2 0 11 P E D I AT R I C C L I N I C A L R E S E A R C H W E B I N A RSERIES        Guidelines for Effective and      Appro...
Angi Robinson                                        Director, Clinical Trials Management                                ...
Elizabeth Jay, RN, MA                                        Clinical Manager II, Clinical Trials                        ...
Regulatory Requirements:       Parental Permission & Pediatric       Assent          ICH-GCP E6: Guideline for Good Clini...
Agency & IRB/EC     Responsibilities5                Review and approve research protocols involving                minors...
Minimal risk n. [mi-nə-məl risk] 1. the  probability and magnitude of harm or  discomfort anticipated in the research are ...
Pediatric Research Approval     Guidelines     United States7     Code of Federal Regulations permits IRBs to assess risks...
Pediatric Research Approval     Guidelines     United States8     Regulations also permit a 4th category of research:     ...
Pediatric Research Approval     Guidelines     Europe9     European Directive 2001/20/EC permits approval of     research ...
Pediatric Research Approval      Guidelines      Europe10       (e) some direct benefit for the group of patients is obtai...
Review of Recent Pediatric          Studies          8 pediatric studies conducted under IND          applications at 96 s...
Cohort Group and      Research Category12                        10                         8       Number of IRBs        ...
Cohort Group and Assent13      40 of 59 sites required and approved one or more      separate assent forms (total of 55 fo...
Review of Parental Permission          Unlike informed consent, parental          permission involves agreeing on behalf  ...
Parental Permission      Permission vs. Consent15         Only patients who have decisional capacity and          legal e...
Parental Permission      Risk and Required Signatures16      45 CFR 46.408 details requirements for      permission by par...
Parental Permission      Researchers’ Responsibilities17         Include all required elements of consent         Ensure...
Review of Pediatric Assent          Pediatric Assent is meaningful           Encourages shared decision-making,          ...
Pediatric Assent      US Regulatory Requirements19      45 CFR 46.408/21 CFR 50.55 details      requirements      for asse...
Pediatric Assent      Minimum Age of Assent20      United States       1979: Belmont Report (report by National Commissio...
Pediatric Assent      Researchers’ Responsibilities21         Obtain written IRB requirement for age of assent         D...
Developing Forms for          Parental Permission and Assent          Need to consider:           Elements of Permission/...
Elements of Informed Consent23         Purpose and duration of research         Targeted number of participants        ...
Elements of Assent24      For research, the goal is to help child achieve      developmentally-appropriate awareness      ...
Adult Reading and      Comprehension25      At what grade level does the average adult read      and comprehend informatio...
Creating Forms26      One size doesn’t fit all!         Determine whether your IRB has specified          minimum age to ...
Forms Should be      Easy to Comprehend27           The information that is given to the subject or the           represen...
Readability Statistics28      Flesch Reading Ease and Flesch-Kincaid Grade      Level       Common method to check readab...
Checking Readability Stats      Word 200729      1)Click on the Microsoft        Button and then Word        Options which...
Checking Readability Stats      Word 97-200330     1)Under the Tools menu,       choose Options which will       open a po...
Hints to Increase Reading      Ease31         Use smaller words with fewer syllables         Use at least 12 point font ...
Hints to Increase Reading      Ease32         Use simple terms rather than medical terms:          –   Medication or medi...
Sample Passage Comparison:      Assent Form for Ages 7–1133      Sample 1                                         Sample 2...
Readability Results34      Sample 1                                         Sample 2     2011 PEDIATRIC CLINICAL RESEARCH ...
Pediatric Assent Process            Who?            Where?            When?            How?2011 PEDIATRIC CLINICAL RES...
Practical Issues36         Does approving IRB have any specific          requirements or guidelines regarding assenting  ...
Documentation              When the IRB determines that assent is              required, it shall also determine whether a...
Recommendations on      Documentation38      Note should contain:       Date and time of discussion       Names/roles of...
Summary: Questions to Consider            Does the number of signature lines on the             parental permission form ...
Summary: Questions to Consider            Do the consent/assent forms contain the             required elements?         ...
Resources41         Code of Federal Regulations. 45 CFR 46:117. Federal Policy for the Protection of          Human Subje...
