# Presentation: 664922

## Precursor Preference in Surfactant Synthesis of Newborns

- Second Joint
- Subpart D ReferralJune 28, 2005

## Sara F Goldkind, MD, MAFDABioethicist Office of the CommissionerOffice of Pediatric Therapeutics-and-

- Bernard Schwetz, DVM, PhD
- Director
- Office for Human Research Protections

## Categories of Subpart D(IRB authorized to approve protocols)

**46.404, 50.51**: Not involving greater than minimal risk
**46.405, 50.52**: Involving greater than minimal risk but presenting the prospect of direct benefit to individuals subjects
**46.406, 50.53**: Involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition

## Categories of Subpart D cont.(IRB must refer to HHS/FDA) 

**46.407, 50.54**: Research that is not otherwise approvable but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children, and-
- Requires that the Secretary of HHS/Commissioner of FDA consult with an panel of experts in pertinent disciplines

## Pediatric Ethics SubcommitteeSome potential considerations

- Determination of risk
- Determination of benefit
- Suggested modifications to protocol
- Necessary modifications to protocol
- Suggested modifications to parental permission and assent processes and documents

## Pediatric Ethics SubcommitteeSome potential considerations

- Necessary modifications to parental permission and assent processes and documents
- Summary response to the specific questions
- Determination of approval categories
- Other pertinent issues

## Possible Recommendations the PES Can Make to the PAC

- Recommend allowing the protocol to proceed because it satisfies 46.404/50.51, 46.405/50.52, or 46.406/50.53
- Recommend allowing the protocol to proceed, with modifications, because it would satisfy 46.404/50.51, 46.405/50.52, or 46.406/50.53
- Recommend allowing the protocol to proceed, either with or without modifications, because it satisfies 46.407/50.54
- Recommend that the protocol not be allowed to proceed, providing specific reasons

## Findings to Support 46.407/50.54 Recommendation

- The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
- The research will be conducted in accordance with sound ethical principals, and;
- Adequate provisions are made for soliciting the assent of children and permission of their parents or guardians, as set forth in 46.408/50.55

## HHS and FDA Regulations regarding allowing a protocol to proceed under

| 21 CFR 50.51 | or | 45 CFR 46.404 |
| --- | --- | --- |
| .52 | .405 |  |
| .53 | .406 |  |
| .54 | .407 |  |

- are comparable.

## After Today’s Meeting of the PES

- Chair summarizes PES review and presents PES recommendations to PAC
- PAC recommendations will be transmitted by the Office of Pediatric Therapeutics, with comments, to FDA Commissioner (along with Chair’s summary)
- FDA Commissioner’s determination will be transmitted by OHRP, with comments, to Assistant Secretary for Health (along with PACs recommendation and Chair’s summary)
- The ASH will make the final determination on behalf of HHS Secretary

## Possible Determinations by Secretary/Commissioner 

- Research in fact satisfies the condition of 46.404/50.51 or 46.405/50.52 or 46.406/50.53
- Support the research under 46.407/50.54 as submitted
- Support the research under 46.407/50.54 with required and/or recommended modifications
- Do not support the research