IRB Frequently Asked Questions (FAQ)
Table of Contents:
Closing a Study
Completion of the new PRO SmartForm
Continuing Progress Report (CPR)
Closing a Study
What do I do if my study is going to close out, but I haven’t received the final paperwork from the sponsor? Should I submit a CPR to keep the study open (and not lapse) or should I wait until the sponsor submits all the closing paperwork and do a “Final CPR”?
Submit an ongoing CPR in order to keep the study from lapsing IRB approval. The study team can always submit another CPR indicating it is the “FINAL” CPR and can close the study out. A final progress report should be submitted within three months after completion of all study activities, in accordance with IRB SOP: Study Closure.
Completion of all study activities means the following study activities are closed:
-Screening and recruiting of new participants
-Enrolling new participants into the study(ies)
-Treatment of enrolled participants
-Follow-up on enrolled participants, including QOL questionnaires and checks for mortality
-Submitting of amendments
-Submitting Continuing Progress Reports
-Filing of SAE's
-Filing of Protocol Deviations
-Analysis of results
Completion of the new PRO SmartForm
If an investigator has a project that includes both local and distant banking, what should they check in Section 3.1?
The investigator should check “Research project plus creating a new local bank.” The investigator will be prompted complete all pertinent sections of the eBridge SmartForm connecting the Research Study to the local Bank. The investigator will open another new application for the local bank and select Local Bank in new application and complete the identified sections in the eBridge SmartForm which will address local banking.
Why can't the Local Bank application be branched off of the current PRO SmartForm rather than completing two separate applications?
There are two reasons why this decision was made: 1) Although related, these really are 2 different types of projects for which very different information is required. From the IRB’s perspective, we need to keep them separate; 2) Even though the bank seems to be “branching off” from the current study at this time, in future other studies might be created out of the bank, or data/specimens from other studies might be funneled into the bank. Therefore it is generally advantageous for both the IRB and the researchers for the bank to be an independent entity from the outset.
How will the IRB handle the following scenario: a new research protocol is being created with the aim of putting unused materials and data from the new protocol into an established bank. Does this require an amendment to the established bank? How can the investigator have the protocol approved until the amendment is approved, and vice versa - without a substantial delay in coordinating these two activities.
Yes, both a new research project and an amendment to the established bank need to be submitted. The connection between the new research project and the Amendment to the bank and their PRO/AME numbers will need to be described in the text sections of both submissions. Both should be submitted on the same day for the IRB to coordinate the reviews.
For research projects plus a new local bank, will there be two CPRs since there are two applications?
Yes, there will be 2 CPRs required since the information you’ll report for the bank will be different than that for the research project.
If some minors will require use of pediatric TRU, what should the answer be in 27.1?
The PI needs to negotiate this separately with pediatric TRU. The MCW/FH IRB does not have authority to negotiate with them. “None of the above” should be checked in this case.
When uploading surveys or other study documents, can multiple instruments be uploaded as the same document or does each instrument need to be uploaded separately?
Each instrument needs to be uploaded separately; however, if the multiple instruments can be combined serially into one document, then only one upload is needed.
Can I use an IRB approved consent form in my consenting process as long as it is used during the approval period documented in the header of the documented in the header of the document?
The short answer is: it depends...
Yes, as long as no changes have been made to the consent document, during the approval period and the information is accurate and complete.
No, if the consent document has been revised. Once the IRB approves a revised consent form to replace a previous consent form, previous consent form can no longer be used.
It is good practice to refer to the study in eBridge to ensure that the correct IRB approved consent form is printed and used in the consenting process.
Is it okay to make revisions directly on the consent form that is signed by the participant?
No. Handwritten revisions should not be made directly to the consent form that is being used to consent a subject. All revisions, including, but not limited to, a change in study team contact information, stipend information, new safety information or a change in the conduct of the study, must undergo IRB review and approval prior to use.
If a revised consent form is pending approval; can subjects be consented using the current approved consent form?
