Research Roundtable: Updated HRP-502 Consent Template - Summary of Changes

Previously, this area before "Title of Research Study" also included "… or Assent of a 14-17-year old to Participate in a Research Study." The UB IRB will also be unveiling a new separate 14-17-year old Assent Form in the near future, although this is not yet available in the Click Library. Until this new Assent Form is available, you may continue to use this option, and please remember on the Signature Page to change "obtaining consent" to "obtaining assent."

Additional information is added in this section regarding whether a pregnancy test will be involved in the research procedures, and to whom the results will be disclosed.

Some suggested language regarding the risk of breach of confidentiality for identifiable information is included here.

The HRP-314 Criteria For Approval Section 7i requires that the consent document disclose "The extent, if any, to which confidentiality of records identifying the subject will be maintained." Previously, this section of the consent would only include the required text in the first paragraph and nothing else, and would not provide study-specific procedures for protecting confidentiality. This instructional paragraph was added in order to focus on this requirement. 

Banking data for future research outside the scope of the current study is becoming much more common. A statement that tells participants that their data or specimens will be retained for future research was added if this is included in the study plans, specifically in Section 32 of the HRP-503 Protocol "Banking Data or Specimens for Future Use." More clarity about how their information will be protected if banked for future use is also included.

As part of the Common Rule changes to 45 CFR 46 that were implemented in January 2019, if a study involves the collection of identifiable private information or identifiable biospecimens, one of the two statements above MUST be included in the study consent form. This is also a requirement in the HRP-314 Criteria for Approval, Section 7p. Oftentimes, this paragraph is skipped, as investigators do not know or do not think that it applies to their study. For this reason, and to make it more understandable to research participants, we simplified the language for both statements which will still meet the approval criteria.

The ClinicalTrials.gov website was changed to a hyperlink.

"Include sub-section below" was added to several places in the "What else do I need to know?" section in order to reduce confusion about when certain sub-sections are needed, as this section tends to blend together pretty easily.

The final sentence of the "Who will pay for my medical care if participating in this research harms me?" subsection is often left out since it is a separate paragraph after describing when a Sponsor will pay for research-related injury. If a study is greater than minimal risk but isn’t industry-sponsored, the last sentence/paragraph is skipped even more frequently, because the first paragraph and bullet points shown here are omitted. Red instructional text was added before the last sentence/paragraph to clarify that the last sentence is needed any time the "Who will pay for my medical care if participating in this research harms me?" subsection is included in the consent form.

Instructions were edited for clarity.

UB recently unveiled a new U.S. Bank Card program for compensating research participants, so the old language used for Greenphire was replaced by U.S. Bank Card information. There are three different types of U.S. Bank Cards that could be used. You will want to include the language that matches the type of card you are using for your study, so please review the options carefully. The text above is for Option 1.

This is Option 2 in the consent for the U.S. Bank Card.

This is Option 3 for the U.S. Bank Card.

The UB Allowable Use of Funds policy updated the minimum card deposit where a W-9 is required to be issued to participants from $50 to $100.

Instructions have been updated for clarity.

Instructions regarding deleting the HIPAA section if not applicable have been moved ahead of the title of the section.

The first option of HIPAA Section A is meant to include a specific and meaningful description of the information that will be collected from the medical records. However, we often see the box checked but no description given. A line was added to imply that the study team can type a description if the box is checked.

Instructions have been edited for clarity. The last sentence of Option D was removed; if Option B is also checked, the statements would conflict.

There are four different signature pages: Page 15 (Capable Adult), Page 16 (LAR of Adult Unable to Consent), Page 18 (Parental Permission), and Page 19 (Assent of Adults who are Legally Unable to Consent). The old template mistakenly said there were three.

After the last Signature Block page, instructional text was added to describe that a flyer for research recruitment by the UB Clinical and Translational Science Institute (CTSI) is included on the following page. The UB CTSI recruitment flyer is now the last page of the HRP-502 Consent Form. If researchers would like to use this flyer as part of their consent, they must include a blank page in their consent between the last Signature Block page and the flyer, so the flyer can be torn off and given to the participant separately. The page with the recruitment flyer is optional and can be removed if the investigator chooses not to include it.