individuals involved in the project is no greater than what is normally involved in their daily lives.
- The purpose of the project is a submission to a National or State registry/database that is mandated for improving the delivery of clinical care.
In general, the following are related to research activities:
- The project is a clinical investigation as defined by the FDA, including randomization and/or placebo controls.
- The project is designed for the purpose of expanding knowledge base of a scientific discipline or scholarly field of study.
- The project is externally sponsored and is based on support of a research paradigm.
Q: Do I need IRB review?
A: IRB review is required for research involving human subjects prior to any research activities being initiated. The U.S. Department of Health and Human Services (DHHS) definition of research includes “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. MU defines a “systematic investigation” as an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. MU defines “generalizable knowledge” as those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. In 2 addition, some funding agencies will require an IRB determination of a study design to ensure the IRB of oversight has had an opportunity to review and confirm both “human subject” and “research” criteria. Please review our definitions.
The following activities have been deemed NOT human subject research by DHHS and researchers may submit a human subjects research determination form through eCompliance for assistance or confirmation:
- Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. Some, but not all, case studies will fall into this category.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for criminal justice agency for activities authorized by law or court solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each federal agency) in support of intelligence, homeland security, defense, or other national security missions.
- Publicly or commercially available information or biospecimens with no restrictions on the use of the information or biospecimens.
IRB process (timeline, types of reviews, etc)
Q: What are the different types of IRB reviews and how long do they take?
A: IRB reviews are classified into (a) exempt, (b) expedited, or (c) full board categories. In accordance with federal regulations and institutional requirements, any undertaking in which any MU faculty, staff, or students investigate and/or collect data on human participants for research purposes is subject to the MU HRPP and review by the Institutional Review Board (IRB) regardless of the funding source or exempt status.
The IRB application form in eCompliance includes questions and guidance related to each research study which will help the IRB determine or confirm the type of research being proposed.
- Exempt – There are six categories of research which will fall into an exempt status for the MU IRB and reviews can take a few days to a week to complete. In general, exempt studies present minimal risks to subjects and data collected is anonymous or collected and stored in a manner where the identity of the human subject is not easy to determine or meets specific criteria for identifiable information which can be collected/utilized as detailed in the Exempt Review SOP as well as included in the IRB application in eCompliance.
- Expedited – Expedited review of studies can occur when risks to participants is minimal and identifying information is being obtained about or from human subjects or for research which doesn’t fall into the exempt criteria mentioned above. These reviews are conducted by a trained IRB member and typically take 14 days to review from receipt of 3 complete and accurate materials. Details regarding Expedited and Full Board Initial Reviews may be found in this policy. In addition, DHHS includes a list of expedited review categories on their website.
- Full Board – Research not meeting criteria for exempt or expedited must be reviewed by the IRB full board process. These are studies which are typically greater than minimal risk and they will be reviewed at the monthly MU IRB meeting. The deadline for submissions can be found here and is typically the 25th of the month prior to the board meeting.
Q: Does someone have to be added to the study if we (MU) are only giving them de-identified data?
A: Data or information which has been de-identified removing any information which could identify an individual, and where there will be no interaction with human subjects, does not require the data recipient to be added as study personnel to an IRB reviewed/approved project. However, the recipient must not attempt to re-identify the subjects, interact in person or via other methods with the subjects of the data and appropriate safeguards should be in place by the investigators/organizations originally collecting the data/information. In some cases, especially when working with an external individual or entity, a signed Data Use Agreement (DUA) or Memorandum of Understanding (MOU) may be needed. The MU IRB can provide contact information for approved officials at MU who can sign these DUAs or MOU agreements.
If interaction with human subjects is occurring or information is identifiable, the MU IRB will need to determine if an individual (either internal to MU or external) is engaged in research and needs to be added to the study. This link to DHHS provides guidance regarding engagement in research activities.
Q: Do you have templates?
A: The MU HRPP/IRB has developed multiple templates to assist researchers in developing protocols, informed consent/assent documents, HIPAA waiver and authorization forms, permission letters, and debriefing forms. These templates are available on eCompliance or here.
Other universities/sites and external investigators
Q: Can researchers rely on an external IRB and what is the process?
A: The MU IRB will work with external IRBs in conjunction with Authorization Agreements. Specific details regarding this process can be found at ../irb/reliance_procedures. The institutions entering into an agreement must be engaged in research. In general, an institution is engaged when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. The MU IRB will work with investigators to help make this determination. Pre-approval from the MU IRB is required prior to entering any decisions about reliance activities.
Q: What does multi-site mean?
A: Multi-site research typically refers to a research project being conducted by investigators at multiple institutions utilizing the same protocol, procedures, and consent forms and processes. These studies include collaboration with external individuals. These external individuals would be engaged in the research. Each site must obtain IRB approval whether it is through their own IRB or using a Single IRB of Record.
Q: Does an investigator from another university have to be added to my project if they are relying on MU IRB for approval?
A: Yes. An investigator from another university, engaged in MU IRB approved research, must be added as study personnel at MU by creating an external account in eCompliance. There are special circumstances where the MU IRB may already have arrangements in place with the relying IRB regarding the monitoring of investigators but this will be a determination the MU IRB must make in consultation with the relying IRB.
Special requirements for subject compensation
Q: Why do I have to collect Social Security Numbers (SSNs) for every kind of payment, no matter how small?
A: The University of Missouri is required to track compensation to research participants for the purpose of reporting 1099 information to the IRS. Although an individual study may not meet the threshold for dollar amounts requiring 1099 reporting, the research participant may be involved in multiple studies at MU where total compensation/non-cash items received within a calendar year do exceed the reporting threshold. This information should be shared with participants during the consenting process, prior to a study-related activity occurring. The following MU financial policies/requirements provide additional detailed information: https://bppm.missouri.edu/policy/research-participation-payments/ and/or https://hrs.missouri.edu/benefits-pay/Nonresident-Alien-Taxation.
