General Requirement for all Submissions:
A detailed cover letter should accompany all IRB submissions. This letter should outline the nature of the submission as
well as the documentation being submitted.
The letter should contain the following information (sample cover letter ):
• Title of the study and IRB study number
• Type of submission, e.g. initial submission, continuing review, revisions/amendment etc.
• The nature of the submission and any special requests, e.g. change of investigator, study title etc.
• A list of all enclosures. Please note if any required documents are missing and if so, why such documents have not been provided.
This will allow our office to quickly determine whether the submission is complete and can be placed on the agenda for the apropriate
meeting.
• Mailing address, telephone and email contact information for the investigator as well as the coordinator, if applicable.
Protocols (if applicable)
For information on writing a protocol, click here
The IRB office has created a number of tools and checklists to assist with the IRB submission process. Please refer to the checklists
and flowcharts link below to access these items. In particular, please use the IRB Submission
Checklist, which gives detailed instructions for each type of submission. Additionally, please note that IRB approval cannot be
granted for initial submissions until all research personnel have satisfied the CITI training requirement. All IRB documents for IRB
submission must be typed.
Please refer to Tips for writing a protocol which outlines all topics to be covered in a complete protocol. If you have any questions or
concerns, please do not hesitate to contact the IRB office. We are here to help!
Incomplete Submissions
The IRB completes a preliminary review of all submissions within 72 hours of receipt into the office. If a submission is determined incomplete,
an email is sent to the investigator noting the items required to complete the submission as well as the deadline for receipt f those items. It is IRB
policy to return incomplete submissions five business days after sending the IRB notification.
Exemptions
OHRP Exemptions – These protocols must satisfy the regulatory requirements set forth in 45 CFR 46.101(b). Exemption requests must be
submitted via the Exemption Request Form. Exempt Checklist is also available under tools and checklists.
FDA Exemptions (Emergency Use of a Test Article) – these protocols must satisfy the regulatory requirements set forth in 21 CFR 56.104(c).
All documentation regarding the emergency use must be submitted to the IRB within five working days of the occurrence.
Initial Submissions
Biomedical – Expedited and Full Board protocols must be submitted via the Initial Submission for Biomedical Research form. Biomedical research is defined as research that is conducted to contribute to an increased understanding of disease processes new
treatments and interventions, and the prevention and control of infectious and chronic diseases in clinical medicine and public health; and research
involving human biological specimens (i.e. collecting or accessing tissues or genetic material for research purposes).
Social/Behavioral – Expedited and Full Board Protocols must be submitted via the Initial Submission for Social/Behavioral Research Form. Social/Behavioral research is defined as research involving the study of social and behavioral human functioning at the
individual, small group, institution, or community levels. The study of behavioral factors such as thought processes, personality and emotion;
also, the study of social and environmental variables are examples. Methodologies include direct observation, interviews and surveys etc.
Expedited Criteria - Biomedical and Social/Behavioral research which adheres to the criteria set forth in 45 CFR 46.110 and
21 CFR 56.110 may be reviewed outside of a ful board meeting. The Expedited Checklist is available under tools and checklists.
Full Board Submissions – Please refer to the IRB Submission Checklist which outlines the number of copies required for
each type of documentation in yor submission.
Research Funding:
Research Sponsored by Pharmaceutical Companies– These initial submissions cannot be reviewed without a signed Office of Research
Administration proposal routing sheet and an T in the amount of 1500.00. Additionally, initial submissions cannot be approved prior to
receipt of the signed clinical trials agreement. Renewal applications cannot be reviewed without an IT in the amount of 750.00.
Federally Funded Research – Initial Submissions cannot be reviewed without a signed Office of Research Administration proposal routing sheet.
Investigator-Initiated Research
Investigator-Initiated Initial Submissions must be signed by the Investigator’s Chair/Department Head or Dean. This ensures that a scientific review is
being conducted within the department/school.
Special Considerations:
Student Research - Student investigators must complete Form A along with your IRB submission. This ensures that a faculty member is
overseeing the research. Additionally, please include the length of your project on your cover letter. This will help us grant an accurate approval
period.
Research Involving Pregnant Women/Fetuses – Please submit Form B along with your IRB submission. This ensures that your research
satisfies regulatory requirements for research involving this vulnerable population.
Research Involving Prisoners - Please submit Form C along with your IRB submission. This ensures that your research satisfies regulatory
requirements for research involving this vulnerable population.
Research Involving Children - Please submit Form D along with your IRB submission. This ensures that your research satisfies regulatory
requirements for research involving this vulnerable population.
Biological Specimen Banking – Please submit Form E along with your IRB submission. This ensures that the IRB has all required information
regarding storing biological samples.
Waiver of Consent/HIPAA Authorization – Please submit Form F along with your IRB submission. This ensures that the IRB has all
required information regarding your request to waive or alter the consent process.
