Human Research Protection Program

Develop & Submit

Knowing how to describe your research project to the IRB is as important as knowing how to propose a project to a potential sponsor. Respond to all questions on the page where they are posed (avoid anticipating what you think the IRB wants) and provide attachments where prompted. Describe the project so that it can be understood by someone outside your field of study. Be clear, concise, and consistent. Look for additional tips under Review & Respond.

Click the boxes below for resources related to each step of the human research process.

Required
Training

Plan &
Collaborate

Develop &
Submit

Review &
Respond

Post Approval
& Reporting

IRB Portal
All submissions to the IRB must be through the IRB Portal. Submission forms are interactive; new pages will open and some may close depending on your response to certain trigger questions. Therefore, it is difficult to provide a sample submission since the content may vary considerably. Drafts can be created, saved, and edited multiple times before submitting. All team members (people listed as Principal Investigator and Study Team members in the draft) can work on the draft.

The Support Appointment Form for the Human Subjects office is a direct form to schedule an appointment to discuss your IRB-related questions. All UGA faculty and graduate students may use the appointment form to schedule one-on-one Zoom meetings or phone calls to speak with the professionals about their submissions or for general guidance.  

Only submit when the project activities have been fully designed and materials have been prepared. Submitting before the design is complete leads to multiple review requests and delays in project start-up. 

Policies and Procedures
Many common questions can be answered by reviewing the Human Research Protection Program Policies and Procedures. The policies provide guidelines for project components such as recruitment, consent, incentives and compensation, and inclusion of vulnerable populations. Search by keyword or view an alphabetical list. Many policies contain links to templates and other helpful resources.

IRB Portal Library
UGA employees and students can also access policies and procedures, templates, and worksheets in the IRB portal.

Educational Videos
Determining Exempt Category Eligibility Research Course – This course includes: links to NIH guidance; the NIH Decision Tool for investigators to make a preliminary determination if their project may be eligible for an Exempt determination; and four videos.

NIH Final Rule Human Subjects Research Exemptions

NIH Decision Tool

Module 1 Introduction to Exempt Research

Module 2 Limited IRB Review

Module 3 Exempt Categories and Examples

UGA Portal: How to Submit a New Exempt Study (Step-by-Step Guide)

Consult with experienced colleagues and faculty but avoid using another investigator’s approved submission or consent document as a template or as an example to draft your materials. Write your submission and materials for your project.

