
HUMAN SUBJECTS (IRB)
Federal Wide Assurance
The Georgia State University Institutional Review Board holds a Federal Wide Assurance (FWA) of Compliance (Number 00000129) with the Office for Human Research Protections (OHRP). An assurance is maintained by the IRB Compliance Officer. The FWA expires 11/07/2028.
Georgia State University assures that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects, 45 CFR Part 46, as amended to include provisions of the Federal Policy for the Protection of Human Subjects (56FR28003) as Subpart A, and as may be further amended during the approval period for this Assurance.
OHRP Registration
Georgia State University's IRB is registered with OHRP under number IRB00000716.
Institutional Official
The Institutional Official (IO) is Vice President for Research and Economic Development, Donald Hamelberg, Ph.D.
Clinical Trials Registration
Georgia State University does not require registration of clinical trials. However, 42 CFR Part 11 clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with FDAAA 801. If your clinical trial falls under the scope of these regulations or the sponsor of your award requires registration, you may register your clinical trial with ClinicalTrials.gov by contacting Alison Alesi to request a user account in the federal system, if you do not already have one. PI's of clinical trial studies that are registered in Clinicaltrials.gov are completely responsible for maintaining these records and providing timely updates and close-out of their clinical trial in ClinicalTrials.gov.
IRB Committee Members
Expedited Panel Board
Member | Department |
---|---|
Cynthia Hoffner, Chair | Dept. of Communication, Georgia State University |
Susan Vogtner, Vice Chair | Associate Director, Human Research Protection Program, Georgia State University |
Catharina Chang, Vice Chair | Dept. of Counseling & Psychological Services, Georgia State University |
Ayanna Buckner | Community Member (Medical) |
Andrew I. Cohen | Dept. of Philosophy, Georgia State University |
Josh Hinkle | Dept. of Criminal Justice and Criminology, Georgia State University |
Cynthia Jackson | Community Member (Dual Committee Assignment) |
Regena Spratling | Dept. of Nursing, Georgia State University |
Erin Tone | Dept. of Psychology, Georgia State University |
John J. Weber, III | Dept. of Mathematics, Perimeter College, Georgia State University |
Feng Yang | Dept. of Kinesiology & Health, Georgia State University |
Jamie Zaikov | IRB Compliance Specialist, Senior, Georgia State University |
Kiki Sindad | IRB Compliance Officer, Georgia State University |
Alison Alesi (Alternate for Vogtner) | Assistant VP, Regulatory Affairs, Georgia State University |
Katherine Hsieh (Alternate for Yang) | Dept. of Physical Therapy, Georgia State University |
Donald Hamelberg | Interim Vice President for Research & Economic Development (Ex Officio without vote) |
Full Board
Member | Department |
---|---|
Ann C. Kruger, Chair | Dept. of Learning Sciences, Georgia State University |
Andrew I. Cohen, Vice Chair | Dept. of Philosophy, Georgia State University |
Amanda Damarin | Dept. of Cultural & Behavioral Social Sciences, Perimeter College, Georgia State University |
Daphne Greenberg | Dept. of Learning Sciences, Georgia State University |
Matthew Hayat | School of Public Health, Georgia State University |
Cynthia Jackson | Community Member |
Javel Jackson | Community Member (Prisoners) |
Dominic Parrott | Dept. of Psychology, Georgia State University |
Regena Spratling | Dept. of Nursing, Georgia State University |
Susan Vogtner | Associate Director, Human Research Protection Program, Georgia State University |
Feng Yang | Dept. of Kinesiology & Health, Georgia State University |
Jamie Zaikov (Alternate for Vogtner) | IRB Compliance Specialist, Senior, Georgia State University |
Kiki Sindad (Alternate for Vogtner) | IRB Compliance Officer, Georgia State University |
Alison Alesi (Alternate for Vogtner) | Assistant VP, Regulatory Affairs, Georgia State University |
Katherine Hsieh (Alternate for Yang) | Dept. of Physical Therapy, Georgia State University |
Donald Hamelberg | Interim Vice President for Research & Economic Development (Ex Officio without vote) |
Meetings and Deadlines
IRB study applications requiring full board review must be submitted by 5:15 p.m.(close of business) on the deadline day (the Monday before the 2nd Thursday of each month).
View Deadlines and Meetings
IRB Application Deadlines | IRB Meeting Dates |
---|---|
January 6, 2025 | January 16, 2025 |
February 10, 2025 | February 20, 2025 |
March 10, 2025 | March 20, 2025 |
April 7, 2025 | April 17, 2025 |
May 5, 2025 | May 15, 2025 |
June 6, 2025 | June 17, 2025 |
July 7, 2025 | July 17, 2025 |
August 11, 2025 | August 21, 2025 |
September 8, 2025 | September 18, 2025 |
October 6, 2025 | October 16, 2025 |
November 10, 2025 | November 20, 2025 |
December 8, 2025 | December 11, 2025 |
*November and December deadlines and meetings may be earlier in the month to accommodate the Thanksgiving and Winter Breaks.
One’s Students in Research
Some options to remedy the situation are offered below:
- The consent form or assent form needs to state that the students will not have any penalty if they do not participate, and they will not make the teacher upset. (This option alone does not satisfy this requirement.)
- The study can be presented by a colleague or somebody not involved with the students.
- The study can be completely anonymous.
- The teacher can collect the data and not use it for research until after the class has been completed and grading is complete.
- A different class can be used so the teacher is not using his/her own students for research.
If you have questions about how to make your research safer for all participants please contact the IRB Office at 404-413-3500.
Policy for Publicly Available, Archival, and Secondary Data
However, for the following datasets listed in this document, the IRB has determined in advance that these datasets can be designated as not human subjects research. For any data sets not listed below, the Researcher must submit a request, through the Data Request Document, to include the new data set on the IRB Approved list or submit an IRB protocol. Thus, research projects involving secondary data set analysis using one or more of the data sources listed below will not require prior IRB approval.
