If a research project involves the collection of blood or blood products, the following questions must be answered and submitted with the HSIRB application form.
Collection of the blood product
- Where will the collection procedure take place? To what extent has the facility been the site of previous collection of blood? Are regular staff of this facility involved in any way with the collection, disposal or storage of the blood or blood product?
- Exactly what procedure will be used to collect the blood sample? Be sure to specify exactly how the blood will be collected. Indicate any point at which the sample or the open wound will have contact with a person, whether that person is the researcher, the subject or a research assistant.
- What sorts of antiseptic will be available to treat the site of the blood collection?
- What sort of protective clothing will be worn by the person collecting the blood sample or any person who handles any item which may be blood soiled? Be sure to indicate training which has taken place with respect to the appropriate use, replacement, and inspection of the protective quality of this clothing.
- How is appropriate medical information regarding the subject involved in the study conveyed to the person drawing the sample?
- Have any of the persons involved in the study been vaccinated for Hepatitis B?
- To whom would accidental contact with a blood product be reported?
- How long will the blood sample be kept?
- Under what conditions will the blood sample be stored?
Treatment of the material used to draw the blood sample
- What procedures will be used to dispose of the instruments used to collect the blood sample?
- If the instruments used for the analysis of the blood sample are not disposable, what antiseptic procedures are used to clean the instrumentation? Be sure to specify how individuals cleaning the instruments will be protected from contact with a contaminated instrument. What or who gives the quality assurance that the instrument is antiseptic or clean?
- What procedures will be used to dispose of any material which may have come in contact with the blood sample (e.g., rubber gloves, protective aprons, slides)? What training procedures will be used to ensure appropriate disposal of all contaminated material?
Storage and disposition of the blood sample
- Under what conditions will the blood or blood product be stored? How long will it be stored?
- What security precautions have been taken to protect individuals from accidental or incidental contact with the blood or blood product sample?
- How will the blood sample be disposed of?