Stroke Oxygen Study Standard Operating Procedure 2
Eligibility to take consent for SO2S
Persons taking consent for SO2S must have appropriate training
They should have knowledge of stroke and be aware how the effects of stroke can
affect the ability to give fully informed consent. This includes:

Awareness of the content of the Declaration of Helsinki

Consent training (e.g. procedure, assessment of competence).

GCP training

Knowledge of the SO2S protocol

Knowledge of the content of the consent form

Working knowledge of potential indications and contraindications for oxygen
(as described in the protocol).
If the person taking consent is not a nurse or doctor who is able to prescribe oxygen
he/she should confirm that the patient has no definite indications for or
contraindications against oxygen treatment at the rate of 2-3 L/min by consulting a
doctor or nurse practitioner able to prescribe oxygen before stating randomization.
He / she should document this in the notes (see text below which could be printed on
a sticker). If the person obtaining consent is a doctor or nurse with experience in
prescribing oxygen no second opinion is required.
SO2S Study ISRCTN 52416964 www.so2s.co.uk
Patient/relatives information leaflet vs4 given Y/N
Informed Consent/Assent vs4 obtained
Y/N
Consent/Assent refused
Y/N
No definite indications or contraindications to O2 at 2-3L/min
(confirmed by doctor/nurse with experience in O2 prescription
_____________________ [name of doctor/nurse]) Y/N
Randomized to SO2S control/oxygen for 72 hours/oxygen for 3 nights Y/N
If the patient develops clinical indications for oxygen, please treat as appropriate.
Please call 01782 555875 (daytime) or 07740372852 for any queries or problems
(example only, always use sticker with correct version number)