This page contains general information to guide researchers though the IRB application. This document is just a guide and additional information about your study may be necessary.
The title should be reflective of the study. Use appropriate capitalization, but do not type in all caps. The title on the application and the consent forms should be the same unless otherwise justified. Once the study is approved, the title on the application cannot be changed.
The PI of a study must be a current GSU faculty member. If this is a student’s research (i.e. dissertation or thesis) the student can be listed as the Student PI. All personnel must have documented human subjects training. Any person that will be working with subjects or identifiable data must be listed on the application. All GSU personnel must have current CITI training.
This should be a brief description or overview of your study. This description will be used as the short summary of your study for the IRB.
This is the main department of the research study. If the researchers on the study have multiple departments, please select the department that is most relevant to this study.
If the study is funded, please list the source and attach the grant to the application.
F. Research Locations
If the research is off-site (not on Georgia State University campus), list the sites and provide documentation of approval to use that site for research (unless it is a public location). If the site has an IRB (e.g., a hospital, another university, or some school systems) you must provide documentation of approval from that IRB.
The documentation of the approval should state that the site is aware of the research and approves the use of their site for the research. The letter should come from an appropriate person that has the authority to grant this type of permission. It is preferable for the letter to be on letterhead from the site and signed.
A. Human Subjects Training
All personnel are required to have human subjects training. If a person from another institution is collaborating on the study, we will accept the human subjects training required by that institution. If you have completed your CITI training and it is not appearing in IRBWise, you can send your CITI completion report to the IRB office so the IRBWise system can be updated.
B. Thesis or Dissertation
If any work on the study will contribute to a thesis or dissertation, this question should be answered ‘yes’.
This section should describe the purpose of the study including the research question. The purpose should be the same in the application and in the consent form. If they are not the same, it is assumed that the proposed research study contains deception or concealment. This question should describe “why” you are completing the study and the Lay Summary D question will be an overview.
D. Human Subjects
This question should describe in detail what you plan to do in the research. Be sure to clearly state, in lay terms what you will be doing in the study. If you are only using pre-collected or archival data, describe how the data were obtained and any identifying information in the data. After the researcher reads the answer to this question, he/she should know what is being done in this research.
Describe who will be conducting each procedure or working with each population.
F, G. Other IRBs
If you will be conducting your research at a location that has an IRB, approval from that IRB will be necessary. If that location does not require you to go through their IRB, please provide documentation of this. Please describe the status of the application in more detail than pending. Unless the other institution requires otherwise, you will need the other IRB’s approval before GSU’s IRB approval. We are willing to work with researchers if they are having difficulty with multiple IRBs.
H, I. International Research
If the research is conducted outside of the United States, additional information must be submitted. We must have an approval letter from an ethics committee or IRB that is local to the research. The research team must also demonstrate an awareness of local culture, customs, or laws and any risks to subjects particular to that area. The researcher must provide specific details and examples of this. Topics such as political conditions, religious factors, social conditions, communication, informed consent, cultures, remuneration, travel, and collaborators should all be considered and described in detail. A plan to maintain contact with the IRB and local IRB or ethics committee must also be established in case there is a requested change to the approved study. Please see section 13 of the IRB Manual for more information.
A. Interaction with Human Subjects
If you are interacting with human subjects in any way you must select ‘yes’ for this question. Only answer ‘no’ if you are using pre-collected data. (If you believe your study may not require IRB approval, please see the Application for Designation of Not Human Subjects Research.)
- Number of Subjects: state the total expected number of subjects for the entire study.
- Subject Gender: If a specific gender is chosen, it must be justified in Subjects B.
- Population Information: select any vulnerable population that will be used in your study.
A. Vulnerable Populations
This question should state how any vulnerable populations, selected from the list in Population Information, will have risks minimized. This answer should specifically state how that population will be kept safe in relation to their vulnerability. For example: non-native speakers of English may need to have a translator and students or trainees should be protected from perceived coercion by their teacher or supervisor. Prisoners, children, and pregnant subjects require special protections as described in the Code of Federal Regulations.