Yes, you can continue to use the current approved consent form in the consenting process under most instances. However, if the changes to the consent form reflect a change of information that may affect the subject's willingness to participate (such as new risks identified or risk identified as occurring at greater frequency, or addition of a procedure involving greater than minimal risk) you may want to hold off on the consenting of new individuals until you have the IRB approved revised consent form. In the event that you cannot delay the consenting process, we recommend that you contact the IRB office to discuss this situation and your plan for consenting.
In the event that the study consent form is revised to reflect a change in a study procedure or new information which may impact the willingness of study subjects to continue study participation, subjects who were previously consented should be provided this new information at the earliest opportunity, and re-consenting should occur with the approved document.
Who can date the consent document for the subject?
MCW/FH IRB SOPs and FDA Regulations require the subject to sign and date the consent document for him/herself. Changes to this process must be submitted to and approved by the IRB. Examples of modifications to the documentation process include the following: 1) If the study involves participants who are unable to physically sign/date the consent document, the plan for documentation on informed consent must be presented to the IRB for review and approval; and 2) Circumstances when a legally authorized representative should be included in the consenting process of decisionally impaired individuals; in this case, the legally authorized representative should sign and date the consent and the enrollee provide assent.
If a subject is physically incapable of signing the consent and requires a legally authorized representative, how should it be documented that the signature on the consent came from the LAR and not the actual subject?
The question above contains information regarding different situations which require different actions, both situations are addressed in the response.
If the subject is fully decisional and is able to determine whether to volunteer in the study on his/her own but is unable to sign and date the consent document, the use of a legally authorized representative (LAR) is not required. The HRPP office encourages study staff to document the consenting process in the research file indicating that the subject verbalized agreement to participate in the study but is unable to sign the document and if there was a witness to the consenting process. If this situation may be encountered more frequently because of study population, the HRPP office would expect the Investigator and study staff to formalize a consenting process which addresses the needs of the study population and submit an amendment for IRB review and approval.
A legally authorized representative (LAR) is required to give permission for the subject's participation in a study when the study subject has decreased decisional ability. Documentation of the consenting process in this situation requires inclusion of the LAR's signature and date on the consent form. The HRPP office encourages documentation in the research file by the individual who obtained informed consent as to why the subject is unable to provide written documentation of his/her assent. Please review the IRB SOP: Research with Subjects Like to Manifest or Develop Decreased Decisional Ability for more information regarding legally authorized representatives.
What’s the difference between “informed consent” and “HIPAA authorization “ for a research study with human subjects?
These two overlap in concept in the regulations and in practice; this is why the difference between "consent" and "HIPAA authorization" is confusing for investigators.
The definition of "human subjects research" includes any use of "identifiable private information" (DHHS regulation language). So peeking into a patient's medical record to determine whether he/she might be eligible for a study or clinical trial qualifies as a "human subjects research" activity. As a human subjects research activity, peeking into a medical record requires prior informed and documented consent (by default) unless the IRB has determined that a "waiver of the informed consent process" is appropriate and approved that waiver.
This is puzzling and annoying for clinical investigators, who don't have to seek consent for comparable clinical activities. A physician is free to use his/her own patients' charts for research screening purposes, or for deciding which patients to approach about a study. But this right applies only to the physician and other clinicians personally caring for patient. Other physicians and employees do not have the same right--even though they may belong to the same practice group, same Division, or same Department as a physician who personally cares for the patient.
HIPAA regulations use the phrase "protected health information" to refer to the medical chart and all other related health information about a patient. "Protected health information" is a subset of a person's "identifiable private information," as defined by DHHS regulations.
For treatment purposes, anyone within a Covered Entity (e.g., MCW or Froedtert Hospital) is allowed to access a patient record. For research or clinical trial purposes, the same is not true. Peeking into a patient's medical record to determine whether he/she might be eligible for clinical trial requires documentation that the patient give prior HIPAA authorization (by default), unless the IRB determined that a "waiver of HIPAA authorization" is appropriate and approved that waiver.
