Consent for & Use of Biospecimens Proposed Changes to the Common Rule

1. Consent for & Use of BiospecimensProposed Changes to the Common Rule Wylie Burke MD PhD Department of Bioethics and Humanities University of Washington Seattle, WA

2. Overview of proposed changes • Informed consent would be required for research using biospecimens • Specifically, a written general consent would be required, using a short, standardized consent form providing broad permission for future research use • Consent could be obtained at the time the sample was collected or subsequently

3. Important context (to be discussed at later session) Mandatory data security and information protection standards

4. General consent “broad enough to cover all data and biospecimens to be collected related to a particular set of encounters with an institution (e.g. hospitalization) or to any data or biospecimens to be collected at anytime by the institution.”

5. Additional consent parameters • In rare instances, research might raise unique concerns, warranting check-off boxes allowing separate yes/no (e.g. creation of cell line; reproductive research) • Participation in a research study could not be conditioned on agreeing to future open-ended use of biospecimens

6. No longer OK “..the allowable current practice of telling the subjects, during the initial research consent, that the data they are providing will be used for one purpose, and then after stripping identifiers, allowing it to be used for a new purpose to which the subjects never consented, would not be allowed.”

7. What biospecimen research would be in “excused” category (replacing “exempt”?) • Biospecimens collected for other purposes, including specimens yet to be collected • No restriction on researcher retaining identifying information • Would apply to all qualifying research occurring in institutions receiving federal funding for human subjects research • Would not apply if results were to be returned to individual participants

8. Potential for waiver of consent • Mentioned, with little specificity • “Q. 23 (also Q. 48): Under what circumstances should it be permissable to waive consent for research involving the collection and study of existing data and biospecimens…? “ (e.g., Q. 53 - consent for future use not obtained at initial collection and therefore impracticable?) • Different rules for waiver if initial collection was for research or non-research purposes?

9. Related questions • Q. 47 - Change current practice of allowing use of discarded clinical material without consent? • Q. 49 – Desirability of standardized general consent? • Q. 50 – Best method to provide meaningful opportunity to refuse? • Q.51 – Application to specimens collected outside US?

10. Submit your comments! http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html