COMMON PROBLEM AREAS ENCOUNTERED IN THE REVIEW PROCESS

Responsiveness - Copying - Formatting - Consent Forms - Privacy and Confidentiality - Completeness of Information - Translations

• Responsiveness The purpose of a form is to elicit relevant information in an order, and with a structure, that allows reviewers to read and comprehend efficiently. For this reason, it is important to fill out the form with responses to the questions that are asked. (Putting "see attached" under the questions, and referring to attached sheets, undermines the purpose of the form, as does cutting and pasting material from another document that does not specifically answer the question after which it has been inserted.) The material must be provided in a form that allows for efficient review before it can be sent to reviewers.
• Copying. Sometimes investigators try to save paper by photocopying the application and materials in double-sided format. There are two problems that arise from this. First, it is harder to review documents that are double sided, since one cannot see the recto and verso of a page at the same time. Second, when documents are carelessly copied into double sided form, one document often begins on the verso of another, thus making it much more difficult to process them. For these reasons, the Committees do not accept double-sided materials for review.
• Formatting. Unusual font formats should not be used. Putting text in very small type, into all upper-case, or all underlined, makes it hard to read, and is an unnecessary burden on reviewers. Similarly, putting the responses to application questions into a font identical to that used in the application form can make it harder to see where the question stops and the answer begins, especially if the response text is made to begin on the same line as the end of the question.
• 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; 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.
  
• Privacy and Confidentiality. Problems in these areas most commonly arise in connection with how subjects are approached to participate in the research and how the confidentiality of data is protected.
  • Approach 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. In many situations in which prospective subjects can reasonably expect privacy, the initial approach should be made by someone whom prospective subjects will recognize as having ordinary access to their names and other (confidential or otherwise private) information about them.
  • Confidentiality of data should be protected by removing direct identifiers (e.g., names, addresses, telephone numbers, social security numbers, hospital numbers) as quickly as possible and by using secure storage procedures. The data storage procedures one proposes to use should be described in the application. In many studies, it is impportant for investigators to reflect on possible limits to confidentiality, and to address any such limits both in the application and in the consent material.
• Completeness of information. Sometimes investigators neglect to include important information without which the Committees cannot make an adequate risk-benefit analysis.
  • include a full description of approach and recruitment procedures; if you will contact prospective subjects by telephone, include a script or protocol for the approach call
  • include a full account of screening procedures, and provide screening materials (scripts, protocols, data abstraction forms, etc.)
  • Include all available information about investigational and non-investigational drugs, devices, substances, and procedures.
  • Provide examples of health histories, questionnaires, activity diaries, standardized tests, or instruments to be administered to subjects.
  • Provide enough information that Committee members are informed about what will happen to subjects and why the procedures are necessary.
  • Because no procedures, instruments or forms are approved in general or at large (they are approved only in the context of a specific Human Subjects Application), those which you intend to use must be submitted for review and approval. Only materials that have actually (a) been submitted for review in connection with a specific application, (b) been reviewed in connection with that application and (c) approved in connection with that application, are actually approved for use in connection with the study covered by that application - and only in connection with that application. Materials that are not provided cannot be reviewed, and cannot be considered approved. Use of such unapproved materials or procedures can constitute a breach of the terms of approval of a Human Subjects Application.
  • Some researchers, especially behavioral researchers, use audio or video recordings as stimuli (for example, audio recordings of narratives, or video from films). These should be submitted for review, and for the application record. Usually only one copy is necessary. At this time, one of the most covenient ways to submit such material is to burn a CD or DVD. When the electronic submission system is implemented, it will be possible to attach digital files directkly to the electronic application.
  • The Committees may approve the use of procedures, instruments or forms only in the context of a specific Human Subjects Application. Procedures or instruments are not given blanket approval, nor can approval of an instrument in the context of one application be extrapolated to assume that it must be approved in the context of any other application, proposed or approved. Failing to submit materials for review may lead to delays, since it will be necessary to obtain and review the material.
  • If Grant Proposals are connected with the application, one full copy of each must be submitted with the application. Without the relevant grant proposals, an application cannot be sent for review. Part of the Committee's responsibility is to certify that what has been reviewed and approved is what is in the grant proposal(s), and this cannot be done if the information is not provided to the Committee at review.
  • If the application is connected with a Master's or Doctoral thesis or dissertation, one copy of the thesis or dissertation proposal must be submitted with the application. Without the proposal, the application can not be sent for review
• Translations: When any 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 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 adapatations 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 those issues preemptively, without waiting to be asked about them, in the application itself. Addressing the issues at the time of application can help reduce delays in screening and review.

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