[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-172080-105":53,"doc-detail-172080-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","guidance-and-template-language-on-specific-types-of-risk-biomedical-research-studies","Guidance and Template Language on Specific Types of Risk - Biomedical Research Studies","","Biomedical research consent guidance providing template language for communicating specific medical procedure risks to study participants. Covers blood draw discomfort and rare complications, ultrasound safety based on non-ionizing radiation alongside possible biological effects, and radiation exposure explanation strategies using clear, participant-friendly statements. Includes variants for standard of care versus non-standard radiation, special statements for radioactive drug reviews, and procedure-specific risk text for PET, CT (including contrast agent allergy, kidney risks, claustrophobia, sedation placeholders), and MRI (magnet safety and contraindications).",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/guidance-and-template-language-on-specific-types-of-risk-biomedical-research-studies/172080/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/guidance-and-template-language-on-specific-types-of-risk-biomedical-research-studies/172080.png","ImageObject",442,249,{"name":88,"@type":89},"Riley West","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-19","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":15},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What risks should be explained for blood draws in biomedical studies?","Question",{"text":108,"@type":109},"Blood draws may cause temporary discomfort, bruising, and rarely infection or fainting. If multiple units are drawn within an 8-week period, a medically appropriate precaution regarding subsequent blood donation is required.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should radiation exposure risks be communicated to lay participants?",{"text":113,"@type":109},"Use simple language that alerts participants to the radiation risk and advises them to speak with the researcher if they have concerns. The document also notes that committees may provide dosimetry and absorbed-dose calculations.",{"name":115,"@type":106,"acceptedAnswer":116},"What additional risks should be covered for CT scans when contrast agents are used?",{"text":117,"@type":109},"Describe radiation risks and include potential contrast-agent discomforts and risks, such as allergic reactions (from mild symptoms to severe outcomes) and possible kidney problems, especially with dehydration or poor kidney function. Also address claustrophobia/discomfort and sedation risks if applicable.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},172080,1790862711,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":15,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":73},1099523885074,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","Guidance and Template Language on Specific Types of Risk (Biomedical Research Studies)\nAdapted from: http://ora.research.ucla.edu/OHRPP/Documents/Consent/ICF_Standards_Biomedical.pdf\nBlood draw risks: Blood draws may cause temporary discomfort from the needle stick, bruising and, rarely, infection and fainting. If more than one unit of blood is to be drawn within an 8-week period, a medically appropriate precaution concerning subsequent blood donation is required.\nUltrasound risks: Ultrasound imaging has been used for over 20 years. It is based on non-ionizing radiation, so it does not have the same risks as X-rays or other types of imaging systems that use ionizing radiation. Ultrasound imaging is generally considered safe when used prudently by appropriately trained health care providers. Ultrasound energy does have the potential to produce biological effects on the body. Ultrasound waves can heat the tissues slightly. In some cases, it can also produce small pockets of gas in body fluids or tissues (cavitation). The long-term consequences of these effects are still unknown. Because of particular concerns for effects on the fetuses, some medical organizations advocate prudent use of ultrasound imaging in pregnancy.\nRadiation risks: Risk from small amounts of radiation exposure is extremely difficult to describe in terms that are meaningful to the average layperson. While comparisons to chest x-rays are often used, most lay people have no way of estimating the risks of exposure from chest X-rays either, even though they are probably familiar with the procedure itself. Use a simple statement that alerts participants to the risk of the radiation exposure and advises him/her to speak with the researcher if there are further concerns about this exposure. The Radiation Use Committee will provide investigators with radiation dosimetry and calculation of the absorbed dose in matter and tissue resulting from the exposure to indirect and direct ionizing radiation.\nStandard of Care (SOC) Radiation Exposure Risks: Since the radiation procedures used in this study are all standard of care, the amount of radiation you will receive is the same as that for similar patients who are not participating in this study. Therefore, you will not be exposed to any additional radiation for participation in this study.\nNon-SOC Radiation Exposure Risks: You are exposed to radiation on a daily basis, both from natural (sun and earth) and manmade sources. The estimated radiation dose that you will receive as a participant for this type of research has been compared to the limits allowed for a radiation worker. This limit is low and is not expected to be harmful. The person obtaining your consent can answer any questions you have, and provide detailed written information about the amount of radiation resulting from this study.\nRadiation Exposure Risk Statement for Studies Requiring Radioactive Drug Research Committee (RDRC) Review: You are exposed to radiation on a daily basis, both from natural (sun and earth) and manmade sources. In addition to the radiation that you may be exposed to as part of your clinical care, you may potentially receive [describe e.g., XXX PET CT scans] in a year while participating in this study.\nThe US Food and Drug Administration (FDA) has set radiation limits for participants for this type of research. The dose you will receive in this study is low and below these limits and is not expected to be harmful. The person obtaining your consent can answer any questions you have, and provide detailed written information about the amount of radiation resulting from this study. Please inform your researcher if you have been exposed to radiation as a result of any other research studies.\nPET Scan - General Risk Statement:  PET scans involve the risks of radiation (see above).  If you have had a PET scan or have been exposed to radiation while participating in other research during the past year, you should inform the researcher(s). This ","cbCaij38KrI8fjYn","https://ap.wps.com/l/cbCaij38KrI8fjYn","docx",39408,"English","# Blood draw risks\n# Ultrasound risks\n# Radiation risks\n## Standard of Care (SOC) Radiation Exposure Risks\n## Non-SOC Radiation Exposure Risks\n## Radiation Exposure Risk Statement for Studies Requiring RDRC Review\n## PET Scan - General Risk Statement\n## CT scan risks\n## MRI risks","[{\"question\":\"What risks should be explained for blood draws in biomedical studies?\",\"answer\":\"Blood draws may cause temporary discomfort, bruising, and rarely infection or fainting. If multiple units are drawn within an 8-week period, a medically appropriate precaution regarding subsequent blood donation is required.\"},{\"question\":\"How should radiation exposure risks be communicated to lay participants?\",\"answer\":\"Use simple language that alerts participants to the radiation risk and advises them to speak with the researcher if they have concerns. The document also notes that committees may provide dosimetry and absorbed-dose calculations.\"},{\"question\":\"What additional risks should be covered for CT scans when contrast agents are used?\",\"answer\":\"Describe radiation risks and include potential contrast-agent discomforts and risks, such as allergic reactions (from mild symptoms to severe outcomes) and possible kidney problems, especially with dehydration or poor kidney function. Also address claustrophobia/discomfort and sedation risks if applicable.\"}]","Guidance and Template Language on Specific Types of Risk - Biomedical Research Studies | DOCX",1788289570]