B. Justification of Limited Enrollment
If the research is being restricted to certain populations, it must be justified. This includes recruiting populations based on race, gender, social standing, or culture. If you are excluding males or females from the study, you must describe and justify it here. If the study is funded, be sure to check for special requirements that restrict excluding certain populations.
C. Justification of Number of Subjects
Provide the rationale for the number of subjects chosen to be in the study.
D. Subjects per a Year
If you plan on conducting the study for multiple years, clarify how many subjects are planned to be enrolled per year.
E. Age Range
The expected age range of participants should be stated. Please keep in mind that if the Georgia State University population is being used, many non-traditional students should be included in this age range. If age is an exclusion criteria, it must be justified in Recruitment B. If minors (under age 18) are not included, it must be justified in Subjects H (below). If your study does not have an upper age limit, it would be appropriate to state, “18 and above”.
F. Duration of Subject Participation
This answer should clearly state how long the subjects are expected to participate. Be sure that the duration of participation is consistent throughout the application and consent form. If there are multiple groups in the study, it should be clear how long each group will be participating. Participation that will occur over long periods of time should state the time requirement for participation within that long period of time (e.g., “Participation will take 2 hours of time, one day a week, for 9 weeks for a total of 18 hours over 9 weeks”)
Describe where the study will take place. If the location is off-campus and not at a public location, documentation should be provided. “Off-site” or “off-campus” are not acceptable answers for this question.
According to the Federal Regulations, minors must be included in research unless their exclusion can be justified. If you are excluding minors from your study, you must provide a justification. For example, you could state, “This study excludes minors because we are testing how adults cope with loss of a spouse.”
Please note that this question asks about minorities and not minors. As defined by the dictionary, minorities are a part of a population differing from others in some characteristics and often subjected to differential treatment or a member of a minority group. If minorities are excluded from research, a valid justification must be provided.
Describe who will invite the potential participants and what will be said or provided to participants (e.g., If you are recruiting in a classroom, clarify how the classroom is chosen, who will make the announcement, and what will be said.). If an email will be sent, provide a copy of the email. If a subject pool such as SONA is being used, provide the paragraph that will be posted as recruitment. If an ad or flyer is used, provide the ad or flyer. This section should also state how subjects are chosen. Please remember that no recruitment can be conducted before IRB approval has been obtained.
B. Inclusion and Exclusion Criteria
Describe any requirements that will be used to determine who can and cannot participate in the study. Examples of this include gender, age, or presence of a condition. These criteria should determine appropriateness for participation and can also be used to ensure safety of participants.
Any compensation that is provided to participants should be described. This includes extra credit, money, gift certificates, prizes, food, day care, Marta tokens, and anything else provided to participants. Compensation should be equal for all participants unless justified. If extra credit is provided an equal amount of credit must be available from an assignment of comparable difficulty and time involved. Justification should be provided for unusual or high compensation. The compensation should be listed in the procedures section of the consent form. Lotteries, raffles, and drawings that randomly select a participant to receive compensation require additional information and documentation. Additionally, if participants will incur any costs, that must be described in this section. Examples of cost could be parking/transportation, medical treatment, or childcare. Any costs should also be included in the procedures section of the consent form.
If the subjects are not expected to benefit, that should be stated in this section. Compensation should not be stated as a benefit of the research. The benefit to science or society should be made clear in this section. The intrinsic benefit of feeling good about participating in research is not usually considered a benefit.
Any risks to the subjects must be stated in this section. When risks are described thoroughly, it indicates the researcher is aware of risks and has thought about the risks carefully. Risks can include becoming upset from recalling a difficult issue or embarrassed because of a topic. If identifiable data could put a participant at risk, it should be disclosed here. This section should also describe how risks will be minimized and handled. If there are no risks, state that there are no more risks than ordinarily encountered in daily life.
B. Proposed Consent Procedures
- Signed Consent - This is the most common consent in research studies at GSU. The participant is presented with a document containing all of the required elements and he/she signs the form indicating a willingness to participate.