Special requirements for clinical trials or studies involving Protected Health Information (PHI)
Q: Can I review the medical records without a HIPAA waiver to determine feasibility?
A: Yes. This would be considered HIPAA preparatory to research activities and the HIPAA Preparatory to Research Form would need to be submitted via eCompliance for acceptance.
Q1: When is a HIPAA waiver required?
A1: If an investigator is utilizing the medical record to identify and contact subjects for a research study, there needs to either be informed consent from the subject or a HIPAA waiver needs to be approved prior to the access. In addition, there must be a treating relationship with a research team member listed on the IRB application, or the research team members must work directly with providers that have a treating (patient-provider) relationship to consult before contacting potential subjects. HIPAA regulations apply to the screening process and access to protected health information. The IRB will review requests for HIPAA waivers or alterations if necessary. There are individuals within MU Health who have the ability to provide researchers with feasibility information without the need for individual investigators to need to obtain a HIPAA waiver or authorization. You may contact the MU IRB for additional information.
Q: Why do I need to provide a MOCode?
A: MOCodes are required for studies which have the potential to result in a charge being created which may be sent to a participant or their insurance for a procedure related to a research study. The patient billing system maintained by MU Health requires specific information to be entered with respect to research studies associated with billable patient services. The MOCode (also referred to as Fund Code for patient billing) is required to ensure there is a research, non-patient option for charging research only procedures.
Q: What if a research participant already has FSC152 and FSC154 loaded on their account and they enroll in a third clinical trial?
A: FSC152 is used for the first study plan on a patient’s account when they enroll as a research participant in a clinical trial and FSC154 is for the second. If a participant enrolls in a third clinical trial, remove the study plan from the participant’s account that the participant has completed and use FSC154 to load the new study plan.
Q: What information is needed on a study visit log?
A: In order to accurately monitor the billing of study procedures, the following information is needed on a study visit log:
- Short Study Name
- IRB Number
- Participant Name
- Medical Record Number (MRN)
- Date of Birth (DOB)
- Date Consent Signed
- Screen Date, Visit 1 Date, Visit 2 Date, etc.
You may add any other information to the study visit log which you find useful.
Q: How does one create a research visit?
A: Research staff are responsible for ensuring the Research FSC 152/154 and appropriate study plans are loaded to research associated visits. In order to accomplish this, provide the participant name, date of service, and study name to your clinic’s Patient Services Representative to create the research appointment/visit in IDX. In cases where procedures/services are being completed in another area, order the procedures, either in PowerPlans or by written orders, on the research visit number to ensure they get charged to the research visit.
Q: Does the research diagnosis code need to be loaded on a visit when all procedures are considered standard of care?
A: Yes. The Z00.6 research diagnosis code must be used as a secondary diagnosis for all services provided as part of a Qualified Clinical Trial or approved study, even if it would otherwise be standard of care for the patient absent the trial. The research diagnosis code reports that the procedure involved the examination of a participant in a clinical trial.
New requirements related to January 2019 Common Rule changes
Q: What is considered key information in the consent document? Isn’t this just duplicated information that’s already in the consent form?
A: Subpart A of 45 CFR part 46, also referred to as the Common Rule, includes regulatory changes which took effect in January 2019. The new requirements include beginning the informed consent document with “a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.” Depending upon the consent form, this key information may be duplicative, but the regulations include the key information in a concise manner to ensure research participants fully understand reasons why they may or may not want to participate in a research study. The MU IRB staff can work with you to write or alter your existing informed consent form to meet the requirements. In addition, templates are available.
Reporting once a study is approved
Q: What items do I have to report to IRB?
A: The following are required to be submitted to the MU IRB:
- Changes in a research activity must be reported to the IRB prior to initiating changes except when necessary to eliminate apparently immediate hazards to the subject. See the Amendment Policy for more information.
- Any unanticipated problem involving risks to subjects or others or any noncompliance issues must be reported to the IRB within 5 business days of becoming aware of the problem or issue. More information can be found in the Unanticipated Problems policy and NonCompliance Policy.
- On-Site deaths of a research subject may need to be reported to the IRB. More information can be found in the Unanticipated Problems policy.
- New conflicts of interest that arises during the conduct of the research.
- Sponsor Monitoring Reports must be submitted on the Monitoring Report in eCompliance within one week of receipt.
- Personnel Changes must be submitted on the Personnel Change Form in eCompliance prior to the personnel engaging in the research.
- Study closure prior to the study expiration date must be submitted on the Completion/Withdrawal Report in eCompliance.
Human protections activities that occur in the HRPP in addition to the IRB review
Q: Can someone come talk to my faculty, staff or students?
A: The MU HRPP/IRB is always happy to present information to MU faculty, staff, and students regarding federal and institutional requirements associated with human subject research. Please contact our office at 573-882-3181 or firstname.lastname@example.org to request a presentation. In addition, please make sure you are on the MU IRB listserv to receive ongoing information and educational opportunities. Please see more information here.
Q: Why was my study chosen for a tracer review?
A: As part of ongoing monitoring and quality improvement efforts, the MU HRPP/IRB works closely with a group of peer reviewers to conduct research tracer reviews. There is a random selection process which occurs to select approved studies for tracer reviews. Principal investigators and primary study 7 contacts will receive emails if their study has been selected for a random review. The researchers work directly with the peer reviewers to schedule a time for the review.