Resources42         US Department of Health and Human Services, Office for Human Research          Protections. Protectio...
Acknowledgement43      The pediatric studies referenced in this      presentation were conducted by the Eunice      Kenned...
Upcoming Webinar44     Register at www.premier-      research.com/webinars     ▪ Pediatric Considerations beyond Assent   ...
Questions?          Angi Robinson          Director, Clinical Trials Management          Email: angi.robinson@premier-rese...
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Guidelines for Effective and Appropriate Pediatric Assent and Parental Permission

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During this presentation, Angi Robinson and Elizabeth Jay reviewed the regulatory requirements for parental permission and pediatric assent; provided practical tips for compliant and age-appropriate form development including which elements to incorporate, the number of required signatures, and how to check for reading comprehension level; and offered recommendations for documentation of the consenting/assenting process.

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  • Thank youWorking in Pediatrics – we often hear the phrase Children are Not Small Adults; the same holds true for Pediatric trials vs Adult trials – there are important intricacies in running pediatric trials and today we will focus on the important topic of parental permission and pediatric assent. While the roles of the IRBs, Sites, Sponsors and CROs may differ – we all partner as researchers to ensure the work we do for permission and assent is both compliant with regulations but also highly effective and respectful of the patients and their families. The goal and agenda here today is that I will review and familiarize the group with the regulations governing this process and provide insight into the areas where special attention should be paid and Elizabeth will review provide practical tips and suggestions for applying these guidances.Focus on US due to the time limitations ; Interject EU guidance where appropriate
  • It’s important to first understand directive for Agency and IRB/EC for PEDIATRIC studiesPrincipal decision makers & assessment impacts researchers responsibilities[[Review responsibilities]]Elements of their assessment are subjective which results in high levels of variability; further emphasizing the need for knowledge and diligence regarding Parental Permission and Pediatric Assent to ensure higher level of consistency and regulatory compliance
  • The IRBs responsibility to review and approve pediatric research is done in part by considering the potential risk and possible benefits. In the US risk is evaluated relative to the term ‘Minimal Risk’Within the regulations Minimal Risk is defined as noted in this slide evaluating the “probability that the harm or discomfort from the research are not greater than those ordinarily encountered”So as you can expect within this evaluation of risk, combined with a similarly subjective assessment of benefit lies the potential for variability both across sites in any protocol but also within an individual IRB
  • Regulations in the US define specific categories to be used by the IRB based on the potential risk and possible benefit to an individual research subjectOften individuals in research are not wholly familiar with these therefore I will review each of them – they are of special importance as these categories align to different requirements by the Investigators and sites[[Review the guidelines]]
  • There is also a 4th category which more rare and many will never see or useIn this category the research does not meet any of the preceding 3 categories however it is expected that this research will provide understanding, prevention or alleviation of serious problem affecting childrenA study in category 407 requires additional review and approval by FDA or HHS
  • In EU the European directive supports similar principals however do not separate the research into categories, including:Focus on Risk and BenefitsRequirement for parental consent/permissionRequire the patient to be informed in line with their capacity of understanding Respect their explicit wish where capable of giving assentClearly place the child's interest before science and society
  • We’ve included all of the guidelines in the directives here in the slides and you will receive a copy of these following the presentation
  • High-level review of the overarching guidances, I want to briefly review the results of a retrospective review of a cohort of pediatric studies completed by Premier Research Group to demonstrate how the guidances were applied – this review was presented at DIA 2009 and ACRP 2010. Elizabeth and I were both involved in these pediatric trials.I will highlight the inconsistencies and areas of variability noted in the reviewIf you would like to see the full results these are available on our Premier Research websiteThese areas will be highlighted to elucidate the importance of our goal here today to increase education and support complianceStudies include neonates, infants, children, and adolescents up to 18 yearsStudies include outpatient and inpatient in multiple therapeutic areas which include complex environments for parental permission and pediatric assent – including the NICU, PICU (intubated patients), patients presenting with status epilepticus in the ER as well as the OR
