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It includes sections addressing study decision authority for guardians or proxies, randomization methods, placebo and multiple blinding approaches, and the conditions under which study details may be disclosed during emergencies. It further enumerates a wide range of procedural risks, subject benefit and cost statements, and banking and future research disclosure 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HYPERLINK \\l \"Child_LAR_Proxy\" \u0014Child/LAR/Proxy Statement\u0015\n\u0013 HYPERLINK \\l \"Randomization\" \u0014Randomization\u0015\n\u0013 HYPERLINK \\l \"Placebo\" \u0014Placebo use statement\u0015\n\u0013 HYPERLINK \\l \"Double_blind\" \u0014Double-Blind Statement\u0015\n\u0013 HYPERLINK \\l \"Placebo_run\" \u0014Placebo Run-In statement\u0015\n\u0013 HYPERLINK \\l \"Single_blind\" \u0014Single Blind Statement\u0015\n\u0013 HYPERLINK \\l \"Central_Bank\" \u0014Central Banking\u0015\n\u0013 HYPERLINK \\l \"Venipuncture\" \u0014Venipuncture Risk\u0015\n\u0013 HYPERLINK \\l \"Finger_stick\" \u0014Blood taken by finger stick\u0015\n\u0013 HYPERLINK \\l \"Heel_stick\" \u0014Blood taken by heel stick\u0015\n\u0013 HYPERLINK \\l \"IV\" \u0014Risk of IV inserted into vein\u0015\n\u0013 HYPERLINK \\l \"Central_Vein\" \u0014Central venous line risk\u0015\n\u0013 HYPERLINK \\l \"Femoral_art\" \u0014Femoral artery catheter risk\u0015\n\u0013 HYPERLINK \\l \"Blood_gas\" \u0014Risks of taking arterial blood gas\u0015\n\u0013 HYPERLINK \\l \"Skin_biopsy\" \u0014Skin biopsy risks\u0015\n\u0013 HYPERLINK \\l \"Muscle_Biopsy\" \u0014Muscle biopsy risks\u0015\n\u0013 HYPERLINK \\l \"Liver_biopsy\" \u0014Liver Biopsy Risk\u0015\n\u0013 HYPERLINK \\l \"Bone_marrow\" \u0014Bone marrow sample risks\u0015\n\u0013 HYPERLINK \\l \"MRI\" \u0014MRI risks\u0015\n\u0013 HYPERLINK \\l \"Radiation\" \u0014Radiation risks\u0015\n\u0013 HYPERLINK \\l \"X_Ray\" \u0014X-ray risks\u0015\n\u0013 HYPERLINK \\l \"DEXA\" \u0014DEXA risks\u0015\n\u0013 HYPERLINK \\l \"CT\" \u0014Computer Tomography (CT) risk\u0015\n\u0013 HYPERLINK \\l \"Angiography\" \u0014Angiography risk\u0015\n\u0013 HYPERLINK \\l \"Radio_tracer\" \u0014Radioactive tracer risk\u0015\n\u0013 HYPERLINK \\l \"Bone_scan\" \u0014Bone scan risk\u0015\n\u0013 HYPERLINK \\l \"Radiation_therapy\" \u0014Radiation therapy risk\u0015\n\u0013 HYPERLINK \\l \"benefit_some_med\" \u0014Benefit statement (with some medical benefit for subjects)\u0015\n\u0013 HYPERLINK \\l \"benefit_no_med\" \u0014Benefit statement (with no medical benefit for subjects)\u0015\n\u0013 HYPERLINK \\l \"Alt_Tx_med_benefit\" \u0014Alternative treatments (with medical benefits for subjects)\u0015\n\u0013 HYPERLINK \\l \"Alt_Tx_Cancer\" \u0014Alternative treatments for oncology studies\u0015\n\u0013 HYPERLINK \\l \"Cost_Sponsor_nothing\" \u0014Costs to subjects (sponsor pays nothing)\u0015\n\u0013 HYPERLINK \\l \"Cost_Sponsor_experimenta\" \u0014Costs to subjects (sponsor pays experimental treatments)\u0015\n\u0013 HYPERLINK \\l \"Cost_Sponsor_drug\" \u0014Costs to subjects (sponsor pays for study drug)\u0015\n\u0013 HYPERLINK \\l \"Cost_Sponsor_all\" \u0014Costs to subject (sponsor pays all costs)\u0015\n\u0013 HYPERLINK \\l \"Cost_high_cost\" \u0014Statement for high-cost treatments\u0015\n\u0013 HYPERLINK \\l \"Drugs_commercial\" \u0014Drugs are commercially available\u0015\n\u0013 HYPERLINK \\l \"Devices_commercial\" \u0014Devices are commercially available\u0015\n\u0013 HYPERLINK \\l \"Subject_payment\" \u0014Subject payment\u0015\n\u0013 HYPERLINK \\l \"Voluntary_medTx\" \u0014Voluntary participation (studies with medical treatment)\u0015\n\u0013 HYPERLINK \\l \"Voluntary_nomedTx\" \u0014Voluntary participations (studies with NO medical treatment)\u0015\n\u0013 HYPERLINK \\l \"Withdraw_medTx\" \u0014Study withdrawal (when there is medical treatment)\u0015\n\u0013 HYPERLINK \\l \"Withdrawal_nomedTx\" \u0014Study withdrawal (when there is