Skip to main content

Forms and Documents

Institutional Review Board (IRB) Documentation

 

ATTENTION: All applications and supporting documents must be submitted via the UD IRB submission portal. When attaching your accompanying documents they should be attached as a zipped folder.    

Please read the following carefully and complete all of the required documents that will need to be included with your submission.

What documents are required for a complete IRB application?

Application Form. See below to determine which of the four types: Fast-Track Exempt Classroom D-1; Fast-Track Survey/Interview D-2; General Application for Exemption; Non-Exempt Application.

Documentation of Faculty Approval. If you are a STUDENT, you must provide documentation that your faculty advisor (1) has read your IRB application, and (2) approves of the research as proposed.

Documentation of Off-Site Approval.  If you will be collecting data OFF-CAMPUS, you must provide documentation of approval by a site administrator (e.g., school principal, facility director).

Consent Document. All human research requires consent from each participant. There are several types of consent documents. Please see below for a description of consent documents.  Please be sure to use the correct format – if you are not sure, contact us for guidance at IRB@udayton.edu.

Study-specific Instruments. A list of survey or interview questions, questionnaires, data collection sheets, evaluative or diagnostic instrument, or debriefing protocol designed specifically for this research.

Recruitment Advertisement.  Please include the ads, brochures, or script you will be using to recruit participants for your study. 

CITI Training. If this is a non-exempt study, please upload the certificate of completion for each investigator. CITI training instructions can be found here.

COVID related IRB Approval Form. If your study involves direct contact with human subjects, you will need approval prior to data collection.

THE IRB CANNOT REVIEW APPLICATIONS UNTIL ALL PARTS OF THE APPLICATION PACKAGE HAVE BEEN SUBMITTED.    


How do I know which application form to use for my research?

It is critical that students work closely with their faculty advisor to design their research projects in such a way that risk is minimized to human participants. Your faculty advisor can assist you in determining which form to use to seek IRB approval. Questions should be directed to IRB@udayton.edu.

D-1 Fast-Track Exempt Classroom Research Application: This may be used by researchers who want to conduct research in established or commonly accepted educational settings, involving only normal educational practices (regular or special education instructional strategies, effectiveness of instructional techniques, curricula, classroom management methods). This application may NOT be used if the research is sponsored with federal funds, or if compensation/incentives are involved. Please complete this application via the UD IRB submission portal and attach any applicable documents (faculty approval, offsite approval, parental consent document, parent notification sheet, etc. as a Zipped folder.)

D-2 Fast-Track Exempt Survey/Interview Research Application: This may be used by researchers who want to conduct anonymous paper surveys, confidential online surveys, or non-sensitive interviews using only adult subjects. Non-sensitive refers to topics and content that would not be considered embarrassing or that would not have a negative impact on a subject’s employability or reputation. This application may NOT be used if the research is sponsored with federal funds, if prison populations are used, if compensation is involved, or if minors under the age of 18 are involved. Please complete this application via the UD IRB submission portal and attach any applicable documents (faculty approval, invitation to participate, interview/survey questions, etc. as a Zipped folder.)

If your project does not fit the description above for the Fast-Track application forms, you should use the appropriate General Application for Exemption or Non-Exempt application below. 

General Application for Exemption: This application is appropriate for federally funded classroom research, surveys, or non-sensitive interviews with adult subjects. This form can also be used for classroom research, surveys, or non-sensitive interviews with adult subjects when compensation or incentives are offered. Please complete the General Application for Exemption form and submit it along with any other required documents (General Application for Exemption form, faculty approval, invitation to participate, interview/survey questions, etc.) See links to forms and documents below and submit them as a Zipped folder via the UD IRB submission portal.

Non-Exempt Application: This application should be used for all other types of research. Please complete the Non-Exempt Application form and submit it along with any other required documents (Non-Exempt application form, consent form, off-site approval, CITI training certificates, interview/survey questions, etc.). See links to documents below and submit them as a ZIpped folder via UD IRB submission portal.

Documents mostly commonly used:

If you are not sure which form to use, or if you review any of the application forms and have questions, please contact us at IRB@udayton.edu.  WE WELCOME YOUR QUESTIONS!


What types of consent document or process should I use for my research?

All human research requires obtaining consent from your participants and the consent process must involve the researcher communicating a specific set of key features of the study to a potential participant. Many studies require documentation of this consent through signed consent forms. To ensure your consent form is complete and correct, please use one of TEMPLATES provided here. 

For use when human subjects are at least 18 years old:

The researcher should use an Invitation-to-Participate document in lieu of collecting signatures for questionnaires, surveys, or non-sensitive interviews. If the research is not eligible for the Fast-Track form, please contact us to see if this method of consent is acceptable.

The Full length consent should be used for all NON-EXEMPT human research. There are templates for full length, traditional consent documents for both Social Science-Behavioral Science studies and for Biomedical studies.

For use when human subjects are less than 18 years old:

For any research involving subjects under the age of 18, the researcher should use the Parental Consent document.

Under certain circumstances for classroom research, with a school principal’s permission, the Parent Notification Sheet can be used in lieu of a signed parental consent form. If the research is not eligible for the B-1 Fast-Track form, please contact us to see if this method of consent is acceptable.

For research involving subjects under the age of 18, in combination with the Parental Consent document, a Child Assent form can be used.


Some other forms you might need for human subjects research:

Request for Renewal of Approval - All approved non-exempt research protocols are under “continuing review” by the IRB. This means the IRB retains oversight of the study until the study is officially closed. Please use this form if you are applying for a renewal of an already approved protocol.

Human Research Closure of Study Form – All non-exempt research studies remain under IRB continuing review until the study is officially “closed.”  It is the responsibility of the researcher to notify the IRB that the study is closed. Please submit this form to close your study.

Adverse Event Report – To learn about adverse events and unanticipated problems in human research, please visit: http://www.hhs.gov/ohrp/policy/advevntguid.html

HIPAA Authorization Form for disclosure of medical information - Authorization for Use or Disclosure of Protected Health Information, as required by the Health Insurance Portability and Accountability Act ---- 45 CFR Parts 160 and 164. To learn more about HIPAA, visit: http://www.hhs.gov/ocr/privacy/

IRB Guidance for International Research 


How to apply

All Human Subject Research must be approved by the IRB and submitted via the UD IRB submission portal. Any questions can be directed to IRB@udayton.edu

CONTACT

Office for Research

Daniel J. Curran Place
1700 Patterson Blvd
Dayton, Ohio 45419 - 7758
937-229-3515