Why should I apply to the IRB for both a “waiver of the informed consent process” and waiver of HIPAA authorization” if I am doing a clinical study of patients and will be using an IRB-approved consent form to enroll subjects?
No one except the physician or nurse providing treatment for the individual patient has the right to screen the medical record for study eligibility. When any other persons will be screening charts to identify study candidates, or to abstract clinical information, it is necessary to apply for the two waivers.
The regulatory criteria for the two types of "waivers" are different. Thus investigators who propose peeking into a patient's medical record to determine whether he/she might be eligible for a clinical trial should routinely ask for both kinds of waivers. While the two waivers may refer to the same activity (peeking), they are associated with different regulatory requirements.
If the IRB blurs the distinction (procedurally or in our minutes), we lay the MCW IRB open to the charge of "not following the regulations" or "not understanding the difference."
Can the study team member use the translated consent forms found on the IRB website to consent a non-English speaking subject?
Yes. When a potential subject who does not speak English is unexpectedly encountered, federal regulations allow for use of a "short form" in a language the subject understands, to document that all required elements of informed consent were presented orally.
-The entire consent form in English should be discussed with the subject and translators.
-The translator should be independent of the subject not related or associated with the subject.
-The short form, in a language the subject the subject understands (currently available in Spanish, Russian, and Hmong), must be presented to and signed by the subject.
-A witness to the oral presentation is required; the translator may be witness.
-A reportable event should be filed within 5 days to the IRB.
If the investigator plans to enroll additional individuals who do not speak English, the investigator should contact the IRB.
I know that if we encounter an occasional subject whose language is Spanish, Russian or Hmong, the IRB has a consent form process and “short form” consents for those languages. But, what should we do if we want to enroll an occasional subject who speaks/reads a different language?
A written “short form” consent in the language the subject speaks/reads is required. The subject must be able to read and sign the “short form” consent in their language. The role of the interpreter is to translate the physician’s explanation of the study procedures, using the study’s IRB-approved English consent as a script, and to translate the subject’s questions and the physician’s answers.
If a “short form” consent in another language is needed, the IRB office should be notified, and the IRB office will facilitate its preparation. It is against OHRP regulations to verbally translate the English “short form” and have the subject sign the English version, if they do not speak/read English.
Please offer suggestions of other languages for which short forms are needed! Complete details can be found on the IRB/HRPP Consent Forms webpages.
If the subject requests the original signed informed consent document can the site retain a photocopy?
No. Per MCW/FH IRB SOPs, the original signed informed consent document must be retained with the study files and a copy given to the subject or the subject's legally authorized representative who signed the consent form.
Is it okay to destroy or discard the signed consent forms of those who later decide not to participate in the study?
No. A signed informed consent document should be kept in the study file; it should not be destroyed or discarded.
Are all individuals identified as members of the study team automatically authorized to consent subjects?
No. Only individuals clearly identified to the IRB in the study application (SmartForm section: 39) as being involved in the consenting process should consent subjects.
What can the member of the study team obtaining informed consent do to ensure the signed consent form is a complete and accurate consent document?
Prior to providing the subject with a signed photocopy of the informed consent, the study coordinator should review the document and ensure:
-The subject signed the most recent IRB approved version of the consent for that study.
-The subject signature is present in addition to the subject's name.
-The subject dated for him/herself and the date is correct.
-If the subject or study staff made an error, the error was corrected by drawing a signal line through the error.
-All pages of the informed consent document are present.
Can subjects undergo screening or study procedures prior to giving written informed consent?
Any study related activity, including screening, should take place after informed consent is obtained, unless the IRB has granted a waiver of consent for that activity. If you have questions or concerns regarding this issue, contact us.
Continuing Progress Report (CPR)
I need to complete the enrollment section of the CPR. The sponsor says that a subject is enrolled after they are determined to be eligible for the study; however, in order for eligibility to be determined, the potential subject has to sign consent and undergo study-specific screening procedures. What does the IRB consider “enrolled”?
