INNOVATIVE CONSENTING METHODSIN PEDIATRIC BIOBANKING

Adam Velenosi, BC Children’s Hospital BioBankMichelle Dittrick, BC Children’s Hospital

October 16, 2019

Definition of a BioBank“A biobank is a facility for the collection, preservation, storage and supply of biological samples and associated data, which follows standardized operating procedures and provides material for scientific and clinical use.” -Hewitt and Watson, 2013

Kid’s definition of a Biobank

A biobank is a bank of body bits!

3

BCCH BioBank• BC Children’s Hospital BioBank recruits:

• Children and young adults • Pregnant women, new mothers and their babies

• Samples and data are collected (for yet undetermined research studies)

• Samples are usually collected at time of medical procedure

• Consenting practices in the pediatric setting:• Consent is obtained from parents• Assent is required from children 7-18 years old• Re-consent is required at the age of majority

Giving Patients and Healthcare Providers a Voice in Pediatric Biobanking

Project funding provided by CIHR SPOR Patient Collaboration Grant and BC Children’s Hospital Foundation

Project Objectives• Engage the community as partners in research

• Understand patient and public opinions on biobanking practices

• Understand needs and opinions of clinicians and researchers

Utilize this knowledge to compile recommendations and improve biobanking practices!

Gathering of Opinions

Clinicians and researchers

Patients, families, BioBank

participantsGeneral public

Recommendations for BCCH BioBank

Research Participants

Patients n=46

Kids 11-13 yr

Public n=25

Teens 14-17 yr

Kids 11-13 yr

Healthcare providers

n=22Doctors

Researchers

Adults

Teens 14-17 yr

Adults

Patient Concerns• Lack of awareness

• Timing of consent

• Length and language of consent (not fun!)

• Privacy

• “Extra pokes”

Health-Care Providers’ Concerns• Lack of research culture• Time• Ethical barriers• Length of consent forms• Unaware of studies/biobank • Unethical circumstances to consent (capacity, rare

disease, erosion of informed consent) • Small window of opportunity to consent diagnostic

samples

Researchers’ Concerns• Lack of samples

• Several initiatives fail due to lack of samples -> need for control samples

• Competing with pharmaceutical companies that pay more $ for clinical trials

• Need for better consenting system including ‘universal’ consent form

• Knowledge translation training needed

• Too many ethical regulations• Consent forms are too long, department has grown, too many

regulations

• Prioritization of studies for newly diagnosed patients

BCCH BIOBANK CONSENT CHANGESAT C&W CAMPUS

Current:1. Verbal Consent Process2. Women’s Consent ProcessFuture:3. Youth-Friendly Assent Form4. E-Consent

Verbal Consent Process

Obtain verbal consentfrom participant Obtain sample

Paperworksigned and filed securely

Sample code andverbal consentstatus entered intothe database

Within onemonth formalconsent meeting occurs

Consent status andclinical information entered into the database

Samples can be released for research

Women’s Consent Process (Before)• This consent form is to help you decide if you want to

participate in the BioBank. Trained BioBank staff will be happy to answer all your questions. It is important that you understand that if you sign this consent form, you are consenting to the banking of your samples for future research projects, which as of now, are undefined.

• This consent form is to help you decide if you want to participate in the BioBank. Trained BioBank staff will be happy to answer all your questions. It is important that you understand that if you sign this consent form, you are consenting to the use of your samples for research projects. If there are current research projects that require samples from mothers and/or babies, a summary of these studies is included at the end of this consent form. Your sample may be used for some or all of these projects, and may also be stored for use in future research which as of now, is undefined.

Women’s Consent Process (After)

Ex. of Current Maternal and Infant Research At BC Women’s Hospital

Youth-Friendly Assent Form

User-centered Design, Experience, and Usability of an e-Consent User Interface to Facilitate Informed Decision Making in an HIV Clinic

• “[User interface] was less intimidating and more to the point. Less is more; and this was more.”

• “This delivers more in less time and is not as intimidating [as a paper consent]. Since we live in an age of technology, people are just more familiar with it and even people that aren’t are going to find [the e-consent] easier.”

• “Honestly, I would never read this much information…if I see it I would just sign it – yeah that’s too many words for me right there. I generally do not read those types of things. I think the electronic version is simple to use. I would read that because they’re more simple, concise paragraphs.”

