Quorum Review Inc. - Additional Services - federally funded studies

By: Quorum Review  09-12-2011

Q.   What is a Certificate of Confidentiality? >>

A Certificate of Confidentiality is a document that federal agencies issue to investigators to protect the privacy and welfare of subjects by preventing the release of protected health information and other sensitive information regarding subjects who are participating in a research study. Certificates of Confidentiality allow investigators to refuse to disclose identifying and sensitive information obtained as part of research, in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. An investigator should consider obtaining a Certificate of Confidentiality for IRB-approved research when he or she collects information from or about a subject that is identifiable and sensitive (i.e., could lead to discrimination, social stigmatization, legal prosecution, damage to their financial standing, employability, insurability, or reputation).

Even if a Certificate of Confidentiality is issued, research investigators should be aware that federal, state, or local law may require that licensed health care providers and/or certain other individuals report identifiable information regarding subjects involved in research if they have reasonable cause to suspect issues such as child abuse, a possible threat to self or others, or reportable communicable disease. Other disclosures may also be required by federal, state, or local law. For example, Certificates of Confidentiality do not authorize researchers to refuse to disclose information regarding a subject if such disclosure is required by federal law (e.g., required disclosures as set forth in the Food, Drug, and Cosmetic Act or if federal agency requests information for auditing or program evaluation purposes).


Other products and services from Quorum Review

09-12-2011

Quorum Review Inc. - Additional Services - prereview

This conference call will involve the following parties: a sponsor representative and other pertinent parties to help give general feedback about the protocol or consent form, the IRB Chairman, and a representative from Quorum's Study Management, Initial Study Support, and Regulatory departments.


09-12-2011

Quorum Review Inc. - Additional Services - services

For studies with tight timelines, this service can often save valuable time during consent form negotiation. Quorum has built out many processes to better accommodate the unique needs of institutions. Quorum Review IRB is a full-service independent review board.


09-12-2011

Quorum Review Inc. - Additional Services - IRB determination

Some research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(federally funded projects), 21 CFR 56.104(FDA regulated studies), and the Tri-Council Policy Statement (TCPS 2), Article 2. Q. Who should I contact if I have questions about completing an Exemption Determination Request. An applicant may therefore apply to Quorum Review for an exemption determination.


09-12-2011

Quorum Review Inc. - Additional Services - institutional partnerships

IRBs within institutions are looking for ways that they can expand their current capacity and improve their review cycle timelines without increasing costs. Some institutions are looking for secondary supplier alternatives while others are looking to focus on research and outsource the IRB function all together.


09-12-2011

HIPAA

For research recruitment purposes, an investigator may wish to use already collected PHI in order to contact potential participants or may collect and record PHI via telephone screens before the potential research participants visit the research site (called a "Partial Waiver". It may not be practical for an investigator to obtain a signed HIPAA Authorization prior to the use and disclosure of a participant’s PHI.


09-12-2011

Quorum Review Inc. - Additional Services - translation

When submitting a new study to Quorum, sponsors, CROs and single sites may request our translation services in the Central Study Questionnaire, Single Site Study Questionnaire, or Principal Investigator Generated Study Questionnaire. When you select Quorum to manage your translations in addition to reviewing your study, we can ensure quality standards are met and translations are completed in a timely manner.