0990-EvaluaMarriageAppendix H OHRP

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Appendix H. Office of Human Research Protections Certification

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Office of Public Health and Science _____________________________________________________________________

Office for Human Research Protections

Department of Health and Human Services

The Tower Building

1101 Wootton Parkway, Suite 200

Rockville, MD 20852

Phone: (240) 453-8141

Fax: (301) 402-2071

E-mail: [email protected]

January 18, 2007

Wendy Vissher, Ph.D.

Director, RTI Office of Research Protection

3040 Cornwallis Road

P.O. Box 12194

Research Triangle Park, NC 27709-2194

OHRP Assurance: FWA# 0003331, IRB# 00000654

DHHS/ASPE Grant: #HHS P23320062920YC

Title of Grant and Protocol: Evaluation of the Marriage and Family Strengthening Grants for Incarcerated and Reentering Fathers and their Partners

Principal Investigator: Anupa Bir

Re: 1) OHRP receipt of 45 CFR 46.305 Prisoner Research Certification

2) OHRP concurrence with IRB determination of 45 CFR 46.305(a)(2)(iv)

Dear Dr. Vissher:

The Office for Human Research Protections (OHRP) acknowledges receipt January 14, 2008 of your institution’s certification request that the research protocol listed above was reviewed by the IRB on December 12, 2007 and that the IRB fulfilled its duties under 45 CFR Part 46, Subpart C.

A duly authorized agent of your institution (e.g., the IRB Chairperson or other suitable official) certifies that the designated IRB for your institution reviewed and approved this protocol only after finding and documenting that it satisfied the seven considerations enumerated in 45 CFR 46.305.

OHRP is authorized to determine whether proposed research that is either conducted or supported by the Department of Health and Human Services (DHHS) fits into any of the four enumerated categories in 45 CFR 46.306(a)(2). Based on the information received to date, OHRP concurs with the cited category, 45 CFR 46.306(a)(2)(iv),“research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject.”

This is a multi-site evaluation of the implementation and impact of the 14 marriage and family strengthening initiatives funded by the Office of Family Assistance, Administration of Children and Families. Sites are implementing a variety of program components, typically delivered in a correctional facility, including marriage education, marriage or family counseling, parenting classes, employment or financial services, and case management. Incarcerated males and their partners will be interviewed at baseline, 9 and 18 months. This study is authorized to include prisoners as subjects.

OHRP appreciates your commitment to the protection of human research subjects. Please feel free to contact me should you have any questions.

Sincerely,

Julia Gorey, J.D.

Prisoner Research Coordinator

OHRP

cc: Ivor Pritchard., Ph.D.

Melody Lin, Ph.D., OHRP

Julie Kaneshiro, M.A., OHRP

Irene Stith-Coleman, Ph.D., OHRP

Linda Mellgren, Ph.D., ASPE

OHRP Phone: 240-453-8141 OHRP Website: http://ohrp.osophs.dhhs.gov/