Frequently Asked Questions

Shortcuts The Application Process Continuing Review Reports Amendments Deviations Adverse Events and Unanticipated Events Causing Harm to Participants or Others Non-Compliance Complaints, Concerns or Comments   Campus Institutional Review Board 483 McReynolds University of Missouri Columbia, MO 65211 573 882-9585 phone 573 884-0663 fax umcresearchcirb@missouri.edu

The Application Process

What activities are subject to IRB review? Activities meeting the MU Human Subject Research Protection program's definition of "human subject research." The institution provides that any activity meeting the Department of Health and Human Services (DHHS) or Food and Drug Administration (FDA) definition of "human subject" or "research" will be subject to IRB review.

What activities must be submitted to the Campus IRB? Any campus based human subject research exclusive of activities involving animals, biomedical, FDA or VA regulated activities.

What are FDA regulated activities? Research falling under the following categories meets the FDA definition of human subject research, and will be transferred to the Health Sciences IRB:

1. The activity involves the use of a drug other than the use of a marketed drug in the course of medical practice.
2. The activity involves the use of a medical device other than the use of a marketed device in the course of medical practice.
3. The results of the activity are submitted to the FDA or held for inspection by the FDA.
4. The tissue specimens are being used to test the effectiveness of a medical device and the information is submitted to the FDA for approval of the device.
5. The activity involves one or more of the following: FDA regulated articles: food or drug dietary supplement that bears a nutrient content or a health claim, a food or color additive for human consumption, infant formula, biological or electronic product for human use, or other article subject to the FD&C Act.
6. Individuals are directed by a research protocol rather than by medical practice, when they are or become participants in research (either as recipients of an FDA regulated product (approved or experimental) or as controls). OR
7. Individuals participate in an investigation either as subjects or as controls where an investigational device is used on them or on their specimens.

What are VA regulated activities? Research falling under the following categories may be subject to VA regulations and will be transferred to the Health Sciences IRB:

1. The researcher or key personnel are employed or associated with the VAMC or VA entity.
2. The research will be conducted at the VAMC or VA entity.
3. The researcher's or key personnel's responsibilities in the proposed activities involve collaboration with the VAMC or VA entity. (i.e. Business Associate's Agreement; Data Use Agreement; etc.)
4. The researcher intends to recruit human subjects or access data under the jurisdiction or auspices of the VAMC or VA entity.
5. The researcher intends to recruit human subjects or access data from the VAMC or VA entity.
6. The research activities fall under the jurisdiction of any Veteran's Administration regulated entity, organization or agency.

Where are you located? The Campus IRB is located in 483 McReynolds Hall. The main telephone number is (573) 882-9585. The fax number is (573) 884-0663.

What is your Web site address? http://research.missouri.edu/cirb/

How do I submit an application? Go to http://irb.missouri.edu/eirb/

What documents do I need to upload with my application? The Campus IRB will review all documents relevant to the research project proposed. The list may include, but is not limited to, sample inventories, survey instruments, focus group or interview questions, oral consent scripts, written consent, parental consent and youth assent forms, sample testing materials, recruitment ads, funding or grant proposals, permission letters from the authorizing individual at the research site, organization, company, association, etc. (i.e. superintendent, principal, CEO, president, institution's authorizing agent, website addresses, etc.).

Do you accept hard copies? No. The Campus IRB utilizes an online application process called the eIRB application. This process electronically writes all information directly into a database that is automatically updated during data input. The system permits the IRB to review all information submitted by the investigator through the online system. The investigator is also able to review the status of the review process online through the "Open Saved IRB Project" link on the main menu.

How do I complete the training requirement? The Campus IRB is required to assure all investigators receive education and training in human subject research prior to project approval. An investigator must complete human subjects training every (3) years through either attending a live presentation conducted by Campus IRB staff or through successfully completing the online Campus IRB: CITI Human Subject Training Program.. The online training can be accessed by following the directions below:

1. Login to the Campus IRB website at http://irb.missouri.edu/eirb and navigate to "Training Requirements."
2. At the Main Menu, click CITI Training
3. Complete the quiz after each module.
4. Save all examinations of each module.
5. PRINT CERTIFICATE: Click on the "print" link to obtain a copy of your training certificate for your records.

