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

The revision of the federal regulations for human subjects research brought changes to exempt categories.  In the course of modifying our own procedures for exempt reviews, we determined that a standard exempt consent form is no longer required for most  exempt research.  Instead there are some basic disclosure statements we recommend for certain types of research, which we have provided below. You can copy and paste these statements into a document or at the beginning of your survey.

Keep in mind your participants should always have a way to contact you if they have questions or complaints--whether that is included in your survey, in any consent statement, or presented to them during research procedures.

The standard Exempt Consent is always appropriate if you feel a more expanded explanation of the research is warranted, and we also recommend using it for situations where more explanation is appropriate. You can copy and paste the statements you need into the template.

If you are studying children, you must use the Parent Consent form and when appropriate, Child Assent which are found in the next table.

TypeForm or StatementPurposeVersion Date
 Anonymous Surveys We are asking you to complete this survey for research.  You do not have to complete it if you decide not to. Your answers will be anonymous--we will not be able to trace them back to you.

 For Exempt 2 research where identities of participants cannot be ascertained. This can be provided at the beginning of your survey.

If you are recruiting via Sona or MTurk, you should include the appropriate statements we have provided below.

 02/24/2019
 Benign Interventions We are asking you to do these activities for research. [Describe activities] You don’t have to finish them if you decide you don’t want to.  [Choose one] Your responses will be anonymous--we will not be able to trace them back to you. [OR] We will be able to identify your responses as yours until [date when data is de-identified].  Your data will be stored [describe].  If you have any questions please ask a member of the research team.

 For Exempt 3 research where no deception is used. 

The new regulations allow for deception in this category if your participants "prospectively agree" to allow it.  We have provide example wording below.

 02/24/2019
 Sona Statement with no identifiers 

Please note that while we have no intention of trying to match your data back to you, for a brief time you will be listed in Sona as signed up for this research, in order for us to issue the ELC.

If you participate, you’ll receive [x] ELCs. There are other research options and non-research options for obtaining extra credit or ELC's.  One non-research option to receive 1 ELC is to read an article and write a 1-2 page paper summarizing the article and your reaction to the article.  More information about this option can be found at: psych.appstate.edu/research. You may also wish to consult your professor to see if other non-research options are available.

 If recruiting via Sona with anonymous or de-identified data, this statement must be provided. 02/24/2019
 Sona Statement with identifiable data 

We will be able to identify your responses as yours until [date when data is de-identified].  Your data will be stored [describe].  If you have any questions please ask a member of the research team.

If you participate, you’ll receive [x] ELCs.  There are other research options and non-research options for obtaining extra credit or ELC's.  One non-research option to receive 1 ELC is to read an article and write a 1-2 page paper summarizing the article and your reaction to the article.  More information about this option can be found at: psych.appstate.edu/research. You may also wish to consult your professor to see if other non-research options are available.

 If recruiting via Sona and you intend to keep identifiable data for a period of time, this statement must be provided. 02/24/2019
MTurk StatementPlease be aware that any work performed on Amazon MTurk can potentially be linked to information about you on your Amazon public profile page, depending on the settings you have for your Amazon profile.  We will not be accessing any personally identifiable information about you that you may have put on your Amazon public profile page.  We will store your mTurk worker ID separately from the other information you provide to us.If recruiting via MTurk, you must disclose the potential for re-identification, even if your data collection is "anonymous."02/24/2019
 Prospective Agreement for Deception 

 

Some research requires that the full purpose of the study not be explained before you participate. If you are not okay with this possibility let us know. [Chose one] We will give you a full explanation at the end of the study. [OR] We will give you a full explanation as soon as you complete the study.


In order to stay exempt with mild deception, you must get agreement from participants that  the research statement may be misleading.  It is important to provide as accurate a description of the procedures as you can.  02/24/2019
 Interviews and Focus Groups You are completing this interview/focus group for research.  You don’t have to answer all of the questions or complete the interview if you decide you don't want to. We [will/will not] record your responses. Your responses will be [anonymous/confidential] and we will store them [describe].

 With changes to the regulations, most interviews and focus groups can be considered for exemption, even if they are recorded.  Feel free to use the exempt consent template to describe the storage, use and disposition of recordings.

It may be more appropriate to use the Exempt Consent form in these situations to better explain the research.

 03/01/2019
Research on students where Investigator is also Instructor of Record The survey/activity is being done for research.  Because I am both a researcher and your instructor for the class, I want to clarify:  1. Being in the research is separate from the assignments you have for this class, which means you still need to complete your coursework.  2. You do not have to participate in the research. If you choose to participate, your participation will not affect your grade or class standing in this course. If you choose not to participate it will also have no effect on your class standing or grade. [3. I will not know who has agreed to be in the research until after final grades are administered, so there is no way for me to be influenced by your participation.] 4. You can opt out of being in the research at any time, just let me know by [describe].  If you have any questions you can ask [name]. This situation makes your students slightly more vulnerable to feeling pressured to consent. It is important to separate the research activities from required assignments as well as assure participants that there is no potential undue influence to participate.  We recommend using the Exempt Consent form whenever possible for this type of research and include these statements or something similar.02/24/2019

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
Concise Summary Examples  Examples of Concise Summary Statements 
Concise Summary Video A short video explaining of what the Concise Summary Statement means for you as a researcher. 
Consent Forms Parent 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