Human Research Protection Program

HITECH Act

Frequently Asked Questions

Below are questions that have been directed frequently to the various auspices of the HRPP. Please note as you read through the topics, questions, and answers that while our goal has been to provide you with a concise reference point for your questions, the page is by no means an exhuastive list of information concerning protocol submission and its related components. Please also utilize the other pages on this website, and for further information or questions, don't hesitate to contact the HRPP at (203) 785-4688 or by email at hrpp@yale.edu. Thank you!

Human Investigation Committee (HIC)

Human Subjects Committee (HSC)

Coeus eIRB Electronic Submission

Submit Your Questions

Human Investigation Committee (HIC)

The HIC is tasked with the review and approval of biomedically themed human subjects research at Yale. Research involving social, behavioral, or educational themes are typically reviewed by the Human Subjects Committee (HSC), which can be viewed below.

Initial Submissions

I have an idea for a research project and wanted to discuss it with somebody. Who should I contact?

You can contact the HRPP office at 203-785-4688 or send your inquiries to the main HIC email. Make sure to provide a description of the project and the Department you are from. Your inquiries will be then triaged to the regulatory analyst team that handles protocols from your department. You can also request a formal consultation, during which you meet with the regulatory analyst in person to discuss your project and the regulatory issues it will entail.   

What is the difference between an expedited review and full committee review?  How do I decide which to request?

  • An expedited review is one that does not have to go before the full committee. It does not mean that the review will be handled in an especially “quick” manner.
  • A full committee review applies to initial review of research proposals that are not exempt and that do not qualify for expedited review procedures.  All new studies requiring full board review will undergo regulatory review by HIC staff and will be scheduled to a meeting when the review process is complete. 
  • At Yale, the determination about expedited or full committee review is made by the IRB staff at time of submission.  It does not influence the application that you will use.

I want to request an expedited review of my project. How do I do that?

You cannot request an expedited review. The HIC regulatory analyst makes the determination of what kind of review is appropriate at the time of regulatory review or triage. Expedited review means that the research proposal does not need to be reviewed at fully convened IRB meeting but rather can be reviwed by a single IRB committee member. There are regulatory requirements that need to be met for the IRB to allow an expedited review. For more information, please see the HRPP procedure 100 PR2.

I am not sure whether the project I want to do falls into a research category or quality improvement. Who can I ask for help?

This checklist will help you determine whether your proposed activity would fall into the category of quality improvement. There is also guidance available on the HRPP website that provides description of quality improvement projects that investigators should familiarize themselves with. For more information, you are encouraged to contact the HIC office at (203)785-4688 or email your inquiries here.

I have a research project that I want to submit for review. Which form do I have to fill out?

There are several different applications for initial review of a research project available on the HRPP website. Each application is tailored to match a different type of a research study, as indicated by the name of the form. For example, if you are interested in creating a repository, you will need to fill out the Repository Application. If your research project does not fall into any of the specific categories that would warrant its own form, you will need to fill out the Application to Involve Human Subjects in Research form. If you need further assistance, you can call the HIC office at (203)785-4688 or send your inquiries to hrpp@yale.edu.

How do I submit documents for initial approval if I do not have access to COEUS?

Hard copy paper submissions can be submitted to the HIC office for review.  Exemption and Not Human Subjects requests require submission of only the request.  For all other submissions, two copies of each document must be submitted along with any other committee approval letters (Yale Cancer Center Protocol Review Committee (PRC), Pediatric Protocol Review Committee (PPRC), Department of Veterans Affairs (VA), other IRB approvals, other institutional approvals or letters of support, etc.). For a link to the current forms and templates as well as additional information on how many copies to submit, click on the following link: http://www.yale.edu/hrpp/forms-templates/biomedical.html

When do I apply for approval from other oversight committees such as Yale Center for Clinical Investigation (YCCI), the Pediatric Protocol Review Committee (PPRC), Magnetic Resonance Research Center (MRRC) and the Yale Cancer Center- Protocol Review Committee (PRC)?

