Application Assistance

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.

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. Once the study is approved, the title on the application cannot be changed.

Short Title

This is for your own personal reference to help you locate your studies at a later date. This has no effect on IRB activities or outcome.

Add Department(s)

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.

By default, iRIS brings in the department associated with the user filling out the application. For detailed steps on how to change the department please review the Step by Step guide.

Assign Study 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.

In iRIS you must also designate a study contact. By default it is set to the Principal Investigator selected, you can change this or add multiple study contacts. You must also designate user’s who are required for sign off prior to submission to IRB. For complete step by step directions on creating and submitting an application please go to the Step by Step Guide.

Purpose

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.

Human Subject Involvement

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.

Who will be conducting the procedures?

Describe who will be conducting each procedure or working with each population.

The remaining portion of this section is a series of “Yes” “No” questions, this will determine which sections you are brought to in your application. If you make a mistake in your selection, you can always navigate back to this section using the side navigation menu.

Research Protocol

In this section you will need to upload your research protocol you will be using for your study. For instructions on how to upload documents you can review the Step by Step Guide.

The research protocol is a separate word document that should include: the study title; a summary; a description that includes a rationale, objectives, methodology, and data management and analysis; ethical consideration, and references.

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.

Research Funding

If you selected yes to the study being funded, please upload the grant application. For instructions on how to upload documents you can review the Step by Step Guide.

Dissertation or Thesis

If you selected yes to the study contributing to your dissertation or thesis, please upload your dissertation or thesis. For instructions on how to upload documents you can review the Step by Step Guide.

External IRB Review

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.

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.

Human Subjects

In this section you will be asked a series of “Yes” “No” questions to determine if additional information is required about drugs, devices, radiation,deception and concealment, surverys, and the need of special certifications. Please fill out everything in its entirety, if you need additional assistance with this please contact the IRB Office.

Investigational Drugs

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, if you need additional assistance with this please contact the IRB Office.

Investigational Devices

The GSU IRB does not review studies involving investigational devices, if you need additional assistance with this please contact the IRB Office.

Radiation Information

Radiation questions must be answered if radiation is being used. This includes studies using DEXA scans and X-rays, if you need additional assistance with this please contact the IRB Office.

Deception

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

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.

Vulnerable Populations

In this section you will designate which populations your study will include. Depending upon which population(s) you select you may be required to answer additional questions. For more information or if you have any questions, contact the IRB Office.

Children

In this section you will be asked to describe the steps taken to ensure the protection of rights and welfare of the children used in your study, how parental permission will be obtained the risk level of the study to the children, the prospect of benefits to the child, and if the children are wards of the state. If they are wards of the state, you must describe how the requirements in 45 CFR 46.409 are met. If you need assistance with this section you may contact the IRB Office.

Decisionally Impaired Adults

In this section you will be asked to describe the steps taken to ensure additional protection of the rights and welfare of the decisionally impaired adults used in the study and how consent will be obtained. If you need assistance with this section you may contact the IRB Office.

Employees or Subordinates

In this section you will be asked if the participants will be recruited by or involed in research with a supervisor and if so you must indicate how percieved coercion will be handled. You must also state how extra steps will be taken to ensure the welfare and rightes are protected. If you need assistance with this section you may contact the IRB Office.

Non-Native English Speakers

In this section you will be asked what steps will be taken to ensure rights and welfare of Non-Native English speakers. For example, a translator may be required to ensure procedures are communicated effectively. If you need assistance with this section you may contact the IRB Office.

Patients

In this section you will be if participants will be recruited by or involved in research with a direct care giver such as the patient’s doctor or nurse and if so how will perceived coercion be handled. You will also need to state how the rights and welfare of participants will be protected. If you need assistance with this section you may contact the IRB Office.

Pregnant Participants

In this section you will be asked if you are specifically recruiting pregnant women as participants because they are pregnant and to state the steps taken to ensure the rights and welfare of the pregnant participants. If you need assistance with this section you may contact the IRB Office.

Pregnant Participants Part 2

In this section you will be asked to describe any preclinical studies and clinical studies that have been conducted and to provide data for assessing potential risks to pregnant women and fetuses in the research that will be conducted. You also will be asked to state any risks and benefits to the fetus and pregnant participant as well as if consent will be sought from the father. In this section you must state if any inducements, monetary, or otherwise are offered to terminate pregnancy, what part, if any, the individuals engaged in the research have in the decision, timing, method, or procedure in terminating a pregnancy, and if individuals engaged in the research have any part in determining the viability of the neonate.

If you need assistance with this section you may contact the IRB Office.

Prisoners

In this section you will be asked to state whether the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers and if the research presents any more than minimal risk to the participant. You must also state what the study examines as it relates to prisoners, any possible advantages to the prisoner and if adequate provisions have been made for any needed follow-up care of subject after the end of their participation.

If you need assistance with this section you may contact the IRB Office.

Students and Trainees

In this section you must state if the participants will be recruited by or involved in research with their own (current) supervisor or teacher and how perceived coercion will be handled. You must also clarify what steps will be taken to ensure the rights and welfare of the student(s) and/or trainees are protected. Please see the IRB Website for more information on using one’s students in research. If you need assistance with this section you may contact the IRB Office.

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.

Number of Subjects & Age

You must state the total number of subjects and if you plan on conducting the study for multiple years, clarify how many subjects are planned to be enrolled per year. Please provide the rationale for the number of subjects chosen to be in the study. You must also state the anticipated age range of subjects to be enrolled in the study (i.e. 25-45).

Duration of Subject Participation and Location

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.

Minors

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.”

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.

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 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.

Inclusion & 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.

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 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.

PHI

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.

Security Measures

If the study does involve PHI or HIPAA you must complete the HIPAA security measures through the HIPAA Privacy Officer in the Office of Legal Affairs. They can be contacted at 404-413-0500.

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.

No Interaction with Humans

In this section you must state how your study does not involve direct interaction with humans, for example, your study may only involve the retrospective review of school records.

Risks & Benefits

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.

Subjects Data

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 additional identifying information?

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.

Review Categories

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.

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.
  • 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

Competency

Describe how informed consent will be obtained if subjects are not competent to provide consent.

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.

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.

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.

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.

Waiver of Documentation of Consent Justification

Use the federal regulations listed in the menu above to justify the waiver of consent.

Conflict of Interest

You will be asked if the Principal Investigator or any other research staff including spouse and dependents have any financial or other conflicts of interest with the study.

Conflict of Interest Form

If you selected “Yes” to either question you will be asked to go to the Conflict of Interest Portal and complete a COI form. You cannot complete the study application until this is done.

Endorsement

By agreeing to the endorsement statement you agree to the following:

  • I will not begin this research study before receiving a formal letter of IRB approval;
  • I will document informed consent according to my approved procedure;
  • I will report to the IRB in a timely manner any unanticipated events to subjects;
  • I will renew my IRB application before expiration or submit a study closure form;
  • I will gain IRB approval before altering the research study and/or consent forms;
  • I will notify the IRB if there are any changes in my contact information.