"Addendum" u pravnoj terminologiji predstavlja dopunu ugovoru (kao što je kolega naveo u svom odgovoru), tj. dokument kojim se menjaju uslovi ugovora (npr. okolnosti koje utiču na sprovođenje ugovora od dana potpisivanja ugovora).

Ovde mislim da je reč o predlošku dopune/dodatka informiranom pristanku jer ispitanici prvo potpisuju ICF (informirani pristanak) čime dobrovoljno izražavaju svoju spremnost da učestvuju u nekom kliničkom istraživanju/ispitivanju ali ako dođe do izmene nekog aspekta kliničkog ispitivanja ili pružanja nekih novih informacija koji mogu da utiču na odluku ispitanika o učestvovanju u istom, onda se ispitaniku dostavlja i taj dodatak/prilog koji mora da potpiše.

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...

ICF Addendum Template
Instructions:
Use this form to give currently enrolled subjects new information about the research. It may be used instead of re-consenting with the full informed consent form.

Summary of changes to the informed consent document
You are currently participating in the above named research study being conducted by << PI name>>. The consent form you previously signed told you that you would be informed of any significant new findings during the research study, such as changes in the risks or benefits of participation, new alternatives to participation, or changes in study procedures. The purpose of this consent addendum is to inform you of changes in the study. All other sections of the original consent form still apply. Please refer to it for any questions you might have.

The following are changes that have been made to this research study since you signed the original consent form...

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...

GUIDELINES FOR PREPARING AN ADDENDUM TO INFORMED CONSENT DOCUMENTS

The addendum consent should only be prepared for subjects who are currently taking part in a study:

1)When subjects need to be informed of any significant new findings developed during the course of participation that may have a bearing on their willingness to continue in the study.

2)When subjects need to be informed of specific changes..
Addendum Consent Template: Always use the current version of the Addendum Consent template.