# Cannabis Science and Research Digest: From population outcomes to demand curves: A… > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/cannabis-science-and-research-digest-from-population-outcomes-to-demand-sep-2026/ > **Published:** 2026-09-27T19:27:22-04:00 | **Last Modified / Clinically Audited:** 2026-10-01T12:32:57-04:00 > **Clinical Summary:** cannabis science digest: CED Clinic analysis of 3 recent cannabis policy, science, and regulatory developments with Dr. Benjamin Caplan. --- CED Clinical Relevance #65 Verified Overview Curated multi-source overview preserving 3 verified developments. Clinical Insight | CED Clinic The practical message is not that cannabis uniformly causes these outcomes, but that it clusters with risk in ways that matter at the bedside. The longitudinal signal for suicidal behaviour is modest but real, and the violence meta-analysis shows a stronger association, especially for criminal-conviction outcomes and in psychiatric cohorts. Policy work adds another layer: changing access, price, or regulation can shift use patterns across substances, so a cannabis policy is rarely cannabis-only. For patients with depression, impulsivity, psychosis risk, or heavy polysubstance use, the threshold for screening and follow-up should be low, and the conversation should include dose, frequency, route, and co-intoxicants. DigestCannabis ScienceRegulationPublic HealthClinical Practice AudiencePatients, clinicians, healthcare professionals, regulators, and industry researchers. Primary TopicCurated updates on From population outcomes to demand curves: A syste. Source[Read the full source](https://pubmed.ncbi.nlm.nih.gov/42790649/) A structured CED Clinic overview of 3 key developments in cannabis regulation, market milestones, and scientific research. What This Study Teaches Us Across 95 policy studies with 250 evaluations, cross-substance effects were common, with 105 independence findings, 71 complementarity findings, and 39 substitution findings, showing that tobacco, cannabis, and alcohol policies often spill over beyond the target substance. In the IYDS cohort of 1,470 young adults, higher cannabis use at age 25 and increased use by age 29 predicted more suicidal behaviour, while Washington State had higher cannabis use but lower self-harm than Victoria. In the 63-study meta-analysis of 265,079 people, cannabis use was associated with higher violence perpetration, with OR 2.05 in the general population, OR 2.49 in psychiatric patients, and OR 1.49 for victimization. Why This Matters These findings matter because cannabis exposure is not just a symptom marker, it may track with higher risk for self-harm, violence, and broader substance-use spillover, especially in younger adults and psychiatric populations. For harm reduction, that means clinicians should ask about cannabis in the context of mood, aggression, suicidality, and co-use with alcohol or tobacco, not as an isolated behavior. Study SnapshotPost TypeCannabis Science and Research Digest using canonical CED layoutItems Reviewed3 verified updatesPrimary DatesSeptember 26, 2026Related Reading3 verified live CED Clinic internal linksStudy 1From population outcomes to demand curve (Freitas-Lemos et al., PubMed) [DOI: 10.1016/j.ypmed.2026.108665 | PMID: 42790649]Study 2Longitudinal Effects of Cannabis Use on (Fitzpatrick et al., PubMed) [DOI: 10.1007/s11121-026-01987-z | PMID: 42782471]Study 3Cannabis use is associated with increase (Trotta et al., PubMed) [DOI: 10.1017/S0033291726105856 | PMID: 42779465] Clinical Bottom Line This cannabis science and research digest preserves key signals across 3 updates without overstatement, offering grounded guidance for patients and practitioners. Digest Contents - [Digest Card 1 | From population outcomes to demand curves: A syste](#digest-card-2-digest-card-1-from-population-outcomes-to-demand-curves-a-syste) - [Digest Card 2 | Longitudinal Effects of Cannabis Use on Suicidal B](#digest-card-3-digest-card-2-longitudinal-effects-of-cannabis-use-on-suicidal-b) - [Digest Card 3 | Cannabis use is associated with increased risk of](#digest-card-4-digest-card-3-cannabis-use-is-associated-with-increased-risk-of) Why These 3 Updates Belong Together This curated cannabis science and research digest brings together 3 key developments across clinical research, public health signals, and therapeutic data. Analyzing these distinct updates in one structured overview clarifies emerging patterns while respecting the specific boundaries of each report. Rather than overextending any single announcement or preliminary finding into an oversized headline, grouping verified updates enables readers and clinicians