The IRB and Sponsor definitions of "enrolled" may be different. The IRB defines a subject as "enrolled" after they have given consent to participate and signed a consent document. The IRB's definition should be used in completing the CPR SmartForm. So, according to the IRB's definition, 100 subjects may have signed the consent and be "enrolled" on the CPR SmartForm. If the Sponsor only counts subjects as "enrolled" who have fulfilled eligibility criteria, then the number according to the Sponsor may be smaller than 100.
For more information see IRB SOP: Submission of Continuing Progress Reports (CPR)
If a study has received IRB approval, but is currently pending OCRICC for FI approval AND has not enrolled anyone (No study activity), does the study still need to submit a CPR?
Yes, the regulations at 45 CFR 46.109 - The IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
If the study has not had any activity, the IRB may review the CPR under expedited category 8b when no enrollment occurred and no additional risks are identified.
I received the email regarding a CPR. I believe the PI submitted the CPR because he closed the study to enrollment (the fellow who was working on the study finished his fellowship). Should he submit an amendment for this instead, or should he just wait until the CPR is due in January?
You don’t need to submit an amendment for enrollment closure – it’s considered a natural part of study progression. The enrollment closure can be noted in the next CPR that is due.
Do I need to wait until eBridge sends the electronic reminder to open a CPR in eBridge? I want to close out the study but was not sure whether I could open a CPR before the system sends the electronic reminder.
The study team may submit a CPR to close out a study (final report) at any time during the study. You do not have to wait until the eBridge system prompts you to open a CPR. It can be opened and submitted to the IRB at any time.
In our study, a subject will be leaving the state from January until the beginning of May. This is significant because subjects have monthly follow-up visits. We are in the process of arranging for the subject to be followed at a site in South Carolina. From the IRB perspective is there any issue with doing this or does the IRB require any specific documentation be sent to committee?
This situation is very common in the Midwest. Often, subjects leave during the winter and live in a warmer region until spring. Sponsors generally have no problem giving approval for a subject to be seen at another site. There must be an agreement between MCW and the other participating site and the sponsor must grant approval. As long as these conditions are satisfied, there is no reason for the IRB to be notified. Per IRB SOP: Requirements for Reporting to the IRB, this situation does not fit any of the definitions provided. The study team should report this situation at the time of CPR in the "PI's Progress Report" section of the CPR SmartForm (Section 14.1).
Can I save the names and phone numbers of persons who call in response to study recruitment ads, or people who have been screened for a study, so I can offer them a chance to participate in future studies? What if the callers and persons screened tell me they are interested in heating about future studies?
Whether the investigator saves a broad diagnosis (e.g., "arthritis") or more detailed medical information (e.g., medical history, laboratory reports) with the contact information, databases created to help identify potential subjects for future subjects have two qualities that trigger IRB review requirements:
- the database includes "private identifiable information" as well as "protected health information about each entry; and
- the "private identified information" is being saved for "future unspecified research purposes" (e.g., future arthritis clinical trials).
The first quality (personal identifiable information, protected health information) invokes the requirement for documented informed consent. The second quality ("future unspecified purposes") invokes the requirement for a banking application to the IRB.
Thus the IRB does not permit an investigator to use contact or health information collected in the course of one study (i.e., subjects screened out of the study, subjects screened into the study) again for any other study, unless that investigator has submitted an application to create a "recruitment database bank" and a banking consent form for IRB review and approval. Once approved, the PI can use the banking consent form to recruit subjects from any study identified in the banking protocol.
The latter policy applies to volunteers who respond to study advertisements by telephone. An investigator has no right to save any contact or screening information about subjects screened by phone or email unless they have enrolled in the studying advertised ( then the information may be used only for one study), or unless they have consented to let their contact information be entered into a "recruitment database" by means of an IRB-approved banking consent form.