- Waiver of Consent or Waiver/Alteration of the Required Elements of Consent– When justified using the four federal regulations the IRB can approve a waiver of consent, meaning that no consent is obtained from participants, or a waiver/alteration of the required elements, meaning that not all of the required elements are included when consent is obtained. Waiver of consent is most often used when researchers have no interaction with human subjects or are only analyzing data. The waiver/alteration of the required elements can be used in studies involving deception or concealment when the true purpose or procedures are withheld from participants. If a waiver/alteration is requested, describe how the research meets all four of the requirements of the federal regulations. This justification must be specific for your study. (i.e., you must describe how the study is no more than minimal risk instead of just stating that it is no more than minimal risk.) If you are using a population which may include participants slightly younger than the age of consent (i.e., younger college students), you may be able to justify requesting a waiver of consent for the parents. That way, you would not be required to obtain parental permission for those participants. The justification should be provided in Informed Consent A (below).
- With a ‘Waiver of Documentation of Consent’, the participant is provided with all of the required elements of consent, but is not asked to sign the form. This is often used in surveys, telephone interviews, or online studies. The model informed consent form should be used as a guide in creating the document or script that is provided to participants (with the signature lines removed). This type of consent can also be used if the highest risk to participants is being linked to the research. With the waiver of documentation, a person can participate in the research anonymously. If you select this option it must be justified in the Informed Consent B section of the application (below).
A. Waiver of Consent or Waiver/Alteration of the Required Elements of Consent
Use the federal regulations listed in the menu above to justify the waiver or alteration.
B. Waiver of Documentation of Consent Justification
Use the federal regulations listed in the menu above to justify the waiver of consent.
Describe how informed consent will be obtained if subjects are not competent to provide consent.
The informed consent procedures should be described in detail. Please remember that informed consent is a process, not just a form. Clarify who will be obtaining consent, what will be said, when the process will be completed, how questions will be answered, and how the researcher ensures that it is understood. If parental permission is being obtained, this process should be described as well.
E. Population Reading Level
State the reading level of your population. Please keep in mind that subjects in college do not necessarily read at the college level and are more likely closer to 10th grade reading level.
F. Reading Level
The reading level of the consent form should be at the reading level of the least educated participant. If the reading level is above the 8th grade level, it must be justified. If the consent form contains words or phrases that increase the reading level, but would be understandable to the subject, please include that in the justification. Other methods can also be used to ensure understanding by the participant such as reading the consent or asking direct questions. The IRB generally uses the Fleisch-Kincaid reading level in Microsoft Word. Suggestions on lowering the reading level can be found on the model consent form.
G. Non-English Consent
If you anticipate that some or all of your population will primarily speak a language other than English, a translated consent form should be provided. The document should be translated by a certified translator and documentation of this should be provided. In some cases in which it is not reasonable to use a certified translator, the IRB will accept a translation and a back translation. Under no circumstances should the researcher translate his/her own document. If you anticipate that the IRB may request changes to the consent, you can indicate that a translated consent form will be uploaded through an amendment after the study is approved. Just like a normal consent form, it cannot be used until it is reviewed and approved by the IRB. Information about certified translators is available at the following link: www.aait.org .
Clarify whether or not consent forms will be uploaded. Remember that consent forms must be in .doc format. We cannot electronically stamp forms that are in any format other than .doc (including .docx, .pdf, or .rtf).
C. HIPAA Questions
The Health Insurance Portability and Accountability Act ensures protection of patients and participants Protected Health Information. If data are collected from participants at a medical center, hospital, or physicians office (covered entity), the consent form must contain the HIPAA language as provided in the model consent form. If data are collected from medical charts, a HIPAA waiver of authorization must be provided. Unless collected at the GSU Health Center, data collected at Georgia State University campus is not considered Protected Health Information.
B. Security Measures
Contact Legal Affairs for more information.
D. Subjects Data
- Identifying Information: If you will be collecting participant names, address, social security numbers, phone numbers, or any other identifying information, that must be described here. If you will be using a key code or link to connect participants identifying information and the data, that must be described. Identifying information should be kept separate from the data. You may want to remove and destroy any identifying information after the data collection is complete.