to track the broader direction of the field with precision. Digest Card 1 | From population outcomes to demand curves: A syste **Title & Source:** [From population outcomes to demand curves: A systematic review of cross-substance effects of tobacco, cannabis, and alcohol policies.](https://pubmed.ncbi.nlm.nih.gov/42790649/) (*PubMed*, 2026Sep25) **Lead Authors & Identifiers:** Roberta Freitas-Lemos, Ana Carolina de Lima Bovo, Laura E Bruckner, Madeleine G Mason, Fábio Henrique Baia, Marcelo Borges Henriques, Vinicius Nascimento, Rafaela M Fontes. | **Primary Record:** DOI: 10.1016/j.ypmed.2026.108665 | PMID: 42790649 Content lane: **Clinical Evidence Update**. **1. Scientific & Clinical Background:** This systematic review examined how policies aimed at tobacco, cannabis, or alcohol affect not only the targeted substance but also the others. It included 95 studies and 250 evaluations, mostly real-world policy analyses, plus five behavioral economic studies. **2. Detailed Findings & Primary Data:** Across evaluations, 105 showed independence, 71 complementarity, and 39 substitution, with four mixed findings and 31 no own-substance effect reports. The direction and consistency varied by policy type and substance combination, and subgroup analyses often revealed patterns hidden in pooled estimates. **3. Dr. Caplan’s Clinical & Practical Guidance:** Policy changes can shift patient behavior across multiple substances, so a cannabis history should always include alcohol and tobacco. For harm reduction, clinicians should anticipate substitution in some patients and additive use in others, especially when access or price changes. **4. Study Boundaries & Methodological Limits:** The review combines heterogeneous policies, outcomes, and populations, which makes pooled interpretation difficult. Only five behavioral economic studies were included, so experimental support remains thin. Digest Card 2 | Longitudinal Effects of Cannabis Use on Suicidal B **Title & Source:** [Longitudinal Effects of Cannabis Use on Suicidal Behaviour in Early Adulthood in Washington State, United States and Victoria, Australia.](https://pubmed.ncbi.nlm.nih.gov/42782471/) (*PubMed*, 2026Sep24) **Lead Authors & Identifiers:** Abbey J Fitzpatrick, Jessica A Heerde, Bosco Rowland, Ebru A Batmaz, John W Toumbourou. | **Primary Record:** DOI: 10.1007/s11121-026-01987-z | PMID: 42782471 Content lane: **Evidence Check**. **1. Scientific & Clinical Background:** This longitudinal study used the International Youth Development Study to compare matched cohorts from Washington State and Victoria, following 1,470 participants at average ages 25 and 29. It asked whether cannabis use differed after legalization in Washington and whether cannabis predicted suicidal behaviour similarly in both regions. **2. Detailed Findings & Primary Data:** Washington participants reported significantly higher past-year cannabis use at age 25 and increased use by age 29, while Victorian participants showed reduced use over the same period. Higher cannabis use at 25 and increased use at 29 predicted more suicidal behaviour, and propensity score analysis confirmed a significant cannabis effect; Washington still had lower self-harm overall than Victoria. **3. Dr. Caplan’s Clinical & Practical Guidance:** In young adults, cannabis use should trigger a direct screen for suicidal thoughts, prior self-harm, and co-occurring substance use. The lower overall self-harm rate in Washington does not cancel the individual-level association, so both population context and personal risk need to be assessed. **4. Study Boundaries & Methodological Limits:** The study relies on self-reported cannabis use and suicidal behaviour, which can introduce reporting bias. Regional differences may reflect unmeasured social, legal, or healthcare factors beyond cannabis exposure. Digest Card 3 | Cannabis use is associated with increased risk of **Title & Source:** [Cannabis use is associated with increased risk of violence: A systematic review and meta-analysis.](https://pubmed.ncbi.nlm.nih.gov/42779465/) (*PubMed*, 2026Sep24) **Lead Authors & Identifiers:** Giulia Trotta, Victoria Rodriguez, Paolo Marino, Meklit Gurmesa, Edoardo Spinazzola, Zhikun Li, Luis Alameda, Marta Di Forti, Robin Murray, Evangelos Vassos. | **Primary Record:** DOI: 10.1017/S0033291726105856 | PMID: 42779465 Content lane: **Clinical Evidence Update**. **1. Scientific & Clinical Background:** This PRISMA-guided meta-analysis pooled 63 peer-reviewed studies with 265,079 participants to examine whether cannabis use is linked to violence as perpetrator or victim. It included both psychiatric and general population samples and