Clinical Trials

Collecting Human Biological Samples

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Samantha Trolli

Published 22 Nov 2022 - Updated 22 Nov 2022

Collecting Human Biological Samples - Infiuss Health


Biological samples are used to determine if a treatment is effective or develops side effects in clinical research. The process of collecting these samples is known as biobanking. The types of biological samples collected vary based on the purpose of the study.

In this article, we will discuss the importance and benefits of collecting human biological samples. While it is not always possible to collect blood or saliva directly from donors, many other types of samples can be collected. For example, you may want to collect urine samples from your participants. In this case, you would need a urine collection cup with a lid that prevents spillage during transportation and storage. You will also need clear instructions on how long the sample should be stored before testing begins so that you don't miss any results due to outdated samples.

One important thing to keep in mind when collecting biological samples is that every donor should know exactly why their sample is being collected and what it will be used for. The participant should also understand how these types of medical tests will help advance knowledge in regards to disease prevention.

Why Collect Biological Samples?

At the most basic level, collecting biological samples helps doctors and researchers diagnose, treat, and monitor patients. However, there are many other usages of biological samples collected.

Some of these usages include:

  • Research. Biological samples are used for research to discover new ways to treat illness, improve health and save lives.
  • Diagnosis and treatment. Blood draws can help diagnose various medical conditions and are often used in conjunction with other tests or treatments, such as surgery or chemotherapy.
  • Disease surveillance. Many diseases are better monitored through blood tests than through symptoms reported by patients or their families (e.g., measles).

Informed Consent for the Collection and Use of Biological Samples in Research

An informed consent is a process by which a potential participant gives permission to be involved in research after being given the appropriate information about the study. The researcher must fully disclose details about the study (including risks, benefits, and compensation) and ensure that both parties understand each other’s rights and responsibilities.

Informed consent may be obtained verbally or in writing, but it is always required from participants regardless of how much time has passed between when they were enrolled in a clinical trial and when they are asked to provide samples needed for your research project. Under most circumstances, you should obtain verbal informed consent before collecting any biological samples from subjects or donation of funds for your project.

Additionally, if you plan on using patients’ identifiable information—namely medical histories—this would trigger additional requirements under HIPAA privacy laws that require specific types of written documentation before gaining access to patient records (as well as additional security measures).

Obtaining Consent for Blood Draws in Children and Adults

Obtaining consent is the first step in the process of obtaining biological samples. Consent must be obtained before any sample can be taken, no matter what it is or how it will be used. The person giving consent should understand what they are agreeing to and whether or not they have any concerns about being a part of the study. If you have any questions about obtaining consent from an adult, see this section for more information on verbal vs written, as well as how to obtain written parental permission for minors.

If you have any questions about obtaining consent from a child or an adult, please contact us at 

Blood draw consent process and considerations by age group

For children under 18, the process and considerations for obtaining a blood sample from children are different than those of adults. Children are more vulnerable to harm during a needle stick injury, and therefore should be treated with extra care. Additionally, it is important to keep in mind that the sample should be collected without causing unnecessary discomfort or trauma to the child.

When collecting samples from adults aged 18 years or older, it is important to obtain written consent before proceeding with any procedure that could possibly cause harm or pain (such as blood draws). This means that you will need to ask each individual if they agree with having their biological sample taken so that you can get their signature on paper stating such consent has been given; this document is known as an informed consent form (ICF). You should also inform those who agree about any possible risks associated with taking part in your study.[1]

You'll need to give extra attention to the blood draw process if you are working with a person whose age, weight or medical condition might increase the risk associated with a blood draw.

If you are working with a person whose age, weight, or medical condition might increase the risk associated with a blood draw:

  • Considerations for the child's body size and anatomy
  • Considerations for the adult's body size and anatomy
  • Considerations for people with medical conditions

There are lots of ways to collect biological samples, and it's important to have proper consent.

You can collect biological samples in a lot of ways. It's important to have proper consent, which is a legal requirement that must be obtained from the subject or their parent/guardian for all types of research, including clinical research and observational studies.

The sample may be collected by qualified professionals who are trained in safe practices, or it may be self-collected by the subject (e.g., blood draw). You should also make sure you get proper consent even if you're collecting data from public records such as medical records or social media posts.

There are a lot of considerations that go into collecting biological samples, and you'll need to think about these things before you start your research. If you're not sure what type of sample will work best for your project, talk with a research supervisor or someone who has experience in this area of research!

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