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Navigating Research in Pediatric Populations
 

Navigating Research in Pediatric Populations

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When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval. ...

When designing pediatric research, one size does not fit all. Simply adapting the adult clinical study protocol into its child-sized version will not be enough to gain IRB approval.

Research involving minors must prioritize the rights, safety, and welfare of its young participants, and the FDA has issued substantial regulations to ensure pediatric research is conducted safely and ethically.

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    Navigating Research in Pediatric Populations Navigating Research in Pediatric Populations Presentation Transcript

    • Navigating Research inPediatric Populations fully accredited since 2006
    • Webinar Housekeeping • Questions & Answers • Feel free to submit questions at any point during the webinar using the chat box on your webinar dashboard • Responses will be sent by the presenters following the presentation4
    • Webinar Housekeeping • Recording & Slide Deck • The webinar recording and slide deck will be posted on our website within 5 business days • We will email you a link to view the recording as soon as it is available • Feel free to share the link with your staff and/or colleagues5
    • About Quorum Review IRB Accredited • Fully Accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP) through 2014 • Fully compliant with FDA and OHRP requirements International capabilities • Boards available for the review of US and Canadian Studies Strong Framework • Approx. 200 employees – one of the largest IRBs in the US Certified IRB Professionals (CIP) • 60% of Affiliated IRB members, 40% of Regulatory staff and 20% of study management & study support positions6
    • The Quorum Advantage • 13 Board meetings each week • 24-hour site turnaround, 36-hour amendment review, and same day site changes • One time CV and audit documentation submission • Support available 8am-8pm ET • Dedicated Study Manager7
    • The Quorum Advantage • Secure portal with Smart Forms, status reports, and approval documents • Customized Phase I and Post-Marketing processes • Flexible, customized process for AMCs • 100% Quality Control on all documents8
    • About the Presenter Regulatory Attorney Mitchell Parrish, JD, CIP IRB Experience • Joined Quorum Review IRB in January 2010 • Regulatory Counsel with WIRB prior to Quorum • Former Regulatory Advisor to the National Cancer Institute Central IRB • CIP certified Legal Background • Juris Doctor from the University of Oregon School of Law • Member of the Washington State and American Bar Associations • Member of the Health and Corporate Law Sections of the WSBA9
    • Webinar Overview Description of Topic Page Importance of Research in Pediatric Populations 11 Regulatory Landscape 21 Research Permitted in Pediatric Populations 24 Recruiting Pediatric Populations 32 Consenting Pediatric Populations 40 Conducting Research in Pediatric Populations 64 Key Take Aways 7410
    • Importance of Research in Pediatric Populations
    • Importance of Research in Pediatric Populations The evolving view of children in research has changed from protecting children from research to protecting children through research12
    • Importance of Research in Pediatric Populations Old View New View Protect children from research Protect children through research • Result = Children not subjected to • Result = Children subjected to the potential harm from research potential harm, but such harm is mitigated by ensuring ethically and scientifically sound research that includes additional protections • End Result = A limited number of medical products evaluated for use • End Result = The development of in children medical products appropriately evaluated for use in children13
    • Importance of Research in Pediatric Populations Supporting the New View Why it’s necessary to develop medical products evaluated for children Without medical products approved for children, certain harms may occur: Denial of a potential treatment o Physicians refusing to use a drug or device approved for adults “off label” The wrong dose o Dose too high (harmful) (Ex. Use of the Antibiotic Chloramphenicol in the 1950s) o Dose too low (ineffective)14
    • Importance of Research in Pediatric Populations Supporting the New View Why it’s necessary to develop medical products evaluated for children Children are not small adults. Simply adjusting a drug’s dose or modifying a device according to a child’s weight is not always sufficient or appropriate due to additional considerations: o dynamics of growth o maturation of organs o changes in metabolism throughout infancy and childhood o changes in body proportion o other developmental changes that affect how drugs are metabolized15
    • Importance of Research in Pediatric Populations Supporting the New View Why it’s necessary to develop medical products evaluated for children Drugs may behave in a qualitatively different manner based on age. There may also be quantitative differences including: o dose-response relationships o pharmacokinetic parameters o magnitude of effect o risk of an adverse event o other variables that require defining based on the study population Basing conclusions on the effects observed in adults is not always useful, or feasible, because responses in pediatric patients may be different from those reported in adults16