Public sources of data sets currently approved for use under this policy
- American College of Surgeons National Trauma Data Bank (NTDB)
- American Hospital Association Annual Survey
- Behavioral Risk Factor Surveillance System (BRFSS; public data only)
- Comprehensive Hospital Abstract Reporting System (CHARS; public data only)
- Demographic Health Survey (DHS), Standard and Interim Surveys
- Fatality Analysis Reporting System (FARS)
- Global School-based Student Health Survey
- Global Youth Tobacco Survey
- Healthcare Cost and Utilization Project (H-CUP) healthcare databases
- The Nationwide Inpatient Sample (NIS)
- The Kids’ Inpatient Database (KID)
- The State Inpatient Databases (SID)
- The State Ambulatory Surgery Databases (SASD)
- The State Emergency Department Databases (SEDD)
- Health Information National Trends Survey (HINTS)
- Higher Education Research Institute (HERI)
- HIV Prevention Trials Network D01: Vaccine Preparedness Study/Uninfected Protocol Cohort – 4 files
- Hospital Compare
- Inter-University Consortium for Political and Social Research (ICPSR) – public use data only
- National Latino and Asian American Study (NLAAS) – public use data only
- Drug Abuse Warning Network (DAWN) – public use data only
- Medical Expenditure Panel Survey (MEPS)
- Household Component Full-Year files
- Household Component Event files
- Household Component Point-in-time files
- Pooled Linkage files
- Medicare Healthcare Cost Report Information System (HCRIS)
- Multiple Indicators Cluster Survey
- National Ambulatory Medical Care Survey
- National Automotive Sampling System (NASS) General Estimates System (GES)
- National Center for Health Statistics
- Life Tables
- LSOAs: Longitudinal Studies of Aging
- NHANES: National Health and Nutrition Examination Survey
- NHCS: National Health Care Survey
- NHIS: National Health Interview Survey
- NIS: National Immunization Survey
- NSFG: National Survey of Family Growth
- SLAITS: State & Local Area Integrated Telephone Survey
- Vital Statistics: National Vital Statistics System
- National Center for Education Statistics
- National Election Studies
- National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)-Wave 1 & Wave 2
- National Home and Hospice Care Survey - public use data only
- National Hospital Ambulatory Medical Care Survey (NHAMCS)
- National Longitudinal Survey (NLSY)
- National Longitudinal Survey of Youth 1997 (NLSY97)
- National Longitudinal Survey of Youth 1979 (NLSY79)
- NLSY79 Children and Young Adults
- National Longitudinal Survey of Young Women and Mature Women
- National Longitudinal Survey of Young Men and Mature Men
- National Survey of Children with Special Health Care Needs (public version)
- National Survey of Children’s Health (public version)
- National Survey of Veterans (2010)
- National Youth Tobacco Survey
- New York City Marathon Database Online, Boston Marathon Database online Chicago Marathon Database on-line
- Organ Procurement and Transplantation Network (OPTN)
- Pathways to Desistance Study
- Program for International Assessment of Adult Competencies (PIAAC)
- Reddit Suicidality Dataset (University of Maryland)
- Roper Center for Public Opinion Research
- School Health Policies and Practices Survey (SHPPS)
- State of Georgia-Governor’s Office of Student Achievement
- Survey of Consumer Finances (SCF)
- U.S. Bureau of the Census
- U.S. Bureau of Labor Statistics
- 2010 National Survey of Veterans (NSV)
Researcher options when working with a database other than those approved and listed above
- Option One: A researcher may complete the Data Request Document to register a dataset for approval under this policy.
- Option Two: A researcher may complete and submit an IRB Application online via iRIS.
- Option Three: A researcher may complete and submit an Application for Designation of Not Human Subjects Research. This application may be found in iRIS.
Investigator guidelines for registering a data set for approval under this policy
- If a data set does not appear above, a researcher may request approval through the IRB. Data sets may qualify for inclusion on Georgia State’s list of approved data sources if prior approval of the IRB is obtained and falls within parameters defined in the IRB Manual.
- Research projects that merge more than one data set in such a way that individuals may be identified are not covered by this policy, and require prior IRB approval.
- Researchers must submit the following information on potentially eligible data sets to the IRB and receive written approval prior to conducting research.
- Name of data set
- URL of the data set or other information on how to obtain the data set
- Abstract (one page maximum) describing the content of the data set and its potential use by other researchers – the abstract must include a brief statement as to the lack of identifying information in the public-use version of the dataset.
Studies Designated as Not Human Research
With some studies, it may not be clear if it is human subject research. Some sponsors or publications may require verification that a study does not constitute human subjects research from the IRB.
You can now use the iRIS system to submit your Application for Designation of Not Human Subject Research. To do this please log in to iRIS and submit the appropriate application. For step-by-step guides on how to access iRIS or how to submit the Application for Designation of Not Human Subject Research look in the HELP menu within iRIS.
The IRB has already designated some data sets as not human subjects research. To view the list or apply to have a study added to the designated list, please see the Policy for Publicly Available, Archival and Secondary Data in the section above..
What to do if something goes wrong – Reporting Requirements
If you have found that you did not follow the approved IRB protocol, you should complete a Protocol Deviation form in iRIS. Instructions on completing the Protocol Deviation form are available in the HELP menu within iRIS.The Protocol Deviation form should include information on the specific incident and how it was handled. If any changes to the consent form, application, or protocol need to be made as a result of the protocol deviation, an amendment should be submitted.
For more information, please see section 20.7 of the IRB Manual.
Some examples of times when the protocol deviation form should be completed:
- You enroll more participants than were approved in the application
- You find that one participant was out of the age range approved by the IRB
- There was a discrepancy in the informed consent process
- An unapproved recruitment method was inadvertently used
What should I do if something unexpected happens with a subject?
Unanticipated problems must be disclosed to the IRB using the Unanticipated Problem form in iRIS. The form should include a detailed account of the occurrence and the outcome. If the event highlights any changes that need to be made to the consent form, application, or protocol, an amendment should be submitted. An unanticipated problem is an incident, experience, or outcome that meets ALL of the following criteria:
- Unexpected (in terms of nature, severity, or frequency)
- Related or possibly related to participation in the research
- Suggests that the research places subjects or others at greater risk of harm that was previously known or recognized
Only events meeting the definition of unanticipated problems must be disclosed to the IRB. The IRB will review the Unanticipated Problem form and determine if an unanticipated problem did, in fact, occur and if reporting is necessary to OHRP or the FDA.
For more information about unanticipated problems please see section 21 of the IRB Manual or the Guidance from the Department of Health and Human Services.
How long do I have to report an incident?
Within seven business days of knowledge of the deviation or unanticipated events, the Principal Investigator (PI) is asked to submit the Unanticipated Event Form to the IRB Compliance Office. Anticipated events (anticipated events described in the risks section of the consent form) are to be reported in the annual continuing review application.
What are some of the consequences of reporting an incident?
The consequences will vary greatly based on the severity of the event and how it is handled. Some examples of possible actions by the IRB for unanticipated events are below.
- Accept the actions taken by the PI to report and resolve the incident
- Notify and re-consent current participants when information about the unanticipated problem might affect their willingness to continue to take part in the research
- Alter the continuing review schedule
- Peer review monitoring
- Approve with explicit changes, such as notification of previous subjects or modification of consent and/or protocol
- Suspension of some or all research activities
- Terminate the study for cause
Some examples of possible actions by the IRB for non-compliance are below:
- informal counseling
- action plan for resolving non-compliance
- audit(s) of active protocols
- subjects previously enrolled in the study contacted and provided with additional information and/or re-consented
- frequent review of compliance
- suspension of research protocol
- termination of research protocol
- letter(s) of reprimand
- suspension of sponsored research grant account
- notification of current participants when such information might relate to participants’ willingness to continue to take part in the research
- prohibit collected data from being used for publication
- report of non-compliance to Vice President for Research and other University administrators, the sponsor, and/or government agencies
- disqualification of Principal Investigator from conducting research involving human subjects at the University
- embargo of publications
- referral of the Claim to the Vice President for Research for investigation
Working with Individuals Outside of Georgia State
All members of the research team who interact with human subjects or have access to data must have human subjects training (see Required Education & Training under Human Subjects). If you are working with a researcher from another institution, we can accept the training that is required by their home institution. If you are working with a researcher who is not affiliated with an institution or whose institution doesn’t require human subjects training, they can complete human subjects training through CITI by listing Georgia State as their institution. For more information on the human subjects training requirement, please see section 5.3 of the IRB manual.
