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Research on Children Exposed to Violence Pre-application Workshop: Registration and Schedule The National Institute of Child Health and Human Development (NICHD), in collaboration with the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, the National Institute of Neurological Disorders and Stroke, the Fogarty International Center, and the Office of Behavioral and Social Sciences Research at the National Institutes of Health; the Children's Bureau of the Administration on Children, Youth, and Families; the Centers for Disease Control and Prevention; the Office of Special Education Programs in the Department of Education; and the Substance Abuse and Mental Health Services Administration, will convene an information/technical assistance pre-application workshop for investigators planning to submit applications in response to the Program Announcement with Setaside (PAS) on Research on Children Exposed to Violence. The purpose of this meeting is to provide prospective applicants with an opportunity to receive answers to their questions about the intent and requirements of the PAS. Federal staff will be available to discuss all aspects of this new initiative, including:
Potential applicants to the PAS are not required to attend this workshop. A list of the questions asked during the workshop and a written summary of the responses from federal staff will be posted on this site following the meeting. Meeting Information: For further information, to submit questions, and to register, please contact: Margaret Feerick, Ph.D. Technical Assistance Workshop There seems to be a tension between rigorous research projects that use well-controlled samples as opposed to research projects addressing topics such as child abuse or violence, where there are many confounds. How does this impact the review of these latter studies? Reviewers want to know if the sample can be defined enough for independent replication. If you are using a treatment modality, you need to make sure that both the sample and the treatment are defined and explicated well enough to permit independent replication at another site. Program Officers can be helpful in assisting you in how you need to define the conceptual areas of the application. The reviewers will score the application according to the type of research that you intend to perform. For example, if it addresses a real world problem such as child abuse or exposure to violence, they will take into account the complexities of these areas. Will the Program Officers assigned to the applications be present at the review? Program Officers may not be involved in review and only attend review meetings as observers. The Scientific Review Administrator (SRA) is the official federal staff member responsible for the review. Program staff do not judge the scientific merit of applications; that is the responsibility of the reviewers. However they are involved (along with the SRA) in ensuring that the review is fair and appropriate. Program staff may recommend reviewers to the SRA, to ensure appropriate expertise, but reviewer selection is an SRA responsibility. With a special initiative such as this, program staff will most likely be invited to make reviewer recommendations and will attend the review as observers. Will the review committee be composed of individuals who have diverse experiences (i.e., those with both research/epidemiology and clinical/treatment backgrounds)? Many standing review committees at NIH are composed of reviewers with diverse backgrounds (e.g., epidemiology and treatment research). Responses to this program announcement will receive a special review, so the committee will be put together based on the expertise needed for the applications that are received. Program Officers have the responsibility of helping to ensure that the committee meets the needs of the specific initiative being reviewed. When there are intervention studies that take place outside of "the laboratory," the reviewers should recognize that researchers are dealing with something that is "messier" than a controlled laboratory study. Reviewers should be aware of the complexities of "real world research." Please address the use of flow charts and diagrams. A picture is worth a thousand words and clear charts and diagrams are highly recommended. What amount of time is expected for these projects (what is a reasonable project duration)? With the R01 mechanism, you can expect a range of project durations, depending on the particular studies. Typically, RO1 projects are for five years, but there is no rule that says an R01 study needs to be five years. New investigators and smaller projects (e.g., pilot studies) tend to have shorter project durations and that is appropriate. Please explain the NIH perspective on single-site as opposed to large multi-site studies. NIH does support multi-site studies; however, it is important to keep in mind that how these are evaluated will depend on how well the research plan is articulated and the quality control you will have over the different sites. Whether multi-site studies are justified also depends on the state of the science and the experience of the investigators; multi-site studies may be justified for more advanced areas of science as well as more seasoned investigators. Ultimately, if the study is large, there should be a justification for the study (and you need the science to justify the study). How innovative should one be (e.g., is