Dates for live training presentations can be viewed on the Live Training Schedule page of our Web site http://irb.missouri.edu/eirb. This section also offers the opportunity for your department or class to schedule a live training session tailored specifically to your needs.

Re-certification

Human subject training certification is valid for three (3) years. If an investigator intends to conduct research involving human subjects after a three (3) year time period, the training certification must be renewed. Training renewal can be completed online or by attending a live Campus IRB training session.

Who must complete the training requirement? All "key personnel" involved in the human subject research must complete the training requirement.

Do I need to upload funding materials? Yes. The federal oversight agency governing human subject research recommends that an IRB review all materials related to the proposed project prior to approving the application. The agency further recommends that the application be reviewed in concert with the funding proposal prior to approval of the project. The Campus IRB will not be able to review your application until we receive an electronic copy of the funding proposal to satisfy this recommendation. If the proposal is inadvertently omitted, the IRB will send a written request for the funding documents.

Are there any other documents or attachments I should upload with the application? The Campus IRB must review all documents that are relevant to the research project prior to approval. If you feel a document will assist the board's understanding of the research concept, you should electronically submit the document(s) to the IRB for review. Additionally, you should electronically submit all documents that the subject will see during the research process.

What will the IRB need to review for web-based research? The IRB will need to review all of the same documents that are required for the application process, along with the web address. The IRB will need to access the website and review the same materials that the subject will see during research process. Full IRB approval will not be granted without access to the website.

Can I obtain consent online, or do I have to have a hard copy written consent document? This will depend on the research project proposed. All projects are reviewed according to their level of risk to the subject on a case-by-case basis. The IRB will assist you in understanding the level of risk to the subjects involved in the proposed project. A minimal risk project may be permitted to obtain consent online with specific restrictions. Please feel free to contact the IRB to discuss your proposed project.

If I am a student, what is my advisor's role in the application process? The advisor is responsible for monitoring the student during the proposed research process. The advisor must review/approve the application prior to its submission to the IRB. The advisor must 1) be listed on the IRB application and 2) complete the Advisor Approval Form located under the IRB Forms link on the main menu. The Campus IRB will not review an application submitted by a student investigator without a completed Advisor Approval Form.

What if my advisor is unavailable? Can I go ahead and submit the application for review to speed up the process? The Campus IRB will not be able to review the application without the electronic Advisor Approval Form. The review process will be delayed and the application will be placed in ON HOLD PENDING PI RESPONSE status until the advisor has approved the proposal. The IRB does not give ON HOLD PENDING PI RESPONSE applications priority review and the file will be reviewed in the order it was received.

If received IRB approval from another institution, do I need to reapply for approval at this institution? Yes. The federal regulations and AAHRPP accrediting organization requires our institution to assure the safety of all human subjects involved in research projects at cooperative sites. The Campus IRB has the authority to review the cooperative site's IRB materials and determine if it meets the standards set forth by our governing policies, procedures and regulations. The investigator should call the Campus IRB at (573) 882-9585 and discuss the proposal with a Compliance Specialist to determine what materials may be needed. Although a Campus IRB application must be completed, many of the materials may not need to be resubmitted. The Compliance Specialist will work with the investigator to assure that all relevant documents and assurances are submitted.

I would like to conduct a research project at another institution. What do I need to do? As indicated in item #13, the federal regulations requires that our institution assures the safety of all human subjects involved in research projects at cooperative sites. The Campus IRB will need information regarding the key personnel involved at the cooperative site, and their role in the research process as it relates to the human subject participants. The investigator should call the Campus IRB at (573) 882-9585 and discuss the proposal with a Compliance Specialist to determine what materials may be needed.

What information will the IRB need from offsite co-investigators? This will be determined on a case-by-case basis. As indicated in item #13 and #14, the federal regulations requires that our institution assures the safety of all human subjects involved in research projects at cooperative sites. The Campus IRB will need information regarding the key personnel involved at the cooperative site, and their role in the research process as it relates to the human subject participants. The investigator should call the Campus IRB at (573) 882-9585 and discuss the proposal with a Compliance Specialist to determine what materials may be needed.

What documents do I need to upload for international research proposals? As indicated previously, the federal regulations require that our institution assures the safety of all human subjects involved in research projects at cooperative sites. This requirement holds true for international research also. The Campus IRB will need information regarding the key personnel, research methodology and its relationship to the human subject participants. The investigator should call a Campus IRB Compliance Specialist at (573) 882-9585 and discuss the proposal, recruitment and consent process, documentation, and any cultural issues that may impact the IRB process.

