CONDUCTING RESEARCH AT CHILDREN'S HOSPITAL - NEW ORLEANS
The LSUHSC-NO and CHNOLA IRB Offices have developed several joint forms for use when HSC-NO investigators are conducting research at Children's Hospital. Please use the following forms as appropriate for the study:
CHNOLA-LSUHSC Joint Informed Consent Template
CHNOLA-LSUHSC Joint Local ICF Cover sheet
CHNOLA-LSUHSC Joint HIPAA Authorization Form
HRPP-2254CH: CHNOLA-LSUHSC Joint Short Consent Form (Spanish)
- HRPP-2257CH: CHNOLA-LSUHSC Joint Consent Template for Emergency Use of a Test Article
CHNOLA, LSUHSC, and TULANE IRBs are providing the following combined general guidance related to assent requirements for pediatric studies where CHNOLA, LSUHSC or Tulane IRB is the IRB of record and one or both of the other IRBs are expected to be engaged. If you have additional questions or concerns please reach out to your specific IRB, however we are all happy to assist:
- Best practices related to the involvement of children in research studies indicate that children 7 years of age and older should assent.
- Best practices related to the involvement of children in research studies indicate that two separate assents are appropriate- one for younger children (age 7 to 12) and an alternative version for older children (age 13-17). These different forms are recommended due to the complexities of studies and the changing language abilities of children across development.
- The assent form should be a separate document from the parental permission/consent.
- If the PI has compelling reasons for single assent form, meaning one consent form for all children or a permisison/assent document, or deviations from age ranges due to concerns about developmental differences, or other study aspects, the PI should discuss this with the IRB of record. If the IRB of record is in agreement with the PI’s proposed deviations from the best practices stated above, for a particular study, then, in general, the relying IRBs will defer decision to the IRB of record.