Volume 9 Research
Chapter 0400 Policy for Research Using Human Subjects or Human-Derived Materials
Responsible Office: Office of Human Research Protection
Originally issued: 10/01/67
All research using human subjects or human-derived materials conducted by Georgia Health Sciences University faculty, staff, or students must obtain Institutional Review Board (IRB) approval prior to the initiation of any research activities that involves human subjects or human-derived materials.
Reason For Policy
The United States Department of Health and Human Services, the Food & Drug Administration, and other Federal agencies have requirements in place to regulate the use of human subjects or human-derived materials in research. Georgia Health Sciences University is required to comply with these regulations. The regulations include education on the ethics of using human subjects and human-derived materials in research, approval of all research protocols involving human subjects and human-derived material, monitoring the progress of all such research, and above all, protecting the rights of human subjects involved in research. Georgia Health Sciences University has established the Office of Human Research Protection to oversee these functions.
Entities Affected By This Policy
All faculty, staff, and students at Georgia Health Sciences University conducting research using human subjects or human-derived materials are affected by this policy.
Who Should Read This Policy
All faculty, staff, and students conducting research using human subjects or human-derived materials or who are considering to carry out such research at Georgia Health Sciences University are required to read and comply with this policy.
|Director, Office of Human Research Protection||706-721-1480||mailto:email@example.com
|Assistant Director, Office of Human Research Protection||706-721-1379||mailto:firstname.lastname@example.org://www.georgiahealth.edu/research/ohrp/index.html|
|Chairperson, Human Assurance Committee||706-721-1483||mailto:email@example.com
The OHRP Web page contains many related documents, including procedures, forms, and templates: http://www.georgiahealth.edu/research/ohrp/irb/hac/index.html
Code of Federal Regulations 45CFR46 Protection of Human Subjects: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
These definitions apply to these terms as they are used in this policy:
|Human-derived materials||Material or information coming from or pertaining to human subjects, including: medical records (electronic or hard copy); data store (i.e., database, spreadsheet, or other document or electronic type); fetal material including the placenta, amniotic fluid, fetal membranes, and umbilical cord; teeth; pathological specimens; diagnostic specimens (blood, sputum, urine), hair, and nail clippings collected in a non-disfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric acid solution to the tongue; placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization; and primary cell lines (or those not generally available through commercial sources). For the purposes of the Federal regulations, any of the above coming from or pertaining to a deceased person is not considered to be a human-derived material.|
|Human Assurance Committee (HAC)||The internal Institutional Review Board at Georgia Health Sciences University.|
|Human subject||A human subject is a living individual about whom an investigator obtains (1) data through interaction or intervention with the individual, or (2) identifiable private information (45CFR46.102). For the purposes of the Federal regulations, a deceased individual is not considered to be a human subject.|
|Institutional Review Board (IRB)||A committee or group composed of scientists and non-scientists established to protect the rights and welfare of human research subjects and their human-derived materials.|
|Research||Any systematic investigation designed to develop or contribute to generalizable knowledge.|
All research using human subjects or human-derived materials conducted by Georgia Health Sciences University faculty, staff, or students must obtain Institutional Review Board (IRB) approval prior to the initiation of any research activities that use human subjects or human-derived materials. This is a federal requirement.
Georgia Health Sciences University agrees with the principles of the Department of Health and Human Services (DHHS) policies, the Belmont Report, the Nuremberg Code, and the Declaration of Helsinki with regard to investigations involving human subjects. Georgia Health Sciences University agrees that a review, independent of the investigator, is desirable and necessary to safeguard the rights and welfare of human subjects of research investigations and to fulfill the moral and legal obligations and commitments of the institution. Georgia Health Sciences University has assured the DHHS that it maintains its own internal IRB, known as the Human Assurance Committee (HAC), and has a relationship with a commercial IRB in compliance with state and federal regulations to review plans of investigations involving human subjects, prior to the initiation of the investigations, to insure adequate safeguards.
This review will be carried out in reference to:
- The rights and welfare of the individuals involved.
- The appropriateness of the methods used to obtain informed consent.
- The risks and the potential benefits of the investigations.
Georgia Health Sciences University also agrees to exercise surveillance of DHHS-supported, as well as all other, research projects using human subjects for changes in protocol that may alter the investigational situation with regard to the criteria cited above. Georgia Health Sciences University further assures that it will provide advice and consultation to investigators on matters of employing human subjects in investigation, and also that it will provide whatever professional attention or facilities may be required to safeguard the rights and welfare of human subjects involved in an investigation.
Records of review and decision on the use of human subjects and of informed consent will be developed and kept by Georgia Health Sciences University Human Assurance Committee, the commercial IRB, and Georgia Health Sciences University’s Office of Human Research Protection in compliance with state and federal regulations. The Human Assurance Committee will be administratively and financially supported by the Office of Human Research Protection but shall report directly to the President of Georgia Health Sciences University. A representative from the Office of Human Research Protection will serve as the liaison to the commercial IRB.
Detailed IRB policies and procedures are available at http://www.georgiahealth.edu/research/ohrp/policies/index.html#rb
The responsibilities each party has in connection with Academic, Research, and Student Affairs Policy 9.0400, Policy for Research Using Human Subjects or Human-Derived Materials, are:
|Director, Office of Human Research Protection||Administers the human research protection program and oversees efforts to promote high quality human research.|
|Assistant Director, Office of Human Research Protection||Manages the Human Assurance Committee (HAC) and serves as an institutional resource for clinical research regulations.|
|Chairperson, Human Assurance Committee||Determines if a project is research, follows all applicable federal and state regulations and laws as well as institutional policies and procedures, and chairs the Human Assurance Committee meetings.|
OHRP Audit Worksheet: http://www.georgiahealth.edu/research/ohrp/audit_compl/index.html
OHRP Medical Record Audit Form: http://www.georgiahealth.edu/research/ohrp/audit_compl/index.html