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What is this study about, and why are you doing it?<\/p>\n<\/li>\n
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What would I actually be doing if I join?<\/p>\n<\/li>\n
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What kinds of information will you collect about me?<\/p>\n<\/li>\n
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What are the possible risks or inconveniences?<\/p>\n<\/li>\n
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Who will be able to see my information?<\/p>\n<\/li>\n
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Can I change my mind later?<\/p>\n<\/li>\n<\/ul>\n
If you\u2019ve gone through the consent materials, asked your questions, and still feel unsure, to me that\u2019s a sign we have more work to do in how we explain things, not that you \u201cweren\u2019t paying attention.\u201d<\/p>\n
![\"Flowchart](\"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-content\/uploads\/sites\/503\/2026\/06\/data-bytes-visuals-visual-selection-2-scaled.png\")
In CPP Tracker and our other digital health studies, we treat informed consent as a step\u2011by\u2011step conversation, not a single checkbox.<\/strong><\/p><\/div>\n
Why consent is more than a signature<\/h3>\n
Yes, in most cases we do need a signed consent form before we can enroll you. But consent is supposed to be a\u00a0process<\/em>, not a piece of paper. For me, that means:<\/p>\n
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Using language you don\u2019t need a medical degree to decode.<\/p>\n<\/li>\n
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Leaving room for your questions, not rushing you through.<\/p>\n<\/li>\n
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Being transparent about what we know and what we don\u2019t know yet.<\/p>\n<\/li>\n
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Making it absolutely clear that \u201cno\u201d is an acceptable answer.<\/p>\n<\/li>\n<\/ul>\n
I think of consent as setting expectations for a relationship. I\u2019m asking you to share sensitive information about your symptoms, your daily life, and sometimes your body\u2019s data from wearables and smartphone apps. In return, I owe you clarity, respect, and honesty about what we\u2019re doing and why.<\/p>\n
How research consent differs from app \u201cterms and conditions\u201d<\/span><\/p>\n
It can be tempting to lump research consent together with those long \u201cI agree\u201d pop\u2011ups you scroll through when you start using a new app or wearable. On the surface, they look similar: lots of text, some legal language, a signature or a click at the end. But they are not doing the same job. Most user agreements are written to spell out what a company is allowed to do with your data and its product. In research, the goal is different: we\u2019re trying to help\u00a0you<\/em> understand what will happen if you join, what we\u2019ll ask of you, how we\u2019ll protect your information, and what your rights are as a participant in a study. That\u2019s why, in our work, we treat consent as a conversation, not a checkbox. You should feel like you can say \u201cI need more time,\u201d \u201cI don\u2019t understand this part,\u201d or \u201cI don\u2019t think this is for me\u201d without worrying that you\u2019ll lose access to care or services. From an ethics point of view, that\u2019s part of informed consent. From my point of view as a PI, it\u2019s also part of basic respect.<\/p>\n
Why digital health studies need especially clear consent<\/h3>\n
Digital tools, like apps, wearables, phone\u2011based sensors, can give us rich, continuous information we simply cannot get from a single clinic visit. That\u2019s exactly what makes them so powerful for understanding conditions like chronic pelvic pain and other women\u2019s health issues. But the same features that make them powerful also make it even more important to be clear and up front about data use and privacy.<\/p>\n
In digital health:<\/p>\n
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Data can be collected frequently (for example, daily symptom reports).<\/p>\n<\/li>\n
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Some data may be captured passively (such as step counts or sleep patterns).<\/p>\n<\/li>\n
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A lot of this happens outside the clinic, in the middle of your real life.<\/p>\n<\/li>\n<\/ul>\n
People are often less familiar with how this kind of data flows through a research study than they are with a traditional paper questionnaire. That\u2019s why, when we design and run studies, we try to be explicit about:<\/p>\n
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What the app or tool\u00a0does<\/em>\u00a0and what it\u00a0does not<\/em>\u00a0track.<\/p>\n<\/li>\n
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How often we plan to ask for your input.<\/p>\n<\/li>\n
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What kinds of patterns we\u2019re hoping to understand in your symptoms and daily life.<\/p>\n<\/li>\n
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How we plan to protect and use that information once you share it.<\/p>\n<\/li>\n<\/ul>\n
My goal is that you\u2019re never left guessing about what\u2019s happening behind the scenes with your health data in our studies.<\/p>\n