it okay to propose a high-risk, high-payoff type study)? Innovation is one of the review criteria. Thus, innovation is important to some extent. However, you should be careful about how innovative your study is as it may limit your ability to present a comprehensive rationale and justification for the study. You must be able to justify what you are going to do in terms of the literature and/or previous work you have done in the area (and/or related areas). Adapting methods that have a research pedigree and moving them into new, related areas may be a good approach. How are the different agency members involved in this process? Outside agencies (the Centers for Disease Control and Prevention, the Administration for Children, Youth, and Families, the Department of Education, and the Substance Abuse and Mental Health Services Administration) and the Fogarty International Center and Office of Behavioral and Social Sciences Research at the NIH will be co-sponsors for applications assigned to the NIH institutes participating in this announcement (NICHD, NIAAA, NIDA, and NINDS), who are the primary funding agencies. While Dr. Feerick is listed as the program contact, you can contact program staff from any of the participating NIH institutes or outside agencies (the contact list is provided in your attachments). If you are not sure where to direct your inquiries, Dr. Feerick can direct you to the appropriate person. How do you address issues of control in adapting an efficacious study? You need to have a plan for the subjects who are not having the intervention and refer the severe cases to appropriate sources (e.g., clinicians, school administrators, etc.). Make sure you emphasize that the control group will receive the standard care as opposed to the experimental group, which is receiving the project intervention. Please give an example of how you account for multiple risk factors. Measure it all and partial it out. Focus on the theme of the theoretical model (i.e., Focus on XYZ). Alternatively, you can randomly assign subjects to groups. Is their any particular font or format that reviewers prefer? All applications are required to follow the PHS-398 formatting instructions, which are very specific on font size and page limits. What is a letter of response (or introduction to the revision)? Following review, a summary statement will be generated with feedback from the review committee. If an application is unscored or does not have a fundable score, the Principal Investigator can revise and resubmit the application. The Principal Investigator is required to respond to the concerns of the reviewers via an introduction to the revised application when he/she resubmits the application. Principal Investigators are encouraged to contact their Program Officers for guidance in revising and resubmitting applications. Do you have an idea of the number of submissions expected for this particular PAR? We don't have any definite number. There is no standard number that is expected. Please clarify the process of resubmitting an application. Before a revised application can be submitted, the Principal Investigator must have received the summary statement from the previous review. The application must include an Introduction to the Revision of not more than three pages that summarizes the substantial additions, deletions, and changes. The Introduction must also include responses to the criticisms and issues raised in the summary statement. The changes in the Research Plan must be clearly marked by appropriate bracketing, indenting, or changing of typography, unless the changes are so extensive as to include most of the text. This exception should be explained in the Introduction. Do not underline or shade changes. The Preliminary Studies/Progress Report section should incorporate any work done since the prior version was submitted. Acceptance of a revised application automatically withdraws the prior version, since two versions of the same application cannot be simultaneously pending. (See also the PHS 398 Instructions.) When would funding begin for applications in response to this PAR? Applications will be reviewed in the fall and then will go to January 2004 council, for a second level of review. Thus, the earliest start date would be in April. Do schools need assurances for human subject research? If, as part of data collection, teachers rate kids (engaged in research), teachers are considered agents of research; therefore, the school needs to get an assurance. Check with OHRP for clarification. If a provider (e.g., a facility or shelter) is contracted with the state, do they need their own a letter of assurance? Should we assume the provider has an assurance? Check with the department that is contracting the provider or with the Office of Human Research Protections (OHRP) for clarification. Can you have an individual vs. institutional assurance? Can an individual be given an assurance? OHRP does not assure individuals, but institutions. Check with OHRP for clarification. Can an institution use an incentive to obtain subjects for research? Phase I Trials If somebody on a history form reports that a child was abused does this need to be reported? You must follow your own state laws and the policies of your Institutional Review Board. You may want to consider a Certificate of Confidentiality to protect against certain types of disclosure (see http://grants.nih.gov/grants/policy/coc/index.htm for more information). Does international law apply? |