Individual Investigator Agreement
An individual investigator agreement is needed when researchers at Georgia State University work with an individual who is affiliated with another institution that does not have its own IRB or Ethics Committee to review a study, the IRB determined that their institution is not engaged, or an institution that does not have a Federal Wide Assurance and does not regularly conduct human subjects research. With the individual investigator agreement, the individual must comply with the human research subject protection policies and IRB oversight of Georgia State University. The agreement describes the expectations and responsibilities for the individual. For more information on these agreements, please see section 24 of the IRB manual. If you would like to initiate an individual agreement, please contact IRB.
Volunteer Form
If you are working with an individual who is not associated with Georgia State or another institution, but would just like to work with you on the study, they must complete the volunteer form. If you would like to complete the volunteer form, please contact IRB.
Adding a Person Outside of Georgia State to iRIS
If you would like to add a person from outside of Georgia State to the iRIS system so you can add them to your study, please complete the form here.
Authorization Agreements
An authorization agreement is a formal agreement between two institutions when one institution is relying on the review from the other institution’s IRB. This way, when a study is being conducted at multiple institutions, the researcher may only need to go through one IRB. If the funding for the study goes through Georgia State University, our IRB must review it. We can generally only rely on the review from other AAHRPP accredited institutions.
If you would like to have an authorization agreement in place, please complete the External Reliance Agreement Application form in iRIS. For more information on authorization agreements, please see section 24 of the IRB manual.
Georgia State Not Engaged
If you are collaborating with a researcher at another institution and all the research and data collection is taking place at that institution, you have no interaction with human subjects, and you are only receiving completely de-identified data, you may qualify for a status of Georgia State not being engaged in the research. Please email Alison Alesi with information about the study and Georgia State’s involvement. If a determination is made that Georgia State is not engaged in the research, you will not need to complete the full IRB application. For more information on engagement, please see section 7.2 of the IRB manual.
Paying Human Subjects and Participant Support
Human subjects are individuals that provide something to the research project such as data or information. Human subjects payments are typically small payments (sometimes referred to as participant incentives and respondent fees) made to individuals who are participating in a research project as “human subjects.” These costs should be expensed to account code 727140.
Participant support includes stipends, subsistence allowances, registration fees, supplies and manuals paid to, or on behalf of individuals who typically get something from the project (not acting as subjects from which data or information is collected). “Participants” may be attendees at conferences, symposia, training activities or workshops that are directly related to the research project or program. These costs should be expensed to either account code 783120 – Participant Support Services for stipends or subsistence allowances or account code 783110 – Participant Support Reimbursement of Expenses for reimbursing such costs to participants. When paying participant support from a sponsored project, such expenses must be part of the approved sponsored project budget and budgeted separately. Participant support costs are not charged F&A (indirect cost) recovery.
Payments to individuals for either type of expense can be made through two mechanisms:
- Project Advance or Imprest Fund accounts (for paying individuals cash or gift cards)
- Purchase vouchers (see “Human Subjects and the Transparency in Government Act” below for information re: protection of privacy information for human subjects)
More information about requesting and managing these accounts or purchasing vouchers can be found on the Finance & Administration webpages.
Human subjects and the Transparency in Government Act
Senate Bill 300, the Transparency in Government Act, was passed during the 2008 legislative session and signed by Governor Perdue in May 2008. This bill requires state agencies and state institutions to extract all trade vendor payment data (vendor ID, vendor name, amount and number of payments) to the Department of Audits and Accounts (DOAA). The DOAA will then make this data available to be viewed by the public via a searchable website.
The DOAA has approved for all state agencies and state institutions to exclude any payments related to the HIPAA and human subjects from this extraction. Georgia State excludes any payments using the account code for human subject payments (727140) from this extraction. It is therefore important to use this correct account code when paying human subjects with a payment request form to ensure this private information is not made available to any searchable public websites.
Recruiting Participants using ResearchMatch
Recruitment made easier!
Georgia State Researchers have access to ResearchMatch, a disease-neutral online volunteer registry and recruitment tool for health-related research. ResearchMatch connects research teams with people who are interested in learning about research studies. ResearchMatch is funded in part by the National Center for the Advancing Translational Sciences (NCATS), an office of the National Institutes of Health (NIH).
Please note: ResearchMatch is intended only for studies focusing on health-related outcomes.
How It Works
ResearchMatch allows researchers to search for de-identified volunteers who have registered themselves as being interested in participating in research. The researcher creates a cohort of people that meet some of the key inclusion and exclusion criteria for their study by using filters on ResearchMatch, and then sends their IRB-approved message to prospective participants via ResearchMatch.
Interested volunteers create a “profile” with their basic health information. This allows researchers to search for potential participants that meet certain criteria. The potential participant can be sent the IRB approved message about the study and can then choose whether to provide their contact information to the researcher. This platform helps researchers looking to identify potential participants outside of usual-care settings.
The researcher finds the contact information of those interested individuals on their ResearchMatch dashboard and can then contact them directly.
Monthly Researcher Training (via Zoom)
2nd Thursday of the month at 2PM (CST) – click here to register!
How to Register as a Researcher with ResearchMatch
Access to ResearchMatch is granted on a study-by-study basis; investigators must individually register each study. Registration takes a few minutes and must be completed in one sitting.
There are two levels of access available to Georgia State University investigators: Feasibility Access and Recruitment Access.
Investigators may sign themselves up in ResearchMatch or may delegate recruitment privileges to a study coordinator or other IRB-approved study team member (a proxy).
Feasibility Access
Feasibility Access gives researchers the ability to view aggregate data on the registry population without an IRB-approved protocol. To register a study for Feasibility Access, you must:
- Be affiliated with Georgia State University
- Provide your Georgia State University email address
- Create a ResearchMatch username and password
Recruitment Access
Recruitment Access gives researchers the ability to recruit volunteers through ResearchMatch. To register a study for Recruitment Access, you must meet the same access requirements as for Feasibility Access, PLUS for each study you want to recruit for, you will:
- Upload an electronic copy of your IRB Outcome Letter
- For exempt studies:
- Upload the Outcome Letter with current expiration date for the study approval
- For expedited or full board studies:
- If use of ResearchMatch was approved via an IRB amendment, upload the amendment Outcome Letter for ResearchMatch as a recruitment method (must be written into the IRB application) and the related contact message
- If use of ResearchMatch was included in the initial IRB application, upload the study approval Outcome Letter with current expiration date
- Note: ResearchMatch must be IRB-approved as a recruitment method in the IRB application, and the contact message itself must be IRB-approved
- For exempt studies:
- Upload your contact message
- For expedited or full board studies, the contact message uploaded to ResearchMatch must match the IRB-approved contact message in the IRB record
- Be the principal investigator (PI) or IRB-approved study personnel authorized to recruit for the study on behalf of the PI
Note: Individuals accessing as a proxy for the PI will be asked to indicate that, and to provide the study PI's name, email address and phone number.