  • The first review looked at the assignment of research category intra-studyReview graph – X axis and Y axisAs you can seeNo study had 100% agreement between the IRBsMany differed on the important determination of direct benefitIn every study there were approvals that did not specify or were unclear on the categoryAdditional findings which were noted but not represented in this graph include14 IRBs approved the study under category 406 (no direct benefit)9 of the 14 parental permission forms included 2 signature lines;5 only included 1 line; despite approval on the same day and the explicit direction in the IRB approval letters that both parents must signFinding points to the potential disconnect between IRB review and approval process and the associated documentsAdditionally, three of the studies were re-review by their IRBs and reclassified during the course of the study; further pointing to variability
  • A second review looked at pediatric assent evaluating the need for assent forms, minimal age of assent and the number of forms per study40 of the sites had 1 or more assent formThe other 19 had no separate assent form (child signed parental permission)Minimum age to sign ICF not specified at 9 sitesSites had minimum age of assent ranging from 7 to 15 years oldAdditional information not represented in this graph include that 37 sites in 2 of the studies waived assent due to the condition under treatment again further highlighting that every situation is not the same and the provision for soliciting assent can vary depending on the type of studyOne example from the cohort of studies run by Premier includes patients presenting to the ER in status epilepticus; these patients were pre-assented in their doctors offices and give a colored study specific wrist band to wear and staff in the ER knew that these patients were enrolled in the study and the complicated situation for parents and researchers alikeThis review of studies highlights the need for more education and diligence in this area and we’re hopeful today's recommendations will further support consistency and regulatory complianceNEED TRANSITON
  • Children are a vulnerable population and special considerations need to be made as parents will be agreeing on behalf of their childBut this is not the same as Informed Consent
  • What does that mean ….As stated here, decisional capacity andlegal empowerment are required to give informed consentQualifiers for legal empowerment include age, marital status, and emancipation statusAs a result the concept of “consent” has limited direct application which has lead to the concepts of Parental Permission and Pediatric Assent and current regulations acknowledge parents/guardians instead grant “permission”
  • In general the risk to the child and the prospect of direct benefit determine whether a single parent/guardian permission may be permittedFor categories 404 and 405 with less than minimal risk or the prospect of direct benefit only 1 signature is requiredWhere there is no prospect of direct benefit (406 and 407) both parents/guardian permission is required.
  • Review responsibilities
  • For both regulatory and ethical reasons Pediatric Assent is very meaningfulUnguru et al, Pediatrics 2010Studied what children aged 7 to 18 with cancer understood about their research-related treatment and their preferences for inclusion in decision-making100% wanted to be involved in decision-making, but 49% did not have or recall having a role in decision to enroll and 38% did not feel free to dissent to enrollmentEmphasising the need for thorough and compliant process
  • For both regulatory and ethical reasons Pediatric Assent is very meaningfulEmphasizingthe need for thorough and compliant processThe IRB is obligated to examine age, maturity and psychological state of children involvedAt times there may be inconsistency between the permission of the parent and assent of the child. Generally a “no” from the child over rules a ‘yes’ from the parents however by no means are all studies the sameWhere assent is required it critical to remember that the absence of an objection is not the same as an assent
  • The US federal regulations do not specify the age at which the written assent form is required ….
  • Review responsibilitiesIt should not be forgotten that the form does not replace a thorough discussionIt is necessary the form contain the essential information a child requires in a manner the child understandsWith that I’ll turn the presentation back to Jacq and Elizabeth
  • National Adult Literacy Survey (NALS) in 1992 and a National Assessment of Adult Literacy (NAAL) in 2003 to "profile the English literacy of adults in the United States” Results: average adult in the U.S. comprehends bestwhen information is written at an 8th - 9th grade reading level Most IRBs recommend 8th grade reading level or below for consent forms
  • You may need more than one form per study(e.g., if only adolescents are involved, one form at a 6th grade reading level might be enough)
  • Can the summary slides be condensed down to one? Or can we put together a one slide checklist?