- If participants will be audio or video recorded, you must describe that here. Recordings should be kept separate from the data. Will recordings be destroyed after transcription? Audio and video recordings are always considered identifiable, but will the recordings contain addtional identifying information? If your study does not involve direct interaction with human subjects, you can answer this question ‘not applicable’.
- Provide information on how data will be protected. State how the hard copy data will be stored (e.g., in a locked cabinet). Consent forms should be stored separately from the data. Describe how electronic data will be kept safe (i.e. password protected, firewalled computer). If data are stored on a lap top or flash drive, describe how it will be kept safe (e.g., encryption). State who will have access to the data. State how long the data will be kept. The IRB does not require or recommend that researchers destroy their human subject’s data at the completion of the research. Indeed, researchers are encouraged, when appropriate, to make provisions in their research protocol and consent forms for future use of their de-identified data. It is suggested that data be made available to other researchers in accordance with what is stated in the consent form and in the application. If you would like to use participants’ identities in a publication or presentation, describe how the participants will be made aware.
E. Type of Review Requested
The list of review categories is provided. Please select the category of research that is believed to be the best fit for the study. The review category could be changed by the compliance staff or the IRB reviewer. (Please note that interviews or surveys of children cannot be exempt. According to GSU policy, any video or audio recording cannot be exempt.) The exempt category does not mean that the study does not need to be reviewed, just that the study may not require an annual renewal.
If the study will use any FDA approved drugs, it must be described in this section. The GSU IRB does not review studies involving applications for new drugs or new uses of drugs.
G. Investigational Devices
The GSU IRB does not review studies involving investigational devices.
Radiation questions must be answered if radiation is being used. This includes studies using DEXA scans and X-rays.
Deception occurs when participants are told something false. The deception must be justified and the researcher must discuss any additional risks that may be caused by using deception. If deception is used, the consent form should state that some information is being withheld, a debriefing should occur after the study to explain the deception and the true nature of the study, and after the debriefing, the participant should have the option of withdrawing his/her data. Studies involving deception must be reviewed by the full board. If information is withheld from the consent, a waiver/alteration of consent must be requested and justified in the informed consent section of the application.
Concealment occurs when some part of the procedure or purpose is withheld from the subjects. The concealment should be justified and the same three requirements stated above under deception must be met. Concealment studies can be reviewed as expedited. Just as with deception, if information is withheld from the consent, a waiver/alteration of consent must be requested and justified in the informed consent section of the application.
C. The Survey Coordinating Committee
This committee is independent of the IRB. Please see their website to ascertain if a study is required to go through their review. In general, if a study is conducted on a certain number of Georgia State University students, faculty, or staff it is required to go through their review.
If the study involves any activity for which a special qualification is required, details on that qualification should be provided here.
E, F. IBC
If the study will use potentially infectious material (blood, bodily fluids, tissue samples, etc.) it must be described in these questions and sent to the Institutional Biosafety Committee for approval.
List any key words that can be used to identify the study.
Be sure to upload any measures, surveys, questionnaires, etc. to the application. A research protocol must be uploaded. The research protocol should include the study title; a summary; a description that includes a rationale, objectives, methodology, and data management and analysis; ethical consideration, and references. If you are uploading a grant proposal, thesis, or dissertation that contains a research protocol, you do not need to upload an additional research protocol. The WHO has a helpful guide for writing a research protocol available on their website at the following link: http://www.who.int/rpc/research_ethics/guide_rp/en/index.html . You do not need to follow the ‘list of suggested documents’. The consent forms must be uploaded in the consent form section of the application (not in this section). Please use short but descriptive titles on documents.
If the application is completed by anyone other than the PI, the option that begins, “Attentions Students and Support Staff…” should be selected and the system will automatically send the application to the PI. If the PI is submitting, the option that begins, “Attention Principal Investigator…” should be selected and the chair, department head, or authorized person should be selected as the recipient. The application will only be accepted by the IRB after it has been endorsed by the PI and the department head or chair.