Ramos SR Comput Inform Nurs. 2017 Nov;35(11):556-564

E-Consent PlatformThe Team:• Suzanne Vercauteren: PI, Director BCCHB• Alice Virani: ethicist• Holly Longstaff: privacy and regulatory expert • Julie Robillard: patient experience scientist • Elodie Portales Casamar: bio-informatician• Ashton Ellis: BCCHB Research Coordinator• Adam Velenosi: BCCHB Research Coordinator• Michelle Dittrick: Research Manager Pathology & Laboratory

Medicine C&W• Ashley McKerrow: REDcap expert• Augusta Lutynski: Graphic arts support , Emily Carr• Katie Plain: C&W Patient & Family Engagement AdvisorFunded by BC Children's Hospital Research Institute, Clinical Research Development Award

Purpose:To develop an interactive, electronic consent process for recruitment of participants to the BC Children’s Hospital BioBank (parental consent and children’s assent)

Hypothesis:We hypothesize that an electronic consent process will be acceptable to potential participants of the BCCHB and will be chosen as the method of consent more often than paper-based consenting.

E-Consent Platform

Iterative development process

E-Consent Platform

Stage 1: Remote Prototype Review and Survey

Stage 2: Focus Groups

Stage 3: Implementation

Stage 1: Prototype Review and Survey• Patient representatives (the BC Children's Hospital

Patient Experience Office)• BCCHB participants

• Adults and children age 7 or older invited to view a prototype of the BCCHB e-consent remotely.

• Survey for feedback to assess understanding of components essential to informed consent.

E-Consent platform

https://rc.bcchr.ca/redcap_demo/surveys/?s=JKTYWMWAC3

Biobank video: https://youtu.be/UxTJRon-oEw

Stage 1: Preliminary Survey Results• Invitations sent out to previous BioBank participants &

C&W Patient Experience Network• Parents and children age 7 or older invited to complete an

anonymous, online REDCap survey

• Number of survey responses: 113 (108 complete)

• 28.8% of respondents were male• 69.4% of respondents were female• 0.9% other • 0.9% prefer not to say

Age Distribution:

7-13 years: 6 ( 5.4%)14-18 years: 24 (21.6%)19-30 years: 16 (14.4%)31-45 years: 33 (29.7%)46-60 years: 27 (24.3%)

>60 years: 4 ( 3.6%)Prefer not to say: 1 ( 0.9%)

Have you previously consented to the BC Children’s Hospital BioBank?

• Yes: 63 (56.8%)• No: 32 (28.8%) • Don’t recall: 16 (14.4%)

If I had the choice of consenting method, I would choose:

Online consent: 45 (40.5%)Paper-based: 18 (16.2%)

Doesn't matter: 46 (41.4%)Other: 2 ( 1.8%)

*Other:• I like this on line consent but I also like being able to ask a person questions• Both

If I had the choice of consenting method, I would choose:

0 5 10 15 20 25 30 35 40 45 50

Other

Doesn't matter to me

Paper-based consent

Online consent

7-13 years14-18 yearsAdults

7-13 yearsn=6

14-18 yearsn=24

Adultsn=80

Online consent 1 9 34Paper-based consent 1 4 13Doesn’t matter to me 4 11 31Other 2

Overall, the online consent clearly describes what a biobank is.

Strongly Agree: 69 (63.3%)Agree: 36 (33.0%)Neutral: 4 ( 3.7%)

Disagree: 0 ( 0.0%)Strongly Disagree: 0 ( 0.0%)

The risks of participating in the BioBank are well explained.

Strongly Agree: 57 (55.3%)Agree: 39 (37.9%)Neutral: 7 (6.8%)

Disagree: 0 (0.0%)Strongly Disagree: 0 (0.0%)

The benefits of participating in the BioBank are well explained.

• Disagree comment: “I think the benefits should be explained. Who benefits. Will big pharma profit?”

Strongly Agree: 63 (61.2%)Agree: 34 (33.0%)Neutral: 5 (4.9%)

Disagree: 1 (1.0%)Strongly Disagree: 0 (0.0%)

I understand that my participation is voluntary and that I can withdraw from the BioBank if I change my mind.

• Adults n=79 • Kids n=30

The e-consent form clearly describes how information is kept private.

Strongly Agree:56 (51.4%)Agree: 45 (41.3%)Neutral: 8 (7.3%)

Disagree: 0 (0.0%)Strongly Disagree: 0 (0.0%)

It is clear to me that researchers need to get permission before they can get samples for their research from the BioBank.

Strongly Agree: 49 (62.0%)Agree: 24 (30.4%)Neutral: 5 (6.3%)

Disagree: 1 (1.3%)Strongly Disagree: 0 (0.0%)

I understand the types of samples that can be donated to the BioBank.

N = 79: Asked adults onlyStrongly Agree: 53 (67.1%)

Agree: 25 (31.6%)Neutral: 1 (1.3%)

Disagree: 0 (0.0%)Strongly Disagree: 0 (0.0%)

I understand all of the information given during the online consent process.