    • Importance of Research in Pediatric Populations Supporting the New View Why it’s necessary to develop medical products evaluated for children • Potential harms • Children are not small adults • Products behave qualitatively and quantitatively based on age Therefore, medicinal products should be studied in children who are representative of the range of patients likely to receive the product once it’s marketed17
    • Importance of Research in Pediatric Populations Examples of demonstrated SUCCESS in conducting research in children: Changing Drug Labels • Ibuprofen: Studies in infants established safe and effective dosing information for children ages 6 months to 2 years • Zantac (ranitidine): Studies in infants established accurate dosing information for safer and more effective use of the drug to manage gastroesophageal reflux in seriously ill infants • Claritin (loratadine) syrup: Treats allergies and hives. Studies established that patients ages 2 to 5 require a lower dose compared to older children and adolescents FDA Web Article, Drug Research in Children18
    • Importance of Research in Pediatric Populations Examples of demonstrated SUCCESS in conducting research in children: Changing Drug Labels • Pepcid (famotidine) tablets, capsules, and oral solution: Studies revealed patients up to 3 months require a lower dose to treat gastroesophageal reflux disease because their ability to get rid of drug is less than that of older children and adults • Midazolam hydrochloride syrup and injection: Used as a sedative. Studies showed a higher risk of serious and life- threatening adverse events for children with congenital heart disease and pulmonary hypertension and identified the need to begin therapy with doses at the lower end of the dosing range to prevent respiratory problems in pediatric populations FDA Web Article, Drug Research in Children19
    • Importance of Research in Pediatric Populations Supporting the New View Ethically and Scientifically Sound Research • While products specifically evaluated in children will help protect children, there are undoubtedly still risks from participating in research • To mitigate these risks, all parties (sponsor, CROs, investigators, research staff, IRB) must ensure research is ethically and scientifically sound20
    • Regulatory Landscape
    • Regulatory Landscape United States FDA DHHS 21 CFR 50 (Protection of Human Subjects) 45 CFR 46 (Protection of Human Subjects) • Subpart D – Additional Safeguards for Children in Clinical Investigations • Subpart D – Additional Protections for Children Involved as Subjects in 21 CFR 56 (Institutional Review Boards) Research FDASIA (FDA Safety and Innovation Act, title V) FDAAA (FDA Amendments Act of 2007, Pediatric Tracking Requirements) PREA (Pediatric Research Equity Act of 2007) BPCA (Best Pharmaceuticals for Children Act of 2007)22
    • Regulatory Landscape Canada • Tri-Council Policy Statement (TCPS 2) (Ethical Conduct for Research Involving Humans) • ICH-E11 (Clinical Investigation of Medicinal Products in the Pediatric Population) • Health Canada Addendum to the ICH-E1123
    • Research Permitted in Pediatric Populations
    • Research Permitted in Pediatric Populations IRBs may only APPROVE research in children that falls into one of the following four categories: 1. Research not involving greater than minimal risk (21 CFR 50.51/ 45 CFR 46.404 ) o Permission of parent/guardian and assent of participant 2. Research involving greater than minimal risk but presenting the prospect of direct benefit to individual participants (21 CFR 50.52/ 45 CFR 46.405 ) o Risk is justified by the anticipated benefit to participant o Risk to benefit is at least as favorable to participant as available alternatives o Permission of parent/guardian and assent of participant Definition of Minimal Risk = the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests25
    • Research Permitted in Pediatric Populations 3. Research involving greater than minimal risk and no prospect of direct benefit to individual subject, but likely to yield generalizable knowledge about the subjects’ disorder or condition (21 CFR 50.53/ 45 CFR 46.406 ) o The risk represents a minor increase over minimal risk o Study presents experiences that are similar to actual non-research medical, dental, psychological, social, or educational situations o Study is likely to yield generalizable knowledge about the participant’s disorder or condition that is vital to understanding or ameliorating the disorder or condition o Permission of both parents/guardians and assent of participant Note: To enroll a “ward” research must be 1) related to child’s status as a ward or conducted in setting where majority of children are not wards (schools, hospitals) and 2) each ward must have an advocate26
    • Research Permitted in Pediatric Populations 4. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (21 CFR 50.54/45 CFR 46.407) IRB may not approve unless27
