The BWH and MGH, as part of Partners HealthCare, have been fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

AARHPP's mission is to protect the rights and welfare of research participants, and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations

that engage in research with human participants.

AAHRPP uses a voluntary, peer-driven, educational model of accreditation.

Receiving full AAHRPP accreditation means that the BWH and MGH meet all of the AAHRPP standards for human research protection programs (HRPP). AAHRPP accreditation demonstrates to the public, to sponsors, and to regulatory agencies that the BWH and MGH make protection of research participants a top priority.

Institutions are accredited for a period of three years. Currently, 20 institutions are AAHRPP accredited; among them are Dana Farber Cancer Institute and Newton Wellesley Hospital.

The rigorous AAHRPP accreditation process included a comprehensive self-assessment of the Partners human research protection program, followed by a 3-day site visit by an AAHRPP team.

The visiting AAHRPP team was impressed by the individuals they met: clinical researchers and research staff; IRB chairpersons, members,

and staff; the QI Program staff; the staff of the research education and support units (the BWH CCI and MGH CRP); and Partners research leadership.

Our site visitors found these individuals to be uniformly committed to the protection of research participants.

The site visitors found no significant weaknesses in our program, but did suggest ways we might

strengthen it.

The Partners IRB staff has been hard at work revising documents to implement AAHRPP’s suggestions.

Several important changes are highlighted in this newsletter. As additional changes and revisions are finalized, we will keep you informed through this newsletter and our web site.

The AAHRPP site visitors identified review of research involving vulnerable populations as an area for improvement.

Federal regulations afford additional protections to vulnerable populations such as prisoners, pregnant women, human fetuses, neonates, and children. However, the Partners Human Research Committee (PHRC) had only one additional protections form aimed at research involving children.

At AAHRPP's suggestion, we have developed new population-specific forms and have revised the Research Application.

The purpose of these new population-specific forms is to provide the PHRC with the information necessary to ensure that these groups are adequately protected.

Investigators will be required to complete the appropriate form when their research includes these vulnerable groups:

• Children
• Individuals with Impaired Decision-making
• Neonates
• Pregnant Women and Fetuses

All new and revised forms will be posted for use on the PHRC website, June 1st.

These forms will be required, and the only version of the forms that will be accepted after July 15th. We encourage everyone to use the new forms as soon as they are posted.

Because the membership of the Partners Human Research Committee (PHRC) does not include someone with the appropriate background and experience to represent prisoners, the PHRC has executed an IRB Authorization Agreement with the Harvard School of Public Health (HSPH). The agreement allows the BWH and MGH to rely on the HSPH IRB for review of research activities that involve prisoners.

The Department of Health and Human

Services regulations at 45 CFR part 46.303(c) define "Prisoner" as "any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing."

The regulations governing prisoners involved in research apply at any point a subject is or becomes a prisoner.

Please contact the PHRC office if you plan to submit a study that will enroll prisoners, or if a subject becomes a "prisoner" while participating in the study.

For more information refer to OHRP Guidance on Approving Research Involving Prisoners.

The PHRC has revised the research consent form template to help research subjects better understand study information before agreeing to participate in a clinical trial.

Approximately half of all Americans read and comprehend at a 7th to 8th grade reading level or lower. However, most legal, government, and medical documents are written at the college reading level or higher. In recognition of this fact, the federal government in 1998 launched an initiative called “Plain Language,” to make government documents understandable to the average reader.

This initiative has been widely adopted by health literacy advocates, as well as by the NIH and its Institutes.

The Office for Human Research Protections (OHRP) and the FDA are supporting and encouraging the Plain Language initiative, as well. In fact, the OHRP, the NCI, and the FDA formed a working group to develop a simple, plain language template for NCI-sponsored research.

The Partners plain language consent form template and its instructions are in the final phase of revision. These documents should be posted on the PHRC website for use by June 1st.

If you are responsible for creating research consent forms, plan to attend a PHRC Consent Writers’ Workshop to develop and practice your plain language skills. The basics of plain language and consent writing will be covered. Beginning in June, we will offer two workshops per month, one at BWH and one at MGH, and will schedule them at other Partners sites as needed. Each workshop will accommodate 15-20 research staff members. Ann Ogletree, Senior Human Research Specialist at the PHRC, will be presenting on June 15th, 23rd and July 8th. The times and locations are posted on our website.

You have been informed that the review of your new study has been delayed. You were told that this delay is due to the IRB’s need to bring in a consultant to assist in the review of your new study. Can the IRB bring in outsiders to be part of their review?