Informed Consent

Image result for informed consent cartoonVoluntary informed consent, a prerequisite for participation in research, is a process and a document.  The informed consent process is about the protection and respect for research subjects. The consent process varies according to the level of review and nature of the research.

In all cases, the informed consent process/document must:

  • Be presented in language easily understood by the subject
  • Minimize the possibility of coercion or undue influence
  • Allow subjects with sufficient time to consider participation
  • Allow subjects to refuse or discontinue participation at any time
  • Distinguish between research and standard medical care
  • Be appropriately presented for the subject’s physical, emotional and psychological capacity, and vulnerable status
  • Assure that subject understands what participation entails

Required elements of informed consent:

  • Purpose and procedures involved in the research
  • Alternatives to participation
  • All foreseeable risks and discomforts to the subject (e.g. physical injury, psychological, social, or economic damage).
  • Benefits of the research to society and the individual subject
  • Person to contact for answers to questions or in the event of a research-related injury or emergency
  • In the state of California subjects must be presented with a copy of the Experimental Subject’s Bill of Rights

Waiver of one or more elements of informed consent may be permitted by the IRB for some research activities if appropriate.

The following are types of informed consent: consent, parental permission, assent, verbal, short form, information/fact sheet, waiver of documentation of informed consent, and waiver of elements of informed consent.

Informed Consent Templates

Informed Consent in Human Subjects Research
This booklet provides an overview of informed consent: its importance, required elements of consent, the consenting process, and documenting consent.

Comparing Certificates of Confidentiality & DOJ Privacy Certificates

Recommendations on Certificates of Confidentiality (from OHRP Secretarial Advisory Subcommittee)

Documentation of Informed Consent

Frequently Asked Questions

Why do we have to submit Informed Consent revisions with tracked changes?
How do you Track Changes while you edit?
Do I always have to submit a “ROC” form with my IRB application?
What do I do if the approval of my study lapses?

Why do we have to submit Informed Consent revisions with tracked changes?

The strike through and clean copy documents allow us to make a side by side comparison of changes so we can review and note changes more quickly. Strike through copies of the informed consents are essential; especially for Spanish translation.

How do you Track Changes while you edit?

    1. Open the document you want to revise.
    2. Go to Tools, click Track Changes > Highlight Changes > Check all three boxes and click OK.
    3. Make the changes you want by inserting, deleting, or moving text or graphics. You can also change any formatting. Microsoft Word uses revision marks to show the tracked changes.
    4. To specify how Word should show tracked changes and how you want inserted, deleted, and changed text to appear, click the Track Changes tab in the Options dialog box (Tools menu).
    5. Tracked changes will look like this:

Original:

Strikethrough:

Final:

Revision mark: A mark that shows where a deletion, insertion, or other editing change has been made in a document. Microsoft Word can track changes in one of two ways: by marking the revisions as you make them, or by marking the revisions later when it compares the two versions of the document.

    1. After you have made your edits, save the document with the track changes.

An example: Study Name. IC. Strikethrough. Date.doc

    1. After it is saved as a strikethrough, open it again and save it as:

Study Name. IC. Final.Date.doc

  1. In this “final” version go back to Tools > Track Changes > Accept or Reject Changes > follow the prompts. After you have accepted your changes, save your document.

You now have a strikethrough copy and clean copy to submit to the IRB! Use this procedure to complete revisions on informed consents, recruitment flyers, or other documents. The IRB staff will be able to review the documents more quickly.

Do I always have to submit a “ROC” form with my IRB application?

The Research Oversight Committee (ROC) Review form must be submitted with your new IRB application if your research will be conducted at a Los Angeles County health facility. This includes LAC+USC General Hospital, Women’s and Children’s Hospital, LAC+USC Outpatient Clinics, and the Comprehensive Health Centers. If you are not conducting research activities at any of these facilities, you do not need to submit the ROC form.

What do I do if the approval of my study lapses?

If the expiration date has lapsed, the investigator must formally request (email or telephone is acceptable) to continue study subjects currently on the trial and/or continue data analysis. The investigator will receive confirmation from the IRB. The investigator may not enter new subjects until the study’s continuing review has been reviewed and approved by the full board. The investigator will receive a separate correspondence at that time.

It is important that investigators comply with 45 CFR 46. 45 CFR 46.109 (e), which requires the IRB to review a study at intervals appropriate to the degree of risk, but not less than once per year.