SECTION 310:551-3-1. Required Information to be Collected from Information Providers

(a)   The Department is required by law to collect the following types of information from information providers:

(1)   Information relating to research performed or conducted on human tissue regeneration using human embryos or adult stem cells.

(2)   Information relating to research performed or conducted on human disease using human embryos or adult stem cells.

(b)   The data elements to be submitted by information providers include the following:

(1)   Identifying name of the research project having unique or individual IRB approval;

(2)   nformation provider name;

(3)   Information provider street address;

(4)   Information provider city;

(5)   Information provider state;

(6)   Information provider address postal zip code;

(7)   Information provider EIN or Tax Identification Number;

(8)   Information provider telephone number;

(9)   Information provider facsimile number;

(10)   Information provider electronic mail address;

(11)   Information provider contact person name;

(12)   Information provider contact person telephone number;

(13)   Information provider contact person facsimile number;

(14)   Information provider contact person electronic mail address;

(15)   Project initiation date;

(16)   Project suspension date, if applicable;

(17)   Project restart date, if applicable;

(18)   Project completion date, if applicable;

(19)   An affirmative indication if the research involves human embryonic stem cells in vitro;

(20)   An affirmative indication if the research involves human embryonic stem cells in vivo;

(21)   An affirmative indication if the research involves the creation or derivation of human embryonic stem cells or cell lines;

(22)   An affirmative indication if the research involves or requires consent for human participation in a research project using human embryonic stem cells or adult stem cells;

(23)   An affirmative indication if the research involves or requires consent for donation of tissue to derive adult stem cells;

(24)   An affirmative indication if the research involves the use of human oocytes for purposes other than assisting a person to achieve a successful childbirth;

(25)   An affirmative indication if the research involves the use of human embryos for purposes other than assisting a person to achieve a successful childbirth;

(26)   An affirmative indication if the research involves somatic cell nuclear transfer for purposes other than assisting a person to achieve a successful childbirth; and,

(27)   The name of the IRB or Stem Cell Research Oversight Committee to which the research institution, entity or research individual makes periodic reports.

(c)   Data file formats that will be accepted include:

(1)   PDF Flat File Format, or,

(2)   Other formats agreed upon by OSDH and the data provider prior to submission.

(d)   Information submitted containing the appropriate data elements but do not adhere to an acceptable file format shall be deemed to be unreadable and will be not be accepted by the Department.

[Source: Added at 26 Ok Reg 2040, eff 6-25-09]