analyzed longitudinal and cross-sectional designs separately. **2. Detailed Findings & Primary Data:** Cannabis users had higher odds of perpetrating violence in psychiatric patients (OR 2.49, 95% CI 1.72-3.61) and the general population (OR 2.05, 95% CI 1.74-2.41). The association persisted in longitudinal studies (OR 1.17, 95% CI 1.07-1.28), was stronger for violence with criminal conviction, and cannabis use was also linked to victimization (OR 1.49, 95% CI 1.38-1.60). **3. Dr. Caplan’s Clinical & Practical Guidance:** Cannabis use should be part of routine violence-risk assessment, especially in psychiatric care and in patients with legal or forensic involvement. The victimization signal, particularly in females and mixed-gender cohorts, supports asking about safety, coercion, and exposure to unsafe environments. **4. Study Boundaries & Methodological Limits:** Most included studies were observational, so confounding and reverse causation remain major concerns. The larger cross-sectional effects suggest that some of the association may reflect selection bias or shared risk factors rather than a direct causal effect. How Strong Is This Evidence? The strongest evidence here is the 63-study meta-analysis with 265,079 participants, which provides a large pooled estimate across settings and designs, though still observational. The policy review is broad and useful, with 95 studies and 250 evaluations, but it synthesizes heterogeneous real-world and behavioral economic data. The longitudinal cohort study is smaller at 1,470 participants, but its matched regional design and repeated measures add useful temporal information. Where This Paper Deserves Skepticism All three papers are limited by observational confounding, especially shared risk factors such as psychiatric illness, trauma exposure, socioeconomic stress, and other substance use. The policy review is vulnerable to heterogeneity in policy definitions and outcome measurement, while the cohort study relies on self-report and cannot fully separate cannabis effects from pre-existing vulnerability. In the violence meta-analysis, cross-sectional studies likely inflate associations, and even longitudinal estimates remain susceptible to residual confounding and reverse causation. What This Paper Does Not Show These studies do not prove that cannabis alone causes suicidal behaviour or violence in any individual patient. They also do not establish which products, THC doses, routes, or patterns of use are most responsible, or whether reducing use will reliably reverse risk in every setting. How This Fits With the Broader Clinical Conversation These findings fit with a broader shift in cannabis science toward studying not only symptom relief, but downstream outcomes like injury, aggression, self-harm, and cross-substance behavior. That matters as legalization expands, because access, potency, and product diversity are changing faster than the evidence base. The policy review also reflects a growing recognition that substance regulation has system-wide effects, with cannabis, alcohol, and tobacco influencing one another rather than behaving as separate silos. Clinically, that pushes screening toward a more integrated model of substance use assessment, especially in adolescents and young adults. Dr. Caplan’s Take *When I look at these papers together, the pattern is less about a single dramatic cannabis harm and more about risk clustering. Heavy or persistent use, especially in younger people or patients already carrying psychiatric vulnerability, deserves a more careful conversation than a casual yes-or-no screen. The useful question is not whether cannabis is always dangerous, but which patients are likely to pay a higher price for it.* *The policy paper is a reminder that changing one substance changes the whole ecosystem. If cannabis becomes easier to access, cheaper, or more normalized, some people will substitute away from alcohol or tobacco, while others will add cannabis on top of existing use. That is why the clinical history has to include co-use, timing, and function, because the harm often comes from the pattern, not the label.