What's New

HERE'S A LOOK AT THE MOST RECENT DEVELOPMENTS IN THE HUMAN RESEARCH PROTECTION PROGRAM:
 

Vendor Vetting Guidance
July 14, 2022

To ensure compliance with AU's Electronic and Information Technology Accessibility Policy, if a research activity includes a purchase that involves technology hardware, software or services, the AU IT Vendor Vetting team must be contacted at vetting@auburn.edu to learn the vendor registration process (prior to completing the purchase. A copy of the documentation of the approval from AU Vetting must be included with the IRB submission.

Clinicaltrials.gov Policy Statement and Sample Dissemination Plan
January 24, 2022
 

Policy Statement Clinicaltrials.gov Registration

Auburn University is committed to ensuring compliance with Federal and State law and funding agencies regulations to meet professional publication standards and requirements concerning the public availability of clinical trial data on ClinicalTrials.gov. AU Researchers have the responsibility to create and maintain records in ClinicalTrials.gov while making determinations about registrations required to comply with International Committee of Medical Journal Editors (ICMJE) and the Center for Medicare and Medicaid Services (CMS).

To review the Sample NIH Plan for Dissemination, click here.

Procedures to Protect Minor Participants
January 20, 2022

The IRB is charged with protecting the rights and welfare of humans participating in human subjects research. To accomplish this purpose, when minors participate in human subjects research, at least 2 adults must be present during all research activities that include minor participants. Revisions have been made to application forms and applicable sample documents to obtain a description of procedures to ensure protecting minor participants is fully considered when preparing your submission.
 

Process to submit for IRB Review

On October 11, 2021, a change to the submission process will become effective. The change is designed to simplify the submission process.

Follow this process to submit all materials for IRB review

• Convert all study materials to PDF.
• Combine all PDF study materials to a single PDF.
• Complete the IRB Submission Page
• Drag the single PDF to the designated space at the bottom of the new IRB submission Page
• When all areas of the IRB Submission Page are completed and the single PDF is loaded, press Submit.
• When the submission process is completed as described an email documenting successful submission is sent to the Principal Investigator.
   

Updated Exemption Guidance
July 26, 2021

Responding to requests by members of the Auburn University research community, guidance and processes related to research activities eligible for EXEMPTION (click here for link), including a WORD version of the EXEMPT application form (click here for the link to the WORD form), have been updated. In the coming months, additional changes designed to streamline and simplify submission and review processes are planned.

Beginning September 1, 2021, only version 07/26/2021 of the Exemption application form will be accepted.

The EXEMPTION application form is a WORD document; however, the form currently requires a signature to be added manually.

Your feedback is welcome. To provide feedback or ask questions call 334-844-5966.

SINGLE IRB Guidance
July 13, 2022

When AU is a Study Site and Will Rely on an External IRB

Auburn University (AU) may be a participating site in multi-site research studies and rely on an external IRB (not the AU IRB).
      -The external IRB may be institutional (like UAB IRB, UGA IRB, etc.) or an
       independent IRB (like WIRB or Advarra).

When an AU Principal Investigator (PI) requests external IRB review of their human subjects research, the AU PI is requesting ceded review; that is, the AU IRB cedes review to an external IRB for study oversight.
      -Ceded review requires that a reliance agreement be executed before research
       activities are performed by the AU site.

Ceded Review Application Instructions:

       1. Email to irbadmin@auburn.edu, as one PDF, the following:
                 a.   A Copy of the completed, signed Ceded Review application;
                 b.   Documentation of CITI human subjects training for all key personnel;
                 c.   A copy of the external IRB-approved consent document or template
                       consent document including required elements from the AU IRB template
                       consent form;
                 d.   External IRB-approved protocol materials; and
                 e.   A copy of the External IRB's Reliance Agreement.

       2. The submission will be reviewed by an AU IRB reviewer and, when all required
           information is received, the AU IRB reviewer will obtain the signature of the AU
           Institutional Official (IO) on the reliance agreement and return the signed
           reliance agreement to the AU PI. 
                  a.   Note when continuing review is required, the IRB expects the AU PI to
                        submit documentation of ongoing approval from the External IRB,
                        using the AU IRB Renewal form and a copy of the External IRB's
                        documentation of approval. 