    • Research Permitted in Pediatric Populations  IRB finds and documents that study will further the understanding, prevention, or alleviation of a serious problem affecting children  The DHHS Secretary or FDA Commissioner in consultation with a panel of experts and following opportunity for public review and comment, determines: o the study presents an opportunity to further the understanding, prevention, or alleviation of a serious problem affecting children o the study will occur with sound ethical principles, and o There are adequate provisions for obtaining both parents/guardians permission and participant assent Note: To enroll a “ward” research must be 1) related to child’s status as a ward or conducted in setting where majority of children are not wards (schools, hospitals) and 2) each ward must have an advocate28
    • Research Permitted in Pediatric Populations Testing Our Knowledge A survey study is being conducted to record statistics on illicit drug use in middle school and high school students. As part of the research, students are asked to complete a series of questions regarding their drug use, if any, and are asked to sign and date the questionnaire. Assuming the study is likely to yield generalizable knowledge about underage drug use and addiction, which regulatory category applies?29
    • Research Permitted in Pediatric Populations A. 21 CFR 50.51/45 CFR 46.404 Research not involving greater than minimal risk B. 21 CFR 50.52/45 CFR 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to individual participants C. 21 CFR 50.53/ 45 CFR 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subject, but likely to yield generalizable knowledge about the subjects’ disorder or condition D. 21 CFR 50.54/45 CFR 46.407 Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children30
    • Research Permitted in Pediatric Populations Answer: C. 21 CFR 50.53/ 45 CFR 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subject, but likely to yield generalizable knowledge about the subjects’ disorder or condition31
    • Recruiting Pediatric Populations
    • Recruiting Pediatric Populations Recruiting activities are the beginning of the informed consent process Recruiting Study Subjects – Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators Most applicable guidance in knowing what to consider when advertising to or recruiting children33
    • Recruiting Pediatric Populations Based on FDA guidance, the IRB needs to review advertising and recruitment to ensure advertisements to children: • Are not unduly coercive • Do not promise or imply a favorable outcome or other benefits beyond what is contained in the protocol • Do not communicate that the study product is safe or effective for the purposes under investigation34
    • Recruiting Pediatric Populations • Do not make claims that the study product is known to be equivalent or superior to any other study product • Do not include language indicating that regulatory authorities, such as the FDA and IRB, have approved the research • Do not cause therapeutic misconception (e.g. modify the word “treatment” or “medicine” with a word that does not imply a benefit)35
    • Recruiting Pediatric Populations • Do not promise or imply free medical treatment when the intent is only to say subjects will not be charged for participation in the investigation • Do not emphasize payment • Provide information limited to that which subjects need to determine their eligibility and interest • Do not include statements that are generally misleading36
    • Recruiting Pediatric Populations Testing Our Knowledge A proposed radio advertisement to be played on the local #1 hit music station reads: Do you suffer from Asthma? Asthma is a chronic disease of the airways that makes breathing difficult. ABC Health Clinics is conducting a research study to test the safety and effectiveness of an investigational drug that will cure asthma. If you are 16-22 years old, have asthma, and want $300 to help buy those next concert tickets, then call 1-800-123-4567 to see if you qualify for the study. What information in the advertisement would the IRB find most problematic? What information in the advertisement would the IRB find most problematic?37
    • Recruiting Pediatric Populations A. “that will cure asthma” B. “want $300 to help buy those next concert tickets” C. “test the safety and effectiveness of an investigational drug” D. A and B E. A, B and C38
    • Recruiting Pediatric Populations Answer: D. A and B39
    • Consenting Pediatric Populations
    • Consenting Pediatric Populations To enroll a child into research there must be permission AND assent41
    • Consenting Pediatric Populations Who Can Give Permission? Parent a child’s biological or adoptive parent LARor judicial or other body individual authorized under applicable law to Guardian individual who is consent on behalf of a child authorized under applicable state or local law to consent Note: There is a significant difference on behalf of a child between having the authority to consent on behalf of a child for medical care versus enrollment in research42
