RFA 67-211 Certifications for the Protection of Human Subjects.pdf
PDF 126 KB Posted
- Attached to
- Spinal Cord Injury Research Grant
- Solicitation number
- RFA 67-2011
- Issued by
- Dauphin County, Harveys Lake Borough, Pennsylvania
About this file
This document is a certification requirement file for the Protection of Human Subjects, issued by the Pennsylvania state government in connection with the Spinal Cord Injury Research Grant program. The file establishes mandatory certifications that grantees must obtain and maintain throughout the research period to ensure compliance with human subjects protection protocols. Researchers conducting spinal cord injury research under this grant program must obtain institutional certifications demonstrating their adherence to established guidelines for the ethical treatment and protection of human research subjects. The certification requirements apply to all research activities funded under Act 77 of 2001, which authorizes the Commonwealth to fund research aimed at improving health outcomes for Pennsylvanians living with spinal cord injuries.
The certifications required include documentation that the research institution has an active Institutional Review Board (IRB) or equivalent ethics committee with appropriate oversight authority, and that all research personnel have completed required human subjects protection training. Grantees must provide proof of current certifications prior to funds being disbursed and maintain compliance throughout the grant term. The certification framework ensures that all research activities meet federal and state standards for human subjects protection, including informed consent procedures, risk assessment protocols, and ongoing monitoring requirements. Failure to maintain current certifications may result in suspension or termination of grant funding.
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Text version
RFA # 67-211
Attachment V
CERTIFICATIONS FOR THE PROTECTION OF HUMAN SUBJECTS AND
REGARDING THE USE OF HUMAN EMBRYONIC STEM CELL RESEARCH
Principal Investigator Name and Title:
Research Project Title:
Principal Investigator’s Institution:
CERTIFICATION FOR THE PROTECTION OF HUMAN SUBJECTS
It is the responsibility of the research institution to assure that the rights and welfare of all human subjects used in any Pennsylvania Department of Health sponsored research are protected. Any research involving human subjects must be reviewed and approved by an appropriate institutional review board (“IRB”).
The applicant agrees to safeguard the rights and welfare of individuals who participate in research activities. The applicant agrees that all experimentation with human subjects shall be prohibited unless the applicant certifies that the prior written approval of its IRB is obtained or is not required, subject to all applicable laws, including but not limited to 42 U.S.C. Section 3515 (b) (relating to prohibitions on funding certain experiments involving human participants) and the regulations thereunder. In addition, such experimentation or research projects involving human subjects must be submitted to the Department’s IRB on the form entitled, “Application to the Pennsylvania Department of Health Institutional Review Board for Approval of Research Project under the Federal Policy for the Protection of Human Subjects.” Further, the applicant must obtain the written, voluntary, informed consent of each subject. If the subject is a minor, or incompetent, the applicant must obtain the written, voluntary, informed consent of their legal guardian. The applicant shall inform each potential subject prior to their consent that refusal shall not result in the loss of any benefits to which the subject is otherwise entitled from the federal government, the Commonwealth, the applicant, any subcontractor of the applicant, or any third-party insurer.
Please check the appropriate statement:
☐No human subjects will be used in any of the proposed research.
☐Human subjects will be used in the proposed research. This is to certify that the proposed activities on human subjects have been reviewed by an IRB on (date) and found to be in accordance with current Department of Health and Human Services policy.
☐Human subjects will be used in the proposed research. This is to certify that the proposed activities on human subjects have NOT been reviewed by an IRB and that prior to initiating research involving human subjects, the applicant will submit to the Department the form entitled, “Application to the Pennsylvania Department of Health
RFA # 67-211
Attachment V
Institutional Review Board for Approval of Research Project under the Federal Policy for the Protection of Human Subjects.”
CERTIFICATION REGARDING THE USE OF HUMAN EMBRYONIC STEM CELL
RESEARCH
Please check the appropriate statement:
☐No human embryonic stem cells will be used in any capacity in the proposed research.
☐Human embryonic stem cells that are approved by the National Institutes of Health and derived from outside of Pennsylvania will be used in the proposed research project.
Applicant Organization
Name and Title of Applicant’s Authorized Official
Signature of Applicant’s Authorized Official Date
| No human subjects will be used in any of the proposed research: Off |
| Human subjects will be used in the proposed research This is to certify that the: Off |
| Human subjects will be used in the proposed research This is to certify that the_2: Off |
| No human embryonic stem cells will be used in any capacity in the proposed: Off |
| Human embryonic stem cells that are approved by the National Institutes of: Off |
| Applicant Organization: |
| Name and Title of Applicants Authorized Official: |
| Date: |
| Text1: |
| Text2: |
| Text3: |
| Date4_af_date: |
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