1. Common Rule Updates Tips and Tricks
Informed Consent
Common Rule Updates
Tips and Tricks
Overview of recent consent form- related updates
Tips and tricks on submitting the best Consent Form possible
IRB Open House May 17, 2019

2. Consent Form Related Updates: Revised Common Rule
The revised federal rule governing human subjects research (the “Common Rule”) requires changes to the format of informed consent documents. This includes the new element of “key information,” which must be presented at the beginning of the consent form.

3. Consent Form Related Updates: Revised Common Rule
Changes were intended to promote autonomy by:
giving potential research participants necessary information to make informed decisions and
making the informed consent process more meaningful

4. Consent Form Related Updates: Revised Common Rule
These changes required that we update our consent form template (Version 16) for all studies initially approved on/after January 21, 2019.
The Version 16 consent has been formatted to include:
Section on “Research Summary (Key Information)”
New required and optional elements of consent
*Any applications approved before January 21, 2019 will live on Version 15 template, even if submitting a new consent for that application in a change in research.

5. Consent Form Related Updates: Revised Common Rule
New general requirements for informed consent [Under (a)]
The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

6. Consent Form Related Updates: Revised Common Rule—Key Information
must be provided first, at the beginning of the consent form
must be presented in a concise and focused manner, not just a list of isolated facts
should be about why one might or might not want to participate – this can include (but is not limited to) information about purposes, risk, benefits, alternatives, cost.
*Short Forms (including oral consents) must also present key information first

7. Consent Form Related Updates: Revised Common Rule—Key Information
Little federal guidance of what key information must include.
Limited early guidance suggests this to be an “Executive Summary” not a copy and paste of information presented in other sections.
JHM IRB has developed some guidance here:

8. Consent Form Related Updates: Revised Common Rule—Key Information
Suggestions:
Consider what key facts and concise information you would present to a lay person if you had less than 10 minutes to explain the study (“what”, “who”, “where”, “when”, “how”) that can be conveyed in 2-3 paragraphs.
Present the key information in the same order in which the information will be presented in the body of the consent form
Should not be a direct cut and paste from information found in the main body of the consent form.

9. Consent Form Related Updates: Revised Common Rule—Key Information
Additional suggestions:
Include why an individual may not want to participate.
State if the study is first in human or first in a particular population (such as children or people with a specific diagnosis)
Key information section is an overview. The sections of the consent form that follow will provide the complete details.
Participants must read the entire document before making their final decision.
Bullet 1: such as significant time commitment or risks
The content of the key information will vary depending on the research.

10. Key Information Sample
The purpose of this research study is to determine the effectiveness of physical therapy in the treatment of people with ABC. Participants will undergo a 2-day screening that includes a blood draw, exercise testing, and completion of quality-of-life surveys. Once screening is complete, participants will complete a physical therapy program that will require visits 3 times each week for 16 weeks, for a total of 48 visits. Each visit will take about 2 hours.
Participants will also be asked to complete a pain diary and have blood samples taken every 4 weeks throughout the study. Follow-up phone calls from the study team will occur at 4 weeks and 8 weeks after completion of the physical therapy program. Total study duration is about 6 months.
The greatest risks of this study include the possibility of injury during the physical therapy program and loss of confidentiality.
*Helpful to include benefits

11. Revised Common Rule: 1 New Required Element
Include a statement about research that involves the collection of identifiable private information or identifiable biospecimens:
A statement that identifiers might be removed from the information or biospecimens and that, after such removal, the information or specimens could be used for future research studies or distributed to another investigator for future studies without additional informed consent being obtained. OR
A statement that the information or biospecimens, even if identifiers are removed, will not be used or distributed for future research studies.
This is included in “new” Section 4a/4b
*New biospecimen guidance on IRB website

12. Revised Common Rule: 3 New Additional Elements
A statement that the subject’s biospecimens may be used for commercial profit, and whether the subject will or will not share in that profit. (Section 4b)
A statement about whether clinically relevant results, including individual results will be disclosed to the participant and if so, under what conditions. (Section 3)
A statement about whether the research will (if known), or might include whole genome sequencing. (Section 4b)
*Bullet 1: This statement was also included in Version 15.
*Bullet 2: Version 16 gives 3 options: will get the results, uncertain about whether the results are clinically relevant, so you will not get results and you will not get results
Additional, not required

13. New Consent Template Version 16:
Main changes:
No separate Parental Consent
Removed section 1 bullets
Data/biospecimens now Section 4
HIPAA broken up into smaller sections
Optional components at the end
-Optional elements at end to consolidate signature lines.

14. Tips and Tricks Things to AVOID: Confusing “research” and “treatment”
Using “patient” instead of “participant”
Describing free testing, incidental findings and/or payment as a benefit
Run-on text
Direct copy and paste from protocol (technical/scientific language)
Including procedures and risks when something is standard of care
Embedding comments to and from Sponsor/PI etc.
Do not describe an investigational test article or experimental procedure as “treatment”
Investigational drugs and devices used in a research study are not
Treatment
Therapy
Medicine
They are also not “new medicine” or “new treatment”
Therapeutic misconception arises whenever human subjects misunderstand the primary purpose of a clinical trial as therapeutic.
People in research studies should not be referred to as “patients” in consent forms.
Once a patient volunteers to take part in a research study, for that role they are “participants.”

15. Tips and Tricks Things to DO: Use bulleted lists Use sub-headings
Use diagrams/flow-charts of study visits, study devices, size of biopsies etc.
Clearly indicate what is standard of care and what is being done only for research
When submitting a CIR, ALWAYS use the currently approved Word version of your CF to track the changes

16. Consent is a Process, not just a Form
Consenting should include discussion
Ask questions to assess comprehension
Signing of consent should happen in person
Make sure each applicable signature line is signed
Use current approved version with stamp
* Bullet 1: Can occur over a few visits so person doesn’t feel pressured. Encourage to discuss with family

17. Where to find consent templates
Version 16:
Version 15:

18. Contacts For consent form related questions: Heather Kammann
Sr. Consent Form Specialist
(410)
Lucas Szylow
(410)
Mary Medak
Consent Form Specialist 
(443)
Lauren Swedberg
Kristen Martin
Consent Form Specialist
(410)
(443)