Application Assistance
This document 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. If you have any questions or concerns, you can contact the IRB office at 404-413-3513.
I. General Protocol Information
A. Protocol Title:
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.
B. Personnel:
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.
C. Protocol Description:
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.
D. Protocol Department:
This is the main department of the research. If the researchers on the study have multiple departments, please select the department that is most relevant to this study.
E. Funding:
If the protocol 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 (i.e., a hospital, another university, or some school systems) you must provide documentation of approval from that IRB.
II. Lay Summary
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. Purpose
This section should describe the purpose of the study including the research question. The purpose as written in the application and in the consent document should be the same. 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 C question will be an overview.
C. Human Subjects:
This question should describe in detail what you plan to do in the research. Be sure to answer all of the questions asked: procedures, measures, who will conduct the study, where, when, how frequently, how long, any audio or video taping that is used, and any identifiable information that is gathered. If you are only using pre-collected or archival data, describe how the data were obtained and any identifying information in the data. To be sure that all the elements have been completed in this question, you may find it useful to bullet or number each of the eight elements.
D, E. 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 that this is the case. Please describe the status of the application in more detail than stating '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.
F,G. International Research:
If the research is conducted outside of the United States, the 6 criteria listed in question G must be met. The letter of approval from an appropriate local or national official must be from a person of authority and state that the research is appropriate to be conducted in that country or location.
III. Subject Information
A. Direct Interaction:
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.
· 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.
Subjects:
A. Vulnerable Populations: This question should state how any vulnerable populations selected from the list in Population Information will have risks minimized. Normal Volunteers are not vulnerable and therefore no description is needed. 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.
C. Justification of Number of Subjects: Provide the rationale for the number of subjects chosen to be in the study.
D. Subjects per Year: If you plan on conducting the study for multiple years, clarify how many subjects are planned to be enrolled per year.
E. 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”)
F. Age Range: The expected age range of participants should be stated. Please keep in mind that if the Georgia State 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 Subjects B (above). If minors (under age 18) are not included, it must be justified in Subjects G (below). If your study does not have an upper age limit, it would be appropriate to state, “18 and above”.
G. Minors: According to the Federal Regulations, minors must be included in research unless their exclusion can be justified. It is an appropriate justification to state that the research is for adults only and the study would not be appropriate for minors.
H. Minorities: 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.
I. Pregnant Women: Please read this question carefully. It asks if women that are not pregnant are going to participate in the research. If women are included in the research study, this question should be answered ‘yes’. Federal regulations require that non-pregnant women be included in research unless their exclusion can be justified.
Recruitment:
A. Compensation: 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 also be listed in the Procedures section of the consent form. Lotteries, raffles, and drawings that randomly select a participant to receive compensation are illegal under Georgia law and therefore cannot be approved.
B. Recruitment: 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 SONA is being used, provide the paragraph that will be posted on SONA. 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.
Incentives and Benefits
A. 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.
Risks
A. 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’ is the most common consent in research studies. The participant is presented with a document containing all of the required elements and he/she signs the form indicating a willingness to participate.
· With a ‘Waiver of Consent’, no consent is obtained from a participant. This is most often used in studies involving only pre-collected data. If this option is requested, be sure the justifications meet the four federal regulations provided on the application. The justification should be provided in Informed Consent B (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 A section of the application (below).
A. Waiver of Documentation of Consent Justification.
B. Waiver of Consent Justification.
C. Competency: Describe how informed consent will be obtained if subjects are not competent to provide consent.
D. Justification: Consent forms must be attached unless justified.
E. Process: 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.
F. Reading Level: The reading level of the consent form should be at the reading level of the least educated participant. Please keep in mind that subjects being in college, does not mean that they read at the college level. 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. Reminder: This question serves as a reminder that all of the required elements of consent must be included in the consent form. If the model informed consent template is not used, a justification must be provided. The IRB understands that deviations from the model may be necessary to make the model fit your study, but any drastic changes outside of the norms should be explained and justified.
H. Confirmation: Confirm that consent forms will be uploaded.
Upload/Mail/Fax Consent forms: Consent forms MUST be uploaded in this section. The consent form must be in .doc format. Be sure that the document is not in .docx format if you are using an updated version of Microsoft Word. The consent forms should be uploaded individually and without surveys attached. The consent form should be uploaded in its final form with no tracked changes. Be sure to double check for any typos, misspellings, or formatting errors.
C. HIPAA Questions:
A. 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.
D. Subjects Data
A. State what identifiers (any identifying information about the participant – name, student number, etc.) will be collected. State how the hard copy data will be stored (e.g., in a locked cabinet). Consent forms should be stored separately from the data. If a code sheet or key is used to link the participants identifying information with the data, the code sheet should be stored separately from the data. Describe how electronic data will be kept safe e.g. 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. Describe how any audio or video tapes will be stored and when they will be destroyed. State how long the data will be kept. 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. 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.
F. Drugs:
If FDA approved drugs or drugs which are seeking FDA approval are used a description is necessary in this section.
G. Investigational Devices:
If investigational devices that are FDA approved or which are seeking FDA approval are used a description is necessary in this section.
H. Radiation:
Radiation questions must be answered if radiation is being used. This includes DEXA scans and X-rays.
IV. Other Questions
A. Deception:
Deception occurs when participants are told something false. The deception should be justified. 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.
B. Concealment:
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.
C. Deception/Concealment Reminder:
This question is a reminder that if concealment or deception is used, the debriefing must be uploaded and the informed consent should contain the language from the model informed consent form to inform participants some information is being withheld.
D. 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.
E. Attachment Description:
Provide any necessary description of attached materials.
F. Qualifications:
If the study involves any activity for which a special qualification is required, details on that qualification should be provided here.
G, H, I. 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.
J. Attachment Reminder:
Any materials used in the study must be attached to the application. Materials should be in final form with no errors or tracked changes.
V. Key Words: List any key words that can be used to identify the study.
VI. Attach Documents:
Be sure to upload any measures, surveys, questionnaires, etc. to the application. 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 descriptive titles on documents.
Routing:
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 protocol 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 protocol will only be accepted by the IRB after it has been endorsed by the PI and the department head or chair.