The application inquires about the selection AND recruitment process. What is the selection process? Federal regulations require that an IRB assure that no specific category of subjects is discriminated against in the human subject research process. This does not mean that a researcher may not choose to only investigate a specific subject group. It simply means that the researcher must have a rationale for specifically excluding a subject category. The "selection process" describes HOW the target subject groups were identified; WHAT subject groups will be excluded; WHY those subject groups will be excluded; and the PROCESS that will be implemented to assure they are excluded.

The application inquires about the selection AND recruitment process. What is the recruitment process? The "recruitment process" is the means by which the researcher will solicit participants. The application probes for the mechanism that will be implemented to "encourage" the subject group to participate (i.e. oral announcement, advertisement, snowball technique, randomization, and many others). The IRB is interested in the process that will be offered to "encourage" participation.

How long does approval take? The approval process is determined on a case-by-case basis. Under normal circumstances, if an application is COMPLETE, the Campus IRB makes every attempt to review applications as follows:

1. Exempt application in 5-7 business days;
2. Expedited application in 7-10 business days;
3. Full board application in 30 business days.

Please be advised that "incomplete" applications do not receive priority review and are placed in ON HOLD PENDING PI RESPONSE status. Incomplete applications do not receive the same review consideration as a "complete" application. Incomplete applications may delay the approval turn around time.

What happens if I submit an incomplete application? Incomplete applications delay the IRB review process. If an investigator submits an incomplete application, the reviewer will request additional requests for information online. The investigator should proceed by the following process:

1. To CHECK THE STATUS of your application, please go to the OPEN SAVED IRB PROJECT section of the main menu. If your project is ON HOLD or DENIED (?), you will need to review the COMMENTS section of the online application.
2. Please upload the requested documents to the Document Storage section of the eIRB at your earliest opportunity so that the application can move forward in the review process.

How can I avoid submitting an incomplete application? The Campus IRB is committed to assuring the safety of all human subjects involved in research under the auspices of this institution. Please contact the Campus IRB office to make an appointment with the staff if you need assistance in understanding the IRB process. If you have questions regarding the processes related to the submission of materials or requested documentation, you will need to contact a Compliance Specialist at 882-9585.

What is "pending" status? Any application that has been reviewed and determined to be incomplete will be removed from the UNDER REVIEW status to the ON HOLD PENDING PI RESPONSE status awaiting a response from the investigator. Pending files do not receive priority review from the Campus IRB. Once the investigator responds to the reviewer's request, the file will be returned to the UNDER REVIEW status category and reviewed in the order by the date the responses were received. In an effort to be fair to the applicant who has submitted a complete application, the investigator who has submitted an incomplete application is not entitled to rely upon the original submission date for review consideration. The resubmitted application is placed back in the files to be reviewed by response date.

How is my application reviewed? Proposed human subject research is reviewed at either the a) exempt b) expedited or c) full board level.

1. Exempt review means the activities must be reviewed by the IRB but may be exempt from certain federal requirements or procedures. Research meeting the criteria for an exempt determination must not pose greater than minimal risk, involve statutory requirements for IRB review, be FDA regulated or involve prisoners. Exempt activities are reviewed by administrative procedures.
2. Expedited review means the activities must be reviewed by the chair or chair's designated voting member and not pose greater than minimal risk. Activities meeting this criteria must be categorized in accordance with regulatory guidelines for certain activities and subject to the requirements set forth in 45 CFR 46.
3. Full Board review means the activities must be reviewed by the convened IRB board and pose greater than minimal risk to the subject participant. The application or proposal MUST BE submitted by the 1st of the month of the respective meeting. The application must be complete for approval consideration. Investigators submitting incomplete applications run the risk of the matter being "tabled" until the next meeting or until such time the application is complete. Such an action will delay any opportunity for the investigator to initiate recruitment and research activities.

NOTE: The investigator should pay close attention to the Application Deadline Requirements to timely submit a proposal for full board review.

Are there different types of applications forms? YES. Exempt activities have a different application than expedited or full board activities. Activities meeting the criteria for exemption are not required to follow the same regulatory submission requirements as expedited and full board proposals.