  • Study team member names, training records (UGA records will display in the portal submission automatically), and roles;
  • Target population characteristics and sampling strategy:
    • Age/range, sex, gender, health condition, race, ethnicity, language, etc.
    • The number of participants needed and number of participants that may need to be invited to reach that target (account for expected attrition and ineligibility determinations)
    • The sampling strategy: where the participants can be found and how they will be identified (determined to be eligible). This information should help the IRB understand how the strategy ensures that the sample is representative of the target population.
    • How participants will be recruited/invited and screened (if applicable) and materials used
    • If participants are vulnerable to coercion or undue influence and how this will be mitigated;
  • Research Design: the purpose, specific aims or objectives; the research question; conceptual framework; theoretical perspective; methodology; hypotheses to be tested; variables or relationships of interest; scientific or scholarly background for, rationale for, and significance of the research and how it will add to existing knowledge;
  • Procedures: all steps/measures to collect data and/or biospecimens including who will do the procedures and when; intervention procedures and materials; the setting for the project (where); how the procedures are conducted; the duration of an individual’s participation; the duration anticipated to enroll all participants; the estimated time to complete the study (i.e., complete primary analyses); primary and secondary study endpoints and other plans for analyses; materials used to record participant information;
  • Risks: all reasonably foreseeable risks, discomforts, hazards, or inconveniences to the participants and that are related to participation in the research; describe the probability, magnitude, duration, and reversibility of the risks; consider physical, psychological, social, legal, and economic risks; if applicable, describe risks to others who are not participants (group harm), and which procedures may have currently unforeseeable risks;
  • Benefits to participants (resulting from participation, otherwise known as “direct benefits”) and benefits to others (otherwise known as “knowledge to be gained”);
  • Steps to protect participant privacy interests and confidentiality of data; explain how data are secured during and after collection; where and how data are stored; explain if data will be moved, or transferred and how. Consult with EITS or your college/department IT professionals to ensure that your proposed processes meet UGA EITS requirements for handling sensitive information;
  • Consent process (where, when, how, by whom) and materials;
  • Action Researchers will complete a brief Action Research Survey and attach a PDF of the results to the Supporting Documents page of the submission
  • Potential participants must be provided with the information that a reasonable person would want to have in order to make an informed decision about participation. They must be provided time to consider their decision, an opportunity to discuss the information and ask questions, and consult with others, when applicable.
  • Consent information must be provided in language understandable to the potential participant
  • Consent information must be presented in a way that helps the potential participants understand why they might, or might not, want to participate and in a way that facilitates comprehension.
  • Consent information must be presented at an appropriate reading level (ideally 8th grade or below). Look here for resources to evaluate reading level.
  • The consent process description must address where the process takes place; the timeframe for providing information, obtaining a decision, and beginning study activities; any measures to minimize the possibility of coercion or undue influence; the method of presenting information; and how comprehension will be ensured.
  • Templates are available in the IRB Portal Library, on the Consent page of the online application, and here. The templates assist with formatting and understanding common elements of consent but do not substitute for consent written specifically for a project.

UGA investigators can request student emails from the Office of the Registrar. Only students who have allowed their directory information to be shared will be included in the list. The list can include: student names, phone numbers, addresses, email addresses, dates of UGA attendance, degrees and awards received, major fields of study, and other information designed by UGA as directory. The list cannot be filtered/limited by the Registrar for gender, age, race/ethnicity, or course enrollment.

The IRB may approve non-exempt research that includes collecting information or biospecimens for the purpose of screening, or determining the eligibility of, prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative if either of the following conditions are met: 

(1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or (2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens. 

If you need to screen or determine participant eligibility before obtaining informed consent, please update your project in the IRB portal with the following information: (The bold titles correspond to the IRB portal application pages) 

Human Research Participants 

On the Human Research Page, provide details about the screening, recruiting, and eligibility verification process for Q4 (Eligibility Criteria). 

Consent and Materials 

To indicate that you will not obtain consent for screening prospective participants, go to the Consent and Materials Page and choose “Informed consent will not be obtained or some or all elements will be waived or altered” for Q1. 

Waiver of Informed Consent 

When completing the Waiver of Informed Consent form, it is not necessary to answer question 1 unless you are wavering or altering the consent processes or elements. Instead, please focus on answering question 2 regarding the screening process. Additionally, be sure to include the final version of the screening questions in a Word document or PDF that the participant will receive, along with any introductory document such as an agreement or partial consent. 

Research Design Methods & Procedures 

Provide the process and procedures for screening potential participants in response to Q4. 

Details should include: 

  • Who will screen (e.g., their role on the study team),  
  • Where will the screening take place? 
  • When will the screening take place? 
  • How will you collect the data for screening? 

HIPAA Protected Information/Study Scope (Only if Protected Health Information (PHI) is used) 

If any protected health information under HIPAA is accessed or used, select “HIPAA – Protected Health Information” on the Study Scope page. Be sure to also complete the HIPAA page by providing either a justification for waiver or a HIPAA authorization template for review. 

 

*Note: if the study is eligible for Exempt determination, consent for the screening is also not required with the exception of access and use of FERPA-protected information or HIPAA-protected information which requires signed, prior authorization from the participant. However, the waiver of consent page will not be presented for completion. The screening materials must be attached to the Data Collection Materials page and the FERPA authorization should be included in the study consent document or HIPAA authorization should be attached to the HIPAA page and HIPAA marked on the Study Scope page. 

