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)

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)

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.

If the research you are proposing involves using your own students or students which you have some responsibility over, then there may be some perceived coercion and special precautions need to be taken to ensure that this is managed. Students may feel that if they don’t participate they will be punished, treated differently, or receive a lower grade.

Some options to remedy the situation are offered below:

1. 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.)
2. The study can be presented by a colleague or somebody not involved with the students.
3. The study can be completely anonymous.
4. The teacher can collect the data and not use it for research until after the class has been completed and grading is complete.
5. 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.

Research activities in which the only involvement of human subjects will be the use of publicly available archival data generally can be designated as not human subjects research. Typically, the researcher would need to complete the Application for Designation of Not Human Subjects Research in order to receive this designation. This application may be found in iRIS.

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.

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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)

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Researcher options when working with a database other than those approved and listed above

1. Option One: A researcher may complete the Data Request Document to register a dataset for approval under this policy.
2. Option Two: A researcher may complete and submit an IRB Application online via iRIS.
3. Option Three: A researcher may complete and submit an Application for Designation of Not Human Subjects Research. This application may be found in iRIS.

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Investigator guidelines for registering a data set for approval under this policy

1. 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.
2. 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.
3. Researchers must submit the following information on potentially eligible data sets to the IRB and receive written approval prior to conducting research.
   1. Name of data set
   2. URL of the data set or other information on how to obtain the data set
   3. 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.

Only the IRB compliance staff may make the determination whether or not a project is human subjects research. The IRB Compliance Office has determined that research using specific publicly available data sets, class projects meeting specific criteria, some oral history projects, and some projects using readily available cell lines or cultures do not constitute human subjects research and do not require you to submit a request for a research determination. Requests to add a dataset to the preapproved list should also be sent to the IRB Compliance Office. The IRB compliance staff will review the submission and email you with a determination.

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 if I don’t follow my approved IRB application/protocol?

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

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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.

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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.

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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

Human Subjects Training

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.

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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.

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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.

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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.

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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.

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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.

Two common expenses for sponsored projects are human subject payments and participant support. These are commonly mistaken for one another. Please refer to the definitions below:

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:

1. Project Advance or Imprest Fund accounts (for paying individuals cash or gift cards)
2. 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.

Visit 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)

2^nd 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
• 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

1. Study personnel recruiting participants should register themselves as a Researcher on ResearchMatch.
2. 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.

1. 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 2^nd Thursday of the month at 2PM (CST) – click here to register!

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.

Category One
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.

Note: The descriptions below are abbreviated from the original. The IRB will be guided by the official wording as printed in the Federal Register.

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.

After a Spelling/Grammar check in Microsoft Word is complete, the readability statistics should appear. If they do not appear, you can use the following steps to turn this feature on:

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.

Georgia State University Procedure:

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.

An MRI (or magnetic resonance imaging) scan is an imaging technique that uses magnetism, radio waves, and a computer to produce images of body structures. The MRI scanner is a tube surrounded by a giant circular magnet. You will be asked to lie still on a moveable bed that is inserted into a small tunnel inside the magnet. You will be asked to conduct certain activities or to listen to certain instructions/music and the MRI scan will produce the resulting images.  The images produced by the MRI are detailed and can detect changes of structures within the body. For some procedures, contrast agents such as gadolinium may be used to increase the accuracy of the images.

You may experience nausea if you have certain conditions such as migraines, vertigo, anxiety, stress, fatigue, pregnancy, food poisoning, digestive disorders, fibromyalgia, concussion, brain injury, appendicitis, kidney or liver disorders, central nervous system disorders, brain tumors, some forms of cancer, or other illnesses. If you are currently experiencing nausea for any reason, you should not have an MRI scan until your nausea has subsided.

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.]

The following risks or discomforts may occur as a result of your participation in this study. The MRI room may be cold and you may become tired or bored from lying in the scanner. If you are cold, you may request a blanket. If you enter the MRI room with any magnetic cards, such as ATM and credit cards, you will risk having the data on the cards erased by the MRI machine. The MRI scanning procedure requires that you be confined in a small partially enclosed space. Some individuals find this to be uncomfortable and may exhibit symptoms of claustrophobia including nervousness, sweating or other minor discomfort. The sound of the MRI scanner can be quite loud; you will be given special ear plugs to minimize the noise. In addition, the magnetism of the machine attracts certain metals; therefore, people with these metals within their bodies (such as pacemakers, infusion pumps, aneurysm clips, metal prostheses, joints, rods, or plates) will be excluded from the study. The “metal” in dental fillings is less responsive to magnetism and is therefore allowed. The MRI technician will ask you if you have any metals within your body. You will be expected to notify us of any metal in your body, other than dental fillings. There are no other known side effects resulting from exposure to the MRI scan. If we do see something abnormal in your MRI scan, there is a risk that you may worry for no reason for a period of time until you can see a physician.

[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.

The MRI scan being done is designed to answer research questions, not examine your body medically. The researchers for this project are not trained to perform radiological diagnosis. This MRI scan is not a substitute for one a doctor would order. It may not show problems that would be picked up by a medical MRI scan. The researchers and Georgia State University are not responsible for failure to find existing abnormalities in your MRI scans. However, on occasion the researchers may notice a finding on a MRI scan that seems abnormal. When this occurs, a radiologist will be consulted as to whether the finding merits further investigation, in which case the researchers will contact you and inform you of the finding as soon as reasonably possible. The decision as to whether to proceed with further examination or treatment lies solely with you and your physician. The researchers, the consulting radiologist, and Georgia State University are not responsible for any delays in contacting you about any abnormal findings or any examination or treatment that you undertake, or fail to undertake, based upon these findings. No information generated in this study will become part of a hospital record routinely. However, if the study detects an abnormality in your MRI scan, then this information may become part of the hospital record. If something abnormal is found, such information may keep you from obtaining health or life insurance, depending on the specifics of your scan. It is possible that you could be unnecessarily worried if a problem were suspected, but not actually found. If you need to talk to someone about your concerns about an abnormal finding, you will be referred to a counselor at your own expense.

Your MRI pictures are for research only and are not meant to evaluate your health (as they would be if they were part of a clinical, non-research visit to the doctor or hospital).

[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.

 

Visit 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 (en Español)

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:

1. People who are trying to find research studies, and
2. 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.

 

Visit 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.