![\"Graphic](\"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-content\/uploads\/sites\/503\/2026\/06\/data-bytes-visuals-visual-selection-1-scaled.png\")
A good informed consent process in digital health research should make it easy to answer these questions before you decide whether to join.<\/strong><\/p><\/div>\n
How this plays out in CPP Tracker<\/h3>\n
In CPP Tracker, we ask participants to report symptoms and related experiences over time. Chronic pelvic pain is not a one\u2011size\u2011fits\u2011all condition; it fluctuates, it clusters with other symptoms, and it interacts with daily life in ways a single doctor\u2019s visit simply cannot capture. That\u2019s why this study lives on your phone, not just in the clinic. When you\u2019re considering whether to join CPP Tracker, the consent process should give you a clear picture of things like:<\/p>\n
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What kinds of questions we\u2019ll ask (for example, about pain levels, mood, or activity).<\/p>\n<\/li>\n
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How often we might send you prompts or reminders.<\/p>\n<\/li>\n
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How long your participation would last.<\/p>\n<\/li>\n
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Whether we use any data from wearables or phone sensors, and if so, which ones.<\/p>\n<\/li>\n
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How we plan to use your responses to better understand chronic pelvic pain over time.<\/p>\n<\/li>\n<\/ul>\n
From our side, every \u201cyes\u201d is a real act of trust – that you\u2019re willing to let us into the private realities of your symptoms and your day\u2011to\u2011day life. The consent process is where we either earn that trust, or we don\u2019t.<\/p>\n
What good consent should feel like<\/h3>\n
My personal benchmark as an investigator is that a good consent process should leave you feeling informed, not pressured; clear, not confused; and free, not boxed in. If you can honestly say:<\/p>\n
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\u201cI know what they\u2019re doing.\u201d<\/p>\n<\/li>\n
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\u201cI know why they\u2019re doing it.\u201d<\/p>\n<\/li>\n
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\u201cI know what it means for me, and I\u2019m okay with it.\u201d<\/p>\n<\/li>\n<\/ul>\n
then we\u2019re closer to doing our job well. And if you decide the study is\u00a0not<\/em>\u00a0right for you, that is still a successful outcome of the consent process. It means the information was clear enough for you to make the decision that fits your life and your values.<\/p>\n
Closing: The Pondering Professor Corner<\/p>\n
This post is the first in our short series The Pondering Professor Corner<\/em> about how we think about your data, your trust, and your participation in digital health research. Here we stayed at the moment of decision: the consent form, and what we are asking of you when we invite you into a study like CPP Tracker. In the next post, I\u2019ll pick up the story from there and walk you through the \u201clife\u201d of your data once you decide to join, such as where it goes, who sees it, and what we do (and don\u2019t do) with it in a digital health context. Because digital health research depends on participant trust, and trust depends on clear communication.<\/p>\n
—
\nAbout the author: Ipek Ensari, PhD, is an Assistant Professor at the Icahn School of Medicine at Mount Sinai Department of AI and Human Health and principal investigator of the CPP Tracker study on chronic pelvic pain. She is a digital health researcher focused on gynecological pain disorders like endometriosis, adenomyosis, and fibroids, wearable and app-based data, and AI-driven methods, with a particular interest in health data privacy, informed consent, and participant-centered study design.<\/p>\n","protected":false},"excerpt":{"rendered":"The Pondering Professor – Reflections on digital data and trust from PI Ipek Ensari Every time we run a study, we are asking people to let us into some of the most personal parts of their lives: their symptoms, their routines, their bodies\u2019 signals. As the study team for CPP Tracker, and our other studies, […]<\/p>\n","protected":false},"author":640,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[36],"tags":[37,38,39],"class_list":["post-5040","post","type-post","status-publish","format-standard","hentry","category-digital-data","tag-digital-data","tag-digital-trust","tag-womens-health"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/posts\/5040","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/users\/640"}],"replies":[{"embeddable":true,"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/comments?post=5040"}],"version-history":[{"count":10,"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/posts\/5040\/revisions"}],"predecessor-version":[{"id":5139,"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/posts\/5040\/revisions\/5139"}],"wp:attachment":[{"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/media?parent=5040"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/categories?post=5040"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/labs.icahn.mssm.edu\/ensarilab\/wp-json\/wp\/v2\/tags?post=5040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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