Registration Instructions
- Study personnel recruiting participants should register themselves as a Researcher on ResearchMatch.
- Your study must be IRB-approved. See the Recruitment Access section above for details on IRB approval and what documentation of IRB approval to provide. To register your study, you must:
- Have IRB approval as detailed above.
- Have a ResearchMatch advertisement (also referred to as a contact message) that meets the Contact Message Rules below. See also the Example Contact Message below.
- Optional: If you have approval and the ability to recruit monolingual Spanish speakers, you will need an IRB-approved contact message in Spanish.
- Log in to www.researchmatch.org/researcher and register your study in ResearchMatch:
- If you are not the Principal Investigator (PI), then list yourself as the proxy. The PI will be emailed to approve you as their proxy.
- You must upload an IRB Outcome Letter as detailed above.
- The liaison will verify that you have IRB approval to use ResearchMatch (for expedited and full board studies) and that you have a ResearchMatch contact message that follows the Contact Message Rules below.
Once you are approved you will have access to search for potential Volunteers and send them your Contact Message.
Contacting Volunteers
Contact Message Rules:
- No URLs
- No study team contact information (no e-mails, phone numbers, lab or PI URLs)
- No embedded survey links
- Maximum 2000 characters
Example Contact Message:
Would you like to help researchers learn more about the causes of motor neuron diseases such as ALS and SMA?
Are you interested in helping researchers who are trying to learn more about the causes of motor neuron diseases such as ALS (Lou Gehrig’s disease) and SMA? Researchers at Vanderbilt are looking for study volunteers.
You may be eligible for this study if:
- You are 18 years or older.
- You are a healthy volunteer OR if a physician has determined that you have ALS, SMA or another disorder affecting the motor neuron or nerve.
- You are available for one visit for approximately 1 hour.
- You are willing to have a small biopsy of skin taken from a small spot on your leg.
The skin around the spot will be numbed prior to the sample being taken. The skin biopsy procedure is a standard technique used to look at nerve fibers in the skin. For this study, the researchers will use the skin cells from the biopsy to grow a lot of skin cells (called a culture) and these will be converted to nerve cells.
ResearchMatch is also available in Spanish
If you have IRB approval, you can message Spanish-speaking volunteers with your IRB approved Spanish contact message. Use the new language filter on ResearchMatch indicating that your message is in Spanish.
Frequently Asked Questions
Please visit ResearchMatch to view frequently asked questions. We also encourage researchers to attend the Monthly Researcher Training provided by ResearchMatch via Zoom on the 2nd Thursday of the month at 2PM (CST) – click here to register!
Getting Started with the IRB
- Complete the required human subjects training. For more information go to Required Education & Training.
- Review the Manual, Policies, and Procedures menu section listed to the left.
- Complete your study’s IRB application using iRIS. See below for helpful information about using iRIS and completing applications. Refer to the step-by-step guides and tutorials in the HELP menu in iRIS.
Getting Help with IRB: Chair Office Hours – Request an Appointment
All Georgia State faculty are invited to attend weekly virtual office hours hosted by the IRB chairpersons. The chairs will provide personalized guidance on topics ranging from formulating protocols to international research considerations. Faculty should email IRB to request a 30-minute appointment during the times below. Appointments will be confirmed on a first-come, first-served basis during these times:
When: Wednesdays, 2 p.m. to 4 p.m., from January 15 – April 23 (no session March 19)
Where: Help sessions will be hosted via Microsoft Teams and a link will be included in your Outlook invitation once a time is confirmed.
Students interested in attending must be accompanied by their faculty advisor or faculty principal investigator.
Get Started with iRIS
All applications to IRB are made through the iRIS system. Information on how to use the iRIS system and on building an IRB application in iRIS can be found in the following places:
- Step-by-Step guides are available under the HELP menu within iRIS.
- See the iRIS Application Guide for targeted assistance on how each question on the application should be completed.
- See Renewal and Status Check Assistance below for general information about the Continuing Review and Status Check procedures.
Continuing Review and Status Check Assistance
General Guidelines for the Continuing Review and Status Check Applications:
New regulations may impact the continuing review status of studies.
- Some expedited studies will require a continuing review and some will require a status check every three years.
- All full board studies will continue to require a continuing review.
- All exempt studies will require a status check every three years.
To help researchers with the continuing review and status check processes, step-by-step guides are available under the HELP menu in iRIS.
Continuing Review:
All Full Board studies will require a continuing review at least every 12 months. Some expedited studies will require a continuing review at least every 12 months. Information on when the continuing review is due may be found in the outcome letter.
Status Check:
If the study requires a status check, complete the Status Check Application in iRIS. All Exempt studies and most expedited studies require a status check every three years. Information on when the status check is due may be found in the outcome letter.
Does a study require a continuing review or status check?:
Log into iRIS, My Studies, to check the status of the study in the Study Status tab. The status will either indicate “Approved – Continuing Review” or “Approved – Status Check.”
When to close:
If all research and data analysis are complete, a study closure can be requested. Any time human subjects’ data are being analyzed, there must be an approved IRB protocol. Even for a study closure, the entire form must be completed because this will serve as a final report for the study. For more assistance see the step-by-step instructions on Submitting the Study Closure.
Consent Form:
If submitting a continuing review and enrollment is ongoing, a consent form must be uploaded to the application. It should be in document format (.doc OR .docx) and without stamps. Uploading consent forms is not required for studies undergoing a status check.
Routing:
Continuing review or status check applications are not required to be sent through the PI and the department chair for approval, but this option is made available to those who wish to use it.
- See Common Stipulations and IRB Tips for iRIS applications for guidance highlighting IRB application responses that most frequently require corrected (or supplemented) responses.
- When you log-in, if you do not have the Study Assistant Tab and are not able to create an application, contact the IRB office.
- For technical assistance with the iRIS system contact the Help Desk by email or by calling 404-413-4357.
- For additional assistance or general inquiries email IRB or iRIS.
Other Helpful Information
- In order to add an individual to your application, they must have an iRIS account. If they are a student or employee at Georgia State University they just need to log into iRIS at least once. If they are external to Georgia State please fill out the Account Request Form and submit online. The person will be contacted if and when approved with instructions for accessing the system.
- On the IRB application you will see several sections with a red asterisk. These sections must be completed in order for the system to allow your application to be properly submitted. If a section is not applicable, answer it as N/A. Do not leave it unanswered.
- Remember to upload all of your documents. These include consent form (s), prospectus, any recruitment material, all survey instruments, interview guides, etc., which you should create on your computer. If your research is funded, you will also need to upload your grant.
- The protocol must be routed from the student/study personnel (if applicable) to the PI (principal investigator). The PI will then route the study to the department head or chair. Once the department head or chair has endorsed the protocol, the department chair or PI can submit it to the IRB.
- You can always see the exact status of the application by opening the study and clicking on the ‘History’ tab.
- The PI should be a current Georgia State faculty member. For thesis or dissertation work, the student is listed as the student PI.