  • Not sure that this is needed – but it brings up good points
  • Guidelines for Effective and Appropriate Pediatric Assent and Parental Permission

    1. 1. 2 0 11 P E D I AT R I C C L I N I C A L R E S E A R C H W E B I N A RSERIES Guidelines for Effective and Appropriate Pediatric Assent and Parental PermissionApril 13, 2011 Presented by Angi Robinson and Elizabeth Jay, RN, MA
    2. 2. Angi Robinson  Director, Clinical Trials Management  10 years of pediatric clinical research experience in pharma and government  Completed a six-year contract as the BPCA-CC for the NICHD/NIH; PM for the first study launched under the BPCA in Pediatric Sedation in the ICU  Global Project Director for Good Clinical Practice Journals (GCPj) 2008 Clinical Research Team of the Year2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    3. 3. Elizabeth Jay, RN, MA  Clinical Manager II, Clinical Trials Management  13+ years of clinical research experience in academic, pharmaceutical, and CRO settings  8+ years of clinical patient care as staff nurse in adult and pediatric ICUs  Masters degree in Bioethics from the Medical College of Wisconsin2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    4. 4. Regulatory Requirements: Parental Permission & Pediatric Assent  ICH-GCP E6: Guideline for Good Clinical Practice  ISO 14155 Parts 1 and 2  United States –45 CFR Part 46 - Protection of Human Subjects –21 CFR Part 50 - Protection of Human Subjects –21 CFR Part 56 - Institutional Review Boards  Europe –European Directive 2001/20/EC –European Directive 2005/28/EC –European Directive 2007/47/EC & related Medical Device Directives2011 PEDIATRIC–Local Laws and Regulations CLINICAL RESEARCH WEBINAR SERIES
    5. 5. Agency & IRB/EC Responsibilities5 Review and approve research protocols involving minors Ensure adequate provisions are made for soliciting the permission of each childs parents or guardian Determine whether children in study are capable of providing assent and if so, confirm that adequate provisions are made for soliciting their assent 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    6. 6. Minimal risk n. [mi-nə-məl risk] 1. 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 tests2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    7. 7. Pediatric Research Approval Guidelines United States7 Code of Federal Regulations permits IRBs to assess risks and benefits and approve research involving children under 3 categories: 45 CFR 46.404/21 CFR Research not involving greater than 50.51 minimal risk 45 CFR 46.405/21 CFR Research involving greater than minimal 50.52 risk but presenting the prospect of direct benefit to the individual child subjects involved in the research 45 CFR 46.406/21 CFR Research involving greater than minimal 50.53 risk and no prospect of direct benefit to individual, but likely to yield generalizable knowledge about the condition 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    8. 8. Pediatric Research Approval Guidelines United States8 Regulations also permit a 4th category of research: 45 CFR 46.407/21 CFR Research that IRB believes does not meet 50.54 other three categories but that presents a reasonable opportunity to further understanding, prevention, or alleviation of a serious problem affecting health or welfare of children  IRB alone cannot approve this category  Protocol needs to be sent to HHS/FDA for additional review and approval 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    9. 9. Pediatric Research Approval Guidelines Europe9 European Directive 2001/20/EC permits approval of research involving children with the following considerations: (a) the informed consent of the parents or legal representative has been obtained; consent must represent the minors presumed will and may be revoked at any time, without detriment to the minor (b) the minor has received information according to its capacity of understanding, from staff with experience with minors, regarding the trial, the risks and the benefits (c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator or where appropriate the principal investigator; (d) no incentives or financial inducements are given except Compensation 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    10. 10. Pediatric Research Approval Guidelines Europe10 (e) some direct benefit for the group of patients is obtained from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods; additionally, such research should either relate directly to a clinical condition from which the minor concerned suffers or be of such a nature that it can only be carried out on minors (f) the corresponding scientific guidelines of the Agency have been followed (g) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress have to be specially defined and constantly monitored (h) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol (i) the interests of the patient always prevail over those of science and 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES society
