Attachment A
PETAL Network Local Context Information
This form should be completed by, or in conjunction with an institutional representative knowledgeable about the items addressed. This form must be completed and approved by the PETAL cIRB before a site can begin any new network studies.
This information below will assist the cIRB in its review of local context issues at the respective network sites. It may be helpful to attach supporting documents, policies and diagrams, if applicable. Please contact Julie Ozier at , (615) 875-8128 or Rebecca Abel at (615) 875-8960 if you have any questions about these items or the application of their information into the review process.
Site and IRB Information
1. Full legal name and location of organization requesting to rely on the PETAL cIRB:
2. Description of site:
3. URL for site IRB:
4. List of investigators to include in IRB protocol (include degree and contact information):
5. Non-investigator research staff (study personnel):
6. Federalwide Assurance (FWA) number:
7. IRB registration number(s):
8. Human Research Protection Program (HRPP) training requirements - Describe the organization’s human subjects protection training and education requirements for researchers and study staff. Please include initial as well as continuing education requirements:
9. Policy, if any, on provision and coverage of treatment costs for research-related injuries. Please attach template informed consent language regarding research related injury:
10. Indicate if the organization has a quality assurance/audit group responsible for overseeing ongoing research:
11. Appropriate local ancillary committee reviews as applicable and required by its policies (e. g. nursing review, radiation safety, pharmacy, biosafety, Medicare analysis or cost/billing analysis, subcontracts/contracts execution and any others):
12. Is the institution is a covered entity under HIPPA?
13. Please attach any template informed consent and/or HIPPA authorization language:
State and Local Institutional Information
Please provide information about the following as they pertain to state, local, or institutional regulations:
1. Legally authorized representatives who can provide consent for research participants:
2. Please describe any institutional policies, procedures or generally accepted ways you operationalize obtaining surrogate consent for adult individuals with impaired decision-making capacity:
3. Age of majority in the state:
4. Circumstances under which children may consent to their own participation in research (emancipated minors, mature minors, etc.):
5. Wards of the state or other special populations (child or adult) participate in research when there are state requirements that go beyond what is required in the corresponding subparts of 45 CFR 46:
6. Obtaining assent for children to participate in research:
7. Enrollment of non-English-speaking participants (specify if you expect a large percentage of the potential research population to speak languages other than English and Spanish (if so, what languages)):
8. Results of pregnancy testing/pregnant women:
9. Other information about the local consent process, including practices regarding recruitment and compensation of participants:
10. Requirements of confidentiality of specific types of health information not under the HIPAA regulations:
11. Special characteristics of your clinical site, your institution or the community:
12. Specific requirements of state or local laws, regulations, policies, standards or other factors applicable to the site or clinical study:
13. Specific requirements for sharing of genetic information to participants or to other researchers:
14. Other requirements or factors as applicable:
Conflict of Interest
1. Please describe how the HRPP addresses conflicts of interest (COI) in the conduct of human research activities such as how information about potential conflicts of interest are identified, reviewed and processed by the IRB/HRPP in reviewing human research protocols:
2. Specify if the IRB or another institutional committee receives COI disclosures:
Contacts
Please Include the official responsible for the organization's conduct of research, the main administrative IRB contact, the chair of your IRB(s), and any other relevant individuals.
PETAL Network Site PI:
Name:
Position:
Contact information:
Mailing address:
Phone:
Fax:
Email:
Site IRB Liaison:
Name:
Position:
Contact information:
Mailing address:
Email:
Phone:
Fax:
Local IRB Chair(s):
Name:
Position:
Contact information:
Mailing address:
Email:
Phone:
Fax:
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