NO medical treatment)\u0015\n\u0013 HYPERLINK \\l \"Subject_advocate\" \u0014Subject advocate available to answer questions\u0015\n\u0013 HYPERLINK \\l \"Photo_Vid_Audio\" \u0014Photography, Video Tape, Audio Tape - Amplifying Text\u0015\n\u0013 HYPERLINK \\l \"Report_violence\" \u0014Reporting of Child Abuse, Neglect, or Threatened Violence\u0015\n\u0013 HYPERLINK \\l \"Report_disease\" \u0014If You Test Positive for Reportable Diseases\u0015\n\u0013 HYPERLINK \\l \"CoC_English\" \u0014Certificate of confidentiality (English)\u0015\n\u0013 HYPERLINK \\l \"CoC_Spanish\" \u0014Certificate of confidentiality (Spanish)\u0015\n\u0013 HYPERLINK \\l \"Detention\" \u0014If you are in a detention facility\u0015\n\u0013 HYPERLINK \\l \"Prisoners\" \u0014If prisoners are included\u0015\n\u0013 HYPERLINK \\l \"Injury_wComp\" \u0014Injury and Compensation—With Compensation\u0015\n\u0013 HYPERLINK \\l \"Injury_noComp\" \u0014Injury and Compensation—No Compensation\u0015\n\u0013 HYPERLINK \\l \"IND_IDE_grant\" \u0014Mandatory language for studies under IND, IDE or as required by the grant\u0015\n\u0013 HYPERLINK \\l \"GINA\" \u0014Genetic Information Nondiscrimination Act (GINA)\u0015\n\u0013 HYPERLINK \\l \"Storage_banking_future_use\" \u0014Storage of blood and /or tissue for this study or for banking for future use\u0015\n\u0013 HYPERLINK \\l \"Future_use\" \u0014Future Research Statement for Pos","cbCaibJkhHAdFHgq","https://ap.wps.com/l/cbCaibJkhHAdFHgq","docx",133934,26,"English","# Child/LAR/Proxy Statement\n# Randomization\n# Placebo use statement\n# Double-Blind Statement\n# Placebo Run-In statement\n# Single Blind Statement\n# Central Banking\n# Venipuncture Risk\n# Blood taken by finger stick\n# Blood taken by heel stick\n# Risk of IV inserted into vein\n# Central venous line risk\n# Femoral artery catheter risk\n# Risks of taking arterial blood gas\n# Skin biopsy risks\n# Muscle biopsy risks\n# Liver Biopsy Risk\n# Bone marrow sample risks\n# MRI risks\n# Radiation risks\n# X-ray risks\n# DEXA risks\n# Computer Tomography (CT) risk\n# Angiography risk\n# Radioactive tracer risk\n# Bone scan risk\n# Radiation therapy risk\n# Benefit statement and treatment alternatives\n# Costs to subjects and subject payment\n# Voluntary participation and study withdrawal\n# Subject advocate\n# Photography, Video Tape, Audio Tape - Amplifying Text\n# Reporting of Child Abuse, Neglect, or Threatened Violence\n# If You Test Positive for Reportable Diseases\n# Certificate of confidentiality\n# If you are in a detention facility\n# If prisoners are included\n# Injury and Compensation statements\n# Mandatory language under IND/IDE or grant requirements\n# GINA\n# Storage of blood and/or tissue for this study or future banking\n# Future research statement for postcard consent/information sheets\n# Optional consent for data and specimen banking for future research\n# Conflict of Interest Disclosure Language","[{\"question\":\"What does the Child/LAR/Proxy Statement explain?\",\"answer\":\"It clarifies that some participants may not be able to make important decisions themselves and that the consent wording “you” and “your” refers to the other person deciding for them when a proxy or LAR is involved.\"},{\"question\":\"How does the document describe randomization in the study?\",\"answer\":\"It states that the study uses a method of chance to assign participants to different research groups, likening it to flipping a coin or rolling dice, with each group receiving slightly different care.\"},{\"question\":\"What is included in the Double-Blind Statement?\",\"answer\":\"It explains that participants will not know which treatment group they are in, and neither will the study doctor, to keep information secret; it also notes that study information can be shared in an emergency.\"}]","List of Additional Standard Language Statements for the Consent Form and Optional Consent for Data and Specimen Banking for Future Research | DOCX",9]