First, you will need to determine that your study meets the definition of human subject research and requires review for either an exempt determination or IRB approval. If you are unsure if your study requires review, use the Human Subject Research Determination Form. If you conclude your study does require review, you will need to prepare a protocol for submission.
An initial protocol submission will require that you:
- Complete one of two initial review applications
- Identify your research team
- Develop a Research Plan and other protocol materials
- Submit required materials to RCS at ResearchCompliance@uoregon.edu
Initial Review Applications
There are two initial review applications – an Exempt Determination Application and an Initial Review Application.
You will want to first consider whether your study qualifies for exemption. To determine if your study may qualify for exemption, use the RCS Self-Assessment Tool to preliminarily assess if your study qualifies for exemption. The Self-Assessment Tool will additionally help you identify the categories of exemption under which your study may qualify. Next, complete the Exempt Determination Application form and the corresponding category worksheet(s). Submit the completed application form and worksheet(s) to RCS for verification. Use the checklist at the end of the application to identify the necessary protocol materials to include with your submission.
If your study does not qualify for exemption, you will need to submit an Initial Review Application. Use the Initial Review Application for all other human subject research that does not qualify for exemption. Submit the completed application to RCS for IRB review. Use the checklist at the end of the application to identify the necessary protocol materials to include with your submission.
Identify Your Research Team
You will need to identify your research team. All research personnel will need to complete the human subject research training requirement. In addition, all individuals will need to complete the Conflict of Interest (COI) Form to screen the research team for any potential conflicts of interest with the research. The completed COI Form will need to be included with a protocol submission only for those individuals who have identified a potential conflict.
All individuals listed below will need to be included on the Research Personnel Form with role and training completion dates provided:
- Principal Investigator. The Principal Investigator (PI) for a human subjects protocol must be the individual most qualified to oversee the conduct of the human subject research and is ultimately responsible for the design, conduct, execution, and/or reporting of the human subject research. See our guidance document for more information about Principal Investigator Qualifications.
- Faculty Advisors. Students conducting research are eligible to act as Principal Investigator only when they are under the oversight of a Faculty Advisor (tenure related and non-tenure track faculty) meeting the qualifications of a Principal Investigator. The Faculty Advisor is an individual with institutional oversight of a student’s academic progress and is positioned to oversee and guide student research.
- Other Research Team Members. Any individuals interacting with participants or identifiable participant information for research purposes are considered engaged in the research and need to be listed as research personnel.
Developing Protocol Materials
Protocol materials required for submission will depend on the type of application submitted. Below are the key materials instructions about when to include these with your protocol submission.
- Research Plan. All good research has a plan. A Research Plan is a blueprint for the conduct of your research and provides details in narrative form. Develop a Research Plan using our research plan template and guidance document.
- Initial Review Applications - the Research Plan is required for submission with your application materials.
- Exempt Review Applications - while not required, it is strongly encouraged that a Research Plan be included with your application materials to assist RCS' verification of the study's eligibility for exemption. Regardless, a research plan should be developed and followed throughout the conduct of your research.
- Recruitment Materials. Materials used to facilitate recruitment will need to be developed such as emails, letters, scripts, advertisements, and brochures.
- Initial Review Applications – recruitment materials are required for submission with your application materials.
- Exempt Review Applications – recruitment materials should be developed for consistency of information provided to participants but are not required for submission.
- Informed Consent and/or Assent Forms. Obtaining the informed consent and/or assent of potential participants is an ethically important consideration in the responsible conduct of research. Researchers will need to develop an informed consent and/or assent process and form. For expedited and full board research, informed consent will need to satisfy the required elements of informed consent, unless waived or altered by the IRB. Exempt studies have more flexibility in the elements of informed consent.
- RCS has developed informed consent guidance document and a template informed consent form with an associated guidance document.
- Initial Review Applications - Researchers will need to develop a consent process (described in the research plan) and submit an informed consent/assent form(s) or script(s) for participants that satisfy all elements of informed consent. If consent needs to be waived or altered, see the Waiver/Alteration Guidance for the criteria and justifications to include within the research plan.
- Exempt Review Applications – Researchers will need to develop and describe a consent process within the Exempt Review Application. Some exemption categories have conditions requiring prospective agreement in some circumstances (e.g., use of deception). The informed consent/assent form or script for participants needs to be included with the application materials.
- Data Collection and Study Instruments. To conduct and facilitate the research, data collection and study instruments will need to be developed for use with participants. These include but are not limited to questionnaires, surveys, data collection forms, and interview guides/scripts. Data collection and study instruments will need to be included with protocol submissions as follows:
- Initial Review Applications - Researchers will need to include all data collection and study instruments with the application materials. If using a lengthy, standardized assessment, consult with RCS to determine if a description of the instrument in the research plan will suffice.
- Exempt Review Applications – Researchers will need to develop data collection and study instruments when developing a research plan. Researchers are strongly encouraged to submit data/information collection materials and assessments (questionnaires, surveys, data collection forms, interview guides/scripts, etc.) to assist RCS’ verification of the exempt determination.
- Data Safety Monitoring Plan. A data and safety monitoring plan (DSMP) may be necessary to ensure the safety of research participants and to protect the validity and integrity of study data. DSMPs are typically required for clinical trials and may be appropriate for other research. If a DSMP is required by the funding agency, consult the agency resources to ensure you meet program requirements (e.g., NIH division website). If conducting a clinical trial, also be sure to visit our Clinical Trials page for further information. If a DSMP is created, this needs to be included with the application materials.
- Data Safety Monitoring Board/Committee (DSMB/DSMC). The Data and Safety Monitoring Board/Committee (DSMB/DSMC) may be appropriate when an independent group of experts is needed to advise the study investigators. The primary responsibilities of the DSMB/DSMC provides periodic review and evaluation of the study data for participant safety, study conduct and progress, and, when appropriate, efficacy. The DSMB/DSMC makes recommendations concerning the continuation, modification, or termination of the study. If a DSMB/DSMC is required by the funding agency, consult the agency resources to ensure you meet program requirements (e.g., NIH division website). If a DSMB/DSMC is being used, provide the details of the committee’s scope, composition, and oversight functions with your application materials.
- Other Materials. Consult the submission checklist at the end of the application to identify any additional materials required for your submission. See our Applications and Forms page for additional sample materials and templates. See our Guidance Library for additional topical guidance that may be useful in developing your protocol.
Email the complete application packet
All application materials are emailed to RCS at ResearchCompliance@uoregon.edu and must be sent from a uoregon.edu email account. Applications may be signed using an electronic signature or a scanned written signature. Additionally, the name(s) of the Principal Investigator and, if applicable, the Faculty Advisor may be typed in the signature block. All persons signing the application must be included on the email submission.