Format For Signed Informed Consent Document (Page 2 of 4) in pdf

Where will this take place and how much of my time will it take?

Tell the person where each part of the study will be conducted and how long each part

will take.

Ex: You will be interviewed in your own home or at a time and place that is

convenient for you. The interview will take about one hour. Three months later,

we will mail you a follow-up questionnaire with 25 questions that will take 20- 30

minutes to complete. You can mail it back to us in the stamped envelope we will

provide.

Will there be any risk or discomfort to me?

Identify any reasonable foreseeable risks, harms, discomforts or inconvenience that the

participant may experience. Indicate the likelihood that it may occur as well as the

seriousness. Consider legal, financial, social, psychological, physical, etc. risks. Describe

the precautions you will take to minimize the risks, discomforts or inconvenience.

Describe follow up for any adverse event (anxiety, physical injury). If there is no

foreseeable risk or discomfort, state that.

Will I benefit by being in this research?

Describe any personal benefits that the participant may reasonably expect from their

participation. If there is no direct benefit, state that. Payment for participation is not

considered a benefit.

Ex: There will be no direct benefit to you for taking part in the study. You may

add, "However, the information learned from this study may help …."

Who will see the information about me?

If the participant’s identity WILL NOT be matched to their responses:

Ex: Your identity as a participant in this study will not be known. That means no

one, not even the researchers, will know that the answers you give are from you.

If the participant’s identity WILL be matched to their responses:

Explain who will have access to information and in what form.

Ex: Your part in this study will be confidential. Only the researchers on this

study will see the information about you. No reports or publications will use

information that can identify you in any way.

Describe the procedures you will use to protect personal information. If codes are used,

describe coding procedures. Explain how data will be maintained, and when/if data will

be destroyed. Audiotapes and videotapes are considered identifiable information, even if

no names are included.

Describe any limits to confidentiality.

For example, identify any legal reporting

requirements, e.g., child abuse. Specify what information must be reported, under what

circumstances, and to whom. Also, explain official oversight or monitoring that may be

done by NU, government agencies, sponsors, etc.

Ex: In rare instances, authorized people may request to see research information

about you and other people in this study. This is done only to be sure that the

NU HSRP Rev. 1/4/2010

TEMPLATE 1 - FORMAT FOR SIGNED INFORMED CONSENT DOCUMENT

Format For Signed Informed Consent Document Page 2