The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision. You can read more information about the revised Common Rule on the OHRP website (https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html).
At this time, two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.
Additional federal websites that would satisfy the revised Common Rule's clinical trial consent form posting requirement might be identified in the future.
Uploading a Clinical Trial Informed Consent form to Regulations.gov
To use regulations.gov to satisfy the 45 CFR 46.116(h) requirement, you must submit the informed consent form as a comment to the appropriate docket folder (Docket ID: HHS-OPHS-2018-0021).
Please use the following instructions to submit:
Step 1: Navigate to the designated docket folder using this link: Docket ID: HHS-OPHS-2018-0021.
Step 2: Scroll to the "Primary Documents" section. The first item is titled "Announcement" and has a blue "Comment Now!" button next to it. Click the blue "Comment Now!" button.
Step 3: After you click on the blue "Comment Now!" button, you will be taken to a page that says "You are commenting on: The Department of Health and Human Services (HHS) other: Announcement."
Scroll past the large "Comment" box. You do not have to add anything in the "Comment" box as long as you include an attachment with your submission.
Scroll down until you see the grey "Choose files" button under the "Upload file(s)" heading.
After uploading your file, the site will ask you to fill out the "First Name" and "Last Name" boxes. This is built into Regulations.gov, but is not needed to post consent forms on this docket. You should leave both boxes blank and Regulations.gov will input "Anonymous" in both fields.
When you have finished inputting all required information, select the blue "Continue" button.
Step 4: You will be taken to a preview page. Review the information you provided. You will then need to review a disclaimer statement and select the checkbox saying that you have read and understood the disclaimer.
If you would like to change anything in your submission, select the grey "Edit" button at the bottom of the page. If you are satisfied with your submission, select the blue "Submit Comment" button.
Step 5: After you have submitted the informed consent form (in the form of a comment), you will be taken to a page titled "Your Receipt." You will be given a comment tracking number and the opportunity to have the receipt emailed to you.
Your comment (with the informed consent form attached) will be viewable on regulations.gov once an OHRP staff person posts it. If you have a question about the status of your submission, contact email@example.com with your comment tracking number provided by Regulations.gov.
Note that each submission will receive a unique tracking number.
Searching Within the Docket Folder
The docket folder (Docket ID: HHS-OPHS-2018-0021) housed on Regulations.gov is fully searchable. The search feature will search within any attached file for words or phrases typed into the search bar.
To search through posted informed consent forms:
Step 1: Go to the "Docket Folder Summary" page by following this link: Docket ID: HHS-OPHS-2018-0021.
Step 2: Click the "View all documents and comments in this docket" link at the top of the "Docket Folder Summary" page (highlighted in yellow below).
Step 3: Under the "Document Type" heading on the left navigation pane, select "Public Submission"
Step 4: In the search bar at the top of the screen, type the key words you would like to search for. You can also search within results by making sure the "search within results" radio button is selected and entering new search terms.
- You can search for multiple key words or phrases at a time by separating these words or phrases by commas.
- If you are looking for an exact match of a phrase, put the entire phrase in quotation marks. For example, if you were searching for the phrase blood sugar, you would enter "blood sugar" into the search box.
Uploading a Clinical Trial Informed Consent form to ClinicalTrials.Gov
Specific instructions on how to register with ClinicalTrials.gov and upload documents (including clinical trial informed consent forms) to that site may be found at https://clinicaltrials.gov/ct2/manage-recs.