Here's a look at the most recent developments in the Human Research Protection Program:
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.
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:
- Participants are reminded to protect their privacy by completing activities in a private space, to ensure conversations are not overheard;
- Participants are encouraged to disable “cookies” and close device browser;
- Participants are told how and where Zoom recordings are saved;
- Investigators must use Zoom provided by Auburn University (safety features built within), as other platforms may have limitations;
- 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 via IRBsubmit@auburn.edu. Documents may be converted to WORD format to complete and converted back to PDF for submission. If you experience difficulties when submitting your PDF application to IRBsubmit@auburn.edu, contact your department IT representative.
- 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.
- 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).
Please note a copy of all study materials must be included with all submissions. Combine documents as a single PDF and submit via IRBsubmit@auburn.edu. Forms may be converted to WORD for completion. Once all information is provided, convert back to PDF prior to submitting via IRBsubmit@auburn.edu. 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.
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.
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 ORC representative is required when the Auburn University IRB will serve as the reviewing IRB.
The Office of Research Compliance is available for assistance. Please contact Niki L. Johnson (phone: 334-844-5914; email: email@example.com) or Roger Bridgman (phone: 334-844-5921; email: firstname.lastname@example.org).
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.
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
AU Policies and Procedures are available online at https://cws.auburn.edu/OVPR/pm/compliance/irb/guidance
Forms may be converted to WORD for completion. Once all information is provided, convert back to PDF prior to submitting via email@example.com
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.