Basic Consent Form Template Instructions
truncated formThis template is basically a skeleton consent form.  It contains all the necessary basic standard statements required for use in a COMIRB consent form and the required COMIRB Heading.  It does not contain any individual standard statements such as for use of a placebo, drawing blood, use of radiation, etc.  The additional standard statements can be found in the document How to Write a Consent Form: Instructions to Clinical Investigators (or in the standard statement document) and pasted into the consent template.  You must provide the details of your study to make the consent form complete.  This template does NOT contain all the necessary elements for a parental consent.
Steps
1.Before making any changes to this file do a “Save As…” to the directory and file
name of your choice
2.Be sure to delete all italicized phrases and statements not used.  This template
does not provide general instructions about how to write each section.  Please
refer to the Instructions for Clinical Investigators for specific instructions
regarding what is necessary to include in the text of each section.
3.This template does contain all basic required standard statements.  However, you
may need to cut and paste standard statements from the Instructions to Clinical
Investigators, to describe specific procedures or circumstances.
4.All the headings should be included as a subject heading in the consent document.
The NCI template for consent in cancer trials is an acceptable alternative format.
5.VERY IMPORTANT:  Check your final version with the spelling and grammar
tool, to determine readability level.  Your consent form must be at an eighth grade
readability grade level.
COMIRB Official Consent Form Heading
The heading must be as it appears in the template.
∙The full name of the protocol and any identifying numbers must be listed in the “protocol title”(i.e. SWOG number).
∙If there are different consent forms for different subjects, name each different consent form (“Normal Control Consent Form”, et c).
∙The date or version of this consent form should be included and changed with each revision to easily discern the most current version.
COMPLETING THE CONSENT FORM:
1.Title:this should match your project title unless reason exists for it to be different
(i.e. desire to avoid any stigmatization in title of consent form, or to simplify title in
laymen’s terms.)
2.Why is this study being done?complete this statement by describing the purpose /
aim of the study, as specifically as possible.  Include the number of subjects in the study.
3.What happens if I join this study?Using bullets, list the activities that subjects will
perform; identify any experimental procedures under a separate “experimental procedures” heading.
4.Time: approximate the amount of subject’s time the research will require.
5.What are the possible discomforts or risks? use the bullets to list the risks and
benefits of being in the study.  If no risk exists indicate, “The risk associated with this study is no greater than everyday li fe.”  Remember to include psychological risk / mental stress and loss of confidentiality.  If appropriate, disclose
alternative procedures or courses of treatment and the alternative’s advantages to the subjects.  If applicable, indicate any anticipated circumstances under
which the PI may terminate the subject’s participation without regard to the subjects consent.  If applicable, list any consequences of subject’s decision to withdraw and the process for orderly termination from research.
6.Confidentiality and Privacy Protections may be main risks:Describe positive steps
taken to maintain and protect the confidentiality of research data and participant’s privacy.  Indicate any conditions under which confidentiality will be broken, for example, criminal activity, child neglect, child / elder abuse, or a clear, serious, and direct harm to self or others.  If conditions exist under which confidentiality may be broken, then indicate to whom necessary information would be reported
(i.e., the police, CPS, school counselor, parent, or appropriate professional).
Studies with audio or video recordings, participants must be told:
(a) interviews or sessions will be audio or videotaped;
(b)tapes will be coded so that no personally identifying information is visible
on them;
(c)tapes will be kept in a secure place (e.g., a locked file cabinet in the
investigator’s office);
(d)tapes will be heard or viewed only for research purposes by the
investigator and his or her associates;
(e)tapes will be erased after they are transcribed or coded.
If you wish to keep the recordings because of the requirements of your professional organization with respect to data or because you may wish to review them for additional analyses at a later time, the statement about erasing them should be omitted and you should state, “To make possible future analysis the investigator will retain the recordings,” and modify (a)-(e) above appropriately.
If you wish to present the recordings at a convention or to use them for other educational purposes, you should get special permission to do so by adding, after the signature lines on the consent form, the following statement:
We may wish to present some of the tapes from this study at scientific conventions or as demonstrations in classrooms. Please sign below if you are willing to allow us to do so with your tape.  In this case, add another signature line prefaced by, I hereby give permission for the video (audio) tape made for this research study to also be used for educational purposes.

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