Review by the oversight committees must be conducted before submitting the protocol to the HIC. A letter documenting that the review and approval has taken place, including all pre-review correspondence must be attached to the protocol when submitting it to the HIC. At times an oversight committee may not issue final approval until explicit revisions are made, but the committee still permits the investigator to submit the protocol to the HIC for review. In this circumstance, the protocol submitted to the HIC must have incorporated or otherwise addressed the revisions required by the oversight committee(s).  For more information, click on the following link.

What if I have a joint appointment at the West Haven Veterans Affairs Hospital (WHVA)?

All investigators who are located at the WHVA and have an academic appointment at Yale must submit their research project to the Yale HIC for review even when the research is conducted exclusively at the WHVA. All studies that are conducted exclusively at the WHVA must obtain approval from the WHVA IRB prior to submission of the research project to the HIC. For protocols conducted solely at the WHVA, the HIC accepts the WHVA application in lieu of the Yale application. See the “How Many Copies” document on the biomedical forms website.

I want to do a medical record review to see whether there is a sufficient population for me to do the research. Do I need to submit anything to the IRB?

Medical record reviews to access a feasibility of a potential project based on the size of the population does not require a review, provided that no identifiable information is being recorded.

Amendments

What documents do I need to submit for an amendment?

  • One (1) tracked changed copy and two (2) clean copies of each amended document
  • An amendment request form outlining the rationale for the amendment and page numbers where the changes can be found on the documents
  • Sponsor summary of changes (if applicable)
  • Amended sponsor documents (if applicable)
  • Other committee approvals (if applicable)
  • Any new documents being added

I want to make a change to my study but my renewal is also due. Should I submit the amendment first or the renewal?

You can submit your request to renew your study at the same time as your request to amend your study. This will allow the HIC to reapprove your study with the requested changes.

Reapprovals

How far in advance do should I submit reapproval documents?

For all reapprovals, regardless of whether they are reviewed by Full Committee or in the office as an expedited review, it is strongly recommended that they be submitted at least 6 weeks in advance. Failure to do so can result in non-compliance.

What happens if my study lapses?

Failing to have protocols reapproved prior to the lapse date could be considered non-compliance or continuing noncompliance per HRPP Policy 700 Noncompliance, and per federal regulations and guidance.

All research and research related activities must cease when HIC or HSC approval of the protocol has expired. Research activities include:

  • Recruitment of subjects;
  • Enrollment of subjects;
  • Research intervention, for example, administering drugs, performing surgery, or counseling;
  • Research interaction, for example, collecting urine or blood, conducting an MRI, conducting interviews, asking for informed consent to use medical records;
  • Collection of data; and
  • Data analysis.

Under no circumstances can federal funds be expended on research and research-related activities during a lapse period. You must immediately contact your Grants and Contract Administration (GCA) and Grants & Contracts Financial Administration (GCFA) representatives for more information.

Closures

When can my study be closed?

If the study is in data analysis only and all of the data being analyzed is de-identified, submit a Request to Close form.  Click here for form templates.

How long should I keep copies of data and how do I dispose of it?

Record retention requirements depend on the funding source. Generally it is three years from the end of the project for keeping copies of original data. For confidentiality purposes it should be appropriately secured (locked cabinet for paper, secured computer for scanned documents). Disposal would be via shredding the paper documents and secure deletion for electronic data.

Yale Cancer Center Specific

What documentation should be submitted from the Protocol Review Committee for New Cancer Center Studies?

In addition to the PRC letter of approval, all review comments/requested changes/ meeting minutes MUST also be submitted. For more information regarding the PRC, click here.

What is the deadline for submission of new Cancer Center protocols, amendments, and reapprovals?

New protocols and amendments to approved protocols requiring full board review will undergo regulatory review by HIC staff and will be scheduled to a meeting when the review process is complete.

Protocols submitted in a timely manner for annual renewal will be scheduled to a meeting within 30 days prior to expiration.

Human Subject Protection Training, HIPAA Training, and Conflict of Interest Disclosures

Who is required to take Human Subject Protection (HSPT) and HIPAA training?