NOTE: Only when a copy of the final version of the IAA which includes all requested information and signatures of both Institutions' Signatory Officials has been received and reviewed by the IRB reviewer will IRB approval be issued. No research activities can occur until IRB approval is issued.

**Please note the Auburn University IRB does not enter into reliance agreements for EXEMPT level research.**

For assistance with the ceded review process, contact the AU IRB at 334-844-5966 prior to submission of the application.

(Single IRB guidance under construction)

Useful Data Storage Resources

Data obtained during IRB-approved human subjects research projects requires secure storage practices. Below find links to useful resources to ensure secure data storage. 

https://libguides.auburn.edu/c.php?g=731051&p=5269743

https://auburn.service-now.com/it/?id=sc_cat_item&sys_id=2c195839dbdd53c0965cf9b9af96197f

Developmental Approval Process
February  8, 2021

When plans for the involvement of human subjects are not finalized and IRB review is required to establish a funding account, then "developmental approval" (118 designation under 45 CFR 46.118) may be granted. For guidance on the process to obtain approval , go to our guidance page.

IRB COVID-19 Guidance
March 27, 2020 (updated April 22, 2020 , June 4, 2020, June 26, 2020)

As COVID-19 presents a new and evolving situation, Investigators conducting human research should stay informed of the latest information on COVID-19 in addition to university guidance and implications for research. 

AU IRB COVID-19 Guidance can be found on the OVPRED's Human Subjects Research COVID-19 Guidance website.

Zoom Guidance
April 20, 2020

Given current safety concerns resulting from the COVID 19 pandemic, more than ever the safety (risks) to research personnel and participants in human subjects research must be a priority.  As a research study continues, the IRB stresses the need for the Principal Investigator to ensure (at least) the following when utilizing Zoom technology and beyond:

1.  Participants are reminded to protect their privacy by completing activities in a private space, to ensure conversations are not overheard;
2. Participants are encouraged to disable “cookies” and close device browser;
3. Participants are told how and where Zoom recordings are saved;
4. Investigators must use Zoom provided by Auburn University (safety features built within), as other platforms may have limitations;
5. Investigators must share Zoom recordings in a safe, private area/way that only research staff can access.

Researchers have latitude how to present Zoom information to participants. Reminders can be part of consent discussions, can be included as a reminder in the information letter/consent form, or as a reminder at the beginning of the Zoom interview, the goal of the guidance is to remind researchers and participants that Zoom use includes privacy concerns.

Order of Materials Submitted for IRB Review 
February 4, 2020

To facilitate the review process and ensure consistency, please note the following when submitting documents. If you experience difficulties when submitting your PDF application, contact your department IT representative.

Original submission:

• Application;
• Consent documents (consent form, information letter, etc.);
• Recruitment materials (flyers, emails, telephone script, etc.;
• Study instruments (survey, questionnaire, etc.);
• Other study documents (data collection form, additional information, etc.):
• Agreements/other IRB approvals; and
• CITI training documentation.

         Revision submission:

• Memorandum addressing IRB reviewer’s requested clarifications and revisions;
• Revised documents (as listed above) “highlighting” all requested revisions;
• “Clean copy” (as listed above) of all revised items; and
• Other study materials (as listed above).

A copy of all study materials must be included with all submissions.  Combine documents as a single PDF. Forms may be converted to WORD for completion.  Once all information is provided, convert back to PDF prior to submitting.  Prior to submission review all study materials to ensure desired text is visible.  The IRB has learned that printing a submission to PDF may strip some interactive functions.  Rather than printing to PDF, the IRB suggests submissions be saved as a PDF.  If problems remain, contact your departmental IT representative for assistance.

Revised Common Rule – Cooperative Research - 45 CFR 46.114
January 20, 2020

The U.S. Department of Health and Human Services issued a final rule to update regulations that safeguard individuals who participate in research. Currently, 20 federal agencies (including HHS) subscribe to the common rule.  Most provisions in the new rule went into effect January 19, 2018. The deadline for compliance with the cooperative research requirements is January 20, 2020.  The cooperative research requirements apply to non-exempt human subject research involving more than one institution when the institutions are located in and the research is conducted in the United States.