How can I expedite the review and approval process? Please upload your documents within the eIRB system at your earliest opportunity so that the application can move forward in the review process. During the review of your file, be sure to label the requested documents with the appropriate document type and use the resubmit button in order to expedite the review process.

How can I check on the status of approval? To CHECK THE STATUS of your application, please review the OPEN SAVED IRB PROJECT section of the main menu. If your project is ON HOLD PENDING PI RESPONSE or DENIED, you will need to review the COMMENTS section of the online application. Please upload the requested documents within the eIRB system at your earliest opportunity so that the application can move forward in the review process.

What if I am experiencing technical problems with the online application? Please complete a feedback form to alert the Office of Research Computer Analyst, who will contact you regarding resolution of the problem. The analyst will follow up with you and our office to resolve the matter. This link is also available on every page of the eIRB website.

The application inquires about whether a conflict of interest exists. What constitutes a conflict of interest? A conflict of interest exists if an issue exists between anyone involved in the research project (i.e., this may include, but is not limited to, the researcher/any team member, the funding source, institution, subject, IRB board member) that could alter or impact the subject's understanding of the participation agreement, willingness to participate, or the IRBs review/approval process. Examples may include financial, institutional, professional, or personal gains. The University of Missouri-Columbia and Federal agencies have specific disclosure requirements for "Financial Conflicts of Interest." Please contact the Campus IRB if you have a question regarding whether or not a conflict of interest exists.

What if I have an urgent matter that needs immediate attention? The Campus IRB office serves a large number of investigators and makes every attempt to efficiently meet the needs of the research community and to assure compliance. Please be advised that the best mode of communication for "urgent matters" is by TELEPHONE (882-9585) rather than email. Feel free to leave a message and our office will contact you as soon as possible. You may also feel free to stop by our office at 483 McReynolds Hall.

Continuing Review Reports

What is a CRR? Federal regulations require an IRB to obtain a status report called a "Continuing Review Report" ("CRR") for all approved research projects at least at a minimum of at least every 12 months. The Campus IRB assigns the approval period for human subject research projects on a case-by-case basis, and notifies the investigator in writing. The approval period may be shortened, depending upon the facts specific to that particular project. An investigator must complete a CRR report at least every 12 months to remain in compliance with the regulations. You should make sure to upload all relevant documents as listed in item # 3.

It is the responsibility of the investigator to timely submit the report to the Campus IRB to avoid suspension or termination actions. The Campus IRB will notify the investigator approximately 60-90 days prior to the approval expiration date, and request that the report be submitted within 45 days to avoid suspension or termination of approval. If the investigator fails to submit the requested report, the IRB will terminate its approval and notify the department and Office of Sponsored Programs. All research must STOP immediately, the funds will be suspended, and the investigator must contact the IRB for directives on how to comply with the IRB process. The investigator may be asked to provide an additional report and/or to appear before the full-convened IRB board.

If you have questions about the CRR process, please contact a Compliance Specialist at (573) 882-9585.

Do I need to complete a CRR if the IRB has determined my research is EXEMPT? NO. You must contact the IRB if any aspects of your exempt activities require a revision or the level of risk to the subject changes. You should contact the IRB if you have questions about whether you need to submit a CRR.

What if I am analyzing de-identifiable data? If an investigator has concluded all activities involving interaction with the human subject and the remaining research will only involve analyzing de-identified data the CRR does NOT have to be submitted. INSTEAD, the researcher may submit a "Analyzing Data Report." If the researcher intends to recruit additional subjects, interact with subjects or analyze data that may be linked or one could reasonably ascertain the identity of the subject - a CRR may be required. Please contact the IRB for specific directions.

Why do I need to complete the CRR report? Federal regulations require an IRB to obtain a status report on all approved research projects. The report assists the IRB in assuring the safety of human subjects participating in research projects.

My consent form was supplied with my original application, why do I need to upload it with my CRR? If the investigator proposes to continue to collect data, they must submit a copy of the current Informed Consent document so that it can be compared with the original. The IRB must review the current Informed Consent form to assure that it is the document that was previously approved, and also to determine if there are any additional risks to the subjects that must be assessed.

If I did not conduct my research, do I need to submit my CRR? Yes. The Campus IRB must still obtain a status report on the project if it will remain "open to enrollment." However, if you wish to "close" the project, you will need to complete a "Completion Report" and submit to the Campus IRB.