    • Consenting Pediatric Populations Permission • Explanation of the research Definition: The agreement of • Any benefits parent(s) or guardian to the • Confidentiality participation of their child or ward in research [21 CFR 50.3(r)/ 45 CFR 46.402(c)] • Contact information • Foreseeable risks & discomforts In other words: A parent must provide their consent consistent • Alternative Procedures with the consent regulations • Compensation and Treatment for injuries Therefore, for a child to participate in research the parent must • Voluntary participation and no loss generally sign a consent form on of benefits behalf of their child and that • Additional elements found at 21 consent form must contain all CFR 50.25(b)/ 45 CFR 46.116(b) applicable consent elements (e.g. costs)43
    • Consenting Pediatric Populations Permission One or both Parents/Guardians 1. Research not involving greater than minimal risk (21 CFR 50.51/ 45 CFR 46.404 ) • One parent/guardian 2. Research involving greater than minimal risk but presenting the prospect of direct benefit to individual participants (21 CFR 50.52/ 45 CFR 46.405 ) • One parent/guardian44
    • Consenting Pediatric Populations Permission One or both Parents/Guardians 3. Research involving greater than minimal risk and no prospect of direct benefit to individual subject, but likely to yield generalizable knowledge about the subjects’ disorder or condition (21 CFR 50.53/ 45 CFR 46.406 ) • Both parents/guardians 4. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (21 CFR 50.54/45 CFR 46.407) • Both parents/guardians45
    • Consenting Pediatric Populations If Permission of both Parents/Guardians is required then . . . both parents/guardians must give their permission unless one is deceased, unknown, incompetent, or not reasonably available, or when only one has legal responsibility for the care and custody of the child46
    • Consenting Pediatric Populations Testing Our Knowledge An IRB is reviewing a Phase III study involving an investigational drug for juvenile diabetes. The drug has some potential significant side effects.47
    • Consenting Pediatric Populations Testing Our Knowledge An IRB is reviewing a Phase III study involving an investigational drug for juvenile diabetes. The drug has some potential significant side effects. Is permission of one or both parents required?48
    • Consenting Pediatric Populations A. One, since the research does not involve greater than minimal risk B. One, since the research involves greater than minimal risk but presents the prospect of direct benefit C. Two, since the research involves greater than minimal risk but presents the prospect of direct benefit D. Two, since the IRB determined that while the research presents the prospect of direct benefit, the drug has potential significant side effects49
    • Consenting Pediatric Populations Answer: D. Two, since the IRB determined that while the research presents the prospect of direct benefit, the drug has potential significant side effects50
    • Consenting Pediatric Populations Who Must Assent? Minor Emancipated Minor a person who, under local law, is under the a person who is recognized to have the full age of majority. The age of majority is the age legal rights of an adult under local law even at which the individual is considered an adult. though he/she is a minor. Minors can become Generally, minors cannot consent to emancipated through certain actions, such as participate in research marriage, enlistment in the military or living independently. Emancipation may require a Child court order. Emancipated minors may be able defined by federal regulations as a person to consent to research depending on local law who has not attained the legal age for consent to treatments or procedures involved in research under local law Mature Minor a person who, under local law, may consent Ward to certain health care treatment or procedures a minor who is has a guardian appointed by a (such as drug or substance abuse or sexually court or governmental agency; in other words, transmitted diseases) even though he/she is a a minor who is under the temporary custody minor. Mature minors may be able to consent or care of the local jurisdiction in which they to research depending on local law reside (e.g. a foster child)51
    • Consenting Pediatric Populations Mature Minor Emancipated (consent) Minor (consent) Minor Child Ward (assent) (assent)52
    • Consenting Pediatric Populations PA NE 21 19 MS AL 19 21 Puerto Rico 21 States that are not “18” – see map53
    • Consenting Pediatric Populations NU 19 YT NT 19 19 NL BC 19 19 NS NB 19 19 Provinces and Territories in Canada that are not “18” – see map54
    • Consenting Pediatric Populations Assent Definition: A child’s affirmative agreement to participate in research (mere failure to object may not be construed as consent) [21 CFR 50.3/45CFR46.402]55
    • Consenting Pediatric Populations Assent To determine whether Assent is required, how to administer assent, and how to document assent the IRB must consider • age • maturity • psychological state56
    • Consenting Pediatric Populations Assent requirements Waiver of Assent. Requirement for Waiver 21 CFR 50.55(c)/45 CFR Based on 46.408(a) age 1. The capability of some or all of the children is so limited that they cannot reasonably be consulted below7 2. or the study presents the prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of research (ex. pediatric oncology trials)57