- Be sure the application and all documents are consistent.
- The application and all documents should be free of typos and grammar mistakes.
- If you are collaborating or working with individuals outside of Georgia State, please see the section on Working with Individuals Outside of Georgia State in the Manuals, Policies, and Procedures tab on this web page for helpful information.
Categories of research that do not require full IRB review:
Exempt Categories
Research activities in which the only involvement of human subjects is in one or more of the following categories are exempt from regulations requiring review.
Exempt Category Descriptions
Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category Two
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7).
This exempt category does not apply to research involving surveys or interviews of children/minors, or to studies involving observation of public behavior of children/minors when investigators participate in the activities observed. For regulatory information about limits on this category involving children/minors click here.
Category Three
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7).
- For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
- If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
This exempt category does not apply to research involving children/minors.
Category Four
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
- The identifiable private information or identifiable biospecimens are publicly available;
- Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
- The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E [HIPAA], for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or
- The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
Category Five
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
- Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
- [Reserved]
Category Six
Taste and food quality evaluation and consumer acceptance studies if,
- wholesome foods without additives are consumed, or;
- if plant or animal raised food products are consumed which are at or below the regulated level found to be safe.
Category Seven
Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §__.111(a)(8).
Category Eight
Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
- Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §__.116(a)(1) through (4), (a)(6), and (d);
- Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §__.117;
- An IRB conducts a limited IRB review and makes the determination required by §__.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and iv. The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.
Expedited Category Descriptions
Research in the following categories, if it presents no more than minimal risk to human subjects, may be reviewed using an expedited procedure. The categories apply to both children and adults.
Expedited Categories
Category One
Clinical studies of approved drugs and medical devices used in accordance with standard approved medical practice.
Category Two
Collection of blood by finger stick, heel stick, ear stick, or venipuncture, in amounts and under schedules specified by federal regulation 63 FR60364-60367. Note: The regulation places differing restrictions on studies of adults and children.
Category Three
Collection of biological specimens by noninvasive means. Examples are:
- hair and nail clippings,
- teeth routinely shed or extracted,
- excreta and external secretions,
- uncannulated saliva,
- placenta removed at delivery,
- amniotic fluid collected at the time of rupture of the membrane,
- dental plaque and calculus collected in accordance with accepted prophylactic techniques,
- mucosal or skin cells collected by scraping, skin swab, or mouth washing, and
- sputum collected after saline mist nebulization.
Category Four
Collection of data through noninvasive procedures routinely used in clinical practice, excluding x rays and microwaves. Examples are:
- physical sensors that involve no significant input of energy into the subject or invasion of the subject’s privacy;
- weighing or testing sensual acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
- moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the subject’s age, weight, and health.
Category Five
Research involving existing data, documents, records, or specimens collected solely for nonresearch purposes. Note, some research of this kind may fall into one of the exempt categories.
Category Six
Voice, video, digital, or image recordings made for research purposes.
Category Seven
Research on individual or group characteristics or behavior (including but not limited to perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Note: Some research of this kind may fall into one of the exempt categories.
Category Eight
Continuing review of research previously approved at an IRB meeting, where no new human subjects have been enrolled, data collection is relatively inactive, and no new risks have been identified.
Category Nine
Continuing review of research previously determined at an IRB meeting to involve only minimal risk, where no new risks have been identified.
FERPA Requirements
If your study involves data from student education records (e.g. class work, grades, attendance records, communications, projects, classroom tests, standardized tests, journals, SAT/ACT scores, etc.) you will need to be mindful of the FERPA requirements. Please note that this list of records is not exhaustive and FERPA regulations apply even when you are using your own records (from your classes/students) that you may already have. Please see section 1.6 of the IRB manual for more information on FERPA records.
Existing, De-identified Records: If you are obtaining or using existing education records that have been completely de-identified and contain no personally identifiable information, you need to explain in the IRB application how the records will be kept safe and confidential. De-identified records must not contain names, addresses, phone numbers, emails, student numbers, etc. and there can be no link or code that connects the data with any identifying information.
Identifiable Records with Informed Consent: For existing education records that contain personally identifiable information, and/or for access to education records that will be created during your research, you can obtain permission for access to the records in the informed consent form. The consent form must contain all the required elements of consent (as found in the model informed consent form) and include a description of the records that will be disclosed, the purpose of the disclosure, and to whom records are being disclosed. If any students are under 18, parental permission must be obtained. In some cases, you may be able to justify a waiver of consent for the parental permission. The FERPA requirements can be met with a waiver of parental permission as long as the student still signs the consent form. A waiver of documentation of consent or a waiver of consent for the student participant can only be used if the researcher is a “school official” with a “legitimate educational interest.” According to Georgia State’s FERPA Policy, a “school official” includes a person employed by the University in an administrative, supervisory, academic, research, or support staff position. The FERPA Policy also states that a school official has a legitimate educational interest if, among other things, the official is performing a task that is specified in his or her position description or contract agreement. Therefore, those Georgia State employees whose job descriptions include conducting research would be considered school officials with a legitimate educational interest. Students conducting research for academic/coursework purposes (as opposed to their employment by Georgia State) may not view any identifiable data without consent. If the researcher is collaborating with another researcher not employed by Georgia State, he or she must de-identify the information before disclosing it to the other researcher. If the outside researcher needs access to identifiable information, the Georgia State researcher should contact the Office of Legal Affairs for assistance prior to submitting the IRB application.
Identifiable Records without Informed Consent: For existing education records that contain personally identifiable information, and/or for access to education records that will be created during your research, you may be able to request and justify a waiver of consent for the use of the data under FERPA if you are a “school official” with a “legitimate educational interest.” According to Georgia State’s FERPA Policy, a “school official” includes a person employed by the University in an administrative, supervisory, academic, research, or support staff position. The FERPA Policy also states that a school official has a legitimate educational interest if, among other things, the official is performing a task that is specified in his or her position description or contract agreement. Therefore, those Georgia State employees whose job descriptions include conducting research would be considered school officials with a legitimate educational interest. Students conducting research for academic/coursework purposes (as opposed to pursuant to their employment by Georgia State) may not view any identifiable data without consent. If the researcher is collaborating with another researcher not employed by Georgia State, he or she must de-identify the information before disclosing it to the other researcher. If the outside researcher needs access to identifiable information, the Georgia State researcher should contact the Office of Legal Affairs for assistance prior to submitting the IRB application.
De-identified Records: A letter from the educational institution maintaining the education records must be attached to the IRB application. The letter must indicate approval to conduct the study at/with that institution, the educational institution’s commitment to FERPA compliance, and an explanation as to how the data will be de-identified. The FERPA compliance commitment can just be a brief statement that they follow FERPA and are in compliance. The explanation of how the educational records will be de-identified should include a statement that no personally identifying information will be available to the researcher. De-identified records must not contain names, addresses, phone numbers, emails, student numbers, etc. and there can be no link or code that connects the data with any identifying information.
