1. Proposed Changes to Common Rule Karen Allen Director, Research Protections Office of Research Administration August 2011 karen.allen@uci.edu 949-824-1558

2. Learning Objectives Why is the Department of Health and Human Services proposing changes to the regulations for the protection of human subjects? What are the proposed changes? How can schools, departments, faculty, staff and students voice their opinion about these proposed changes?

3. Changes are being proposed to… 45 CFR Part 46 –Subpart A – Common Rule –Subpart B,C,D – Vulnerable Populations –Subpart E – IRB Registration Office for Human Research Protections (OHRP)

4. Current Federal HRP Regulatory Structure

5. Why are changes being proposed? It’s about time… –1981 – Regs. revised and expanded based on National Commission/Belmont Report recommendations –1991 - Subpart A adopted by 14 other federal agencies; became known as the “Common Rule” –No significant changes in 30 years Yet, Human Subjects Research has changed… –Increase in Human Subjects Research Domestic and International Multi-site research Biospecimens and Repositories –Social and Behavioral Scientists Concern that S&B research is over-regulated Common Rule does not apply; imposes a biomedical model

6. Henrietta Lacks – HeLa Cells

7. Havasupai Indians and Arizona State Univ

8. Unpublished Guatemala Syphilis Research

9. President Obama November 24, 2010 - Asked the Commission for the Study of Bioethical Issues to conduct a thorough review of human subjects protections to determine if Federal regulations and international standards adequately guard the health and well-being of research participants January 18, 2011 - Issued an Executive Order requiring all federal agencies to streamline the regulatory process while continuing to protect public health and safety

10. ANPRM to Common Rule July 26, 2011, the Department of Health and Human Services (DHHS) announced an ambitious plan to update the regulations regarding the protection of human subjects in research. The changes can be found in the Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators The government is seeking the public’s input on several issues related to the oversight of human research. The DHHS summary table of all 19 proposed revisions is also available.DHHS summary table

11. The Process Advanced Notice of Proposed Rule Making (ANPRM ) Notice of Proposed Rule Making (NPRM) Rule Open Comment Period Comments Reviewed NOTE: All comments will be posted without change to http://www.regulations.gov

12. Proposed Changes include… Improving Efficiency –No Annual Review of Minimal Risk Research –No Annual Review of Greater than Minimal Research if activities limited to Long-term Follow-up or Data Analysis –Exempt = “Excused” Research primarily risk is informational; must meet standards to protect privacy/confidentiality register research using a simple form expand categories to include more social/behavioral methods – for example interviews, focus groups, and surveys with competent adults even if identifiable information retained use of biological specimens even with identifiers

13. Proposed Changes include… Improving Efficiency (cont.) –Minimal Risk Categories would be regularly updated; include research procedures currently reviewed by full board Dexa Scan Skin Biopsy –Mandate that a single IRB conduct the review of domestic multi-site studies –Coordinate and harmonize, where possible, with other federal agencies Department of Defense Department of Education FDA

14. Proposed Changes include… Enhancing Protections –Use of biospecimens would require written informed consent, even if specimens are derived from a non- research procedure (i.e., discarded tissue) and will be de-identified Could use a standardized form allowing open-ended use in future research –Mandate new, HIPAA-like data security and information protection standards that would apply to all research data Use of encryption Audit trails for repositories

15. Proposed Changes include… Enhancing Protections (cont.) –Standardize Informed Consent Documentation Revise required elements of informed consent Limit length of document Standardize templates –Extend federal oversight to non-federally funded studies if institution receives any funding from Common Rule agencies –Adverse events and unanticipated problems would be submitted to and stored in a central database

16. How to Comment on ANPRM How to submit your input to inform the UC/UCI and other professional organizations (i.e., COGR): Send comments via e-mail UCI Office of Research to Comments.DHHS-ANPRM@research.uci.eduComments.DHHS-ANPRM@research.uci.edu Deadline is Friday, October 14, 2011, 5 pm

17. How to Comment to ANPRM Submit your individual comments directly to HHS: You may submit individual comments, identified by docket ID number HHS-OPHS-2011-0005, by one of the following methods: –Federal eRulemaking Portal: http://www.regulations.gov. Enter the above docket ID number in the ``Enter Keyword or ID'' field and click on ``Search.'' On the next Web page, click on ``Submit a Comment'' action and follow the instructions.http://www.regulations.gov –Mail/Hand delivery/Courier [For paper or CD-ROM submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. –Deadline is Wednesday, October 26, 2011, 5 p.m. EST –Comments received, including any personal information, will be posted without change to http://www.regulations.gov.http://www.regulations.gov

18. Questions? Contact… Bruce Morgan Assistant Vice Chancellor for Research Administration 949-824-5677 bruce.morgan@uci.edu Karen Allen Director, Research Protections 949-824-1558 karen.allen@uci.edu Beverley Esparza Assistant Director, Human Research Protections 949-824-5746 besparza@uci.edu