All research personnel must complete Human Research Protection Training.  Researchers working on School of Medicine or School of Nursing protocols must also complete HIPAA Privacy training for researchers. An individual is considered engaged in human research when he/she for the purposes of the non-exempt research project, obtains: (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.  An institution is considered engaged when its employees or agents conduct the above activities, or when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor. For more information, click here.

How often does Human Subject Protection Training HIPAA training for researchers need to be done?

Research personnel are required to complete a human research protection training offering at least once every three (3) years to stay current in issues and regulations regarding human research. HIPAA training for researchers only needs to be completed once. Completion of one Yale Human Research Resource and Education Program module, one (1) CITI module, attendance at a large group session or student group/department session, fulfill the requirement for continued education. For more information, click here.

Who needs to complete a Conflict of Interest form?

All Yale University faculty, staff and students  who are responsible for the design, conduct or reporting of a human research project and all Yale New Haven Hospital individuals who are listed as co-investigators on a protocol with a Yale University Principal Investigator must have a current financial disclosure form on file with the University’s Conflict of Interest Office.   The Principal Investigator (Project Director), upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct or reporting of the research.

If this has not been done, the individual(s) should follow this link to the COI Office Website to complete the form.

NOTE: The requirement for maintaining a current disclosure form on file with the University’s Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital personnel. Whether or not they are required to maintain a disclosure form with the University’s Conflict of Interest Office, all investigators and individuals deemed otherwise responsible by the PI who are listed on the protocol are required to disclose to the PI any significant financial interests or perceived interests that are specific to this protocol.  For more information, click here.

Grants

What is a grant congruency review?

Grant congruency is the IRB’s determination that a grant/proposal has been compared to the HIC or HSC protocol application, and the research aims are found to be consistent (congruent) between the documents. Federal regulations require IRBs to make this determination (see 45 CFR 46.103(f)). The IRB looks to the funding source listed on the protocol and does a comparison of this to the protocol. Provided there is a match, depending on the type of grant and the specificity of its aims, the IRB will either state in a letter that the grant and protocol aims are consistent, or the IRB acknowledges that the grant supports the protocol. Grants & Contracts reviewers check to be sure that this determination is made in order to release funding for your research.

What if I have a new funding source to add to my study?

The new funding sourceneeds to be added to the HIC or HSC protocol application as a new funding source. This is done by submitting an amendment request to the IRB. Where applicable, be sure to include the full grant number, its institutional number (e.g., "M-number"), the title of the grant/proposal, and the PI of the grant. The IRB staff will find the grant in IRES and compare it to the protocol, and issue a congruency determination in the approval letter. For additional information, visit the Office of Grant and Contract Administration at Yale here.

How Many Copies Do I Need?

Documents to be submitted with HIC submissions:

New Protocols

  • 1 HIC application and 1 copy of the HIC application
  • 2 copies of the consent documents
  • 1 copy of sponsor protocol (if applicable)
  • 1 copy of the Investigator’s Brochure (if applicable)
  • 2 copies of the HIPAA form(s) (if applicable)
  • 2 copies of any ads that have been developed
  • 1 copy of approval letters from other reviewing bodies (Protocol Review Committee (PRC), West Haven VA, Pediatric Protocol Review Committee (PPRC), Magnetic Resonance Research Center (MRRC), external IRBs, Radiation Safety Committee (RSC), etc.)

For new protocols that take place exclusively at the West Haven VA, the following is required:

  • VA letter of approval
  • VA calidated consent form
  • VA IRB approved protocol
  • VA request to review research project (this contains needed funding and IND/IDE information)
  • VA conflict of interest disclosure.

* Be sure to note on the materials submitted to us if the funding does not come through Yale.

Reapprovals

Please do not submit copies of any documents with previous HIC approval stamps!

