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BRANYplus

What is BRANY?

BRANY is an independent IRB that provides national support to institutions, sponsors, and investigators.

What will be the turnaround time for initial review from BRANY?

Expedited reviews are completed within 10 business days or less (generally between 5-10 business days), provided IRB conditions are met promptly.

Full Board reviews are generally completed in 10-15 business days.

Will a submission be needed in WRG or a different portal?

Yes. As a means of tracking these BRANY<em>plus</em> studies, the following process will be followed:

Additional resources and guidance on this process will be provided shortly.

ClinicalTrials.gov

What is ClinicalTrials.gov?

ClinicalTrials.gov is a service of the U.S. National Institutes of Health that acts as a registry and results database of publicly and privately supported clinical studies of human participants. The Department of Health and Human Services (HHS), the Food and Drug Administration, the National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE) all require the public registration of clinical trials and, in some cases, the posting of trial results.

What does posting to ClinicalTrials.gov achieve?

As outlined in the Declaration of Helsinki, researchers, authors, and sponsors have an ethical obligation to publish and disseminate research results, whether positive, negative, or inconclusive. As outlined by the ICMJE and ClinicalTrials.gov, registering your trial and posting results serves to:

  • Help patients and the public know what trials are planned or ongoing into which they might want to enroll.
  • Prevent selective publication and selective reporting of research outcomes.
  • Prevent unnecessary duplication of research effort.
  • Help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering.
  • Help editors and others understand the context of study results.
  • Promote more efficient allocation of research funds.

Which research studies need to be registered on ClinicalTrials.gov?

Interventional investigator-initiated trials sponsored by Weill Cornell Medicine must register. Use our decision tool, available here, in order to determine whether your trial needs to be posted to ClinicalTrials.gov. (Survey responses will be anonymously recorded to assess how often the research community is making use of this resource.)

When should I register on ClinicalTrials.gov?

It is WCM policy and a condition of publication in ICMJE journals that studies are fully registered (i.e., an NCT # is obtained) prior to enrollment of the first participant. You can begin the registration process once you have a completed IRB protocol application and protocol document. You do not need IRB approval to initiate the registration process on ClinicalTrials.gov.

How do I obtain an account in order to register?

Principal Investigators must register their own studies in the PRS (Protocol Registration & Results System) at http://register.clinicaltrials.gov. To obtain a user account or to appoint a designee to maintain the ClinicalTrials.gov record on their behalf, Principal Investigators must email our office with CWID and phone number of whomever needs access along with the applicable IRB protocol number.

Please note that only Principal Investigators can appoint their own designee(s) and a designee must have a WCM email address to qualify for a user account.

How do I complete the registration process?

Use the following guidance documents, available for download in the Guidelines portion of the Policies and Forms section above:

  • ClinicalTrials.gov PRS Registration User Guide - A step-by-step guidance with screenshots.
  • Data Sharing Plan Info Sheet - Guidance on how to meet the ICMJE's data sharing requirement, which is a condition of publication.
  • Requirements for Posting - Institutional requirements for every registration record.

Remember that:

  • ClinicalTrials.gov QC Criteria should be followed.
  • The registration is not submitted for internal QC review until the user clicks "Entry Complete" in the system.

Help sessions via Zoom are available upon request.

How long does it take to register a study on ClinicalTrials.gov?

Internal QC review of a ClinicalTrials.gov registration record is a collaborative process between our office and the study team that can take approximately 2 weeks, depending in part on how quickly the study team resolves internally identified QC issues and whether a Zoom help session is needed. Once the record is released to ClinicalTrials.gov, the ClinicalTrials.gov QC review typically takes 2 to 5 days. If the QC review identifies issues requiring further edits by the study team, the record will undergo another internal QC review before being re-reviewed by ClinicalTrials.gov according to the same timelines.

When do I need to update my ClinicalTrials.gov study record?

ClinicalTrials.gov study records must be updated at least once per year. Additional, more rapid updates are required according to the table available here.

How do I enter trial results on ClinicalTrials.gov?

