Elements of Informed Consent

Note: Always use lay language that is appropriate to the population being asked to sign the form. Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form template (pdf) for more help and sample language.

1. Title of the Study
2. Names and Affiliations of the Primary Investigator
  • If a student is conducting the study, state the student's information first.
3. Purpose of the Study
  • Describe the general purpose of the study.
4. Subject Selection Criteria
  • Describe how the subjects were chosen.
5. Study Procedures
  • In chronological order, describe what the subject will be asked to do (an activity, completing a survey).

  • Describe the total length of time for participation (how long, how often).

  • If applicable, explain that the investigator will be audiotaping or videotaping, and if this is optional.

6. Potential Risks and Discomforts
  • Describe any potential for psychological, social, legal or financial risk or harms to the subject and their probability as a direct result of participation in the research and/or from breach of confidentiality. (Remember: There is no such thing as risk-free human subject research.)
7. Potential Benefits
  • Describe any expected benefits to the subjects themselves (clearly state if subject will not benefit directly from the study).

  • Describe any expected benefits to society and/or science.

8. Cost and Compensation
  • Describe any cost to the subject (include time spent).

  • Describe any compensation the subject will be offered as a result of participation in the research (if partial participation will result in partial compensation, explain).

9. Future Use of Data
If working with identifiable data:
  • Explain that identifiable private information/de-identified data may be retained and used for additional or subsequent research, and if this is optional .

– OR –

  • State that the data collected will not be distributed for future research, even with the identifiers removed (note that some funders and journals require de-identified data to be made available to others postresearch/publication).
10. Confidentiality
  • Describe the level to which subject information will be kept confidential (describe procedures that will be used to safeguard data, including where it will be kept, who will have access to it and at what point it will be destroyed; note the difference between anonymous and confidential).

  • Note that data will only be kept confidential to the extent permitted by law.

11. Participation and Withdrawal
  • State clearly that participation is voluntary and that the subject may refuse to answer any questions or withdraw from the study at any time without penalty (including loss of benefits to which they would otherwise be entitled).
12. Contact Information
  • Give the contact information of the principal investigator and supervised researcher (if applicable) for questions about the study.

  • Give the contact information of the Brandeis University HRPP (hrpp-group@brandeis.edu or 781-736-8133) for questions about the subject's rights as a human subject or concerns about the research.

13. Subject Consent

Example

I have read (or had read to me) the contents of this consent form and have been encouraged to ask questions. I have received satisfactory answers to my questions. I understand that my participation is voluntary and that I may withdraw my participation at any time without penalty. I voluntarily agree to participate in this study.

__  I do  __  I do not give you permission to make audio/video recordings of me during this study (if applicable).

__  I do  __  I do not give you permission to retain and use my data for future research (if applicable).

  • Signatures of subject and investigator.

Additional statement of confidentiality to be used for research involving focus groups:

14. Focus Group

Example

Note that we cannot guarantee that others in the group discussion will keep what you say private. When you sign this form, you agree to not talk about what was said in the group with anyone not part of the group. Everyone in the group will have agreed to this – but we cannot guarantee that everyone will keep their promise.

Additional statement of procedure to be used when appropriate for research involving incomplete disclosure:

15. Incomplete Disclosure and Deception

Example

Research sometimes requires that information regarding its purpose not be shared with the participant. The reason for this is that if you know what the purpose is, it could impact your answers. We will not ask you to do anything that has not been described in this form. At the end of your participation, we will explain the details of the research to you. At that time you will have the opportunity to ask questions. You will also be given the opportunity to tell us not to use your answers. Note that if we told you the purpose of the research now, we do not believe it would change your mind to participate.

Additional statement of confidentiality when collecting identifiable, sensitive information for research funded by NIH, or when a certificate of confidentiality has been issued by NIH, CDC, FDA, HRSA or SAMHSA:

16. Certificates of Confidentiality

Example

This research is covered by a Certificate of Confidentiality. That means any identifiable information you share cannot be used as evidence in court – unless you say it’s okay. This does not mean you can’t share your information with anyone if you want to. But, if you want us to share your information with anybody, you will need to sign another consent form.

Additional statement to be used if researcher is a mandated reporter

17. Mandated Reporting
  • Include a statement that if the subject reports information concerning child abuse (or other information you are mandated to report) you are obligated to report it.

Additional elements of informed consent to be used when appropriate (generally only necessary for biomedical/clinical research):

18. Experimental Procedures
  • Identify and describe any procedures that are experimental.
19. Alternative Procedures
  • Include a statement of any alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
20. Possibility of Unforeseeable Risks
  • Include a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
21. Compensation or Treatment in Case of Injury
  • Explain whether any compensation or medical treatments are available if injury occurs, what they consist of, and where further information may be obtained.
22. Potential Termination Without Regard to Consent
  • Include a statement of anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
23. Additional Costs
  • Describe any additional costs to the subject that may result from participation in the research.
24. Consequences of Withdrawal
  • Review the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
25. Provision of Significant New Findings
  • Include a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
26. Number of Subjects
  • State the approximate number of subjects involved in the study.
27. Commercial Use of Biospecimens
  • A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
28. Clinically Relevant Research Results
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
29. Genome Sequencing
  • A statement of whether the research will or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).