HERE'S A LOOK AT THE MOST RECENT DEVELOPMENTS IN THE HUMAN RESEARCH PROTECTION PROGRAM:
Clinicaltrials.gov Policy Statement and Sample Dissemination Plan
Policy Statement Clinicaltrials.gov Registration
To review the Sample NIH Plan for Dissemination, click here.
Procedures to Protect Minor Participants
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
Updated Exemption Guidance
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.
SINGLE IRB Guidance
When AU is a Study Site and Will Rely on an External IRB
2. The submission will be reviewed by an AU IRB reviewer and, when all required
(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.
Developmental Approval Process
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
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.
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:
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
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.
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
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.
New Personnel Modification Form Available
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
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.
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:
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
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
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.
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