Identifiable Records with Informed Consent: For educational records that are personally identifiable and signed informed consent is obtained, a letter of permission must be uploaded to the application from the school or institution from which the records are obtained. The letter must indicate approval for the research to be conducted at or educational records obtained from the institution, the education institution’s commitment to FERPA compliance, and an explanation as to how the FERPA consent will be obtained (e.g. FERPA release provided by educational institution). The FERPA compliance commitment can just be a brief statement that they follow FERPA and are in compliance. Many schools have a separate FERPA release form that is signed to release the records to a third party. If the school elects to use such a form, the school is responsible for ensuring the form is signed before the informed consent form and before any release or collection of data. If the students are under 18 the FERPA release should be signed by the parent/guardian. Some schools may ask that FERPA information be included in the informed consent forms. If this is the case, the consent form must contain all the required elements of consent (as found in the model informed consent form) and include a description of the records that will be disclosed, the purpose of the disclosure, and to whom records are being disclosed. If any students are under 18 years old, parental/guardian permission must be obtained. If the FERPA information is included in the consent form, it must be signed – the IRB cannot approve use of the waiver of documentation of consent unless the researcher is a school official with a legitimate education purpose (see the section, identifiable records and no consent, with a school official).
Identifiable Records and no Consent, with a School Official: Identifiable education records with no informed consent can be obtained if the researcher is a “school official” collecting or obtaining data for a “legitimate educational purpose”. This means the researcher must be an employee or other school official that has access to the records because he or she is involved in the education of the student. A letter from the educational institution or school must be attached to the IRB application. The letter must indicate approval for the research to be conducted at or data obtained from the institution, the education institution’s commitment to FERPA compliance, and verification by the educational institution that the investigator is a “school official” with a “legitimate educational purpose.” The FERPA compliance commitment can just be a brief statement that they follow FERPA and are in compliance. In this case, only the school official can have access to any identifiable education records. Any other researchers associated with the study cannot have access to personally identifiable education records if they are not school officials with a legitimate educational purpose.
Identifiable Records and no Consent, with a Contract: Identifiable education records with no informed consent can be obtained if Georgia State has contracted with an educational institution to develop, validate, or administer predictive tests; administer study aid programs; or improve student instruction. The fully executed contract that has been approved by the Office of Legal Affairs or the Office of Sponsored Programs for the services must be attached in the documents section of the IRB application.
Informed Consent
All participants must be adequately consented to participate in research. It is important to remember that informed consent is a process and not just a document.
Different terms are used to describe the various forms employed during the informed consent process.
- Consent forms – Used for consenting participants 18 years or older.
- Permission forms – Used to obtain permission from parents or legal guardians of participants 17 years or younger.
- Assent forms – Used to obtain agreement (assent) from a minor participant to be in a study.
Consent forms must include certain required elements. Please utilize the Model forms for Expedited and Full Board studies or the one for Exempt Studies linked below.
Expedited and Full Board studies
- Informed Consent Form
- Parental Permission Form
- Combined Parental Permission Form and Informed Consent Form
- Assent Form
Exempt studies
These forms are provided to assist the researcher in creating an appropriate informed consent form by detailing general guidelines for language and formatting. These forms should be modified to fit each study. The model informed consent forms are updated regularly. Be sure to use the most up to date version for each consent form.
Consent forms should be uploaded in their final form with no tracked changes, incomplete information, or directions. The document should be uploaded in the .doc or .docx format. Do not use.pdf or any other format.
Readability
- You must write the consent form at the reading level of your least educated participant. Unless otherwise justified, this is an 8th grade reading level.
- Consents must be written in the second-person perspective. Refer to the potential participant as "you." Do not use “the participant” or “I.”
- Do not say "You are being asked to be in a research study..." Use active voice instead. You can say, “We are asking you to be in a research study...”
- Avoid using technical terms as much as possible. If you must use technical terms, explain what they mean in plain language.
- Avoid long, complex sentences. Write in short declarative sentences.
- Use simple words of fewer than three syllables whenever possible.
- Most word processors include utilities in the “Review” or "Tools" menu to analyze the reading level of text. For directions on how to obtain the grade level information in Microsoft Word, please see below
To check the reading level of your informed consent document, click the link below.
Teach Back
Nationally 20% (or 1 in 5) of all adults have less than basic literacy skills, which means they have only basic vocabulary knowledge and struggle when working with anything other than short texts. Plain language in all participant-facing documents is about clarity and making sure research participants understand what is expected of them and from them. Teach Back is a simple method to confirm understanding. There are 5 parts:
- Use simple terms to explain or demonstrate: Check the person’s baseline understanding
- Check understanding: Ask the person to repeat back in their own words.
- Clarify: Identify and re-explain any misunderstandings
- Re-check and re-clarify: Repeat Steps 2 - 3 until no misunderstandings
- Close the loop: Once all misunderstandings are clarified, ask the person to repeat everything back in their own words.
To learn more about Teach Back, a method that helps researchers confirm whether study information has been adequately described in the consent process, view this video resource.
How to Check Reading Levels
In Microsoft Word:
- Click the File tab.
- Click the word ‘options’.
- Click Proofing.
- Make sure ‘show readability statistics’ is selected.
- Once the spelling and grammar check has been completed (Click Review then the Spelling and Grammar check button) a window will open with the readability statistics.
- The statistic that the IRB is concerned with is the Flesch-Kincaid Grade Level.
In Microsoft Word 2007:
- Click the Microsoft Office Button , and then click Word Options.
- ClickProofing.
- Make sure “Check grammar with spelling” is selected.
- Under “When correcting grammar in Word”, select the “Show readability statistics” check box.
- Complete the spelling and grammar check.
- Once the spelling and grammar check has been completed a window will open with the readability statistics.
- The statistic that the IRB is concerned with is the Flesch-Kincaid Grade Level.
In older versions of Microsoft Word:
- From the Tools menu select Options.
- A new window will open with all of the available options. Select the Spelling and Grammar tab.
- Under Grammar, put a check in the box next to Check readability statistics.
- Click OK. This will close the window.
- Select Spelling and Grammar from the Tools menu.
- Complete the spelling and grammar check.
- Once the spelling and grammar check has been completed a window will open with the readability statistics.
- The statistic that the IRB is concerned with is the Flesch-Kincaid Grade Level.
Child Assent Procedure
If minors under the age of 18 will be participants in the research, appropriate assent procedures must be in place.
Child Assent Procedure Details
Under 6:
No assent is required. Provide to the IRB information about how you will ensure that the children want to participate and are not getting upset.
Ages 6-10:
Verbal assent must be obtained and documented by PI. Submit an assent script to the IRB for review. The assent script must be age and cognition appropriate for the population.
Ages 11-17:
This age group must sign a separate assent document. The document will explain what will happen, and why, risks involved, any benefits, and the option that they could withdraw e.g., "you don't have to be in this study, and your parent(s)/legal guardian(s) cannot make you be in it." Also, a statement which would in effect say that they can "stop being in the study at any time" It does not necessarily need to contain other standard items like alternatives, cost/compensation and disclaimers, new findings, contacts, and confidentiality, but must be age and cognition appropriate for the population. Once the study is explained to the child, he or she should be asked to sign the assent. if signing a form is too intimidating or not appropriate for the population, the researcher can request a waiver of documentation of consent.
