100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Previously searched by you
Previously searched by you
logo
Group report Clinical Development and Clinical Trials (AM_1180) $5.56
Add to cart
Quickly navigate to
Preview
  2.  
  3. Vrije Universiteit Amsterdam (VU)
  4.  
  5. Clinical Development and Clinical Trials (AM_1180)

Case

Group report Clinical Development and Clinical Trials (AM_1180)
 0 purchase
  • Course
  • Clinical Development and Clinical Trials (AM_1180)
  • Institution
  • Vrije Universiteit Amsterdam (VU)

This is the group report for Clinical Development and Clinical Trials, about access to trial data in case of emergencies, such as pandemics. It was a mandatory, graded assignment.

Preview 1 out of 3  pages

Document information

  • June 8, 2024
  • 3
  • 2023/2024
  • Case
  • Eric klaver
  • 8-9

Subjects

  • trial data
  • accessibility
  • emergencies
  • informed consent
  • ethics
  • pandemics
  • clinical
  • drugs

Written for

  • Vrije Universiteit Amsterdam (VU)
  • Management, Policy-Analysis and Entrepreneurship in Health and Life Science
  • Clinical Development and Clinical Trials (AM_1180)
All documents for this subject (5)

Seller

avatar-seller
yaralangeveld

Reviews received

Content preview

RFI - Access to Trial Data for Emergencies
January 29th 2024 - Word count: 498


Dear Ms. E.M. Janse and Mr. E. Klaver,


Collecting informed consent (IC) from participants is important for clinical trials, IC should
be freely given and should consist of information about the aim of the study and processing
of personal data (GDPR, 2021). However, in emergency settings, such as pandemics, trial
data might contain important information for research outside of the initial intended use. To
enable the use of trial data for future objectives, we propose three strategies.


Additional informed consent with de-identified data
When IC is obtained from trial participants for the current trial, additional IC can be acquired
for the future reuse of data. The participant must be informed that data might be used in a
de-identified form, for future research purposes. De-identifying data includes removing all
information deemed as “first identifier data”, such as names, social security numbers and
addresses (Stanford University, n.d.). The revised common rule, known as “the federal policy
for the protection of human subjects”, from 2018 states the possibility of including IC for
de-identified data to be used in future research in informed consent forms (ICFs) (Cip, 2023).
In ICFs, it must either be stated that de-identified data can be used by other researchers for
other research purposes, or that it cannot be used for any future research purposes (Cip,
2023).


Approval from an Ethics Committee
If additional IC from trial participants cannot be obtained in emergency cases, approval from
an Ethics Committee (EC) should be sought (WMA, 2022). In addition, the use of the trial
data should be specified in the protocol of the new research, as included in the Declaration of
Helsinki for research involving human data. This is applicable to medical research using
human data, where obtaining IC is impossible or impractical (WMA, 2022). In such cases,
data can be collected, stored and reused with approval from an EC. For instance, this may
occur during pandemics, when such data must be accessed quickly to enhance the
development of a suitable treatment and diminish the spread and impact of a disease, and
obtaining informed consent can cause delays (Voit et al., 2023).

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

Guaranteed quality through customer reviews

Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.

Quick and easy check-out

Quick and easy check-out

You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.

Focus on what matters

Focus on what matters

Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!

Frequently asked questions

What do I get when I buy this document?

You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.

Satisfaction guarantee: how does it work?

Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.

Who am I buying these notes from?

Stuvia is a marketplace, so you are not buying this document from us, but from seller yaralangeveld. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $5.56. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

64419 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 15 years now

Start selling

Recently viewed by you

Summary ·

(0)

omgaan met agressie

Package deal ·

(0)

assignment answers 1 to 3

Summary ·

(0)

Samenvatting Duurzame ontwikkeling

Summary ·

(0)

Portrait of a loaf of Bread (Mtshali) Poem Analysis (IEB)

Exam (elaborations) ·

(0)

SBB Review 255 QUESTIONS WITH COMPLETE SOLUTIONS

$5.56
  • (0)
Add to cart
Added