  • 2 copies of the Form 5R
  • 2 copies of the HIC application
  • 2 copies of any consent documents
  • 1 copy of the sponsor protocol (if applicable)
  • 2 copies of the Investigator Brochure if it has been revised, and not previously submitted to the HIC
  • 1 copy of DSMB reports
  • If the protocol is greater than five (5) years old, two (2) copies of a re-written HIC application using the most recent version of the HIC application inclusive of all amendments

*Note that the HIPAA Research Authorization Form (RAF) is not required to be submitted at this time unless the content is being amended.

Amendments at the time of Reapproval

Please do not submit copies of any documents with previous HIC approval stamps!

  • 2 copies of the Form 5R
  • 2 copies of the amendment request form
  • 1 copy of the HIC application with the changes highlighted using track changes to indicate the amendment
  • 2 copies of the HIC application with the changes accepted
  • 1 copy of the sponsor letter requesting the amendment (or other supporting documentation, sponsor’s summary of changes, FDA, MRRC, RSC, etc. if applicable)
  • 1 copy of the sponsor protocol tracked (if applicable)
  • 1 copy of the sponsor protocol with the tracked changes accepted (if applicable)
  • 1 copy of the consent form using tracked changes to indicate the amendment (if applicable)
  • 2 copies of the consent form with the tracked changes accepted (if applicable)

Amendments

Please, do not submit copies of any documents with previous HIC approval stamps!

  • 2 copies of the completed HIC amendment request form (or PRC amendment request form if applicable);
  • 1 copy of the HIC application using track changes to indicate the amendment
  • 2 copies of the HIC application with the changes accepted
  • 1 copy of the sponsor letter requesting the amendment (or other supporting documentation—sponsor’s summary of changes, Food & Drug Administration (FDA), MRRC, RSC, etc. if applicable)
  • 1 copy of the sponsor protocol tracked (if applicable)
  • 1 copy of the sponsor protocol with the tracked changes accepted (if applicable)
  • 1 copy of the consent form using tracked changes to indicate the amendment (if applicable)
  • 2 copies of the consent form with the tracked changes accepted (if applicable)

*NOTE the only exception to the above is an amendment to add or remove study personnel. For these the HIC only requires that two copies of the request form be submitted; however, at the time of reapproval, the protocol application should be resubmitted to include all investigators, no track changes copies are necessary then, either*

Permission to serve as PI

Only the Request is needed, with no copies.  Remember to attach a CV or biosketch.

Medical Record Review (MRR) Request

The Medical Record Request and 1 additional copy of the Request

Request for Exemption and Not Human Subjects Research form

Only the Request is needed, with no copies.

Requests to Close – HIC Form 5C

Only the Request is needed, with no copies

Disclaimer: In some cases, the HIC may request additional copies for review of specific protocols. If added materials are needed, the Regulatory Analyst will contact you.

Human Subjects Committee (HSC)

The Human Subjects Committee is tasked with the review and approval of human subjects research that falls primarily within the social, behavioral, and educational realms. Biomedical research is typically reviewed by the Human Investigation Committee (HIC), as indicated above.

Amendments

What documents do I need to submit for an amendment?

  • One (1) tracked changed or highlighted copy and one (1) clean copy of each amended document, preferably as MS Word files
  • An amendment request form outlining the rationale for the amendment
  • Other committee approvals (if applicable)
  • Any new documents being added

I want to make a change to my study but my renewal is also due. Should I submit the amendment first or the renewal?

You can submit your request to renew your study at the same time as your request to amend your study. This will allow the HSC to reapprove your study with the requested changes.

Reapprovals

How far in advance should I submit reapproval documents?

Regardless of whether they are reviewed by Full Committee or in the office as an expedited review, it is strongly recommended that all reapprovals be submitted at least 6 weeks in advance. Failure to do so can result in a lapse in protocol approval during which time no human research may be conducted, including analysis of identified data. Additionally, grant or contract funds may not be expended for human research projects during a lapse in IRB approval, including salary support from federal sources.

What happens if my study lapses?

Failing to have protocols reapproved prior to the lapse date could be considered non-compliance or continuing noncompliance per HRPP Policy 700: Noncompliance, and under certain circumstances may be reportable to such outside federal agencies as the Office for Human Research Protections (OHRP).

