Document 11224469

advertisement
Boston College [SAMPLE] Telephone Consent Script
This is a guideline for a Telephone Consent Script that may be used for studies that are no more than minimal risk
where oral consent is applicable with a partial waiver of the subject's signature (see the Informed Consent
Waiver/Alteration Form on the website: http://www.bc.edu/research/oric/human/irbappforms.html). The
telephone consent script should contain all of the standard elements of consent and be customized according to
the purpose and procedure of your study. The script should be in a language which the average lay person is likely
to understand and appropriate for the specific research population involved in the particular project.
Sample Verbal Consent Script
Personal Introduction
 Hello, my name is....

I work with (name of PI, who is doing a research study)....

I am contacting you because....

Would you like to hear more about this study?

If a participant declines participation, thank them for their time and end the call.
Description of the Purpose of the Study

Do you have any questions before we get started? You can stop me at any time and ask questions

This study is funded by…. (if applicable)

The purpose of this study is ....(explain research question and purpose in lay language)

Participants in this study are from (state what area) AND/OR The total number of subjects is
expected to be… (give estimated number of participants)
Description of Participation

If you agree to be in this study, you would …..(explain procedures and tasks, describe length of time
for participation, frequency and duration of procedures, etc.)

After I start asking you the study questions, you can refuse to answer any questions that you don’t
want to or tell me that you want to stop answering the questions and that would be fine.

If you stop being a part of the study, it will not have any effect with your current or future
relationship with Boston College.... (name of site/s, if applicable)

If I feel that the questions are making you uncomfortable, I may stop the study…(include any
referrals/resources as appropriate)
Description of the Risks/Discomforts and Benefits

If you agree to participate in this study you may.... (brief description of risks). There may be unknown
risks.

By doing this study … (brief description of benefits) Compensation is not a benefit.

Do you want to continue?
Description of Payments and Costs
 You will receive X for participating in this study: [explain amount of payment or other reimbursement
information (e.g., class points, tokens, donations, etc.), as well as when payment and/or
reimbursement will occur and in what cases payment will not occur if any. ]. The IRB prefers that
compensation be prorated. If there will be no payment, state this.

There is no cost to you to participate in this research study.
Description of Confidentiality
 The records of this study will be kept private. In any sort of report we may publish, we will not include
any information that will make it possible to identify you. Research records will be kept in a locked
file and available only to (name those having access).
 All electronic information will be coded and secured using a password protected file. [If audio
recordings are made, explain specifically who will have access to them, if they will be used for
educational purposes, and when they will be erased/destroyed and indicate how they will be destroyed
or erased..]
 Access to the records will be limited to the researchers; however, please note that [if applicable
sponsors or funding agencies] regulatory agencies, and the Institutional Review Board and internal
Boston College auditors may review the research records.
Contact Information

If you have any questions about the study, please contact …(name and telephone number/email)

If you have any questions about your rights as a research participant, please contact the Director of
the Office for Research Protections, Boston College, at 617-552-4778 or irb@bc.edu

If you have no questions, we can begin the study; do you give your consent to participate in this
study? (If affirmative – document that. If, negative - thank them for their time and end the call)
Download