# How to Draft a Consent Form for Future Use of Biospecimens By the end of this article you will be able to draft a consent form that lets participants approve storage and future research use of their biospecimens, choose between broad consent and study-specific consent language, structure the optional elements (protected health information, commercial use, sharing, return of results), and check the finished document for readability and completeness before submitting it to your ethics review body. You will need three things on hand before you start: your study protocol, the local requirements of your Institutional Review Board (IRB) or national ethics committee, and the current version of whatever national regulations apply to your site. In the United States, the Revised Common Rule (2018) and the 2016 CIOMS Guidelines define the essential elements that broad informed consent forms are expected to contain, and auditors of international trials measure completed forms against those elements [1]. Everything below assumes you are writing for human participants in a biomedical study, not for animal or environmental samples. ## Why future-use consent is a separate drafting problem A biospecimen is any biological material collected from a person, such as blood, tissue, urine, saliva, or DNA extracted from those sources. Future-use consent is the part of a consent form that asks whether the specimen can be stored after the current study ends and used in studies that have not yet been designed. This part of the form fails more often than any other. A systematic review of national ethics guidance across Sub-Saharan Africa found that of 49 countries, 29 had some form of national ethics guidance, but only 17 contained language specific to biospecimen research, covering consent (14 countries), reuse (10), storage (9), export and transfer (13), and ownership (6) [2]. When guidance is thin, researchers copy old templates, and old templates rarely anticipate modern [genomic analysis](/blog/guides/genomic-analysis), data sharing, or commercial questions. The consequences reach far beyond paperwork. Genome-wide association studies rely on samples collected years earlier, and an analysis of 40 GWAS consent documents found that 70 percent either explicitly stated that individual genomic results would not be returned or were silent on the issue entirely [3]. A form silent on return of results sets participant expectations that a later sequencing study cannot honor without a new consent process. There is also a historical reason participants may be skeptical. The Havasupai Tribe case, in which blood samples collected for diabetes research in 1989 were later used for studies the tribe had not agreed to, remains the standard cautionary example in responsible conduct of research training. A staged professional reading of the play Informed Consent, which dramatizes that controversy, measurably lowered trust in medical researchers among 421 surveyed attendees and increased agreement that group identity protections need improvement [4]. Your form is where trust is either built or lost. Donor evidence supports asking properly. In a survey with interviews of 302 cancer patients who had recently signed broad consent at four US academic medical centers, the majority believed the form gave them sufficient information about future uses, and concerns centered mainly on for-profit research and research by investigators in other countries [5]. Participants are not the obstacle. Vague forms are. ## Step 0: Choose your consent model before you write a word ![Decision path asking if future research is bounded by disease area, if samples stay identifiable, and if donors want study-by-study control.](/article-images/illustrations/consent-form-template-future-use-biospecimens-consent-model-choice.webp) Every downstream sentence depends on which model you select. Three models are commonly presented to donors: study-specific consent, broad consent, and a notice model in which no individual permission is sought and specimens are used under institutional oversight [6]. Practice varies widely. Among 200 protocols submitted to the Medical Research Council of Zimbabwe between 2009 and 2016 that involved biospecimen collection or biobanking, 99 (49.5 percent) used specific consent, 37 (18.5 percent) used broad consent, and 37 (18.5 percent) used blanket consent, with 2 protocols using notification instead of a signed form [7]. Blanket consent, which asks for permission without describing any category of future research, is the weakest model ethically and is increasingly rejected by review boards. | Model | What the participant approves | Typical wording anchor | Strengths | Limits | |--|--|--|--|--| | Study-specific | One defined study only | "Your samples will be used only for this study" | Easiest for participants to understand | Every new study requires reconsent or an ethics waiver | | Broad (open-ended) | Storage and future use within stated categories (for example, cancer research) | "Your samples may be stored and used in future research on [disease area]" | One enrollment supports years of research, endorsed by most donors [5] | Must still define scope, oversight, and withdrawal [1] | | Layered / conditional | Base consent plus optional checkboxes | Two separate questions for use with and without identifiers [8] | Captures individual preferences on sensitive elements | Longer form, more [data management](/blog/guides/data-management-basics-principles-processes-and-best-practices) | | Notice | No individual consent, institutional review governs use | Used for de-identified leftover specimens | Practical for archival material | Not acceptable for identifiable samples in most frameworks | Patient preferences lean toward specificity. In a survey of 548 Polish cancer patients, 93.1 percent were willing to donate leftover biospecimens to a biobank, but most preferred one-time or study-specific consent over blanket consent, most believed future use of previously collected tissue required second contact, and most supported the right to withdraw at any time [9]. If your population resembles that one, a broad form with clear limits will outperform an unrestricted one. ## The essential elements your form must contain Audits of broad informed consent forms give you a practical checklist. In an analysis of 54 broad consent forms used in international multicenter clinical trials between 2019 and 2024, most forms included over 90 percent of required essential elements. Consent documentation appeared in 100 percent of forms (54 of 54), storage conditions and duration in 98.2 percent (53), and voluntary participation in 98.2 percent (53) [1]. Two elements were frequently incomplete or absent: an explanation of what broad consent actually means (present in only 64.8 percent, 35 of 54) and information on sharing of specimens or data with other researchers [1]. Those two gaps are exactly where participant confusion begins, so your draft should treat them as mandatory sections, not optional extras. Use this working checklist, which mirrors the audit categories: 1. Statement of what broad consent means in plain terms 2. Description of what is collected and how much 3. Storage conditions, location, and duration 4. Categories of future research covered 5. Whether identifiers or protected health information (PHI) will accompany the sample 6. Sharing, export, or transfer to other institutions or countries 7. Return of individual results or a clear statement that results will not be returned 8. Commercial use and benefit sharing 9. Withdrawal procedure 10. Voluntary participation statement 11. Signature and date lines, including a legible personal signature for consent documentation ## The walkthrough: drafting the form section by section Work through the following eight steps. Each step shows template language you can adapt, followed by what a correctly completed section looks like. ### Step 1. Header and purpose statement Open with identity, purpose, and the distinction between the current study and future storage. ``` STORAGE AND FUTURE RESEARCH USE OF YOUR BLOOD AND TISSUE SAMPLES [Sponsor / Institution name] Protocol number: [XXXX] Study title: [Title] Today's study: We are asking you to take part in a study of [disease/ exposure]. Your samples will be tested for [primary analysis]. Future research: We would also like your permission to store leftover samples and related health information so that researchers can use them in future studies that have not yet been designed. ``` Expected output: a one-page header that a reader can scan in under a minute and still understand that two separate permissions are being requested. If a reader cannot tell where the current study ends and future storage begins, redraft before adding anything else. ### Step 2. Describe the specimens concretely Name each specimen type, volume, and collection method. Vague phrases such as "biological material" fail comprehension testing. ``` What we will collect: - About 2 tablespoons (30 mL) of blood from a vein in your arm - Leftover tissue from the biopsy your doctor already planned - A saliva sample in a small tube ``` ### Step 3. Storage conditions and duration State where samples are stored, how they are protected, and for how long. This element had near-universal compliance in the international audit (98.2 percent) [1], so reviewers will look for it first. ``` How your samples will be stored: - Samples will be stored in a locked freezer at [institution name] biobank, labeled with a code number instead of your name. - The list linking codes to names will be kept separate and secure. - Your samples will be stored for at least years or until they are used up, whichever comes first. ``` If your biobank is hospital-integrated, describe that relationship explicitly, since hospital-integrated biobanks are now a standard design and participants frequently assume their treating physician controls the samples [10]. ### Step 4. The future-use clause (the heart of the form) Explain what broad consent means, in one plain sentence, before asking for it. This is the element most often missing in real forms [1]. ``` What does giving permission for future research mean? If you say yes, your samples may be used in many future studies on [disease area] and related conditions. Researchers will not contact you before each study. An ethics committee at [institution] must approve every study before your samples can be used. Future studies will not include [excluded categories, e.g., reproductive cloning, research on topics you name here]. Please mark one box: [ ] YES, store my samples for future research as described above. [ ] NO, use my samples only in today's study, then destroy them. ``` Restrict the scope by disease area rather than leaving it unbounded. Donors consistently endorse future use across a wide range of research contexts, but their concerns concentrate on for-profit research and foreign investigators [5], so those two items deserve their own explicit treatment in Steps 5 and 7. ### Step 5. Identifiers and protected health information Split the question. A large prostate cancer biorepository study asked donors two separate questions, one covering future use without protected health information and one covering future use with PHI, and categorized donors accordingly as Yes-Always, Yes-Conditional, or Never. Of 1,931 men, 99.33 percent consented to future use overall, 88.19 percent consented to use without PHI, and among those, 10.2 percent also consented to use with PHI attached [8]. That 10 percent difference is real consent capacity you lose if you merge the questions into one checkbox. ``` Your samples can be studied two ways. Please mark a box in each row. Row 1: Use WITHOUT your name or health records attached (coded, de-identified samples) [ ] YES [ ] NO Row 2: Use WITH your health records attached (allows researchers to connect results to your medical history) [ ] YES [ ] NO ``` ### Step 6. Return of results and recontact Say plainly whether participants will receive individual findings. Silence is the default failure mode: 70 percent of GWAS consent documents analyzed either excluded individual genomic results or said nothing about them [3]. If results will not be returned, write that in the same font and section as everything else, not in an appendix. ``` Will you get results from future studies? - You will NOT receive individual results from research done on your stored samples. Results from future studies are not reliable enough to use for your medical care. - We may contact you in the future to ask for updated health information or for new permission for a different kind of research. You can say no at that time. ``` Recontact matters to participants. In five focus groups with 21 cancer patients, participants strongly supported recontact and reconsent when possible and supported the concept of broad consent at the time of tissue collection, but were unwilling to have other patients' specimens used beyond the original consent without their say [11]. Building a recontact clause into the original form costs you nothing now and preserves that option later. ### Step 7. Sharing, export, and commercial use State who may access the samples, whether they leave the country, and who may profit. Sub-Saharan Africa review found that only 13 of 49 countries had guidance language on export and transfer, yet export is where donor concerns about foreign investigators surface [2][5]. Only 22 percent (44 of 200) of Zimbabwean protocols included a plan for sample destruction, a gap reviewers increasingly flag [7]. ``` Sharing with other researchers: - Your coded samples may be sent to approved researchers at other institutions, including [list categories or countries]. - Any samples sent to for-profit companies will be used only for research on [disease area]. You will not be paid, and neither will your family, if a company makes a product from research using your samples. [Adapt to institutional policy.] Please mark a box: [ ] YES, my samples may be shared as described above. [ ] NO, my samples stay at [institution] only. ``` Note on benefit sharing: in the Polish survey, most patients believed that all parties, including the biobank, sponsors, and donors, should hold rights to donated tissues and share in profits [9]. Your wording must reflect your institution's actual policy, not aspirational language, because participants will hold the form to its words. Trust depends on researchers conducting studies as promised and using outcomes in line with stated objectives [12]. ### Step 8. Withdrawal and signature blocks Give a concrete withdrawal mechanism with a named contact, then close with signature lines for participant, person obtaining consent, and, where required, a witness. ``` Stopping storage of your samples: You may change your mind at any time by calling [name, phone, email]. We will destroy your remaining samples that have not already been used. Research already completed with your samples cannot be undone. Your samples may also be destroyed if they are used up, if the biobank closes, or if storage is no longer scientifically useful. Participant: ____________________ Date: __________ Obtained by: ____________________ Date: __________ Witness: ____________________ Date: __________ ``` Only 22 percent of Zimbabwean biospecimen protocols included destruction plans [7], and absence of a destruction clause is among the first items an experienced reviewer will question. ## Checking the draft: a completeness and readability pass Run a two-part check before submission. First, audit against the eleven-element checklist from the section above, marking each element present or absent. An international audit used exactly this approach across 54 forms and found the recurring failures were the meaning of broad consent and information sharing [1]. Your draft should score 11 of 11, because those two failures are known, preventable, and the most commonly missed. Second, run a readability check. The international audit measured English-language forms with the Flesch Reading Ease (FRE) and Flesch-Kincaid Grade Level (FKGL) metrics [1]. These are standard readability formulas available in Microsoft Word (Review, then Check Document, which reports grade level) and in free online checkers. A rural cancer biobank in Maine set its consent forms at an 8th-grade Flesch-Kincaid level and achieved a 97.6 percent consent rate