IRB Forms

For application forms, see IRBIS. For guidance on exempt consent/assent forms, and additional IRB-related forms such as template letters of agreement, see below. 

Research Protections regularly reviews and updates these forms in an effort to improve usability and IRB review turnaround times. If you keep copies of the forms on your local drive, please visit this site periodically to ensure you have the latest versions.


Exempt Research

 

TypeForm or StatementPurposeVersion Date

Standard Exempt Consent

Consent form for exempt research (docx 21.27 KB)

This consent template can be used for all exempt research procedures involving adults.

Exempt research conducted under the education category should use parent and/or student consent forms.

Remove all red and italicized text after completion.

12/18/2013

 

Non Exempt Research forms


For research that is not exempt, a consent form is usually required.  For more complex consent forms, the new regulations require a Concise Summary at the beginning of the consent.  This is separate from recruitment materials and  consent forms.  

TypeFormPurposeVersion Date
Concise Summary Concise Summary Template

The changes to the regulations for Human Subjects Research now requires a Concise Summary for longer, complex consent forms.  The IRB will notify you when you need to use one, or you may voluntarily add it if  you feel it clarifies your consent form.

This serves as a first page but does not replace the consent form or the consent process.  The purpose of the Concise Summary is to provide the main highlights of the research to a lay reader who is a participant or legally authorized representative so they can make a reasonable decision about whether to participate in the research.  Please remove all the highlighted text as you complete the template.  Attach it in IRBIS and choose the attachment type name "Concise Summary Statement."

02/23/2019
Consent FormsParent Consent This is a template for parental consent which much be used when children are participants in research unless the IRB finds a waiver is appropriate. 02/24/2019
Assent Form for Minors (doc 33.5 KB)Used when participants are under the age of 18 years but capable of reading and understanding the study (e.g., participants age 7-17).  May also be used for populations with English literacy challenges (the IRB must approve).09/14/2015
Biomedical Research Consent Form (doc 87 KB)Use this form for biomedical research, including approved wording for frequently used procedures.  Updated October 2014 to change contact information.09/14/2015
Focus Group Participation (doc 42 KB)Used when research activities include only focus groups of participants or a subset of participants.  Addresses confidentiality and photography/videography.  Can be used for exempt focus group research.  Form was updated October 2014 to change contact information.10/10/2014
Interview Consent Form (doc 38.5 KB)Used for interviews (audio or video recorded) of participants.  Can be used for exempt interviews. 08/15/2014
Social Behavioral Education Research Consent Form (docx 64.03 KB)

Covers all non-biomedical research including combination activities such as survey/test/interview.  

09/14/2015
PHI Release

If you need access to Private Health Information protected by HIPAA, participants must provide consent for you to receive or access their health data.  This form specifies the access is for research purposes.

02/24/2019

Additional IRB Related Templates and Forms

The templates below can be used for specific research projects that may require some additional forms. 

Adverse Event Form (pdf 119.74 KB)

Used to report an Adverse Event that occurs during the course of your research project.

03/20/2018

Exercise Screening Tool - ASU (doc 36 KB)Used to screen participants for studies involving exercise. The American College of Sports Medicine criteria for risk is included so that investigators can determine which participants are classified as "low risk" for physical activity.01/14/2011
Letter of Agreement (doc 28.5 KB)Used when another organization is involved in recruiting participants/allowing access to participants/allowing access to data.07/30/2010
Letter of Agreement for Using Student Data (doc 29 KB)Used when Appalachian student records data is used for research purposes. Explains protections in place as required by FERPA.08/19/2010
Individual Investigator AgreementIf you are collaborating with a researcher who is not affiliated with Appalachian State or any other institution with an IRB, this form is to request that Appalachian State's IRB provide the appropriate oversight.  This form does not apply when a Reliance Agreement is being used.02/24/2019