Human Protections Forms

 

You must submit a protocol and consent form, as well as supporting documentation for your research project. This section contains templates of all the forms you may need to submit, and descriptions of when you need to submit them.

 

IMPORTANT: Please delete italicized directions before turning in. Use a 12-point font.

 

Form Name Description

Application for Determination of Exemption from IRB Approval

This online form is used to apply for a determination of Exemption.  No other forms are needed for this review.

 

Protocol Submission Forms

Student - Protocol Approval Form Approval form indicating protocol title, contact information, and approval from department advisor. All research protocols submitted to Human and Animal Protections must use this form. Two separate advisor signatures are required. Download [Student Protocol Approval Form in Word] or [Student Protocol Approval Form in PDF].
Faculty  - Protocol Approval Form Approval form indicating protocol title, contact information, and approval from the Department Chair (required). All research protocols submitted to Human and Animal Protections must use this form.  Download [Faculty Protocol Approval Form in Word] or [Faculty Protocol Approval Form in PDF].
Protocol Statement
Protocol Template All research protocols submitted to Human and Animal Protections must follow this protocol format.
Informed Consent/Assent Templates
Informed Consent All research protocols submitted to Human and Animal Protections must follow this template.
Parental Permission This can be used when your volunteers are under the age of 18. If your volunteers are within the ages of 8-17, you will also need a Minor Assent Form.
NOTE: Before downloading this form, read the Guidelines for Minor Assent.
Minor Assent to Participate in Research This can be used when your volunteers are between the ages of 8 and 18. Read the Guidelines for Obtaining Minor Assent which include samples. You will also need to supply a Parental Permission to Participate in Research with this form.
Implied Consent for Surveys This can be used when you are conducting a non-sensitive survey (online or in-person) of non-vulnerable adults.
Verbal Consent Form You might use this when conducting phone interviews. The volunteer will not sign this form as it will be read aloud to the volunteer.
Witness/Translator Consent Form Use this form for volunteers who do not speak or read English (the alternative, and preferred method, is to translate an Informed Consent form into the volunteers' native language). The researcher can read this aloud to the volunteer and the witness/translator will verify that the volunteer understands.
Focus Group Consent Form Add this paragraph under the "Risks" section in the informed consent when you are conducting research where volunteers will be involved in group discussions or focus groups.
Recruiting
Permission to Recruit / Conduct Research If you are recruiting volunteers through a teacher, department, organization or agency, or if you are conducting research in the classroom, or at a business, organization or agency, provide HAP with a letter of permission to recruit and/or conduct research. Please make sure the letters are signed and on the organization's letterhead. Emailed versions are accepted on a case-by-case basis.
Recruiting Script A script template for recruiting volunteers.
Related Documents
Photo Release Use only the elements that apply to your research when utilizing photographs.
Video Release Use only the elements that apply to your research when utilizing video recording.

 

Renewing / Modifying Research

Renewal Form Please answer all questions and include a brief description of your research up to this point.
Modifications Form Please answer all questions.  In addition, please update the protocol or other accompany documents that are affected by this change.

 

Completion of Research

Completion Form Notify HAP when you have completed your research with this form.

 

Adverse Events & Protocol Deviation/Violation

Adverse Events Report Form Serious and Significant adverse events must be reported to HAP as soon as possible for the protection of the research volunteer, but within at least 5 working days using the Serious/Significant Adverse Event Report Form.
Deviation Report Form Deviations from the approved protocol that have already occurred and breaches of scientific integrity and ethics on the part of the researchers should be reported on the Deviation/Violation Report form.