Skin Biopsies in Children for the Purpose of Research

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Minimal Risk vs. Greater Than Minimal Risk Skin Biopsies

IRB Application and Consent Form Sample Language

Additional Information

 

Minimal Risk vs. Greater Than Minimal Risk Skin Biopsies

We have published the following guidance for researchers who plan on performing skin biopsies in children for research purposes. This guidance will help researchers consider whether the skin biopsy involves minimal risk or greater than minimal risk and what regulatory requirements are involved.

  • Minimal Risk Skin Biopsy: We have determined that a single skin biopsy <2mm on affected children and children who are healthy controls is a minimal risk procedure.
  • Greater than Minimal Risk Biopsy: We have determined that a single skin biopsy >2mm on affected children as well as children who are healthy controls (see note) is a greater than minimal risk procedure.

Important note: A single skin biopsy >2mm for children who are healthy controls will require additional review. If there is federal funding, the study will be sent to the Department of Health and Human Services for additional review.

Minimal risk definition

Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(i)).

IRB Application and Consent Form Sample Language

IRB Application: In the requested information in the following sections. Revise as appropriate.

Procedures

After selecting a biopsy site on the forearm, thigh or lower back (child/parent preference), a numbing cream (EMLA or Lidocaine) will be applied to the biopsy area and the area will be cleansed with an antiseptic solution. A single 2mm piece of skin (the approximate size of a pencil-end eraser) will be removed via punch biopsy and a sterile gauze pad will be placed over the site to control bleeding. The biopsy site may be closed with a stitch. The parents will be provided with post-biopsy care instructions.

Risks and Benefits

A small number of people are allergic to the local anesthetic (numbing medication). The local anesthetic injection may sting while being injected. There is a risk of scar formation at the biopsy site. There is also a small risk of infection.

Inclusion of Children in Research

  • Minimal risk skin biopsy: No greater than minimal risk
  • Greater than minimal risk skin biopsy on affected children: Greater than minimal risk (though only a minor increase over minimal risk) and no prospect of direct benefit but likely to yield generalizable knowledge about the subjects disorder or condition
  • Greater than minimal risk skin biopsy on healthy controls: Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

When determining the risk category, take into account other research procedures, i.e, blood draws, lumbar punctures, etc.

 

Consent Form: Include the following information in consent form sections and revise as appropriate.

What will happen if I take part in this research study?

A member of the research team will perform the skin biopsy on your child. This involves taking a small piece of skin from your child’s forearm, thigh or lower back. A numbing cream will be placed on the skin biopsy site. After the skin is numb, the site will be cleansed with an antiseptic solution and an additional, injectable numbing medication will be given. The injection may sting a little, but the numbing cream should lessen the burning sensation. Once the skin is completely numb, a 2 millimeter piece of skin (about the size of a pencil-end eraser), will be removed. The biopsy site may be closed with a stitch. You will be provided with instructions on the care of the skin biopsy site.

What side effects or risks can I expect from being in the study?

There are some risks associated with a 2 mm skin biopsy. The medication that numbs your skin may sting or burn while it is being injected, and there is also a small risk of an allergic reaction. The biopsy site will bleed and leave a scar and there is a small risk of infection. Measures will be taken to minimize these risks.

Additional Information