* What a Careful Reader Should Take Away Screen cannabis use alongside mood, suicidality, aggression, and other substances, especially in young adults and psychiatric patients. Treat these findings as risk signals that justify closer assessment, not as proof that cannabis is the sole cause of harm. Evidence Interpretation Guide Table of Contents - [How to Interpret This Cannabis Science and Research Digest](#How_to_Interpret_This_Cannabis_Science_and_Research_Digest)[Three Rules for Critical Reading](#Three_Rules_for_Critical_Reading) - [CED Perspective Lens: Eight Viewpoints on These Updates](#CED_Perspective_Lens_Eight_Viewpoints_on_These_Updates)[What this means if you use cannabis](#What_this_means_if_you_use_cannabis) - [What to screen for in practice](#What_to_screen_for_in_practice) - [Safety signals worth taking seriously](#Safety_signals_worth_taking_seriously) - [What policy makers should notice](#What_policy_makers_should_notice) - [What the evidence base is good at, and not good at](#What_the_evidence_base_is_good_at_and_not_good_at) - [Where the evidence can mislead](#Where_the_evidence_can_mislead) - [What families and caregivers should watch for](#What_families_and_caregivers_should_watch_for) - [Bottom line](#Bottom_line) - [Frequently Asked Questions](#Frequently_Asked_Questions)[Related](#Related) ## How to Interpret This Cannabis Science and Research Digest These studies point in the same direction: cannabis use often sits inside a broader risk profile that includes suicidality, violence, and shifts in other substance use. The numbers are useful, but they need to be read as associations shaped by population, policy, and psychiatric context. ### Three Rules for Critical Reading **1. Separate association from causation**The cohort and meta-analysis show higher odds of suicidal behaviour and violence among cannabis users, but they do not prove cannabis is the only driver. Look for baseline psychiatric illness, other substance use, and prior self-harm, because those factors can explain part of the signal. **2. Pay attention to the outcome definition**Violence involving a criminal conviction had much larger odds ratios than general violence, and policy effects differed by substance pair and subgroup. That means the endpoint matters, because administrative or legal outcomes can behave very differently from self-report outcomes. **3. Read policy studies as systems data**The policy review found 105 independence, 71 complementarity, and 39 substitution findings across 250 evaluations, which means one policy can shift use in several directions at once. Clinically, that argues for asking about alcohol, tobacco, and cannabis together, not in separate silos. Key Evaluation Question After adjusting for psychiatric history, other substance use, and prior self-harm or violence, how much of the observed cannabis association remains, and does it differ by dose, frequency, or route? The Patient Question If I use cannabis, what should we watch for in my mood, sleep, impulsivity, or use of alcohol and tobacco, and when would you want me to cut back or stop? The Bottom Line These papers support careful screening and harm reduction, not simplistic conclusions about cannabis being uniformly harmful or harmless. CED Perspective Lens ## CED Perspective Lens: Eight Viewpoints on These Updates Why these developments matter across clinical, patient, safety, and policy perspectives Lens OverviewEight distinct clinical and regulatory perspectives on From population outcomes to demand curves: A . #### What this means if you use cannabis These studies suggest cannabis use can travel with higher risk for suicidal behaviour and violence, especially when use is frequent or increasing over time. The signal is strongest in young adults and in people already dealing with psychiatric illness or other substance use. That does not mean every person who uses cannabis will have these outcomes. It does mean it is worth paying attention to mood changes, impulsivity, sleep disruption, and whether cannabis is being used alongside alcohol or tobacco. Lens takeawayIf cannabis use is part of your life, ask whether it is helping, worsening, or masking other risks. #### What to screen for in practice The cohort and meta-analysis support routine screening for suicidality, aggression, and victimization when cannabis use is present. The policy review also argues for asking about alcohol and tobacco together, because changes in one substance can shift use of the others. The most useful history is specific: frequency, potency, route, age of onset, co-intoxicants, and whether use is escalating. In psychiatric patients, cannabis should be treated as a risk modifier, not just a recreational detail. Ongoing observation across diverse patient groups provides essential clarity on how these findings hold up over extended timeframes. Lens takeawayAsk about cannabis the way you ask about sleep, mood, and other substances, because the pattern matters. #### Safety signals worth taking seriously The violence meta-analysis found higher odds of perpetration and victimization, and the suicidal behaviour study found risk rose with higher use and increasing use over time. Those are