In order to avoid delays in the review process and to allow for a suitable evaluation of the scientific merit of the study, please ensure that the following elements are included in the protocol:
- Study purpose and rationale;
- Description of study population, inclusion and exclusion criteria;
- Sample size and how it was determined;
- Design and description of methodology;
- Definition of end-points;
- Measurements and study instruments (including questionnaires, data collection forms, etc);
- Data analysis plan;
- Recruitment procedures including copies of advertisements;
- Details on confidentiality (ex. Is there a link to data and participant, where will data be maintained, who has access, for how long will the information be kept, etc.)
- Statement on ethical considerations (ex. Study will be conducted according to ethical principles stated in the Declaration of Helsinki (2013), ethics approval will be obtained before initiating study, consent forms will take into consideration the well-being, free-will and respect of the participants, including respect of privacy, etc);
- References;
The study must also be accompanied by consent forms which adhere to the 91社区 guidelines (Guidelines on Consent Forms[.doc] and Genetic Research and DNA Banking Consent Forms[.doc]).