among 83 eligible newly diagnosed cancer patients, later recontacting 60 of 69 surviving donors successfully for specimen transfer [13]. Target FKGL 8 or lower. Practical moves that reduce grade level without losing content include the following: 1. Replace "utilize" with "use" and "commence" with "start" 2. Split any sentence over 20 words into two 3. Convert passive constructions ("samples will be stored by the biobank") to active ones ("the biobank will store your samples") 4. Put checkboxes and short paragraphs on facing pages so no section reads as a wall of text A third check is cognitive interviewing, the method of asking a small number of target-population members to read the form aloud and explain each paragraph back. A cancer biobank study developed plain-language brochures explaining the three consent models and tested them through individual cognitive interviews with 14 women, gathering feedback on understandability, layout, and cultural appropriateness before deployment [6]. Five to eight interviews will surface nearly all confusing passages in your draft at negligible cost. ## Governance after the signature: keeping the form's promises A consent form is a promise your institution must operate. Repositories that succeed build the governance structure before enrollment. The VA Cooperative Studies Program Epidemiology Center in Durham built a single-request process with scientific and ethical review of every application, metadata standards for cross-study data storage, and a mechanism allowing data and specimens from older studies whose forms never addressed reuse to be shared only when the new research falls within the scope of the original consent [14]. That "within the scope of the original consent" test is the phrase your future-use clause exists to make possible. Community engagement belongs in the plan, not after complaints. Three focus groups of 10 adults each in a medically underserved, predominantly African American community produced three themes about a proposed institutional biobank: the importance of trust, the importance of community in research, and concrete suggestions for building trust [15]. Where your participant population includes groups with documented research grievances, budget engagement time before the form is finalized, since low trust shows up as low enrollment and as skepticism about exactly the elements donors flag most (profit, outside investigators) [5][12]. Finally, think about what the form enables downstream. Biospecimen and data sharing from clinical trials is central to biomarker research, yet among 29 breast cancer registrational trials reported between 2017 and 2024, none produced biomarker research that changed a drug's approved indication, a gap investigators attribute largely to obstacles in sharing specimens held by sponsors [16]. Forms that explicitly permit specimen sharing with defined oversight are the mechanism by which donated samples actually get used. ## Common Mistakes and Limitations ![Four warning pillars: blanket consent, merged identifier questions, silence on return of results, and missing withdrawal and destruction mechanics.](/article-images/illustrations/consent-form-template-future-use-biospecimens-common-mistakes.webp) - Using blanket consent. Asking for unlimited future use with no description of research categories reads as a rights waiver, and review boards increasingly reject it. In one national sample of protocols, blanket consent appeared in 18.5 percent of submissions, alongside more defensible models [7]. Replace it with a bounded broad-consent clause (Step 4). - Merging the identifier question into the future-use question. When use without PHI and use with PHI are asked separately, a measurable share of donors approves the first and declines the second [8]. One merged checkbox forfeits that granularity. - Silence on return of results. If the form does not say whether individual results will come back, participants may assume they will, and later studies inherit an expectation problem [3]. - Missing destruction and withdrawal mechanics. Writing "you may withdraw at any time" without naming a contact, and without a destruction statement, leaves the promise unenforceable. Only about a fifth of protocols in one audit included destruction plans [7]. - Skipping the plain-language definition of broad consent. Fewer than two thirds of audited broad consent forms explained what broad consent means [1]. A one-sentence definition in Step 4 fixes this. - Writing at graduate reading level. Long sentences and legal phrasing push grade levels up. Eighth grade on the Flesch-Kincaid scale is an achievable, evidence-supported target [1][13]. - Ignoring future health-record linkage. If the form grants access to future medical records, note that future records can contain stigmatizing or sensitive information the participant has not yet anticipated, and consider reasonable limits on record linkage rather than open-ended access [17]. - Assuming one template fits every country. Where national guidance on consent, ownership, reuse, storage, or export is absent or thin, the reviewing committee, not the template, fills the gap, and requirements differ [2][10]. Confirm requirements with your own IRB before drafting. - Forgetting that no template substitutes for local review. The form you draft is a proposal. Your IRB or ethics committee makes the final call, and its revisions are binding. Individual studies also face design-specific questions this