not trivial associations, particularly in patients with prior self-harm, psychosis risk, or unstable housing. Safety planning should include access to weapons, intoxication patterns, domestic conflict, and whether cannabis is being used to manage distress. If the patient is escalating use, the threshold for closer follow-up should be low. Lens takeawayCannabis is a safety issue when it sits next to suicidality, aggression, or unstable living conditions. #### What policy makers should notice The policy review shows that substance regulation rarely stays inside one lane. Across 250 evaluations, cross-substance effects included independence, complementarity, and substitution, which means a cannabis policy can alter alcohol and tobacco use patterns too. That makes routine surveillance essential after policy changes, especially in young adults and high-risk groups. If policymakers only measure cannabis sales or use prevalence, they may miss the downstream shifts that matter clinically. Ongoing observation across diverse patient groups provides essential clarity on how these findings hold up over extended timeframes. Lens takeawayMeasure the whole substance ecosystem, not just the target product. #### What the evidence base is good at, and not good at The meta-analysis is strong on sample size and consistency across many studies, while the cohort adds temporal direction, and the policy review broadens the lens to real-world systems. Together, they point to a reproducible association, not a single isolated finding. What remains missing is cleaner causal identification, better dose data, and more work on product type, potency, and route. Future studies need to separate cannabis alone from the common reality of polysubstance use. Ongoing observation across diverse patient groups provides essential clarity on how these findings hold up over extended timeframes. Lens takeawayThe evidence is suggestive and clinically useful, but it is still not the final causal word. #### Where the evidence can mislead Self-report, confounding by indication, and reverse causation are real problems here. People at higher baseline risk for self-harm or violence may also be more likely to use cannabis, which can make the association look stronger than it is. The policy review is especially vulnerable to heterogeneity, because different laws, markets, and populations are being grouped together. Even the meta-analysis mixes cross-sectional and longitudinal studies, and those designs do not carry the same weight. Ongoing observation across diverse patient groups provides essential clarity on how these findings hold up over extended timeframes. Lens takeawayA real association is not the same thing as a simple causal story. #### What families and caregivers should watch for If a young adult is using cannabis more often, becoming more withdrawn, or showing more irritability, that is worth noticing. The studies here suggest that rising use can track with more suicidal behaviour and violence-related risk, especially when mental health is already fragile. Caregivers should also watch for mixing cannabis with alcohol, tobacco, or other drugs, because the policy review shows these substances often move together. A calm, specific conversation about sleep, mood, and conflict is more useful than a moral argument. Lens takeawayWatch for changes in mood, conflict, and co-use, not just the fact of cannabis use. #### Bottom line These studies support a careful, integrated approach to cannabis screening, especially in young adults and psychiatric patients. The most actionable signal is not a single diagnosis, but a pattern of rising use, co-use, and worsening safety markers. Cannabis policy and cannabis care both need to account for spillover effects. The clinical job is to identify who is at higher risk, ask about the full substance picture, and respond early when the pattern starts to change. Lens takeawayUse cannabis data to sharpen risk assessment, not to oversimplify patient care. Join the Conversation Have a question about how this applies to your situation? [Ask Dr. Caplan](https://benjamincaplan.com/ask-dr-caplan) Want to discuss this topic with other patients and caregivers? 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Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](https://cedclinic.com/book/) [Cannabis Care](https://cedclinic.com/book/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Share this Evidence Watch [X](https://twitter.com/intent/tweet?text=Cannabis+Science+and+Research+Digest%3A+From+population+outcomes+to+demand+curves%3A+A...