I am creating a new study application for a clinical trial in which MRI’s will be done during some of the study visits. All the MRI’s are being done per standard of care. Do I still need to submit a form to the MRI safety committee?
Yes, if the MRI is required by the clinical trial protocol, even though the MRI may be standard of care, the MRI safety committee wants to review its use. This is required by the MCW MRI Safety Committee and is independent of the IRB review process.
If the MRI procedure follows clinical procedures, then you can check the first 3 boxes of the form (clinical procedures, clinical scanner, clinical technician), skip to the PI signature, and submit. The MRI use will be approved as exempt from further review by the MRI Safety Committee.
If your study procedures involve MRI scans, please select “Safety (Carcinogen, Pathogen, Recombinant DNA, Radioactive Materials, & Toxic Chemicals)” in section 27.1 of the study smart form, and complete and submit the MRI Research using Human Subjects form found on Research MRI Safety webpage.
Why do I have to fill out a separate Initial Smart Form application form if I would like to bank specimens or data collected at MCW as a part of another new research project?
Most research studies or projects have distinct starting and ending points. The IRB recognizes this and in our SmartForm request for an anticipated start date and completion date for the project. Banks are different from most research studies as the purpose of a bank is to collect, store and utilize the resources to answer future research studies. When the activities, data analysis and/or papers published at the end of a research study, the Investigator can close the study with the IRB. By closing the study, the IRB acknowledges per the Investigator all research activities (including analysis of the data) is complete and will end their oversight of the project.
If a study had a local MCW bank associated with it (not approved as a separate project), when the study closed because all the research activities had been completed, the banking activities would need to cease too, including collection, management and distribution of the banked material. Or the Investigator would be forced to keep the study open to continue the local bank approved in combination with the research study.
My department chair says that my project qualifies as exempt. Do I still need to submit paperwork to the Human Subject Protection Program?
Yes, your protocol must be submitted through eBridge. A determination of "exempt" does not mean that it does not need IRB review, but that it is exempt from the requirements of 45 CFR 46. The "exempt" determination must be made by the IRB.
I have several studies in my department for a particular group of people, and:
We would like to be able to present the studies during some community outreach events
In terms of study advertising, how would I be able to present the study information without requiring the IRB’s approval?
Recruitment plans; advertisements or soliciting potential subjects for research must be reviewed and approved prior to implementing these recruitment practices. The investigator must obtain IRB approval for all television, radio, videotape or print advertisements, posters, flyers, handouts, e-mail solicitations, internet websites, and other recruitment methods and materials intended for the recruitment of prospective subjects to a research protocol.
Under Federal regulations, an Institutional Review Board (IRB) is required to ensure that appropriate safeguards exist to protect the rights and welfare of research subjects [21 CFR 56.107(a) and 56.111]. In fulfilling these responsibilities, MCW IRB must review and approve methods used to recruit subjects to ensure that the methods do not present an undue influence and that the confidentiality and privacy of potential subjects are maintained. Every protocol should include a recruitment section that clearly describes:
- How potential subjects are identified
- How and by whom subjects are approached about participation (if applicable)
- When consent is obtained in relation to the start of the study procedures (if applicable)
- Whether third parties (calling centers/centralize screening centers) will assist with recruitment of subjects for Partners' sites (if applicable)
It is important to be aware that the IRB considers recruitment methods are the first step in the informed consent process. FDA information sheets provide instruction to IRBs and Investigators indicating the following: the text of all direct advertising for research subjects, i.e., advertising that is intended to be seen or heard by prospective subjects, must be reviewed and approved by an IRB prior to distribution, posting, publication, or broadcasting. Direct advertising includes, but is not limited to newspaper, radio, TV, bulletin boards and the internet. IRB approval for recruitment materials is not required only in very specific circumstances. If the recruitment/advertisement will be posted on a website such as clinicaltrials.gov or the posting on a website only includes th following information:
- Study Title
- Purpose of the study
- Protocol summary
- Basic eligibility criteria
- Study site location(s)
- How to contact the study site for further information
Other examples include the following which do not qualify as an advertisement and do not require IRB review:
- Communications intended only to be seen or heard by health professionals, such as letters to physicians.