    • Consenting Pediatric Populations Assent requirements Option 1: Assent form Based on for ages 7-18 with reading levels at lowest age Between age • participant signs 7 and 18 assent (or assent is documented in participant’s chart) Reminder! • Different ages of majority • Whenever a participant turns the age of majority during a study that participant must be consented with the consent form58
    • Consenting Pediatric Populations Assent requirements Option 2: Assent Form Based on for ages 7-11 and 12-18 with reading levels at age Between the lowest age • participant signs assent 7 and 18 (or assent is documented in participant’s chart) Reminder! • Different ages of majority • Whenever a participant turns the age of majority during a study that participant must be consented with the consent form59
    • Consenting Pediatric Populations Assent requirements Option 3: Assent form Based on 7-15; or assent forms 7- 11 and 12-15; and age Between consent/assent form for participants 16-18 • 7 and 18 means the consent form is written at a level in which a 16 year old could understand and means that the participant will provide their written assent on the actual consent form after their parent/guardian’s consent Reminder! signature • Different ages of majority • Whenever a participant turns the age of majority during a study that participant must be consented with the consent form60
    • Consenting Pediatric Populations Waiving Assent no matter the age, maturity, or psychological state 45 CFR 46.408(a) The IRB can always waive assent altogether for all participants if the following criteria are satisfied: • The clinical investigation involves no more than minimal risk to the subjects; • The waiver will not adversely affect the rights and welfare of the subjects; • The clinical investigation could not practicably be carried out without the waiver; and • Whenever appropriate, the subjects will be provided with additional pertinent information after participation61
    • Conducting Research in Pediatric Populations Testing Our Knowledge An IRB reviewing a non-Hodgkin’s lymphoma oncology clinical trial (with the potential for direct benefit) waived the requirement for assent for those participants under the age of seven. A six-year-old child with non- Hodgkin’s lymphoma is enrolled in the trial. After three months in the trial, the child has her seventh birthday. Must the child be provided with the assent form for participants 7- 11 years old and provide her assent in order to remain in the trial?62
    • Conducting Research in Pediatric Populations Testing Our Knowledge An IRB reviewing a non-Hodgkin’s lymphoma oncology clinical trial (with the potential for direct benefit) waived the requirement for assent for those participants under the age of seven. A six-year-old child with non- Hodgkin’s lymphoma is enrolled in the trial. After three months in the trial, the child has her seventh birthday. Must the child be provided with the assent form for participants 7- 11 years old and provide her assent in order to remain in the trial? NO63
    • Conducting Research in Pediatric Populations
    • Conducting Research in Pediatric Populations In order to approve Pediatric research that is permitted under the regulations an IRB must ensure . . . • risks to participants are minimized • risk to benefit ratio is acceptable • selection of participants is equitable • informed consent and assent will be sought and documented • adequate safety monitoring is in place • adequate privacy protections are in place • additional safeguards are in place to protect the rights and welfare of participants 21 CFR 56.111 and 45 CFR 46.11165
    • Conducting Research in Pediatric Populations In order to approve Pediatric research that is permitted under the regulations an IRB must ensure . . . • risks to participants are minimized • risk to benefit ratio is acceptable • selection of participants is equitable • informed consent and assent will be sought and documented • adequate safety monitoring is in place • adequate privacy protections are in place • additional safeguards are in place to protect the rights and welfare of participants 21 CFR 56.111 and 45 CFR 46.11166
    • Conducting Research in Pediatric Populations In order to approve Pediatric research that is permitted under the regulations an IRB must ensure . . . • risks to participants are minimized • risk to benefit ratio is acceptable • selection of participants is equitable • informed consent and assent will be sought and documented • adequate safety monitoring is in place • adequate privacy protections are in place • additional safeguards are in place to protect the rights and welfare of participants 21 CFR 56.111 and 45 CFR 46.11167