  • Incentives and monetary compensation should not be described as research benefits.
  • Incentives are for participation and should not be paid contingent upon completion of all project activities so pro-rate the incentive based on individual activities completed or duration of participation.
  • The UGA Business Office or an individual college, sponsor, or department may require tracking of payments, so please check with the people who will be processing the payments and describe the process in your submission.
    • For example, compensation via ClinCard requires Personal Identifiable Information from each human subject to be entered (name, address and DOB). If a virtual card is selected, an email address will also be required for distribution.
    • Please note: IRB application/request must list Greenphire/ClinCard as the source of payment in the compensation section (can submit a modification, if necessary).
  • Georgia law requires a license or an open invitation for raffles/drawings. If conducting outside of GA, check local laws.
  • Subject privacy – is related to setting; it relates to control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. The concept of privacy can be extended to control over your biospecimens and information/data related to you. There are several countries with specific privacy laws pertaining to data that are collected from or about you, or shared with others after collection, via the Internet. Researchers conducting transnational research must be aware of these laws and requirements and provide the IRB with sufficient information to assess the project’s compliance.
    • The European Union has passed a data privacy regulation that is applicable throughout the entire European Union (“EU”), and to those who collect personal data about people in the EU. See UGA’s GDPR policy for more information.
    • Other countries with specific privacy laws include: India, Brazil (LGPD), China, and Canada (PIPEDA).
  • Confidentiality – is related to information/data; it pertains to the steps taken to protect an individual’s personal information (limited access; masking with a code; password-protection) including the assurances made to a subject in the consent form that his/her information will not be divulged to unauthorized personnel without their permission.

These are considered direct identifiers, so you need to be very clear about

  • How long you will keep them
  • How you will keep them secure
  • How you will use them

If the project involves access and use of Protected Health Information (PHI), see additional FAQs.

Certain federal grant proposals lacking definite plans for involvement of human subjects may qualify for Developmental Review and Determination. This determination is granted by the Human Subjects Office for the period of time that the proposal states is needed for preliminary activities (e.g., purchase and set up equipment, obtain and implement software, develop data collection materials) but no longer than one year. These preliminary activities do not need to be reviewed by an IRB before an award may be made. However, no human subjects may be involved in any project activities supported by these awards until the IRB has reviewed and approved the human research activities in the project.

The process to request a determination for research supported by a federal agency:

  1. Log into the IRB portal
  2. Select Create Submission
  3. On the Project Basics page, answer “Yes” to Q5 “Are you requesting determination if your project meets the criteria for developmental review?”
  4. Complete the remaining submission pages accessed by navigating via the “Continue” button at the bottom of each page. Be sure to consult the Help Text for questions that have the icon.
  5. You must have your Grants Portal ID ready. Submissions missing the identification for the funding will be returned without review.
  6. After finishing the forms, be sure to execute the Submit activity from the submission workspace.
  7. Note: the dates selected for the anticipated date of submission to IRB and the anticipated date to begin human research activities should be carefully considered and must align with the preliminary activities described in the proposal. The submission date should be at least six months in the future and the anticipated begin date should allow sufficient time for IRB review after submission (typically 4-6 weeks).

Occasionally a non-federal sponsor or SPA may request a determination letter as well. The process to request a determination for research supported by an external, non-federal entity:

  1. Log into the IRB portal
  2. Select Create Submission
  3. On the Project Basics page, answer “Yes” to Q5 “Are you requesting determination if your project meets the criteria for developmental review?”
  4. Complete the remaining submission pages accessed by navigating via the “Continue” button at the bottom of each page. Be sure to consult the Help Text for questions that have the icon.
  5. You must know your UGA Grants Portal ID. 
  6. After finishing the forms, be sure to execute the Submit activity from the submission workspace.
  7. You will receive an email with instructions to complete the submission by creating an assurance. Follow the link and instructions in the email and read the instructions in the portal carefully to create the assurance.
  8. The assurance letter will be a PDF. Convert the PDF to a Word document and edit any fields that need revision (e.g., add the funding proposal number and sponsor name). Consult your IT staff if you have questions or difficulty with converting the PDF for editing.
  9. The final version of the letter should be provided to SPA/the sponsor as requested. If edits were made, add the revised letter to the IRB portal record via Add Public Comment.

