Informed Consent Template

WINSTON-SALEM STATE UNIVERSITY
INFORMED CONSENT FORM

Title of Study* - required

Headings with (*) are required for all studies

IMPORTANT: BEFORE FINALIZING & PRINTING THIS DOCUMENT REMOVE THIS TEXT & ALL RED AND BLUE INSTRUCTIONAL TEXT (this document is ONLY a recommended template).

Preamble: include the following information.

• Statement that study involves research, 116(b)(1)

• Explanation of the purposes of the research and the expected duration of the subjects’ participation, 116(b)(1)

• A description of the procedures to be followed, 116(b)(1) and

• Identification of any procedures that are experimental 116(b)(1) Description of any reasonably foreseeable risks or discomforts to the subject 116(b)(2)

• Description of any benefits to the subject or to others that may reasonably be expected from the research 116(b)(3)

• Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject 116(b)(4) If clinical research only

Example: You are being asked to participate in a research study. Participation in this study is completely voluntary. The purpose of the study is . The duration of the study is . The procedures to be followed . The procedures that are experimental are . The benefits to the subject that may be expected are . Please read the information below and ask questions about anything that you do not understand before deciding if you want to participate. A researcher listed below will be available to answer your questions.

RESEARCH TEAM*

Principal Investigator:

Name and Title:

Department:

Telephone Number:

Faculty Sponsor:

Name and Title:

Department:

Other Co-Investigators or Researchers:

(List only those researchers qualified to be involved in the informed consent process)

Study Location(s):

Study Sponsor(s):

PURPOSE OF STUDY*

SUBJECTS*

Inclusion Requirements

Exclusion Requirements (Optional)

Number of Participants and Time Commitment*

This study will include approximately subjects and will involve approximately of your time.

PROCEDURES*

RISKS AND DISCOMFORTS*

UNKNOWN RISKS (Optional)

BENEFITS*

Subject Benefits

Benefits to Others or Society*

ALTERNATIVES TO PARTICIPATION*

Students Participation (if subjects are students of Principal Investigator)

COMPENSATION, COSTS AND REIMBURSEMENT*

Compensation for Participation*

[CHOOSE ONE OPTION]

You will be paid $

OR

You will be paid $ after each study visit. There are visits. Total payment for participation in this study is $. If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits that you have completed.

OR

You will not be paid for your participation in this research study.

Costs (Optional)

There is no cost to you for participation in this study.

OR

Reimbursement (Optional)

You will be refunded for the following expenses that you incur…

Examples: parking fees, transportation fees

You will not be reimbursed for any out of pocket expenses, such as parking or transportation fees.

Compensation for Injury – [Required if research involves greater than minimal risk]

WITHDRAWAL OR TERMINATION FROM THE STUDY AND CONSEQUENCES (Optional)

CONFIDENTIALITY*

Subject Identifiable Data*

Data Storage*

Data Access*

Data Retention*

OTHER CONSIDERATIONS (Optional)

Use of Specimens

Investigator Financial Conflict of Interest

NEW FINDINGS (Optional)

IF YOU HAVE QUESTIONS*

CONSENT STATEMENT*

I agree to participate in the study.

Printed Name of Subject*

Printed Name of Legally Authorized Representative/Guardian’s

Printed Name of Legally Authorized Representative/Guardian’s

Printed Name of Researcher*