Proposals
Any principal investigator proposing a project subject to the cooperative research requirement should describe a Single IRB Plan in the proposal.  The Single IRB Plan must be approved by the reviewing IRB, which will need to provide a letter of support accepting the roles and responsibilities.  In addition, the plan should identify the relying sites which will also need to provide documenting acceptance of the Single IRB Plan.  Further, the Single IRB Plan should describe how communication and coordination will occur between the reviewing IRB and the relying IRB(s).  It is important to note that IRB review for cooperative research may have budget implications for the project.  Please begin discussions with the compliance office and development of a Single IRB Plan for cooperative research as early as possible, but at least 3 weeks prior to the proposal deadline. 

Awards
Principal investigators receiving an award subject to the cooperative research requirement may need to assist in coordination and communication with other research sites.  A pre-IRB protocol submission meeting between the principal investigator and an AU IRB/AU ORIC representative is required when the Auburn University IRB will serve as the reviewing IRB.

New Personnel Modification Form Available
September 17, 2019

Based on popular demand, the AU IRB has created a PERSONNEL MODIFICATION FORM.  The form is for use when the ONLY modification to an approved protocol is the addition or removal of research staff.  The new form is available under the FORMS tab, listed under the Continuing Review Forms section.

AU HIPAA Authorization
June 6, 2019

AU HIPAA-covered entities engaged in research are required by federal regulations to obtain authorization (agreement) from participants to use or share identifying health information.  Under the FORMS tab, you can find the AU HIPAA Authorization.  The authorization form should be added as the last page of the consent form and should be included in the total number of pages for the consent form. 

Guidance Tab
May 15, 2019

It is the goal of the IRB to provide helpful, relevant information to all AU research personnel.  To obtain guidance on a wide variety of relevant topics, please look to your left and find the new Guidance tab.  Useful information and “aging” notices from the What’s New page will be available under the Guidance tab.  If you find there are specific topics requiring additional guidance to completely understand, please email us at IRBadmin@auburn.edu. 

IS MY ACTIVITY RESEARCH?

May 8, 2019

The Office for Human Research Protections (OHRP) has prepared human subjects regulations decision charts to help researchers, IRBs, and others determine whether an activity is research involving human subjects that must be reviewed by an IRB per requirements of the US Department of Health and Human Services (HHS) regulations at 45 CFR part 46.  The charts address decisions on:

• whether an activity is research that must be reviewed by an IRB;
• whether the review may be performed by expedited procedures, and
• whether informed consent or its documentation may be waived.

The charts are for use in conjunction with, not excluding, applicable regulatory provisions and requirements including FDA, NIH, sponsors, or state or local governments.  The charts are available online

https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html.  

AU Policies and Procedures are available online at https://cws.auburn.edu/OVPR/pm/compliance/irb/guidance

Updating forms – An Ongoing Process. 

As the AU Human Research Protection Program (HRPP) continues to respond to researchers’ suggestions and changes to the common rule, members of the AU research community can anticipate changes to many familiar forms.  To stay abreast of the improvements, we encourage you to periodically check the What’s New? page on our website. 

On our forms page a new version (04.22.19) of the AU IRB Request for Exemption form has replaced the previous version of the form.  As of April 22, 2019, this version of the form is the only version that will be accepted. Click here to access the revised Exemption form.

On our forms page a new version (04.15.19) of the AU IRB Request for Modification form has replaced the previous version of the form.  As of April 15, 2019, this version of the form is the only version that will be accepted. Click here to access the revised Modification form.

AU Campus Alcohol Policy and Human Subjects Research
June 25, 2019

The possession, consumption, and/or distribution of alcoholic beverages by students, employees and visitors are prohibited on Auburn University property with limited exceptions. 

For Human Subjects Research, the relevant exception to the policy reads, “Research studies with volunteer human subjects involving alcohol that have approved protocols through the AU Institutional Review Board (IRB) are excluded from this policy.” 

This AU policy was effective April 24, 2015.