1. Informed Consent (SBER)
2018 Revised Common Rule
Informed Consent (SBER)

2. NOTE & DISCLAIMER
January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule.
This means that applications currently submitted and awaiting review may require revision based on the revised common rule requirements.  Please be patient...

3. TOPICS
Introduction and Background
Major Changes
Sample Consent Form

4. ABOUT THE REGULATIONS
Common Rule – Federal regulations governing human subjects research
U.S. Department of Health and Human Services (HHS) regulations - 45 CFR 46, Subpart A “Federal Policy for the Protection of Human Subjects”
Current regulations published in 1991

5. THE NEW REGULATIONS
The Revised Common Rule (2018 Common Rule) was published on January 19, 2017
Effective date is January 21, 2019
Why revised?
The revisions are intended to:
Better protect human subjects involved in research
Facilitate research
Remove ambiguity
Reduce regulatory burden

6. “Key information” at beginning of consent document
MAJOR CHANGES
“Key information” at beginning of consent document
New required elements of consent
Changes to waiver criteria and documentation
“Broad consent” option

7. ADDED BONUS
The HIPAA language is being incorporated into the consent form
There will be a new section in the revised Sample Consent Form: Confidentiality and Authorization to Use and Disclose Information for Research Purposes

8. KEY INFORMATION
The consent form must begin with a “concise and focused presentation of the key information” that will assist subjects in deciding why they might or might not want to participate in the research.
Key information must be organized and presented in a way that facilitates comprehension.
Key information appears at the beginning of the consent form and is presented first in the consent discussion.

9. KEY INFORMATION
The key information is information that a “reasonable person” would want to have.
Investigator is still responsible for providing more information when requested by subjects, allowing sufficient time and opportunity to discuss the research, and answering questions from subjects.

10. KEY INFORMATION Five Factors
The fact that consent is being sought for research and that participation is voluntary
The purposes of the research, expected duration of the prospective subject’s participation, and procedures to be followed in the research
The reasonable foreseeable risks or discomforts to the prospective subject
The benefits to the prospective subject or others that may reasonably be expected from the research
Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject

11. KEY INFORMATION Concise Summary Table
[Insert applicable Concise Summary Table – see samples in separate document]
General Information
You are being asked to take part in a research study. This research study is voluntary, meaning you do not have to take part in it. The procedures, risks, and benefits are fully described further in the consent form.
Purpose
The purpose of the study is…
Duration & Visits
You will be in this study for…
Overview of Procedures
This study will include…
Risks
The most likely risks are…
Benefits
The benefits are…
Alternatives
If you do not want to take part in the study…

12. DRAFT - Concise Summary for Drug/Device Study

13. DRAFT - Concise Summary for Other Treatment or Intervention Study (No Drug/Device)

14. DRAFT - Concise Summary for Survey & Focus Group Study

15. FOUR NEW ELEMENTS
For research that involves collection of identifiable private information or identifiable biospecimens, include a statement indicating whether:
identifiers may be removed, and
de-identified information or biospecimens may or may not be used or shared for future research

16. DRAFT of the Revised Sample Consent

17. FOUR NEW ELEMENTS
For research involving use of biospecimens, include a statement indicating whether:
biospecimens may be used for commercial profit, and
the subject will share in that profit

18. DRAFT of the Revised Sample Consent

19. INFORMED CONSENT – FOUR NEW ELEMENTS
For research expected to generate clinically relevant results, include a statement indicating whether:
the clinical results (including individual research results) will be returned to the subject, and
if so, under what conditions

20. DRAFT of the Revised Sample Consent

21. INFORMED CONSENT – FOUR NEW ELEMENTS
For research involving whole genome sequencing, include a statement that the research will or might include whole genome sequencing

22. DRAFT of the Revised Sample Consent

23. INFORMED CONSENT – BROAD CONSENT
Broad consent is an optional, alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for unspecified future research
Requires recording and tracking who has agreed to or refused consent
Requires you apply that agreement/refusal of consent to all secondary use research – waivers would no longer be allowed
UAB not adopting broad consent at this time.

24. STAY TUNED
As we move forward, business decisions will continue to be made.
Guidance documents from OHRP may prompt revisions to our implementation strategy.
Be mindful of ongoing communications:
IRB website
IRB Listserv
Training sessions
Contact the Office of the IRB with any questions.