Strongly Agree: 58 (53.2%)Agree: 47 (43.1%)Neutral: 4 (3.7%)

Disagree: 0 (0.0%)Strongly Disagree: 0 (0.0%)

I feel the amount of information given is:

0=too little 50=just right 100=too much

Median 50.0; Mean = 50.3Kids median: 51.5

Teens median: 50.0Adults median: 50.0

Overall, the pictures match the information given and are pleasing to look at.

Disagree comments: “friendlier imagery would be more in line for Children's. Not cartoony though”

Strongly Agree: 48 (44.0%)Agree: 44 (40.4%)

Neutral: 15 (13.8%)Disagree: 2 (1.8%)

Strongly Disagree: 0 (0.0%)

Other Feedback/Comments• I am a parent of a child who has been diagnosed with a life-threatening

disease and has been fighting for her life at BC Children's Hospital. I have a vague memory of two young ladies approaching us in the early days of our daughter's battle, explaining the BioBank program and requesting that we consider participation. At that point, we were completely overwhelmed with the recent discovery of our daughter's illness, traumatized by all she was being subjected to, and in no condition to understand the complexities and implications of the BioBank program, as presented in a few minutes by even well-meaning and articulate BioBank workers. This online consent form is a far superior way to present the BioBank information to patients and their families. It allows for much-needed time for a gradual absorption of information as well as the time to make an informed decision about an important but delicate subject that carries enormous scientific and moral implications.

• I think this really helps explain what the BioBank is in a clear and easy to understand process, but I think if it were also used in addition to the paper consent/talk with doctors, that would put people's mind at ease.

• Nice and quick and easy!• I didn't really notice the pictures as I was more focused on the content. • Very nicely designed.• It would be great to have a hot link in some areas for more

information (more details) for people that want more information

More Feedback

More Feedback• The pictures and text are great and providing clarification. I love the

online consent process, it is very streamlined and easy to understand. I found myself ignoring/skipping some sections because it was just a big block of text. Perhaps highlighting/bolding relevant info or putting relevant info into bullet points would make the information more easily digestible.

• I am not very familiar with online consent forms yet. As long as I had a contact person if I had questions, I am ok with the online form

• …Once online consent is given, a paper copy or online copy of all the specifics should be provided for future references

• As always very informative• Good job.

• I like the gender neutral / cultural neutral drawings. Use of colour on the screen, and video ‐ more approachable than the large stapled handout. But I feel having the human request from the BioBank rep. Critically important. We would not have said yes otherwise. During stressful life events ‐ a package of paper or any type of questionnaire seems not important. But the human connection, the empathy of conversation is very helpful to the whole process. The understanding that this stressful event could somehow result in improvements in treatment, cures, or ... gives a positive twist to the current stressful event. The understanding that tissue that might otherwise be destroyed could be stored and positively impact science is important. The most important message is your child will not suffer any additional painful processes if they participate.

More Feedback

• This is fabulous. Although I have not consented with the BC Children's biobank before I have consented to quite a few other studies. I wish every study had an easy to follow system like this for consenting. I usually don't really read the consent forms as they are too long and have a lot of unfamiliar terms so I trust researchers and just sign it. This was much easier to follow! I'm just wondering how I would ask questions if I had them?

More Feedback

E-Consent Platform

Refining e-consent in REDCap

Stage 2: Focus group• View the revised prototype and gather feedback through open

discussions during user navigation. • Identify words/phrases for clarification• Discuss practical aspects (setting, timing, presence of BB staff)• Assess appropriateness of quiz at end of consent form

E-Consent Comprehension Quiz• What does a biobank do?

• It collects samples and health information for research• It collects samples and health information for my treatment• It collects samples for my treatment and research

• To be a part of the biobank you have to:• Voluntarily agree to take part in the Biobank • Have an extra poke to get a blood sample• Come for extra visits

• Who will know I am part of the biobank? • My classmates• The biobank staff• Researchers asking for your samples

E-Consent PlatformStage 3: Implementation- Choice of consenting via either e-consent, or traditional

paper-based forms for new BCCHB participants.

- Track uptake, including demographics

- User survey to assess comprehension and satisfaction

AcknowledgmentsBioBank StaffAugusta LutynskiGeorge LeiAdam VelenosiAshton EllisVeronica Chow

Special ThanksBill GibsonJohn Bhullar

Questions:Suzanne VercauterenBCCHB, Directorsvercauteren2@cw.bc.ca

BCCH BioBank teambiobank@cw.bc.ca

www.bcchbiobank.ca