&url=https%3A%2F%2Fcedclinic.com%2Fcannabis-science-and-research-digest-from-population-outcomes-to-demand--sep-2026%2F) [LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fcedclinic.com%2Fcannabis-science-and-research-digest-from-population-outcomes-to-demand--sep-2026%2F) [BlueSky](https://bsky.app/intent/compose?text=Cannabis+Science+and+Research+Digest%3A+From+population+outcomes+to+demand+curves%3A+A...%20https%3A%2F%2Fcedclinic.com%2Fcannabis-science-and-research-digest-from-population-outcomes-to-demand--sep-2026%2F) [Instagram](https://www.instagram.com/drcaplan/) [Substack](https://doctorapprovedcannabis.substack.com/) [RSS](https://cedclinic.com/feed/) Source: [Primary Sources: PubMed, PubMed, PubMed](https://pubmed.ncbi.nlm.nih.gov/42790649/) Related Reading at CED ClinicContinue exploring the evidence[Prenatal Cannabis Exposure and Neurodevelopment: What the New Systematic Review Actually Shows](https://cedclinic.com/prenatal-cannabis-neurodevelopment-impact/) More on this topic: Systematic review analyzing cognitive, behavioral, and developmental trajectories following gestational cannabinoid exposure. [More on this topic: Fetal neurodevelopment](https://cedclinic.com/prenatal-cannabis-neurodevelopment-impact/)[The Multifaceted Impact of CBD on Sleep: A Comprehensive Guide for Better Rest](https://cedclinic.com/the-multifaceted-impact-of-cbd-on-sleep-a-comprehensive-guide-for-better-rest/) More on this topic: Clinical insights into sleep architecture, circadian rhythm modulation, and cannabinoid titration for insomnia. [More on this topic: Cannabinoids & sleep](https://cedclinic.com/the-multifaceted-impact-of-cbd-on-sleep-a-comprehensive-guide-for-better-rest/)[Adolescent Cannabis Use and Its Impact on Cognitive Development: Insights from the ABCD Study](https://cedclinic.com/adolescent-cannabis-use-cognitive-development-risk/) More on this topic: Long-term ABCD study findings on adolescent brain development, executive function, and early cannabis susceptibility. [More on this topic: Adolescent brain health](https://cedclinic.com/adolescent-cannabis-use-cognitive-development-risk/) ## Frequently Asked Questions What is covered in this cannabis science and research digest? This edition reviews 3 verified developments across cannabis policy, regulatory oversight, and clinical science. How are stories selected for CED digests? Stories are curated from official primary sources, government agency dockets, and peer-reviewed journals, focusing on practical relevance for patients and clinicians. Do preliminary reports establish medical efficacy? No. Observational reports, preprints, and regulatory filings describe emerging trends and require formal clinical trials before treatment efficacy can be claimed. How should clinicians use these updates? Clinicians can use these updates to understand patient questions, stay current with state regulations, and maintain evidence-informed counseling. Where can readers find Dr. Caplan's clinical insights? Dr. Caplan provides comprehensive clinical perspectives, patient consultations, and educational resources at CEDclinic.com. Why are multi-topic digests published instead of single stories? Digests group related updates together to provide a broader thematic overview while preserving important nuances and methodological limits. What is the primary role of laboratory testing in cannabis policy? Laboratory testing verifies cannabinoid potency and screens for harmful contaminants like heavy metals, pesticides, and molds to protect consumer health. How do state regulatory milestones impact [patient access](https://cedclinic.com/tsa-rules-on-cbd-gummies-travel-guidelines-2026/)? Administrative milestones establish the licensing rules, product categories, and retail standards that determine how and where registered patients obtain care. What precautions should families take with medical cannabis at home? Families should keep all medical cannabis products securely locked in child-resistant containers and clearly labeled to avoid accidental exposure. How often does CED Clinic publish clinical and policy updates? CED Clinic publishes regular morning, afternoon, and evening evidence reviews and news digests to keep the community informed. ### Related --- ### Verification & Medical Governance - **Lead Clinical Author:** Benjamin Caplan, MD - **Credentials:** Board Certified in Family Medicine (ABFM), Former CMO Canna Care Docs (250,000+ patients supervised), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House). - **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`). - **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/). - **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637). - **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).