My project is completed. Do I still need to submit a CRR? No. You will need to complete a status report to "close" the project. Complete the "Completion Report" and submit it to the Campus IRB.

What do I do if a subject complains or requests to withdraw from the study? Please complete the relevant information on the CRR report along with a detailed explanation of the nature of the complaint or reason for withdrawal. If you have the complaint in writing, please upload a copy with the report.

How many CRRs should I submit? One CRR submission is required per year per project before its expiration date, unless otherwise specified. Student investigators must also direct their advisor to complete the Advisor Approval Form to accompany each CRR for IRB approval.

What is SUSPENDED approval status? The Campus IRB may "temporarily remove" or suspend an investigator's IRB approval for many reasons. This means that an issue has been raised that is cause for concern and the IRB is investigating the matter to determine whether to permit the research activities to continue. The IRB suspends approval for projects when it is concerned that there is an increased risk to the subject participants. If approval is suspended, all research activity must STOP until further directives are received from the IRB. The Office of Sponsored Programs will be notified and funding may be affected. The IRB may request a written report and/or an appearance before a fully convened board. Please contact the Campus IRB immediately if you have been notified that approval has been suspended.

What is TERMINATED approval status? The Campus IRB may "permanently remove" or terminate an investigator's IRB approval for many reasons. This means that an issue has surfaced that is cause for concern and the IRB will investigate the matter to determine whether to permit the researcher to continue to conduct research. The IRB terminates approval for projects when it is concerned that there is an increased risk to the subject participants. If approval is terminated, all research activity must STOP until further directives are received from the IRB. The Office of Sponsored Programs will be notified and funding may be affected. The IRB may request a written report and/or an appearance before a fully convened board. Please contact the Campus IRB immediately if you have been notified that approval has been terminated.

Amendments

I need to make some minor adjustments to my study. Do I still need to submit an amendment form? Why? YES. The Campus IRB must review and approve ALL changes to research projects PRIOR to implementation to assess the risk to the subjects. If an investigator modifies a previously approved research project prior to the IRB's review and approval, they may be subject to restrictions, suspension or termination actions by the board. Any human subject research activity conducted without prior IRB approval is considered NONCOMPLIANT and therefore the researcher is subject to penalties by the board.

What materials are needed for amending my application? You will need to complete the online Amendment form. You should make sure you upload all relevant documents as listed in item # 3.

My project was just recently approved, why do I need to wait for my amendment to be reviewed at a later date? Why can't it be reviewed today? All applications submitted to the Campus IRB are reviewed in the order received. Due to the voluminous number of activities that are received daily in our office, this seems to be the fairest way to review applications.

I am a student and need to amend my project. My advisor is out-of-town, can I go ahead and submit the amendment request for review? The Campus IRB will not review any application submitted by a student without the Advisor Approval Form completed by the advisor. This policy prevents our office from duplicating review efforts, in the event the advisor does not approve the application as originally proposed. Our office frequently observes numerous modifications made to student projects, in an effort to satisfy department curriculum requirements. Since the advisor is responsible for monitor the student's research project, it is our policy to make certain that the application has been reviewed and approved by the faculty member prior to being reviewed by the IRB.

What form do I complete if I want to add or remove someone from the project? Complete the Project Personnel Change form. These are reviewed internally.

Deviations

What is a deviation? This is a "variation" from the approved research methodology that was originally proposed. Many times emergency situations arise that require an investigator to "vary" or "alter" the previous research process to assure the safety of the human subject. When this occurs, the investigator must contact the Campus IRB immediately to receive directives on how to proceed. Please be advised that "deviations" should not be considered as a routine course of action or as a "convenience" option for investigators.

What should I do if an emergent situation arises that requires me to change my research process before I can speak to the IRB? If an emergency arises, you should take every precaution necessary to assure the safety of the human subject participant. You should immediately contact the Campus IRB for further directives and complete the Deviation Form located under the "IRB Forms" link on the main menu.

Adverse Events and Unanticipated Problrms Causing Harm to Participants or Others

What is an adverse event? This is an "unexpected" event. Adverse events are unforeseeable outcomes that arise during the course of the research process.