The following resources are available to you:

For instructions on uploading your protocol and statistical analysis plan, refer to the guidance available in the Policies and Forms section above.

Help sessions via Zoom are available upon request.

What do I do if I'm a Principal Investigator leaving WCM?

Contact our office as soon as possible so we can work with you to either update and finalize your public records or, if applicable, transfer them to your new institution.

General Questions

Can students serve as investigators on protocols?

Students may not serve as Principal Investigators on protocols. However, students may serve as "co-investigators" or research personnel on protocols.

Who can serve as a Principal Investigator (PI) on a protocol?

WCM paid faculty can serve as PIs on all categories of protocols. Voluntary faculty cannot serve as PIs, but may serve as co-investigators.

In addition, employees of New York Presbyterian Hospital/Weill Cornell Medicine (only pharmacists, nurses, dieticians) can serve as PIs on protocols, except clinical trials that include an intervention with human subjects. However, medical residents cannot serve as PIs, but may serve as co-investigators.

When can I add a non-WCM/non-NYP co-investigator to my study?

The WRG-HS IRB Application includes a section for external non-affiliated personnel (non-WCM/NYP). Non-WCM/NYP investigators should only be added to this section when the WCM IRB will serve as the IRB of record and an IRB Authorization Agreement has been executed. This agreement can only be executed between IRB offices. The WCM IRB will not provide oversight for non-WCM/NYP investigators without an IRB Authorization Agreement.

The WRG-HS IRB Application will not allow the addition of external non-affiliated personnel if WCM is not serving as the IRB of record. If you wish to collaborate with non-WCM/NYP investigators, you must:

1.    Include details of the collaboration in the protocol document and informed consent form;

2.    Confirm with the non-WCM/NYP investigators that they have consulted their local IRB(s) on whether their research activities on the WCM protocol require local oversight; and

3.    Confirm that WCM requirements for data/specimen sharing, such as the Data User Agreement (DUA) or Materials Transfer Agreement (MTA), have been met.

Does my study qualify for exemption?

To understand whether your study may be eligible for exemption, consult these decision charts from the U.S. Department of Health & Human Services (HHS) Office for Human Research Protections (OHRP). Only the WCM IRB office can make a determination.

Click here to view exemption decision charts pertaining to studies approved by the IRB prior to January 21, 2019.

What are my responsibilities after IRB approval?

The PI/Study Team must conduct the study in accordance with the WCM IRB-approved protocol and policies.  

There are reporting requirements post IRB approval that require further submission to the IRB:

  • Amendments: Any modifications to the study must be approved by the WCM IRB prior to implementation.  Click here for the Amendments to Previously Approved Research Procedure policy document 
  • Continuing Review: IRB review is required at least annually for all non-exempt research, unless a shorter approval period was determined by the WCM IRB.  Click here for the Continuing Review Procedure policy document 
  • Reportable Events: Serious Adverse Events, Unanticipated Problems, Protocol Deviations and other events must be reported as detailed in the following Unanticipated Problems Procedure document and Other Reportable Events Procedure document
  • Study Closure: Studies should be closed in accordance with the policies set forth by your department and chair

o   Click here for the HRC Record Retention Policy

What does "expedited review" mean and how long will it take for me to hear back from the IRB about an expedited submission?

Expedited review means the submission (e.g. new protocol, amendment and/or continuing review) will be reviewed by one member of the IRB. As such, expedited submissions do not have specific submission deadlines. Expedited reviews are reserved for minimal risk studies that fall into designated categories as prescribed by the federal regulations. It is also used for minor amendments (those that do not affect study design or risk to subjects) and some Continuing Reviews.

It is important to note that expedited review does not necessarily mean that the submission will be reviewed more quickly than a submission reviewed at a convened IRB meeting. Please allow a minimum of 10 business days for issues raised/approval to be communicated to the research team.

If I am collaborating with the Cornell University Ithaca campus, which IRB should I submit to?