    • Conducting Research in Pediatric Populations • Medical facilities are scary and Minimizing cause distress Conduct the research in a child friendly Risks To atmosphere to reduce distress Participants ex. play equipment, furniture, age appropriate food, activities • Medical procedures hurt Use procedures to reduce pain To help understand ex. topical anesthesia to place IV catheters, indwelling catheters rather than what it means to repeated venipunctures for blood sampling minimize risks to • More procedures equal more children evaluate risks distress and more pain Be efficient to reduce distress and pain from the perspective of ex. if possible, conduct interventions at the a child: same time clinically indicated interventions are scheduled; utilize staff that is experienced working with children to ensure they are skilled and quick at administering procedures, such as blood draws68
    • Conducting Research in Pediatric Populations • Minimizing Minimize risks to children by tailoring the consent process to children Design the consent and assent process to ensure Risks To comprehension, appropriate parental/guardian involvement, and privacy issues Participants • Ex. Assent forms written at the appropriate reading level • Ex. Inclusion of graphs, charts, or visuals incorporated into the assent discussion • To help understand Ex. Separate discussions with children and their parents as necessary what it means to • Minimize risks to children by minimize risks to scientifically evaluating risks Design protocols to protect against adverse children, evaluate the outcomes that generally only affect minors protocol and consent • Ex. impairments of cognitive growth or skeletal development process specifically for • Ex. reduce the overall amount of blood required for the study by using sensitive children assays, pediatric-enabled laboratories, and population pharmacokinetic approaches69
    • Conducting Research in Pediatric Populations Blood Draw • Type of research in which Volumes in the child is enrolled Children • Severity of the child’s The IRB determines an condition appropriate blood draw volume • Hemoglobin levels taking into account the following • Frequency of blood draws Ex. Various Children’s Hospitals throughout the United States follow these recommendations: • Collection procedure Maximum Allowable Blood Draw Volumes (Clinical + Research) • Age of population Maximum of 2.5% of total blood volume in one blood draw and a maximum of 5.0% of total • Protocol justification for the blood volume in a 30 day period. volume www.seattlechildrens.org/pdf/blood-volume-chart.pdf70
    • Conducting Research in Pediatric Populations Testing Our Knowledge A study in children involves several blood draws over the course of 30 days. The target total amount of blood drawn within that time is 5% of a participant’s blood volume. The protocol for the study notes that a blood draw may have to be repeated in the event that a child’s blood sample is contaminated in the laboratory. Is the potential blood collection volume acceptable?71
    • Conducting Research in Pediatric Populations Testing Our Knowledge A study in children involves several blood draws over the course of 30 days. The target total amount of blood drawn within that time is 5% of a participant’s blood volume. The protocol for the study notes that a blood draw may have to be repeated in the event that a child’s blood sample is contaminated in the laboratory. Is the potential blood collection volume acceptable? NO72
    • Conducting Research in Pediatric Populations Additional • Require that each Investigator has the appropriate training and Safeguards expertise in pediatric populations (i.e. use a pediatrician, pediatric oncologist, pediatric cardiologist, First, one additional safeguard is etc.) ensuring the protocol fits into one of • More frequent DSMB meetings the categories of research in children. Remember, the IRB cannot approve • Omit any discussion of the research unless it fits into one of compensation from the assent the four applicable regulatory discussion categories • Develop documents to periodically check a child’s willingness to Second, other examples include: continue in the research (remember, assent is an active and ongoing process!)73
    • Key Take Aways
    • Key Take Aways • Research in children is important and know how to protect the rights, safety, and welfare of these young participants • The key regulatory documents are 21 CFR 50, Subpart D; 45 CFR 46, Subpart D; and in Canada ICH-E11 • The IRB can only approve research in children that falls into one of four categories and these categories also tell us whether the consent of one or both parents/guardians is required • Tailor advertisements appropriately to children when they are your audience • Permission and assent are required in order to enroll children into research and understand how to obtain and document both • Always ensure the research minimizes risks to children and includes additional safeguards75
    • Additional Questions • You may submit questions during our webinar survey, or • You may email your questions to: clientrelations@quorumreview.com • We will do our best to follow-up individually or answer your questions in the Q&A we post on our website76
    • Webinar Follow-Up • The webinar Recording, Slide Deck, and Q&A will be posted on our website • We will email you a link to view these items as they become available • We value your opinion – please take our SURVEY and provide us with feedback77
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    • Thank You for Attending!79
    • Navigating Research inPediatric Populations fully accredited since 2006