Research Involving Non - English Speakers – Please submit Form G along with your IRB submission. This form allows you to explain
the consent form that you will be using (short form or translated versions). If you will be translating the consent into another language,
please provide the consent in English and the foreign language as well as a certification that the consent is accurate. The certification can be
provided by a person who is not involved with the research project.
Research Involving Deception – Please submit Form H along with your IRB submission. This form allows you to explain the justification
for using deception in your research.
Research Involving Medical Devices – Please submit Form J along with your IRB submission. This form ensures that your research
satisfies regulatory requirements for research involving medical devices.
Research Involving the Use of a Drug – Please submit Form K along with your IRB submission. This form ensures that your research
satisfies regulatory requirements for research involving the drugs.
Research Involving the Cognitively Impaired – Please submit Form L along with your IRB submission. This form ensures that your
research provides adequate protections for this vulnerable population.
International Research – We cannot impose our standards for written documentation on other cultures; however, we do not relax our
standards for ethical conduct of research or for a meaningful consent process. Special attention should be given to local customs and to
local cultural and religious norms in drafting written consent docuents or requesting a waiver or alteration of consent using Form F.
If the research involves Non-English speakers, submit Form G. If you will be translating the consent into another language, please provide
the consent in English and the foreign language as well as a certification that the translation is accurate. The certification should be provided
by a person who is not involved with the research project. Protocols must be approved by the local equivalent of an IRB before they are
reviewed by the University IRB. When there is no equivalent board or group, investigators must rely on local experts or community leaders to
provide approval. This “local approval” must be submitted prior to IRB approval.
For all projects with an international scope, the principal investigator must submit an International Projects Preliminary Questionnaire (“IPPQ”) through the Tulane University Office of Research Administration. Access the IPPQ through the following link: www.som.tulane.edu/researchadmin/forms/IPPQ.pdf
Retrospective Chart Reviews – Retrospective chart reviews are generally reviewed via the expedited review procedure. Please submit Form F if you are requesting a waiver or alteration of consent/HIPAA authorization.
Continuing Review
You will receive renewal notices at 60 and 30 days prior to the scheduled meeting your protocol is to be reviewed. Please submit the
Continuing Review Form along with any updated materials (e.g. project summary, consent/assent forms, DSMB reports etc.). Please
note that you will be required to submit an updated consent form with the appropriate version date if the protocol is till open to accrual.
All research sponsored by pharmaceutical must be submitted with the IRB renewal fee of 750.00. A protocol is administratively closed by
the IRB if no renewal application is received prior to the expiration date.
Amendments/Revisions
Any changes to a research protocol must be approved by the IRB prior to implementation. Failure to do so will result in a compliance issue.
Please submit any changes to the project along with any new or updated materials using the Amendment Request Form.
Adverse Events
In an effort to meet the needs of both the IRB and the Investigator, the IRB has revised the Adverse Event reporting procedure, as follows:
I. Local Adverse Events/Adverse Events that are Unanticipated Problems:
Please submit ALL local adverse events as well as any adverse events that meet the below criteria using the Adverse Event Reporting Form along with a detailed cover letter and any applicable documents such as revised consents, protocols and safety reports.
Criteria for Adverse Events that are Unanticipated Problems:
• Unexpected AND
• Related or possibly related to participation in the research OR
• Related and suggests that the research places subjects or others at greater risk for harm.
Submission Timeline: Local adverse events and any other adverse events that meet the above criteria must be submitted to the IRB as soon as possible or within one week of investigator notification of the occurrence.
II. Offsite Adverse Events that are NOT Unanticipated Problems*:
* These adverse events do not meet the above criteria and do not require any changes to the protocol or consent, or increase risk for participants
The IRB will accept offsite adverse events that are NOT Unanticipated Problems on a Quarterly basis in table format, along with a cover letter.
Ex. of Adverse Event Table
Patient ID Number |
Initial of Follow-Up |
Type of Event |
Severity |
Relationship to Study |
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Submission Deadline: Please submit on a quarterly basis on the dates outlined below.
April 1, 2008 |
July 1, 2008 |
October 1, 2008 |
Unanticipated Problems
The IRB requires unanticipated problems to be submitted regardless of location based on the following criteria:
Compliance Concerns
Please submit any compliance concerns in a detailed cover letter containing the protocol title, IRB number, Investigator/Coordinator information,
and a description of the compliance concern as well as any corrective measures being taken.
Study Closures
Please submit all study closures using the Research Closure Form.
If the study was discontinued, you must provide an explanation as well as any supporting documentation for the closure. If the termination of
the protocol places subjects at risk, please submit a plan for treatment of currently enrolled subjects and/or notification for previously enrolled
subjects.