- News stories where reporters or other non-study personnel are responsible for the final content, e.g. MCW Office of Public Affairs.
I have been told that a multi-site study is still considered “active” if any type of data analysis is going on, even if everything is closed here at the site. I’ve read the CPR form and the IRB’s SOP on Study Closure and do not see this requirement stated. If all patients have finished the study and the Sponsor/Site have agreed to close the study; can a final CPR be submitted and the study closed even if data analysis is going on at the central site?
Yes. For most multi-site studies, the MCW/FH site investigator may file a final, closing CPR as long as all the following conditions are satisfied:
- MCW is not a coordinating center for the multi-site study
- All subjects have completed study interventions, procedures, and/or follow-up at the MCW/FH site
- No further contact or communication with subjects is expected
- All data has been collected and has been sent to the sponsor, coordinating site, or data coordinating site ; no further data analysis will take place at MCW or Froedtert and none of the MCW/FH investigators have any access to the pooled Data.
What exactly does multi-center mean? I’d like to run a few behavioral experiments at Marquette University prior to running the imaging experiment at MCW and both experiments have the same PI. Is this considered multi-centered?
Your example would not be considered a multi-centered trial. A Multicenter trial or a multicenter study are studies which are conducted according to a single protocol, at more than one site, by more than one investigator. With this model, the lead PI (if NIH funding is involved) or the Sponsor are the central coordinators of the protocol, monitoring for study wide issues, revising the protocol and keeping all investigators apprised of changes, outcomes and results. A common example of a multicenter trial is an Industry Sponsored clinical trial. Experiments conducted by the same PI by at different locations may need to be submitted as separate protocols to each institution's IRB, depending on the experiments to be conducted.
Does our FWA state that all studies, (not just federally funded studies) will b conducted according to the code of federal regulations?
"FWA" means "Federalwide Assurance", a promise that the US Department of Health and Human Services (DHHS) requires every institution receiving federal research support to sign. In their FWAs, MCW and Froedtert demonstrate their awareness of the federal regulations, and they promise to follow the regulations. It's an honor system.
All FWAs also ask the institution: "Do you intend to apply the federal research regulations to 100% of the research you do--not just to the federally-funded research?"
Both MCW and Froedtert have answered "No" to this question in their FWAs.
The Medical College of Wisconsin commits to apply its ethical standards to all Human Research regardless of funding source.
- When the Medical College of Wisconsin is engaged in DHHS Human Research that is conducted, funded or otherwise subject to regulatory requirements by a federal department or agency who is a signatory of the Common Rule, the organization commits to apply the regulations of that agency relevant to the protection of Human Subjects.
- When the Medical College of Wisconsin is engaged in FDA Human Research, the organization commits to apply the FDA-=regulations relevant to the protection of Human Subjects.
MCW and Froedtert do review this decision periodically, looking for other meaningful and efficient ways to achieve consistency and protect all human subjects.
My sponsor has said that IRBs are now required to register with the FDA. Has the MCW/FH IRB registered yet with the FDA?
The FDA does not require that IRBs are registered and the MCW/FH IRB has complied with that requirement. If your sponsor is requesting IRB numbers or an FWA number, these can be found on the IRB website. You or the sponsor can also check the OHRP database for information on the MCW/FH IRB.
Doesn’t the HIPAA “preparatory to research” provision allow investigators to use medical records to identify potential research subjects without requiring a “waiver of the informed consent process” and “waiver of HIPAA authorization?
IRBs at some other institutions invoke the HIPAA "preparatory to research" provision [45 CFR 164.512 (i)(1) (ii) so that researchers can use medical records to identify potential study or clinical subjects without requiring the two described IRB waiver actions.