All research and research related activities must cease when HIC or HSC approval of the protocol has expired. Research activities include:

  • Recruitment of subjects;
  • Enrollment of subjects;
  • Research intervention, for example, administering drugs, performing surgery, or counseling;
  • Research interaction, for example, collecting urine or blood, conducting an MRI, conducting interviews, asking for informed consent to use medical records;
  • Collection of data; and
  • Data analysis.

Under no circumstances can federal funds be expended on research and research-related activities during a lapse period. You must immediately contact your Grants and Contract Administration (GCA) and Grants & Contracts Financial Administration (GCFA) representatives for more information.

Closures

When can my study be closed?

If the study is in data analysis only and all of the data being analyzed is de-identified, submit a Request to Close form. Click here for form templates.

How long should I keep copies of data and how do I dispose of it?

Record retention requirements depend on the funding source. Generally it is three years from the end of the project for keeping copies of original data. HIPAA related documentation such as research authorization forms must be maintained for 6 years from the data they were last in effect. For confidentiality purposes data should be appropriately secured (locked cabinet for paper, secured computer for scanned documents). Disposal would be via shredding the paper documents and secure deletion for electronic data.

Exemptions

How do a make changes to an exempt study?

Each exemption determination letter describes the federal regulation criteria upon which the exemption is based. Only changes that would impact the cited exemption criteria need be submitted to the IRB for review. For example, a study that is determined to be exempt because the data will be collected anonymously may be changed without further involvement of the IRB as long as the changes do not impact the ability to identify the participants. Note however, that expanding the participant population to include children or prisoners will generally render the exemption no longer applicable.

What do I need to submit to renew my exempt study?

Studies determined to meet the exemption criteria do not require annual review and may continue indefinitely without further review by the IRB unless the nature of the research is changed such that the exemption is no longer applicable.

General Questions

If my study is being reviewed as an expedited study, why is it taking so long?

An expedited review is one that does not have to go before the full committee, but rather can be conducted by an individual IRB member. It does not mean that the review will be handled in an especially “quick” manner. How long a review takes is based on how many studies have been submitted, what order they are received in, and what the time constraints are for each of those studies.  Typically, it can take up to three (3) weeks from start of review to approval, but can take longer during busier times in the academic year (e.g. Spring).

When is the next deadline for submitting to the HSC?     

Only studies involving greater than minimal risk and which do not fall into one of the expedited review categories need to be reviewed by the full committee. Our deadlines are once a month and can be found here (under "General Information"). If you have questions about the risk level of your project or the expedited review categories, please contact the HSC at 203-785-4688 or human.subjects@yale.edu . If you believe your project qualifies for expedited review, you can submit your application at any time.

Who can serve as a faculty advisor?

Per Yale policy, the following people have the authority to serve as faculty advisors and sign off on student projects: Professor, Associate Professor, Assistant Professor, Senior Research Scientist, and Research Scientist.

How do I fill out an application for a study limited to existing data?

Answer the questions as they pertain to that data set. For example, briefly describe how the data set was created and whether consent was obtained. The bulk of the application would describe how the data set will be used and secured for your analysis.

I have approval but I now need to make some changes. Do I need to get these changes approved by the IRB or can I just make them?

If any aspect of the study needs to be modified, you need to submit the request for review and approval using our Amendment Request Form found here. Any changes in the protocol must be approved by the HSC prior to their implementation.

Is renewal needed if the project is in data analysis?

If data is identified, it should still be under an IRB approval for the duration of the analysis. This mainly comes from cases where there is a need to intervene or contact participants based on the data analysis. If data are completely de-identified, the study can be closed. You can request to renew or close your study by submitting a Request for Renewal or Closure Form found here: http://www.yale.edu/hrpp/forms-templates/index.html.

How long should I keep copies of data and how do I dispose of it?

Record retention requirements depend on the funding source. Generally it is three years from the end of the project for keeping copies of original data. For confidentiality purposes it should be appropriately secured (locked cabinet for paper, secured computer for scanned documents). Disposal would be via shredding the paper documents and secure deletion for electronic data.