Parental Permission:
Consent must be obtained from the parent or legal guardian of children involved in research through a Parent Permission Form. This document needs to be in the format of an informed consent, but should be in third person (i.e. your child). The title of the document should the Parent Permission Form. Only a parent or legal guardian can sign a parental permission form for a child participating in research. A care giver, nanny, or grandparent cannot sign the form unless he/she is the child's legal guardian.
Should the assenting child decline participation in this study, the PI, the parent(s), or legal guardian(s) cannot force the child to participate.
The Georgia State University IRB may determine that a waiver of consent is appropriate for parental permission for some studies. A waiver of consent for parental permission could also be requested for children 17 years old depending upon the type of research being conducted (i.e., the research study is conducted on a University campus, is a survey or questionnaire, and is determined to be a minimal risk.) The waiver must be requested and justified in the IRB application.
Imaging Studies Involving MRI Scans
The following represents the minimal information that must be on informed consent forms for studies using MRIs. It may be modified or supplemented to fit the particular needs of your study, including any particular guidelines provided by your funding agency, as applicable. The MRI language is not meant to be a stand-alone consent form. This language should be inserted into the consent form only if a research study is using MRI scans. Depending on your study’s participants, the readability of this form may be too high – although some difficult words cannot be avoided, many of the complicated words can and should be simplified to increase readability. For research conducted at the Center for Advanced Brain Imaging (“CABI”) please visit CABI and review the CABI Use Guidelines to incorporate that facility’s MRI-related consent requirements into your study’s consent form(s).
MRI Explanation/Procedures
MRI Exclusion/Inclusion Criteria
It may not be safe for you to have an MRI scan if you have certain metals in your body or have certain medical conditions. If you have any of the following, you will be excluded from this study for your own safety: Cardiac pacemaker; hearing aid; any other implant metal in your body or eyes, including pins, screws, shrapnel, plates, braces on your teeth, or dentures; Parkinson’s, Alzheimer’s, or other dementia; sickle cell anemia; epilepsy; bipolar disorder; multiple sclerosis; or brain surgery.
If you have tattoos, you could experience some irritation and redness at those sites. Tattoos on the head, such as eye liner or other permanent makeup, may make it impossible to get clear and usable images. If you have tattoos or permanent makeup of any type, you should inform us immediately.
[Researchers should also state any other exclusionary and inclusion criteria in this section.]
Risks or Discomforts
[If women of childbearing potential will be enrolled, and if there are no other known risks to them or their possible fetuses, the following statement is required:] For women of childbearing potential, there are no known cases of a fetus being harmed by MRI procedures.
Incidental Findings
MRI Pictures
[If the Principal Investigator intends to provide copies of the images to the participant, then the following sentence should be included:]
However, you will be provided with a copy of the MRI pictures at no cost to you to keep and review as you see fit.
Georgia State University conducts a variety of human subjects research activities.
You can learn about research happening at GSU and other institutions at ResearchMatch and ClinicalTrials.gov. Please see below to learn more about these opportunities.
ResearchMatch
ResearchMatch helps connect researchers and study volunteers
Georgia State University encourages anyone interested in volunteering for research studies to register with ResearchMatch, a secure, easy-to-use volunteer registry funded by the National Institutes of Health. Researchers from academic institutions like Georgia State University use ResearchMatch to find volunteers who are a “match” for their study.
People of all ages and health conditions, including healthy people, are welcome to join. Volunteers under the age of 18 must be registered by a parent or guardian. Registering with ResearchMatch takes less than 10 minutes. You are not registering to participate in any particular study. Registration lets you indicate your willingness to be contacted about studies that may be a good fit for you. Your name and personal information are not released to any research team until you indicate you would like to know more about their research study.
ResearchMatch is also available in Spanish! Volunteers can now sign-up in Spanish and receive Spanish messages from ResearchMatch about research studies.
ResearchMatch es una plataforma en línea gratis, segura creada por instituciones académicas de todo el país que desean incluirlo en su misión de ayudar a que los estudios mejoren la salud en el futuro.
ResearchMatch has a simple goal – to bring together two groups of people who are looking for one another:
- People who are trying to find research studies, and
- Researchers who are looking for people to participate in their studies.
ResearchMatch is a confidential, free, and secure registry that has been developed to involve you in their mission to help improve health and wellbeing through research.
ClinicalTrials.gov
ClinicalTrials.gov provides patients, their family members, and the public with easy and free access to information on clinical studies for a wide range of diseases and conditions.
Before you join a research study, you should know what it means to be in a research study. Please see our brochures on participating in research.
- Becoming a Research Volunteer: It’s Your Decision
- Ser Voluntario en Estudios Clinicos: Es Su Decision
- How Are You Protected? AAHRPP Accreditation
Please remember that participation in research is always voluntary. If you have any concerns, please feel free to contact the IRB office.
Please complete this survey to let us know how we are doing with community outreach.
Advarra IRB
NIH Multi-Site
- Effective January 25, 2018, the National Institutes of Health (NIH) mandated compliance with the Single IRB (sIRB) Policy for Multi-site Research for multi-site, non-exempt human subjects research studies conducted within the United States and funded by NIH.
- Effective January 20, 2020, the Revised Common Rule's Cooperative Research Provision mandated that US institutions engaged in HHS-supported cooperative research rely on a single IRB, or sIRB, to oversee the portion of the research conducted at US sites.
- Georgia State University’s IRB intends to serve as the sIRB for non-exempt, federally-funded multi-site projects where
(a) a GSU Principal Investigator is the primary awardee; and
(b) GSU IRB’s resources are adequate to support the project.
If neither GSU’s IRB nor the IRB from a cooperating institution provides review for a multi-site project, compliance with the sIRB mandate may require PIs to contract with a commercial IRB. - GSU IRB’s commercial IRB partner is Advarra®. GSU IRB strongly encourages PIs to anticipate project needs and to assess GSU’s IRB and cooperating institutions’ IRB capacity early in the grant writing process so that expenses related to commercial IRB review can be considered when preparing budgets.
- The Principal Investigator should submit the External Reliance Agreement application in iRIS for projects requiring the use of a commercial IRB.
Institutions that hold an Office for Human Research Protections (OHRP) Federal Wide Assurance (FWA) are required to have procedures in place that include formal mechanisms for monitoring compliance with human subjects requirements. Post approval monitoring provides one mechanism for ensuring compliance with this requirement.
Post approval monitoring of research studies involving human subjects is conducted to identify possible weaknesses and elicit process improvements in human subjects protections. This internal strategy also serves to increase investigator awareness of regulatory requirements and improve the ethical conduct of research.
Post approval monitoring may be study-oriented or investigator-oriented. Post approval monitoring that is study-oriented, also referred to as “random”, is conducted routinely as a part of human subjects protection to maintain consistency and evaluate documents that have been submitted and approved as part of the IRB process.
Post approval monitoring designated as Investigator-oriented, frequently referred to as “for cause” is based on known or suspected information regarding an investigator’s procedures in conducting a study, will involve the study in question, and can subsequently lead to audits on all active studies conducted by the investigator.