The WCM IRB and Cornell-Ithaca IRB have a reliance agreement in place for cross-campus collaborations. Refer to the "Establishing a Single IRB (sIRB) Reliance and sIRB Submission Process" document under the Policies section as well as the "Human Subjects Research Inter-Campus Collaborations" document under the Guidelines section for more information.

For additional information regarding Ithaca-WCM efforts, please contact singleIRB@med.cornell.edu and visit the Office of Academic Integration.

How can I establish the use of electronic informed consent, or eConsent, for my research protocol?

All use of eConsent must be IRB approved before it can be implemented. Use of DocuSign is required for FDA-compliant research, whereas REDCap can be used in other cases. For complete eConsent guidance, requirements, and template language to use when submitting to the IRB, click here. Still have questions? Contact econsent-support@med.cornell.edu.

How can I establish the use of electronic informed consent, or eConsent, for my research protocol?

All use of eConsent must be IRB approved before it can be implemented. Use of DocuSign is required for FDA-compliant research, whereas REDCap can be used in other cases. For complete eConsent guidance, requirements, and template language to use when submitting to the IRB, click here. Still have questions? Contact econsent-support@med.cornell.edu.

Where can I find the status of my submission?

All submissions in WRG submitted after March 27, 2020 include a "Submission Progress" tool that provides you with a visual of where your submission is in the PRMC and IRB review process.

What could delay the release of IRB approval?

The following may delay the release of an IRB approval letter and documents:

Study team members should also check the Study Activation Status Page (SASP) for their study to ensure all applicable approvals are obtained PRIOR to starting human research activities. The SASP page is your "one-stop" location for all required approvals.

My protocol came back from the IRB meeting with a status of "Modifications Required." Is it required to go to another meeting?

It depends on the type of modifications required.  

Prescriptive Modifications Required: 

Your response to questions (RTQ) will be reviewed via expedited review procedures. It does not have to go to another meeting. Responses must be received by the IRB office within 60 days of the date the letter is issued. An extension to respond can be requested by emailing the IRB team who sent the letter.

Substantive Modifications Required:

Your RTQ must be reviewed by the same committee at the next scheduled convened meeting. Thus, it is required to go to another meeting. Responses must be received by the IRB office within 60 days of the date the letter is issued. An extension to respond can be requested by emailing the IRB team who sent the letter.

Be sure to include a cover memo with a detailed point-by-point response to all issues raised. This memo should indicate how the issue was addressed, changes to the text, and where the changes can be found (e.g., in the protocol document, IRB application, attachments, etc.). If you disagree with an issue that was raised by the IRB, please provide justification for why you are not making the requested changes. This memo should be uploaded in the "Attachments" section in WRG-HS.

What if my protocol's IRB approval has expired?

Submit your Continuing Review or Post-Approval Monitoring Report-Annual Review (PAM-AR) as soon as possible, unless 90 days have past since the expiration, in which case the IRB's Guidance on Lapses in IRB Approval should be followed. This guidance is available for download in the Guidelines section above.

If it has been less than 90 days since expiration, all requests for Continuing Review/PAM-AR and approval must include an explanation of why the approval lapsed and the steps the investigator will take to ensure it does not happen in the future. No study related activities can continue beyond the WCM IRB expiration date, including subject recruitment, enrollment, intervention and data analysis. 

However, OHRP guidance suggests that study intervention for subjects already enrolled can continue past the expiration date if the IRB determines that it is in the best interests of subjects already enrolled to continue participating in the research (e.g., when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects). While this determination may initially be made by the investigator, WCM requires that the investigator must seek confirmation that the IRB agrees with this determination as soon as possible.

If you submit your Continuing Review or PAM-AR such that the IRB will be unable to conduct continuing review prior to the expiration date, and you believe it is in the best interest of the subjects to continue study intervention, please send your request to irb@med.cornell.edu.

  • If the IRB agrees that it is in the best interests of the subjects to continue with the study intervention, then the request for an extension will be granted.
  • If the IRB concludes that it is not in the best interest of the subjects to continue the study intervention, or that there will not be an increased risk to the subjects, then the request will not be approved.