    11. 11. Review of Recent Pediatric Studies 8 pediatric studies conducted under IND applications at 96 sites between 2004 and 2009 Study Indication Clinical Setting Age Range 1 Bipolar Disorder Type 1 Outpatient 7-17 years 2 Spasticity due to Cerebral Outpatient 2-16 years Palsy 3 Sedation Inpatient (Intensive Care 3 months – 18 Unit) years 4 Status Epilepticus Inpatient (Emergency 3 months – 18 Room) years 5 Status Epilepticus Inpatient (Emergency 3 months – 18 Room) years 6 Blood Pressure Control Inpatient (Operating Room) 0-17 years 7 Blood Pressure Control Inpatient (Intensive Care 0-17 years Unit)2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES 8 Suspected or Complicated Inpatient (Intensive Care Neonates (0-91
    12. 12. Cohort Group and Research Category12 10 8 Number of IRBs 6 4 2 0 Study 1 Study 2 Study 3 Study 4 Study 5 Study 6 Study 7 Study 8 46.404 46.405 46.406 Not Specified Unclear or Incomplete 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    13. 13. Cohort Group and Assent13 40 of 59 sites required and approved one or more separate assent forms (total of 55 forms) 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    14. 14. Review of Parental Permission Unlike informed consent, parental permission involves agreeing on behalf of a child  Children are a vulnerable population  Implications for weighing the potential risks and benefits of proposed treatment  Standards even higher in research2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    15. 15. Parental Permission Permission vs. Consent15  Only patients who have decisional capacity and legal empowerment can give informed consent to medical care  In all other cases, parents or other legal representatives give “informed permission” for care  Same standards apply to medical research 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    16. 16. Parental Permission Risk and Required Signatures16 45 CFR 46.408 details requirements for permission by parents or guardians • Correlates  risk and  prospect of direct benefit to the number of signatures required • When parental permission is obtained: – IRB may find that permission of 1 parent is sufficient for research under 45 CFR 46.404 or 46.405 – 45 CFR 46.406 requires signature of 2 parents/legal guardians whenever possible 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    17. 17. Parental Permission Researchers’ Responsibilities17  Include all required elements of consent  Ensure IRB assessment of research category is specified  Use IRB assessment of research category to ensure correct numbers of parental/guardian signature lines are present  Obtain written permission from the parent/guardian before contacting the children for participation in research 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    18. 18. Review of Pediatric Assent Pediatric Assent is meaningful  Encourages shared decision-making, active participation of research subject  Supports ethical standard of respect for all persons  Alleviates feelings of powerlessness2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    19. 19. Pediatric Assent US Regulatory Requirements19 45 CFR 46.408/21 CFR 50.55 details requirements for assent by children  IRB should take into account the ages, maturity, and psychological state of the children involved  Determination about soliciting assent may be made for all children for a particular protocol or for each child  Under certain circumstances, IRB may waive assent even if children are capable of assenting 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    20. 20. Pediatric Assent Minimum Age of Assent20 United States  1979: Belmont Report (report by National Commission) recommended age 7 for age of assent  1977, 1995, 2010: AAP Committee on Bioethics and AAP Committee on Drugs recommends age 7 as minimum age of assent for medical decision-making including research Europe  Age is not defined uniformly for all EU countries  Ethics Committees recommends the age from which assent should be obtained from minors  7 years is probably OK for most countries but some require assent for younger children (6 years) and some only for older children who can already read and write (8 years) 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    21. 21. Pediatric Assent Researchers’ Responsibilities21  Obtain written IRB requirement for age of assent  Determine if a separate assent from will be used – If no, and the Parental Permission Form will be used, the form should written at grade level of youngest person who will sign – If yes, generate at least one separate assent form, more if study covers a wide range of ages  Include all required elements and determine appropriate readability based on age of subject – Consider requiring only the child’s signature to encourage a sense of autonomy 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    22. 22. Developing Forms for Parental Permission and Assent Need to consider:  Elements of Permission/Assent  Assessment of readability  Age-appropriateness2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    23. 23. Elements of Informed Consent23  Purpose and duration of research  Targeted number of participants  Research procedures  Risks or discomforts and potential benefits  Disclosure of alternatives  Level of confidentiality  Contact information for additional questions or in case of study-related injury  Cost to participants  Statement that study is research rather than treatment  Statement that participation is voluntary 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    24. 