Additional Resources
FREQUENTLY ASKED QUESTIONS
Human Subjects/IRB
The length of time a study will take to be reviewed depends on the type or level of review required. The quickest way to obtain study approval is to submit a complete, thorough study application. Listed below are approximate times for review.
Exempt Review
From application submission to pre-review by an IRB staff member: 0 – 3 business days
Review by a Board member (once all stipulations have been met): 5 business days
Expedited Review
From application submission to pre-review by an IRB staff member: 0 – 3 business days
Review by a Board member (once all stipulations have been met): 5 business days
Full-Board Review (days after a monthly committee meeting): 7 days
Note on review times: Studies that are assigned stipulations will take additional time, depending on how fast these stipulations are met by the researcher. If a study needs to be reviewed by a Board member more than once, each review is allowed 5 business days.
Research can only begin once an approval letter is received from the IRB. Therefore, subjects should not be contacted or recruited before the approval letter is obtained.
Research activities designed, conducted, and presented as an assignment within a research practicum or class with the goal of providing students with research experiences and there is no intent to add to generalizable knowledge via dissemination outside of the research practicum or class do not meet the federal regulatory definition of research with human subjects.
Additionally, teacher-driven classroom-based action research studies designed and conducted with the purpose of improving pedagogical practice, student learning, or classroom behavioral outcomes with dissemination limited to teachers and administrators within the school do not meet the federal regulatory definition of research with human subjects.
Does my teaching study require IRB approval?
The answer is yes, if:
- You will be using the data in your dissertation or thesis.
- The data will be published (including at the Georgia State library).
- The data will be used to create a presentation that will be given at an academic or a professional association conference or meeting.
The answer is no, if:
- You will be collecting the data only to better your teaching skills.
- The data will be shared only on a casual basis with other teachers close to you.
- You will share the data only within the school.
- You will present the data only to the principal.
- You will be presenting the data only to your teacher, class members, and other Georgia State students and faculty, including research conducted for presentation at the Georgia State Undergraduate Research Conference (not for a thesis or dissertation).
Yes. Research involving the study of pathological specimens requires IRB review. The research may be exempt per category 4; however this type of research may need additional review by Georgia State's Institutional Biosafety Committee.
Studies that involve secondary analysis of data generally are not considered human subjects research. Please complete the Application for Designation of Not Human Subjects Research. This application may be found in iRIS.
If you will be using a publicly available, de-identified data set, please see the policy for those data sets in the Manuals, Policies and Procedures Section.
A decision whether oral history or other activities solely consisting of open-ended qualitative type interviews are subject to the policies and regulations outlined in an institution's Federal Wide Assurance (FWA) and HHS regulations for the protection of human research subjects (45 CFR 46) is based on the prospective intent of the investigator and the definition of "research" in 45 CFR 46: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. "Specifically, for Georgia State researchers, the evaluation of such activities hinges upon whether the person is engaged in the creation of "generalizable knowledge" that is, whether the activity represents a systematic investigation in which the person engaged in such activities intends to develop or contribute to generalizable knowledge. Oral history activities are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge.
It is recommended that all researchers undertaking oral history projects contact the Georgia State IRB Office to discuss their proposed oral history activities to ascertain whether the project requires IRB approval.
Pilot studies and feasibility studies, including those involving only one human subject require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily, the data collected from subjects in a pilot/feasibility study are not used for study findings. It must be explained to subjects during the consent process that the study is a pilot. When the pilot study becomes a full study, the PI will need to apply for IRB approval again.
Department chairs or their designees are required to review and attest to a protocol’s scientific validity before it is submitted to the IRB for review and approval. The review and attestation at the department level must be undertaken with care, and chairs are encouraged to utilize expertise within the department to ensure appropriate peer review of a protocol before it is submitted to the IRB.
Any change to a study must be reviewed and approved by the IRB. This includes any revision of the consent form, alteration of questionnaires or interviews, a change in study procedures, or a change in the way data is being managed. This is by no means an exhaustive list, but it gives an idea of what requires IRB review.
A step-by-step guide on how to submit the amendment application is available in the HELP menu within iRIS. Provide to the IRB all documents with a description of the change, a justification, and all documents revised or added as a result of the proposed change (i.e. consent/assent forms, recruitment letters or ads, revised protocols, questionnaires, permission letters from sites, etc.).
The amendment will be reviewed by the same method in which the study was first reviewed, either by the full board or through the expedited/exempt review process.
Any change in research personnel must be submitted via a personnel amendment in iRIS.
Illiterate persons may have the consent read to them and "make their mark." 45 CFR46.117(b) (2) and 21 CFR 50.27(b)(2) requirements for the signature of a witness to the consent process and the signature of the person conducting the consent interview must be followed, although a special "short form" consent need not be prepared.
If the study is going through exempt/expedited review, a waiver of documentation of consent may also be pursued.
Principal Investigators are required to promptly disclose to the Institutional Review Board (IRB), appropriate institutional officials, and appropriate regulatory agencies of unanticipated problems involving risks to subjects or others. Unanticipated problems may be adverse events, serious adverse events, or protocol deviations. Unanticipated problems must be reported to the IRB within seven (7) days of the investigator becoming aware of the event. It is unacceptable to wait until the next scheduled IRB review.
An unanticipated problem must meet the following criteria in order to require review by the IRB:
- Unexpected: (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related: to participation in the research (possibly related means that there is a reasonable possibility that the incident, experience, or outcome may have been caused by the study procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Passive consent occurs when a person is included in research unless the participant actively objects to being in the research. This is most commonly seen when a letter is sent to parents and the child of the parent is included in the research unless the parent objects. Passive consent is not considered true consent. A waiver of consent must be justified and granted if this method is used.
The State of Georgia closely regulates the operation of lotteries, raffles, and other games of chance. Please see section 6.10 of the IRB Manual for the list of criteria that must be met to use a raffle in your study.
EXTERNAL RESOURCES
External Website Resources to Regulations, Guidance and Ethical Codes Related to Human Research Protection
U.S. Regulations
Guidance
Ethics
- Belmont Report
- Declaration of Helsinki
- Nuremberg Code
- American Psychological Association Ethical Principles and Code of Conduct
- Ethical Principles and Code of Conduct, Research Ethics: How to Treat People who Participate in Research (by NIH)
Organizations
Find Training
Find Resources
Report Compliance Issues
General Inquiries
[email protected]
Alison Alesi, JD, CIP
Assistant Vice President, Regulatory Affairs
404-413-3514
[email protected]
Susan Vogtner, MPA, CIM, CIP
Associate Director, Human Research Protection Program
404-413-3513
[email protected]
Kiki Sindad, MPH, CIP
IRB Compliance Officer
404-747-4023
[email protected]
Jamie Zaikov, BA, CIP
IRB Compliance Specialist, Sr.
404-413-3638
[email protected]
Laurel Benta, MS
IRB Compliance Specialist
404-413-3551
[email protected]
Vee McConnell
IRB Compliance Specialist
404-413-3503
[email protected]