• Consent forms: Often consent forms omit required elements of informed consent and are written in technical language that subjects do not understand. Use everyday language and avoid technical terms and professional jargon as much as possible. Use short words and short sentences. Avoid the passive voice. Include consent forms for all groups of adult subjects, and assent forms for minor subjects. Include all required elements of consent.
  • Protection of privacy: the two biggest problems are how subjects are approached to participate in the research and how the confidentiality of data is protected. Subjects should be approached to take part in the research by someone with whom they have had prior contact. This person explains the study briefly and requests permission to release the potential subject's name to the investigator. These so-called "intermediaries" may include the subject's health care provider, teacher, friend, leader of an organization, etc. The important thing is that the person's involvement in the research is entirely voluntary and they were not coerced in any way to participate, nor did they feel compelled to participate for reasons other than their own desire to partake in the research process. Their privacy should be protected by removing identifiers as quickly as possible and by secure storage procedures.
  • Including all necessary information: Please carefully read and follow the How to Apply instructions and include all requested attachments.
  • Translations: When materials (whether approach, recruitment or consent forms or procedures, or questionnaires, surveys or other study procedures or materials) are to be administered in a language other than English, the materials should ideally be submitted in the target language(s), accompanied by English translation(s) that accurately represent the materials one actually intends to use. The following points should be considered.
    • Approach, recruitment and consent materials are often revised as a result of review. It is often better to submit English versions for initial review, and explain that translations will be submitted after English versions have been approved. However, because translation sometimes requires re-thinking and revision, it may be that the approved English versions no longer correspond to the actual materials. If this occurs, it is important to submit new English versions for review and approval.
    • Similarly, questionnaires and interview material to be used in several languages may require adaptations that make each translation a separate version. In such cases, it may be necessary to submit an English translation of each version.

Issues arising from use of materials in several languages can become complex, and must often be handled on a case-by-case basis. When submitting an application involving use of translated materials, it is generally helpful to address the issues preemptively, in the application itself. Addressing the issues at the time of application can help reduce delays in screening and review.