If I am collaborating with a PI from NYP-Queens Hospital or NYP-Brooklyn Methodist, which IRB should I submit to?

Oncology Network Trials: The WCM IRB serves as the IRB of Record for oncology trials conducted at WCM, NYP-Queens and NYP-Brooklyn Methodist under an existing IRB Authorization Agreement. Submit to the WCM IRB for review and approval. In accordance with this agreement, NYP-Queens and NYP-Brooklyn Methodist require designation of a local site PI for each location and an administrative approval from their respective IRB offices.

COVID-19 Studies Led by WCM: The WCM IRB serves as the IRB of Record for COVID-19 studies led by WCM and conducted at WCM, NYP-Queens and NYP-Brooklyn Methodist under an existing IRB Authorization Agreement. Submit to the WCM IRB for review and approval. In accordance with this agreement, NYP-Queens and NYP-Brooklyn Methodist require designation of a local site PI for each location and an administrative approval from their respective IRB offices.

All Other Studies: These studies must be submitted separately to each IRB office for separate IRB approval.

For questions related to NYP-Queens, please contact Nancy Garcia, IRB Manager, NYP-Queens.

For questions related to NYP-Brooklyn Methodist, please contact Pearlia Fullard, IRB Coordinator or Dr. Ted Gaeta, IRB Chair, NYP-Brooklyn Methodist.

Key Information Section for the Informed Consent Form

Tell me about the Key Information section of the consent document.

The Key Information section is a new regulatory requirement under the Revised Common Rule that potential subjects be first presented with, “a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension”. Sample Key Information sections are available here (ADD IRB SITE LINK). The section is also integrated into our consent template (ADD LINK TO CONSENT TEMPLATE).

Do I have to begin a consent document and presentation with a concise summary of Key Information?

Full Board and Expedited studies approved after 4/4/2019 are required to include AND begin with a concise and focused presentation of the key information relevant to the study

If your study received initial approval between 1/20/2019 and 4/3/2022, you must add the Key Information section to your existing ICF and submit it with your next Continuing Review, or as an Amendment.

Exception: For an expedited study that recevied initial approval betwen 1/20/2019 and 4/3/2022 that also has an ICF 6 pages or shorter (including the signature blocks), a Key Information section is not required, but strongly encouraged.

Is the Key Information section required for all consent documents?

If your study is MINIMAL RISK (expedited) AND your consent form is 6 pages or shorter (including the signature blocks), the new Key Information section is not required.  However, we  strongly encourage you to submit a revised consent form with the new section when we publish the revised template in the Summer of 2022.

When does this new requirement go into effect?

Beginning April 4, 2022, all studies approved by Full Board or Expedited review after 1/20/2019 will be required to submit updated consent documents at their next continuing review (CR), but may choose to submit an amendment prior to CR submission.

For PAM-AR eligible studies (expedited), an amendment will be required AFTER PAM-AR report is submitted.

Do I need to revise my existing IRB-approved consent document?

The new section is required for all studies approved by Full Board or Expedited review after 1/20/2019. Studies that received Full Board review prior to 1/20/2019, but did not receive final IRB approval until after 1/20/2019 are also subject to this requirement. Expedited studies that have consent forms 6 pages or shorter (including the signature blocks) are not subject to this requirement.

Any study that received final IRB approval prior to 1/21/2019 will not need to amend its consent documents to meet this requirement.

Are there any samples of this section that i can review?

Yes.  Sample key information sections for different types of studies are below:

for Biorepository Studies: 

You or your child are being asked to take part in this research study because you have XXX. 

The purpose of this study is to collect and store data and samples, such as blood and saliva, for future research (about XXX). The future research will include genetic testing. You will not receive results from any of the tests that are performed as part of future research studies.  

If you agree to take part, you will need to give a blood or saliva samples once. We will also review your medical records. The information from your medical record will be collected once a year (Or other frequency).  