Coeus e-IRB Electronic Submission FAQ

General Info

What is Coeus?

Coeus is an electronic human subjects research system that is used by the Human Research Protection Program (HRPP) office to track and monitor submissions of research protocols. It is also available to the researchers to submit their research protocols to the HIC and certain other approval bodies (such as Pediatric Protocol Review Committee, PPRC or Magnetic Resonance Research Center, MMRC) for review. Please see Coeus website for training, link to the application, and other pertinent information: http://www.yale.edu/coeus.

How can I get access to Coeus?

Currently, with the exception of individuals who replace previous users, we do not allow access to Coeus to new users. The system is undergoing stabilization and once we ensure that all issues are resolved, the improved system will be open to all departments. However, if your responsibilities include submitting IRB documentation for protocols that have been previously converted to the electronic system, you should contact Christine Mangler at christine.mangler@yale.edu to request the access and training.

I already have access to Coeus.  A different Principal Investigator (PI) asked me to submit protocols electronically on his/her behalf.  Can I submit those protocols?

No, you cannot submit protocols on behalf of an investigator unless he/she has access to Coeus, as that would prevent the PI from receiving communications regarding his or her protocols. In order for protocols to be submitted electronically, the PI and the Chair of the Department that the PI works for must have access to Coeus and have undergone training in the electronic systemNew users, however, cannot be added at this time, as explained above. If the PI has Coeus access, he/she can give you access to his/her protocols by following these instructions.

I already have access to Coeus but changed positions and now work for a different Principal Investigator (PI). Her protocols are also electronic but I don’t see them in my Inbox. How can I get access?

The PI can give you access by following the instructions on our website.

Notifications

I think my protocol was reviewed at a Committee meeting last week but I haven’t received any notifications about the Committee’s decision yet. Does it mean it was rescheduled?

Once a protocol is assigned to an agenda, it is unlikely that it gets rescheduled. For initial submissions you can confirm the date of the committee meeting by opening the action on the protocol with the status of ‘Submitted to IRB’.  It is possible that the notification from Coeus went to your Junk Mail folder.  It is also possible that Coeus did not send the notification to you due to an unexplained malfunction. It is important for you to check the status of your submission in the system a few days after the scheduled meeting.

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I never got the reminder notice from the system that my protocol is about to expire. My request for renewal was submitted late. How can I make sure I am always notified?

Coeus is designed to send reminders 60, 45 and 30 days prior to the expiration date to the PI and correspondent who have current email addresses on record in the HR department. In order to receive any Coeus notifications, make sure that your name is listed in the Correspondent Tab.

If you are an employee of an outside institution for which the Yale HIC serves as the IRB of record, verify with HR that your email account is officially on file. Please, remember that as with any electronic system, unexpected issues occur and you should not rely solely on Coeus reminders.

It is the regulatory responsibility of the PI to monitor the expiration date of his/her protocol(s) at all times and make sure it is submitted for annual approval prior to the expiration date.

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Documents

What forms do I use for the electronic submissions?

Most of the forms that are used for paper submissions have their electronic counterparts. They are modified not to repeat the information that you enter directly into Coeus e.g. research staff. You find them on homepage of your Coeus application, on the left hand side of the screen after you first log in.  Be sure to always pull the form from the website, to ensure that you are using the most current version. If you already started filling out the "paper version," do not worry about transferring the information to the electronic form. Both versions are acceptable for electronic submissions.

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How do I get the Principal Investigator’s signature on the requests and the protocol?

The electronic protocol application, amendment and renewal documents do not require the PI’s signature. Documents that do require a PI signature, e.g., an amendment to change a PI, should be submitted as a PDF.  The Principal Investigator has an obligation to ensure the completeness and accuracy of documents submitted for review. Once the submission is sent to the HIC, the system will prompt the user to send an email to the Principal Investigator and co-investigators to notify them about the submission and their involvement in the study.

What format should I use to upload my protocol documents? Does it make a difference if I submit my documents as PDFs?

