Binghamton University. Stem Cell Research Oversight Committee (SCRO)

Transcription

1 Binghamton University Stem Cell Research Oversight Committee (SCRO) Application for Approval for the Use of Human Stem Cells or Human Stem Cell Lines in Research Note: Activities using stem cells that remain restricted in tissue potential and are t kwn to possess totipotent or pluripotent potential are NOT subject to the Stem Cell Research Oversight Committee s oversight. Only research involving the use of one of the following stem cells is subject to oversight: 1. Human embryonic stem cells (hescs) 2. Human totipotent or pluripotent stem cells 3. Human n embryonic pluripotent stem cells 4. Human neural and gonadal progenitor stem cells or any other tissue stem cells kwn to possess totipotent or pluripotent potential Principal Investigator s name Date Title of Project Department Phone No E mail Address Location of Laboratory where work will be done I. Personnel Training Have all personnel working with on human stem cells received training? In order for you to be certified to conduct research with human embryonic or induced pluripotent stem cells, you must satisfy the training modules available in the CITI training program (citiprogram.org). Yes No II. Research Plan (Please write at a high school reading level) A summary of the proposed research including: a. Objective

2 b. Hypothesis to be tested c. Experimental approach d. The scientific necessity for using human stem cells e. Address the ethical concerns by identifying the potential benefits of the research, the advancement of kwledge and the benefit to society III. Cell lines to be used: Please provide the following information about the cell lines to be used. Is this line pluripotent? Cell line 1 Is this an embryonic stem cell Has this line been approved by the NIH? If, please specify Cell line 2 Is this line pluripotent? Is this an embryonic stem cell

3 Has this line been approved by the NIH? If, please specify Is this line pluripotent? Cell line 3 Is this an embryonic stem cell Has this line been approved by the NIH? If, please specify Is this line pluripotent? Cell line 4 Is this an embryonic stem cell Has this line been approved by the NIH? If, please specify

4 IV. Confirmation of compliance with Binghamton University requirements on human stem cell research: Review and confirm (by checkmarks in the circles) that the research DOES NOT involve any of the following: Research involving in vitro culture of any intact human embryo, regardless of derivation method for longer than 14 days or until formation of the primitive streak begins. Research in which hescs are introduced into nhuman primate blastocysts or in which any embryonic stem cells are introduced into human blastocysts. Research in which any products of the research involving human totipotent or pluripotent cells are implanted into a human or n human primate uterus. No animal into which hescs have been introduced at any state of development are to breed. No contribution to the germ line is permitted. Research on a stem cell line derived from human embryos created for research purposes rather than reproductive purposes. Research on a line derived from human parthegenesis. V. Material Transfer Agreement Binghamton University s researchers must execute, through the Office of Entrepreneurship and Invative Partnerships, a Material Transfer Agreement prior to obtaining any human stem cell lines from an external entity. Does this research require a Material Transfer Agreement? Yes No Please include a copy of the agreement with this application Please describe how the lines were obtained N/A

5 VI. Principal Investigator Certification Your signature on this application means that you agree: 1. To execute the research activity as approved by the SCRO initially and as amended. 2. To request and received approval from the SCRO prior to implementing any changes to the research activity. 3. To file an annual continuing review submission for approval by the SCRO. 4. That you have adequate resources and facilities to carry out the proposed research 5. To comply with federal, state and campus regulations with regard to stem cell research and other issues covered by applicable federal, state and campus regulations. 6. To assure that all individuals conducting the procedures described are appropriately trained/ credentialed or to make provisions for training prior to conducting the research. 7. To be responsible for the supervision of staff conduction the procedures described in the application. 8. To maintain adequate, current and accurate records of research data, outcomes and adverse events (if applicable) to permit an ongoing assessment of this research project. 9. To ensure that all personnel listed on this application will read and understand the contents of this protocol before beginning any procedures. VI. Certification of Study Personnel The signature of study personnel on this application certifies that: 1. They are fully cognizant of the details of this activity, and will conduct all aspects of the study as approved by the SCRO. 2. They will t be involved in any aspect of the study or conduct any procedure for which they have t been trained. 3. They have been informed of potential hazards, safe work practices, availability of medical surveillance and training related to this project. Signatures required for this application: Principal Investigator(s)