Your data and samples will be shared with other researchers at CHOP as well as researchers at other institutions or for profit companies. Before sharing your data or samples, all information that can identify you will be removed. These researchers, who use your samples for future research, will not know who you are.  

The main risks from this study are related to bleeding or infection from the blood draw and risks related to a possibility of a breach of confidentiality of your samples and data. Every precaution will be taken to secure your personal information to ensure confidentiality.  

You will not benefit directly from taking part in this study.  

If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time. If you do not choose to take part in this study, you can discuss treatment options with your doctor. You may also be eligible for a different research study (only if applicable).  

Please see below for additional details about the study.  

For Minimal Risk Studies

You or your child are being asked to take part in this research study because you have XXXX.  Briefly include the major reasons why the subject is being approached to participate. For example, “…you have been diagnosed with sickle cell disease and are scheduled to have an MRI.”   

This is a research study to learn more about how XXXX effects/relates to/changes XXXX.  

You will be asked to come to CHOP for X study visit(s) that will (each) last about XX hours. If you take part, you will be asked to (this listing of procedures should be limited to the most burdensome and/or main procedures that a reasonable person would want to know): 

  • Complete cognitive function tests and questionnaires; 
  • Have a research blood draw; 
  • Perform computer tasks. 

The main risks of this study are from the cognitive assessments. These include fatigue and embarrassment.  

You will/not benefit directly from participating in this study (if there are direct benefits, describe them).  

If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time. If you do not choose to take part in this study, you can discuss treatment options with your doctor. You may also be eligible for a different research study (only if applicable).  

Please see below for additional details about the study. 

For Greater than Minimal Risk Studies

You or your child are being asked to take part in this research study because you have [DISEASE/CONDITION].  

The purpose of this study is to find out if the study drug works better than current drug. The study drug is not approved by the FDA. 

If you agree to take part, your participation will last for XXX and will involve XX study visits. You will need to take the study drug or placebo for XXX weeks. A placebo is an inactive substance. There are differences between this study and your usual care. As a participant in this research you will: 

  • Receive a study drug or a placebo; you will not know which 
  • Stop your regular medication 
  • Have X extra research clinic visits;  
  • Complete a double-blind food challenge; 
  • Have research blood tests, skin prick allergy tests, and other procedures. 

The main risks of this study are from the study drug. These include: allergic reaction and skin irritation.  

You may benefit if drug ABC or XYZ proves to be more effective. OR – You will not benefit directly from participating in this study.  

If there is anything in this form you do not understand, please ask questions. Please take your time. You do not have to take part in this study if you do not want to. If you take part, you can leave the study at any time. If you do not choose to take part in this study, you can discuss treatment options with your doctor. You may also be eligible for a different research study (only if applicable).  

Please see below for additional details about the study. 

Does the information provided in the Key Information section have to be exactly what is in the WCM template?

Not verbatim. The intent of the rule is to consider what key information a potential subject would need to know up front. It is the most important information that would influence a potential participant to say “Yes” and the most important thing that would influence a potential participant to say “No” to participation. This allows the individual to weigh the key pros and cons of volunteering early in the process.

Isn't the reason someone would or wouldn't participate always going to be a risk or benefit?

Not always, but it depends. The most significant deterrent could be a serious potential risk or a number of benign but unpleasant risks. In other cases, it may be merely inconvenience. The key reason to participate could be a personal gain or to help advance science. A proven alternative treatment may be considered more advantageous that an experimental treatment. The most influencing factor could be the implication of the risk. A breach of confidentiality may have minor repercussions for a survey study, while the same occurrence with genetic testing could affect family planning. The idea is not to present all considerations first, but start with the most influential pros and cons to participation.

How do I know what information would be key to someone's decision to participate or not?

The choice may be based on the investigator’s experience with the study population. Support groups or associations may provide insight into participant perceptions. You may also search for empirical research (e.g., Participant perception of risks and benefits of genetic research; or Participant perceptions on data sharing). The patient-centered and participant-centered movements have prompted considerable research on subject perceptions of research consent.