What should I do if an adverse event occurs? If an adverse event occurs, the investigator should take every precaution necessary to assure the safety of the human subject participant and then immediately contact the Campus IRB for further directives and complete the "Unanticipated Problem or Adverse Event" Form located under the "IRB Forms" link on the main menu. The Campus IRB is required to report serious adverse events to federal and institutional officials. In an effort to be proactive, to further protect subjects, the Campus IRB requires investigators to report all unanticipated problems and adverse events to the IRB for a determination of what should be reported to federal or institutional officials. Please contact the Campus IRB if you believe an unanticipated problem has occurred.

What is an unanticipated problem? Any information, event, or activity that at the time of its occurrence is either (1) unexpected; or (2) unforeseeable based on the information that was proposed or previously provided to the IRB. The Campus IRB is required to report unanticipated problems causing serious harm to subjects to federal and institutional officials. In an effort to be proactive, to further protect subjects, the Campus IRB requires investigators to report all unanticipated problems and adverse events to the IRB for a determination of what should be reported to federal or institutional officials. Please contact the Campus IRB if you believe an unanticipated problem has occurred.

What should I do if an unanticipated problem occurs? If an unanticipated problem occurs, the investigator should take every precaution necessary to assure the safety of the human subject participant and then immediately contact the Campus IRB for further directives and complete the "Unanticipated Problem or Adverse Event" Form located here:

• Unanticipated Problems or Adverse Events Causing Harm to Participants or Others Policy (PDF, 112K)

Non-Compliance

What is meant by noncompliance? This involves any research activities that are "not in conformance" with the federal, state, or local law; or the University of Missouri's Campus Institutional Review board policies/procedures governing human subject research. The Campus IRB considers a breach of compliance as one of the areas of highest risk to subject participants.

What should I do if I suspect I am involved in a noncompliant human subject research project? Contact the Campus IRB immediately at (573) 882-9585.

What is the IRB process for the noncompliance? Each case is reviewed independently. The Compliance Officer will notify the investigator with directives on how to proceed. The investigator must STOP all research immediately. The IRB will notify the department and the Office of Sponsored Programs accordingly. The investigator will work closely with the Compliance Officer to assure compliance.

Will I be able to conduct research in the future? Each case is reviewed independently. The investigator will work closely with the Compliance Officer to assure compliance. The investigator will receive written notice of the board's determination regarding conducting future research.

Will I be able to use the data I collected from the research project? Each case is reviewed independently. The investigator will work closely with the Compliance Officer to assure compliance. The investigator will receive written notice of the board's determination regarding the use of data.

Complaints, Concerns or Comments

What if a researcher has a concern or question about the IRB process? The Campus IRB has an "OPEN DOOR POLICY". Investigators are free to stop by the office to ask questions email inquiries or concerns, or telephone during business hours. It is the policy of the Campus IRB to provide the investigator with an opportunity to address concerns about the IRB process by also addressing anonymous complaints.

What if I have concerns or questions about the electronic application process? The Campus IRB also has an online feedback system developed in "eIRB" in the event the investigator has questions or concerns about the electronic system.

What if I want to ask questions in person? The Campus IRB welcomes appointments, and also offers "QUESTION & ANSWER SESSIONS" that are tailored to the specific research community of the invitee. Please contact the Campus IRB to schedule a Q&A session.

Does the Campus IRB offer small training sessions? The Campus IRB offers trainings to every department, unit or office and provides tools to areas conducting research under the jurisdiction of CIRB. A unit or department may also contact the CIRB and schedule a special training to be tailored specifically to the research team's needs.

Are there special IRB procedures required to address complaints or concerns? YES! The Informed Consent process MUST provide prospective participants with contact information for a research team in the event they want to ask questions and voice concerns or complaints to the investigator. The Informed Consent process MUST also provide prospective participants with contact information for the Campus IRB, as a person independent of the research team, in the event the research staff can't be reached; or the participant wishes to speak with someone other than the research team about question/concern/or complaints about the research team.

What if a research participant has a complaint or concern about the research process? The investigator shall make every attempt to mitigate the circumstances and address the subjects concerns immediately. The Campus IRB offers outreach opportunities to participants to facilitate the understanding of the IRB process. The researcher may guide the subject to the Campus IRB website for general inquiry questions. Concerns that rise to the level of a complaint are deserving of more immediate attention and resolution. The Campus IRB requires the researcher to make every attempt to address the subjects concern. The subject may complete a "Complaint, Comment or Concerns Form" and submit it to the Campus IRB.

• Complaints, Concerns or Comments Form (PDF, 24K)