Activities must meet the DHHS or FDA definition of “research” involving “human subjects” for the activity to fall under IRB oversight. Activities that do not meet the definition of “Research involving Human Subjects” are not subject to IRB oversight or review. Review the policy for Determination of Human Subjects Research and contact the Human Subjects Office in cases where it is unclear whether an activity meets the regulatory definition of Human Research for additional assistance.

When considering if a project is “research”, an important question to ask yourself to determine whether a project meets the regulatory definition is “Would this project be conducted as proposed if I cannot receive any form of academic recognition for the project, including publication in a peer-reviewed journal or presentation of the project at an academic meeting?” If the answer is “no”, the project is likely to be considered research and the remaining analyses should be limited to determining if human participants are involved. (Bankert, et. al., Institutional Review Board: Management and Function, 2021, 3rd Edition, Jones & Barlett Learnin, Burlington, MA.)

Projects that are not “research” as defined in federal regulation do not need to be submitted for determination unless it is required by a sponsor or for publication (or conducted for a graduate student’s thesis or dissertation). Projects that are research but do not involve human subjects must be submitted for formal determination by the Human Subjects Office staff. Refer to the following table to determine if you are eligible for self-determination or must submit for a formal determination.

The investigator has determined that: Submission Required?
Data will contribute to a graduate student thesis/dissertation project Yes
The project does not meet the DHHS or FDA definition of research/clinical investigation No
The project does meet the DHHS or FDA definition of research but human subjects are not involved Yes

The process to request a determination:

  1. Log into the IRB portal
  2. Select Create Submission
  3. On the Project Basics page, answer “Yes” to Q5 “Are you requesting determination if your project meets the definition of human subjects research?”
  4. Complete the remaining submission pages accessed by navigating via the “Continue” button at the bottom of each page. Be sure to consult the Help Text for questions that have the icon.
  5. After finishing the forms, be sure to execute the Submit activity from the submission workspace.

The IRB Portal will send an email confirmation to the Principal Investigator and selected Contacts for each successfully submitted project. Also the project status for the submission will transition to the appropriate review state. Submissions in state “Pre-Submission” or “Draft” have not been submitted for review and are editable by the study team.

Protocols eligible for review by expedited procedure or for exempt determination are processed in the order received by the Human Subjects Office.  Expedited review takes an average of 40 days and exempt determinations take an average of 20 days. (Note this estimate depends on the volume of submissions and available HRPP resources.)
New protocols, modifications, and continuing reviews must be submitted for Full Board review by the submission deadline posted in the meeting schedule.

Secondary Research is research that uses human data or biological specimens that were collected, created, or obtained for non-research purposes (e.g., medical records, clinical/medical care) or were collected during the conduct of a different human research project. More info can be found at: U.S. Dept. of Health and Human Services website and in this informational video.

There are three review paths for such studies: Not Human Research Determination, Exempt Determination, or Expedited review.

If the data/biospecimens do not include any identifiers (i.e., direct identifiers like names or indirect identifiers like codes or participant IDs where the code key link the code to the person still exists), the Human Subjects Office can grant a not-human research determination. See our website for more info or our course in PEP (pep.uga.edu) “Am I conducting Human Research?”

If the dataset does contain identifiers but they will not be used in analyses, the IRB may provide an exempt determination if certain criteria are met. Help for drafting this submission can be found on our website: Determining Exempt Category Eligibility Research Course

If the exemption cannot be applied, secondary research is eligible for review via Expedited procedure, category 5.