Guide-Preparation of Informed Consent

General Guidelines for Informed Consent

• The form must include a brief, clear statement of exactly what constitutes participation so that there can be no question later as to whether the individual or parent/guardian was properly informed.  
• The form should not be deceptive in any way.  The consent form itself must neither deceive nor mislead subjects.
• The form should be written in the second person (“You will be asked to complete the following tests….") so that it accurately reflects the exchange between investigator and subject.
• The form should be written in a manner that will be fully understood by the subject.
• The "Consent Form" heading should be clear and separate.
• The form should clearly indicate that the subject is free to withdraw from the study at any time and without penalty.
• The form must not include any language suggesting that the subjects waive their rights by signing—the right, for instance, to sue.
• The form should assure the subject that appropriate steps will be taken to preserve privacy, confidentiality and anonymity.  The form should assure the subject that their name or other identifiers will not be revealed.  In those unusual instances where permission is sought to identify a subject in a research report (or any subsequent publication), then the IRB will determine whether a sufficient reason is given for doing so, and that the subject has been fully informed of that risk.
• In instances where subjects are asked to reveal personal experiences and states of mind, the form should make clear that if the subject should reveal something which Federal or State laws require the researcher to report, then the researcher will be obliged to do so, even where such reports appear to violate confidentiality – applicable Federal and State laws take precedence.

Specific Guidelines for Informed Consent Letters

1. Title:   Descriptive title.    

2. Principal Investigator: Include name of Principal Investigator and other researchers as appropriate with their contact information and institutional or program affiliations.  This includes the faculty principal investigators supervising research carried out by students (including doctoral and master's).

3. Sponsor: If the study is funded, include the sponsor's name.

4. Description and Purpose: (Required in all consent forms). May be one or more sections; modify heading(s) as appropriate. This part of the consent form must include:

• A clear explanation of the purpose of the research;
• The expected duration of the subject's total participation;
• The approximate number of subjects to be enrolled in the study at Lesley University and elsewhere. (This information is only required when the number of subjects is material to the person's decision to participate; e.g., small sample size might compromise anonymity.)

5. Procedures: (Required in all consent forms)

a) A description and explanation of the procedures that will be performed on the subject, e.g., filling out questionnaires, being interviewed, being audio and/or videotaped, engaging in role-playing or performing computerized experiments. b) A full explanation of all responsibilities and expectations of the subject.  Be sure to communicate the following:

• All of the different people with whom the subject will interact.
• Where the research will be done.
• When the research will be done.
• How often the procedures will be performed.
• How much of the subject's time will be involved in each session and the number of sessions.

6. Risks: (Required in all consent forms)

a) A description of any possible discomforts or risks that may exist. Explain how confidentiality will be assured if that is a potential problem.  Explain what will happen to data collected, including any video and/or audio recordings, once the study is completed.

This section should include a statement that the research may not provide any benefit to the subject. Any benefits to the subject or others that can be expected should be described in a way that is not coercive, enticing, or self-serving.  Benefit to society is appropriate.  Do not refer to financial compensation in this section. The following is acceptable wording for this section:

Participation in research is voluntary.  You have the right to refuse to be in this study.  If you decide to be in the study and change your mind, you have the right drop out at any time. You may skip questions. Whatever you decide, you will not lose any benefits to which you are otherwise entitled.

b) If your study does involve any risk of physical harm to subjects, the following statement shall be included on the consent form:

If you are injured during the course of the study and as a direct result of this study, you should contact the investigator at the number or e-mail address provided.  Although compensation is not available, Lesley University will assist you in obtaining medical treatment, including first aid, emergency treatment, and follow-up care as needed.  Your insurance carrier should be billed for the cost of such treatment.  If your insurance carrier denies coverage, Lesley University is under no obligation to pay for the treatment but may do so at its discretion. By providing financial or other assistance, neither Lesley University nor the researchers are stating that they are legally responsible for the injury.

7. Confidentiality, Privacy and Anonymity: (Required in all consent forms)

The following is acceptable wording for this statement, but this wording can be modified as appropriate:

You have the right to privacy. Your records will be kept private and confidential to the extent allowed by law. Numerical identifiers rather than your name will be used on study records. Your name and other facts that might identify you will not appear when this study is presented or published.

The consent form should end with statements similar to the following:

You will be given a copy of this consent form to keep.     

Both the investigator and the subject should keep a copy of the signed form.

We require that you add this exact paragraph at the bottom of the form:

There is a Standing Committee for Human Subjects in Research at Lesley University to which complaints or problems concerning any research project may, and should, be reported if they arise. Contact the Committee Chairperson at irb@lesley.edu.

 8. Signatures and names: (Required in all consent forms)

a) Investigator's Signature:

__________    __________________________________    ___________________

Date                Investigator's Signature                              Print Name

b) Subject's Signature:

I am 18 years of age or older. The nature and purpose of this research have been satisfactorily explained to me and I agree to become a participant in the study as described above.  I understand that I am free to discontinue participation at any time if I so choose, and that the investigator will gladly answer any questions that arise during the course of the research.

__________    __________________________________    ___________________

Date                Subject's Signature                                     Print Name

If needed (This line is required only if the subject is not able to consent for herself or himself):

__________    __________________________________    ___________________

Date                Signature  Parent/Guardian or                      Print Name

                      Legally Authorized Representative