24. Elements of Assent24 For research, the goal is to help child achieve developmentally-appropriate awareness including:  Why child is being asked to participate  Basic study procedures, potential risks and benefits  Disclosure that participation is voluntary and child can stop at any time  Statement that child is being asked to agree to research (not medical care) AAP recommends not disclosing any financial information to child until study participation ends to avoid possible coercion 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    25. 25. Adult Reading and Comprehension25 At what grade level does the average adult read and comprehend information? a) 12th grade or higher b) 10th – 11th grade c) 8th – 9th grade d) 6th – 7th grade e) 4th – 5th grade 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    26. 26. Creating Forms26 One size doesn’t fit all!  Determine whether your IRB has specified minimum age to give assent  Consider ages of children involved and how many forms will be needed  Most IRBs recommend 8th grade reading level or below for consent forms  Write and rewrite as needed until each form is written at the reading grade level of the youngest person who will sign but still contains all relevant information 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    27. 27. Forms Should be Easy to Comprehend27 The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. 45 CFR 46.116 Readability is defined as the quality of written language that makes it easy to read and understand  Equates to grade reading level  Readability Statistics give you information about grade level and ease of reading 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    28. 28. Readability Statistics28 Flesch Reading Ease and Flesch-Kincaid Grade Level  Common method to check readability statistics  Spelling & Grammar function of Microsoft Office Word  Reading Ease index from 0 (hardest) to 100 (easiest)  Grade Level assesses reading grade level* 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    29. 29. Checking Readability Stats Word 200729 1)Click on the Microsoft Button and then Word Options which will open a pop-up menu 2)On Proofing tab, check the Show Readability Statistics box and click OK 3)On the Review ribbon, click on Spelling & Grammar to run the readability statistics for 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES your form
    30. 30. Checking Readability Stats Word 97-200330 1)Under the Tools menu, choose Options which will open a pop-up menu 2)On the Spelling & Grammar tab, check the Show Readability Statistics box and click OK 3)On the Standard toolbar, click on the Spelling & Grammar icon to run the readability statistics for your form 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    31. 31. Hints to Increase Reading Ease31  Use smaller words with fewer syllables  Use at least 12 point font  Use shorter sentences  Decrease number of passive sentences – DO: A lab tech will take your blood and test it. – DON’T: Your blood will be taken by a lab tech and tested. 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    32. 32. Hints to Increase Reading Ease32  Use simple terms rather than medical terms: – Medication or medicine → Drug or study drug – Investigator or physician → Study Doctor – Participate → Take part – Bacteria → Germ – Catheter → Tube – Intravenous → In your vein 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    33. 33. Sample Passage Comparison: Assent Form for Ages 7–1133 Sample 1 Sample 2 To take blood samples, we will To test your blood, we will give you have to insert a needle into your a needle stick in your arm. We will veins. We will try not to hurt you try not to hurt you. We will try to and will try to put in a plastic tube put a soft plastic tube in your vein that stays in your vein so we don’t so we don’t have to give you have to stick you with a needle another needle stick for other again. We will also try to give you blood tests. First we will put a a medicine that will numb the special numbing cream on your pain. Even though we will try not arm so the needle stick does not to hurt you, there may be some hurt so much. Even though we will pain with the blood samples. try not to hurt you, it might hurt Remember that you can say no at when we do the blood tests. You any time and we will not try to can say no at any time. We will not stick you more than three times try to stick you more than three for any sample or to place the times for any test or to put in the catheter. tube. 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    34. 34. Readability Results34 Sample 1 Sample 2 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    35. 35. Pediatric Assent Process  Who?  Where?  When?  How?2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    36. 36. Practical Issues36  Does approving IRB have any specific requirements or guidelines regarding assenting procedure?  Who will conduct assent discussion?  Will form be read by child or to child?  Where will discussion take place?  Will parent(s) be present?  When will assent be solicited?  How will process be documented?©copyright ACRP 2010RESEARCH WEBINAR SERIES 2011 PEDIATRIC CLINICAL