Research protocol documents such as protocol application and consent forms should be submitted saved in MS Word. Once approved, protocol application and consent documents will be converted into the PDF format by the IRB staff and validation watermarks will be applied to indicate the approval and expiration dates. Sponsor documents such as an Investigator’s Brochure or Sponsor Protocol can be submitted in the format they were provided to you. Make sure that the documents are not password protected since they are not compatible with Coeus and will result in an error message. 

Where can I find the most recent versions of the consent and protocol documents saved as WORD?

If submitted correctly for reviews, protocol documents in the electronic file are layered in historical order according to their type. For example, the approved version of the consent form is saved as PDF on top of the WORD version that was submitted for review.  If there were prior submissions of the consent forms, they should show underneath.  You can view and download the WORD version of the most recently approved document by clicking ‘HISTORY’ to the right of it. The WORD document will show right underneath. It will probably show track changes that were requested in the previous action, so make sure to accept them before you incorporate new ones.

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Some of the approved documents that are uploaded in Coeus received approval stamps and expiration watermarks, some of them did not. Does it mean they are not approved?

The only documents that receive electronic approval and expiration watermarks are the documents that would require the expiration date stamp and signature if they were paper: the HIC applications/protocols and documents used for consenting (including addenda, information sheets, assent forms).  Other documents (such as recruitments ads or HIPAA RAFs) no longer receive approval/expiration watermarks. You can read more about the documentation of the approval on the HRPP website.

Please note that Coeus automatically applies an expiration watermark to any document that is saved as a PDF. That means that if you submitted a sponsor protocol as a PDF, it will receive the watermark, even though the HIC does not ‘stamp’ sponsor documents.

That said, if your consent document or HIC protocol did not receive an approval stamp, you should contact the HIC office at (203) 785-4688 and speak to the Regulatory Analyst who worked on approval of your protocol.

Submitting Initial Appications, Revisions and Notifications

Where can I gain/refresh my knowledge of how to create and submit new protocols, amendments, renewals, and revisions?

The HIC offers several resources for you to learn or refresh your knowledge about various Coeus functions. You can watch our online tutorials here. There are four training modules: ‘Creating a new protocol’, ‘Submitting a revision’, ‘Submitting an amendment’, and ‘Creating a renewal’.

The Coeus website also lists several Coeus IRB Guides, which are step by step instructions including screenshots for different functions. Click here for access.

For more comprehensive instructions, please see the Coeus manual.

 

I submitted an amendment and specific minor revisions were requested. After thinking it through, I no longer wish to pursue the amendment. What should I do?

Coeus does not allow for deleting or withdrawing actions if specific minor revisions were requested. Instead, you can abandon the submission, by clicking "Submit to IRB" and then choosing ‘Abandon’ option in the protocol with the status of Specific Minor Revisions Requested’. This way the system will retain a record of the original action and the revisions that were requested but it will also indicate that no action is required as you decided to forego that amendment.

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The sponsor issues a new Investigator’s Brochure. It does not require any changes to the protocol or consent forms. How should I submit it via Coeus?

Updated versions of Investigator’s Brochures that do not require amendments should be submitted to the HIC office via a notification.  Please see our quick guide for detailed instructions on how to use the Notify the IRB function.

A subject on the study experienced a serious adverse event. How do I report it to the HIC if my protocol is electronic?

Serious, unanticipated adverse events should be reported to the HIC via a notification. Please see our quick guide for detailed instructions on how to use the Notify the IRB function

Submission Status

Why do my submissions sometimes get “rejected” and are then sent back to me?

Before your submission can be officially reviewed either via an expedited review (single IRB member) or at a fully convened committee meeting, the HIC staff needs to ensure that all the necessary elements of your submission are present. This is done during a triaging process, when your submission is initially received by the HIC staff. If the staff notes any deficiencies or missing pieces of information, your submission will be rejected and sent back to you, along with notes about what needs to be corrected. You will be notified of any rejections via email.

 

I submitted a new protocol a few weeks ago and haven’t heard back yet. How can I check what the status of the submission is?