MCW/Froedtert Hospital IRB policy takes a different position. The IRB's perspective is that:
- Documented informed consent (or waiver thereof) is always necessary for researchers who plan to use medical records to identify potential subjects;
- HIPAA authorization (or waiver thereof) is required whenever a researcher might remove any protected health information from the covered entity, and whenever a person who is not part of the covered entity might contact prospective subjects; and
- The "preparatory to research" provision will only be invoked to help a researcher determine whether there are enough potential subjects to propose a study.
Therefore investigators who propose using a patient's medical record to determine whether he/she might be eligible for a study clinical trial should routinely ask both kinds of waivers.
I received a notice from the Sponsor of our study regarding drug storage. In the notice it states that the IRB should be notified. However, since we do not have any patients on this study and the study is currently on hold, is this something that still needs to be submitted to the IRB?
First, ordinarily this situation would not require immediate reporting, because it does not involve an increase in risks to subjects or others, but the IRB would allow it only due to the specific sponsor request.
Second, please check to see whether the sponsor letter mandates reporting to the IRB, or whether it asks for reporting to the IRB “in accordance with IRB policies” in which case it would not need immediate reporting, but instead should be submitted with the next CPR or with an Amendment if the notice will require any changes to the study or protocol.
However, if the sponsor specifically mandates immediate reporting… and, since the study is still open at MCW/FH, then you should submit the notice from your Sponsor via a Reportable Event in eBridge. Select the “Safety Notice/Report from Sponsor or Central Site regarding study-wide issue, e.g. lot recall, sudden termination of study” option as the Submission Type in Section 1.3.
I will be submitting a protocol that will include enrollment of students and staff at MCW. Are there specific policies that address these subjects?
The research study must involve human subjects. The IRB is required to have oversight, a MCW faculty member is required to be the investigator, and any part of the research, even solicitation, is being conducted at MCW or is utilizing MCW resources.
If you are a faculty member, fellow, or staff member you can’t receive any type of compensation or reimbursement for participation that is greater than the compensation or reimbursement established for non-MCW subjects. All faculty members, fellows, or staff members can’t participate in the research study during their normal working hours. The research study staff can’t have any Reporting or Evaluative Relationship with the research subjects. Reporting or Evaluative Relationship is defined when the PI has potential to influence, directly or indirectly, the educational status, grades, salary, faculty appointment, promotion, tenure, or other conditions of employment of the proposed research subject.
If the investigator learns a subject in the study is a faculty member, fellow, or staff member the PI is to immediately advise the Dean and Executive Vice President in writing. The Investigator is also encouraged to notify the IRB Committee overseeing the research.
For additional information, please read the policy located on InfoScope. If you have access to InfoScope, search for keywords Participation as Research Subjects Policy and select the first link among the search results.
We have recently hired a new research coordinator in our department and would like to add her to one of our studies. What do we need to do for this to happen?
Before she can be included in the conduct of human subject research, there are 3 criteria that need to be met.
- CITI certification. MCW requires that all individuals involved in the design, conduct, or review of human subjects research must obtain CITI certification. New employees must complete the required modules and obtain CITI certification within 90 days from date of hire. For more information on this program please see the Research Education website
- eBridge. Only those individuals registered in eBridge can be added to a study. If the new study team member cannot be found in the current eBridge list of study staff, she will need to register in eBridge. Self-registration can be completed from the eBridge Home Page or individuals can contact the eBridge Help Desk for further assistance (email@example.com or 456-8476).
- Smart Form Update. Submit a Smart Form Update to add the new study staff to an IRB approved study. needs to be submitted and approved by the MCW IRB. The Smart Form Update should be completed to list the new member and his/her roles in the study.
I missed the last IRB Lunch & Learn; is the presentation available to study coordinators who miss the meeting?
Yes, the IRB Lunch & Learn presentations are available to anyone who is a member of the IRB distribution list. To get a copy of the presentation or to be added to the IRB distribution list, please contact Victoria Hohlfeld or 955-8422.