IRB Forms

Request For Review Forms

Form

Purpose

Version Date

Exemption Request for Research with Human Participants  

Submit a request for exempt research to the Western Human Research Committee/IRB.

07-01-2013

Request for Initial Review

Submit a human subject research study to the Western Human Research Committee/IRB.

07-01-2013

Request for Initial Review of VO2 Max Test  

Submit a human subject research study that involves conducting VO2 Max tests on participants who are considered low risk for a cardovascular event (per the ACSM guidelines) to the Western Human Research Committee/IRB.

07-01-2013

Request for Modification/Addendum

Use to request changes (other than personnel) for an IRB approved study. May be used in conjunction with renewal applications, when the renewal involves changes other than personnel. If the study is not up for renewal, and the only change is personnel, send an email to irb@western.edu with a list of the changes.

07-01-2013

Request for Continuing Review  

Used to seek renewal of IRB approval (annual renewals). The only changes permitted on this application are personnel. Any other changes require a Request for Modification/Addendum form in addition to the renewal.

07-01-2013

Event Report Form  

Use when, during your human subject research, an unanticipated or adverse event occurs requiring notification to the IRB. 

07-01-2013

Study Closure Form

Use to notify the IRB that your research is 1) no longer enrolling subjects, 2) all intervention and/or interactions with enrolled subjects have ended, and 3) the collected data does not include private identifiable information (i.e., participant's identity cannot be ascertained and associated with private information).

07-01-2013

Research Personnel Form

Researchers submitting requests for review which require expertise to perform study procedures (e.g., blood draws, interviewing participants about sensitive topics) should document experience and training to show that risks to participants are minimized. Other members of the research team (including students) who need to demonstrate similar expertise may also use this form.
Note: This form is kept on file so that research personnel do not need to submit a new form with every IRB application unless training has changed.

07-01-2013

 

 

Consent Forms

Form

Purpose

Version Date

Assent for Minors Under 18

Used when participants are under the age of 18 years but capable of reading and understanding the study (e.g., participants age 7-17).

07-01-2013

Consent to Participate in Biomedical Research

Covers biomedical research, including approved wording for frequently used procedures.

07-01-2013

Consent for Exempt Research  

Used for minimal risk research activities other than a survey. (If you are using an online survey, use the "Exempt Survey Consent" template.)

07-01-2013

Consent to Participate in Research

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

07-01-2013

Survey Participant Information

This exempt survey consent can be added to the beginning of any minimal risk survey where documentation of informed consent (signature) is not needed or required.

07-01-2013

Focus Group Participant Consent Form

Used when research activities include only focus groups of participants or a subset of participants.

07-01-2013

Interviewee Consent Form  

Used when research activities include only interviews of participants or a subset of participants.

07-01-2013

 

Additional IRB Related Templates and Forms

Form

Purpose

Version Date

Screening Questionnaire for Research Involving Exercise

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.

07-01-2013

Letter of Agreement

Used when another organization is involved in recruiting participants/allowing access to participants/allowing access to data.

07-01-2013

Letter of Agreement for Using Student Data  

Used when Appalachian student records data is used for research purposes. Explains protections in place as required by FERPA.

07-01-2013

Instructor’s Approval of Class Research

Used to cover exempt classroom research that fits into specific restrictions and is monitored by the faculty instructor. 

07/01/2013