You can check the status of the protocol in Coeus by clicking on "Approval Routing" tab in that protocol. You will be able to see whose approval the protocol is waiting for and what additional routing stops the protocol will need to pass. You are encouraged to check with the person listed in the current stop to confirm that they are aware of your submission. For detailed instructions on how routing works, please see page 53 of the Coeus manual.

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I received a notice that the reviewer requested revisions to my protocol. I submitted the revised protocol through Coeus. How will I know that they were received and reviewed?

Any electronic submission comes to the HIC general Inbox. Every day triagers sort through the submissions to make sure they get to the right regulatory analyst. The system does not notify individual reviewers that the revisions they requested are submitted. Thus, it is a good practice to let the regulatory analyst know that the revisions were submitted for them. The name of the contact person for your revisions should be included in the Coeus letter that listed the revisions.

Where can I find my approval letter?

The approval letter can be found in the "View History" tab that contains all protocol action details. In order to see details regarding an action e.g. review of your protocol or approval of an amendment, you need to click on the plus sign (+) next to that action. Underneath, you will see Correspondences section that contains the approval letter. You can open the letter by clicking the VIEW button. 

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Troubleshooting

Why can’t I log in?

If you forgot your password, you can reset it yourself by following the instructions in our quick guide.

It is possible that your password has expired or has been locked and needs to be reset by the ITS. You should change your password once a year to prevent it from expiring. If you try to log in using an incorrect password 5 times in a row, your password will be locked. You cannot reset your password yourself if the password is locked or expired.

I got an error message when trying to submit a protocol. What do I do?

You should try to capture the print screen of the error message by holding CTRL and PrtScr keys at the same time and then pasting it into an email to Christine.Mangler@Yale.edu.  Make sure to include a detailed description of what actions you had taken prior to the error message. If the problem cannot be fixed internally, we will seek ITS help to fix it.  

I logged in but all the action tabs are grayed out. What do I do?

If you are the aggregator for the protocol (a person who is authorized to modify it), you may simply be locked out. The system does not allow for more than one person to work in the protocol or submission at the same time so it locks access to the protocol. Sometimes, access is denied even if there was only one person working in the protocol. In order to reset it, click on ‘Current Locks’ tab in the right top corner and then remove your name from the box that will appear. Make sure to log out and then log back in to access the protocol. If you are not the aggregator, you may need to ask the PI of the protocol to assign you as a user by following these instructions.

My protocol has always been submitted electronically. I have some issues with my computer and I need to submit a request for renewal. Can I submit it in paper?

No, once the protocol is ‘electronic’, meaning an action was submitted to the HIC via Coeus, it needs to stay electronic as we may no longer retain the paper file for it. Please, make sure to contact your department’s ITS Help Desk if you have computer problems.

I am adding new research staff for a personnel amendment and red X's appear next to their names. Can I still add them?

Generally, a red ‘X’ next to a person’s name means that they do not have required training. Confirm with that individual that they have completed HIPAA training, initial Human Subject Protection Training, and, if applicable, Human Subject Protection Continuing Education (for individuals whose initial training was completed three (3) or more years ago). The individual can access his/her training record by logging onto http://yale.edu/training/. If they have not completed the required training, do not submit the amendment to add that person until the training is completed. If the individual has completed the training and the red X continues to appear, upload the training certificates in the Attachments or contact the administrative assistants at the HIC office at (203) 785-4688 who can manually enter the training into the system.

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Submit Your Questions

If you have questions about any of the content on this website, please don’t hesitate to contact us via our new “Submit Your Questions” section below! In the spirit of continued education for the Yale Research Community, our eventual goal is to create and maintain a running list of Frequently Asked Questions. To this end, your general HRPP or IRB-related questions may be posted anonymously to the website for other study team members' reference.

Please note, questions will be routed to members of the Human Research Protection Program or Institutional Review Board as appropriate, and answered in the order that they are received. For protocol–specific questions, please direct your correspondence to the Regulatory Analyst(s) with whom you have been working, or the coordinator on call at (203) 785–4688. We look forward to hearing from you!

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Last revised: February 18, 2013

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