general template cannot anticipate, and your institution's compliance office resolves those case by case. ## Frequently Asked Questions ### What is broad consent for biospecimens? Broad consent is a consent model in which a participant permits collection, storage, and future research use of their biospecimens and related data under ethical oversight, without being reconsented for each individual future study [1]. It differs from study-specific consent, which covers one defined protocol only. ### Can I ask for future-use consent on the same form as my main study? Yes, and most trials do. The recommended format is a clearly separated section, or a one-page insert, so the participant can see that two distinct permissions are being requested. Layered checkbox designs let donors accept the study and decline or accept storage independently. ### How long can I say samples will be stored? State a specific number of years or an event such as "until used up," and match it to your institution's biobank policy. Audited forms achieved near-complete compliance on this element, meaning reviewers expect a concrete answer, not "indefinitely" [1]. ### Do participants need to approve commercial or for-profit use separately? There is no universal mandate, but donor concerns concentrate on for-profit research and research by foreign investigators [5], so a separate checkbox for commercial use is a defensible design choice that preserves trust and gives participants genuine control. ### Do I need to reconsent participants for every new study using stored samples? Not if your original form used bounded broad consent and the new study falls within the stated scope and has ethics approval. Many participants still favor recontact when feasible [11], so building a recontact clause into the original form is good practice even when reconsent is not required. ### What reading level should a consent form be written at? Target 8th grade on the Flesch-Kincaid scale. A rural cancer biobank that set its forms at that level recruited successfully and later recontacted most surviving donors without difficulty [13], and readability metrics are now standard audit tools for broad consent forms [1]. ### Can participants withdraw consent for stored samples? Yes, and the form should say so with a named contact, a description of what withdrawal does (destruction of unused samples), and its limit (already-used material cannot be recalled). Most surveyed patients explicitly supported a right to withdraw at any time [9]. ### Where can I find a free consent form template for future use of biospecimens? Free starting points include the template language in the numbered steps of this article, model consent documents published by the National Cancer Institute and ISBER best-practice materials referenced in published biobank protocols [13], and your own institution's IRB template library. Adapt any template to your protocol, population, and local regulations before submission. ## Sources 1. [Analysis of compliance and language use in broad informed consent forms in international multicenter clinical trials after the implementation of the 2018 common rule.](https://pubmed.ncbi.nlm.nih.gov/42163212/) 2. [National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.](https://pubmed.ncbi.nlm.nih.gov/27770794/) 3. [Return of individual genomic research results: what do consent forms tell participants?](https://pubmed.ncbi.nlm.nih.gov/27329739/) 4. [An empirical assessment of the short-term impacts of a reading of Deborah Zoe Laufer's drama Informed Consent on attitudes and intentions to participate in genetic research.](https://pubmed.ncbi.nlm.nih.gov/29513089/) 5. [Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers.](https://pubmed.ncbi.nlm.nih.gov/29390947/) 6. [Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process.](https://pubmed.ncbi.nlm.nih.gov/27037699/) 7. [Strengthening ethical oversight in genomics and biobanking: a retrospective analysis of research practices in Zimbabwe.](https://pubmed.ncbi.nlm.nih.gov/40634959/) 8. [Secondary consent to biospecimen use in a prostate cancer biorepository.](https://pubmed.ncbi.nlm.nih.gov/27431491/) 9. [Perception of Polish patients with cancer of the ethical and legal issues related to biobank research.](https://pubmed.ncbi.nlm.nih.gov/38666716/) 10. [Informed Consent in the Newly Established Biobank.](https://pubmed.ncbi.nlm.nih.gov/31623267/) 11. [Secondary Use of Patient Tissue in Cancer Biobanks.](https://pubmed.ncbi.nlm.nih.gov/31182655/) 12. [Conditional trust as a driver of public engagement in Korea's national project of bio-big data.](https://pubmed.ncbi.nlm.nih.gov/41555922/) 13. [Informed consent for biobanking research: cancer patient recruitment from rural communities in Maine.](https://pubmed.ncbi.nlm.nih.gov/24845431/) 14. [Development of a Multi-Study Repository to Support Research on Veteran Health: The VA Cooperative Studies Program Epidemiology Center-Durham (CSPEC-Durham) Data and Specimen Repository.](https://pubmed.ncbi.nlm.nih.gov/33681131/) 15. [Perspectives from a Predominantly African American Community about Biobank Research and a Biobank Consent Form.](https://pubmed.ncbi.nlm.nih.gov/35802790/) 16. [Enhancing Clinical Cancer Research Through Sharing of Data and Biospecimens.](https://pubmed.ncbi.nlm.nih.gov/41410930/) 17. [Reconsidering Open-Ended Consent for Biospecimen and Health Record Research in the United States and Europe.](https://pubmed.ncbi.nlm.nih.gov/40658779/)