Abstract: . . .  be disapproved: 1) Concern that the analysis or interpretation may be flawed; 2) Inclusion of clinical or public health recommendations that are not consistent with or supported by (usually they simply over-extend) the data presented; or 3) Conflict with NHLBI or DHHS policies. Differences of opinion about the scientific interpretation of results can be a reason for returning a paper without approval, if reviewers' opinions are well-founded and adequately justified. Interpretations that overstep the data; for instance, implying causality where none can be inferred, or suggesting the need for intervention when it has not been proven to be effective, can be highly embarrassing to the authors and the Institute.  . . .
. . .  Page 5 The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Page 5 of 12 10. Recipient's Compliance with IRB Requirements. Recipient acknowledges that the conditions for use of these Data are not exempt from review and have been approved by the Recipient's Institutional Review Board (IRB) operating under an Office of Human Research Protections (OHRP) - approved Assurance and in accordance with Department of Health and Human Services regulations at 45 CFR Part 46. Recipient agrees to comply fully with all such conditions. Recipient agrees to report promptly to the NHLBI any proposed change in the research project and any unanticipated problems involving risks to subjects or others. This Agreement is made in addition to, and does not supercede, any of Recipients institutional policies or any local, State, and/or Federal laws and regulations which provide additional protections for human subjects. 11. Amendments. Amendments to this Distribution Agreement must be made in writing and signed by authorized representatives of all parties. 12. Termination. NHLBI may terminate this Distribution Agreement if Recipient is in default of any condition of this Distribution Agreement and such default has not been remedied within 30 days after the date of written notice by NHLBIs Authorized Representative of such default. 13. Disqualification, Enforcement. Failure . . .
--3000,2,750,2418,23579