    37. 37. Documentation When the IRB determines that assent is required, it shall also determine whether and how assent must be documented. 45 CFR 46.408 How often is a separate note about the assenting process written?2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    38. 38. Recommendations on Documentation38 Note should contain:  Date and time of discussion  Names/roles of those present including who actually conducted the assenting discussion  Information about whether form was read to child/ adolescent or they read it themselves  Notation that any question(s) subject had were addressed  Comment that assent was obtained prior to any study-related procedure being performed 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    39. 39. Summary: Questions to Consider  Does the number of signature lines on the parental permission form match the IRB’s assessment of research risk category?  Will children sign the parental permission form or a separate assent form? – If separate assent, how many different forms will be needed and for which age groups? – What is the readability level of each form and does this match the minimum age specified to sign the form?2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    40. 40. Summary: Questions to Consider  Do the consent/assent forms contain the required elements?  If the study involves compensation, does this information appear in the assent form? – If no, when is the child told of this?  Have you planned out the whos, whens, wheres and hows in advance, and is this consistent with your IRB’s SOPs?2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    41. 41. Resources41  Code of Federal Regulations. 45 CFR 46:117. Federal Policy for the Protection of Human Subjects (Subpart A). Washington, DC: United States Department of Health and Human Services; 1991.  Code of Federal Regulations. 45 CFR 46:404-408. Additional Protections for Children Involved as Subjects in Research (Subpart D). Washington, DC: United States Department of Health and Human Services: 1991.  Code of Federal Regulations. 21 CFR 50:51-53. Additional Safeguards for Children in Clinical Investigations (Subpart D). Washington, DC: United States Department of Health and Human Services: 1991.  Research Involving Children: Report and Recommendations of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Federal Register. 1978; 43:31785-31794.  National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html.  Unguru Y, Sill A, Kamani N. The Experiences of Children Enrolled in Pediatric 2011 Oncology Research: Implications SERIES PEDIATRIC CLINICAL RESEARCH WEBINAR for Assent. Pediatrics, 2010: 125:876-883.
    42. 42. Resources42  US Department of Health and Human Services, Office for Human Research Protections. Protections for Children in Research: A Report to Congress in Accord with Section 1003 of P.L. 106-310, Children’s Health Act of 2000.2001. Available at http://www.hhs.gov/ohrp/reports/ohrp502.pdf.  Committee on Bioethics. Informed Consent, Parental Permission and Assent in Pediatric Practice. American Academy of Pediatrics. Pediatrics. 1995;95:314‐317.  Committee on Drugs. Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations. American Academy of Pediatrics. Pediatrics. 2010;125:850- 860.  Korn AA. Assent in Pediatric Research. Pediatrics. 2006;117:1806-1810.  Whittle A, Shah S, Wilford B, Gensler G, Wendler D. Institutional Review Board Practices Regarding Assent in Pediatric Research. Pediatrics. 2004;113:1747-1752.  Kirsch I, Jungeblut A, Jenkins L, Kolstad A. Adult Literacy in America: a first look at the findings of the National Adult Literacy Survey. U.S. Department of Education: 1993. NCES publication 93275.  US Department of Education. Institute of Education Sciences., National Center for 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES Education Statistics (NCES). National Assessment of Adult Literacy (NAAL).
    43. 43. Acknowledgement43 The pediatric studies referenced in this presentation were conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the Best Pharmaceuticals for Children Act (BPCA) of 2002 and 2007 and have been funding in whole or in part with Federal funds from the NICHD, National Institutes of Health, Department of Health and Human Services, under Contract No. NO1- HD-3-3351. 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    44. 44. Upcoming Webinar44 Register at www.premier- research.com/webinars ▪ Pediatric Considerations beyond Assent 11 May at 11:00 am ET Speakers: Krista Armstrong, Ph.D. and Patricia Molloy, M.D. Listen to past webinars: ▪ Developing a Feasible Pediatric Plan for PREA/PMDSIA Compliance Speaker: Charlene Sanders, M.D., F.A.A.P. ▪ Planning your Paediatric Investigation Plan (PIP) Submission in Europe 2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES
    45. 45. Questions? Angi Robinson Director, Clinical Trials Management Email: angi.robinson@premier-research.com Phone: 215.282.5419 Elizabeth Jay, RN, MA Clinical Manager II, Clinical Trials Management Email: elizabeth.jay@premier-research.com Phone: 727.470.9878 www.premier-research.com2011 PEDIATRIC CLINICAL RESEARCH WEBINAR SERIES

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