Informed Consent To Participate In A Research Study printable pdf download

SAMPLE INFORMED CONSENT

Informed Consent to Participate in a Research Study

Smithsonian Institution

[Insert Unit Name and Address]

Title of Research Project:

Name of Principal Investigator:

Phone Number of Principal Investigator:

A. PURPOSE AND BACKGROUND

[Insert researcher’s name and affiliation] is conducting research on [insert what the research is about

in terms understandable to the potential participant]. The purpose of your participation in this

research is to help the researcher [insert why you are doing this research.] You were selected as a

possible participant in this study because [state why the subject was selected]. NOTE: If Researcher is

not the Principal Investigator, add information regarding supervision of researcher.

B. PROCEDURES

If you agree to participate in this research study, the following will occur: [State your process step by

step with detail and include the approximate amount of time the process will take. You should include

information on interview or questionnaire topics, any personal information requested, data collection

methods (audio, video, written) and frequency (if more than one collection).]

C. RISKS

[If there are risks you must state what they are. NOTE: Being uncomfortable, embarrassed and/or

inconvenienced are risks]

D. CONFIDENTIALITY

The records from this study will be kept as confidential as possible. No individual identities will be

used in any reports or publications resulting from the study. All [insert data collection and retention

method i.e. questionnaires, tapes, transcripts, summaries] will be given codes and stored separately

from any names or other direct identification of participants. Research information will be kept in

locked files at all times. Only research personnel will have access to the files and [insert data

collection and retention method] and only those with an essential need to see names or other

identifying information will have access to that particular file. After the study is completed [state time

frame for retaining collect data and whether it will be destroyed].

NOTE: All informed consent forms must have an explanation of the procedures by which participant

confidentiality will be protected and/or the extent that information will be disclosed and to whom.

E. BENEFITS OF PARTICIPATION

There will be no direct benefit to you from participating in this research study. The anticipated benefit

of your participation in this study is [insert the objective you are trying to achieve with this study].

NOTE: “direct benefit” is something that benefits the individual participant such as free medical care

or compensation. If the participant is being given something for participating, state that here in

substitute for the first sentence.

S:CATHYIRB-Human SubjectCONSENTSConsent sample.doc

Informed Consent To Participate In A Research Study