Has COVID-19 Affected the Handling of Biospecimens?

The collection of biospecimens continue even during the midst of the Coronavirus pandemic. Even though there is a global concern about COVID-19, laboratories, experimentation, and sample collection must continue. Some biorepositories and laboratories will turn to focus on the collection and examination of Covid-related biospecimens, others will continue to forge ahead trying to make a difference in their fields of influence. Research must continue as patients are not exempt from serious diseases and conditions due to the pandemic. Repositories must continue collecting tissue and cell samples and making them available for research purposes. But how does the Covid pandemic affect biospecimen collecting, storage, and distribution?

Handling Biospecimens

In general, guidelines for the safe handling of biospecimens are in place and do not require further recommendations. Precautions are in place for the purpose of infection control when handling all types of biospecimens. The CDC has offered some safe-handling guidelines for laboratories and related facilities. These guidelines include:

·   Laboratories should perform a site-specific and activity-specific risk assessment and continue to follow standard precautions when handling any biospecimen.

·   Environmental Protection Agency-approved disinfectants should be used to control viral pathogens.

·   Biospecimens which are suspected to be positive or confirmed SARS-CoV-2 positive specimens, isolates, or cultures, should be packaged and shipped as a Category B UN 3373 Biological Substance.

General Biospecimen Handling

Biospecimen quality has a direct and significant impact on diagnostic testing, clinical and preclinical research. Specimens of poor quality can lead to inaccurate test results and experimental errors. Because we understand the importance of high-quality specimens, our biorepository handles all specimens with care and precision, so our clients receive the highest quality of specimens. We observe the strictest guidelines including those set forth by the CDC and WHO to maintain sample quality across the board.

Labs must be adamant about ensuring COVID-19 lab safety and following standard biological safety procedures whether handling COVID-19 and other biospecimens. Staff should have PPE (personal protective equipment) available for staff including disposable gloves, eye protection, and lab coats or gowns. Biobanks should have a dedicated area for staff to put on or remove PPE.

The World Health Organization and the Centers for Disease Control and Prevention have both stressed the importance of using standard precautions. These precautions include decontaminating workspaces, treating waste to ensure viral particles are inactive, and eliminating unguarded aerosol production. As the pandemic continues to unfold guidelines will continue to be updated.

WHO and CDC Biosafety Guidance During the Covid-19 Pandemic

The CDC and WHO have issued interim biosafety guidance. Here are some of the current recommendations for the handling of biospecimens if they have known or are suspected to have contacted COVID-19.

·   Continue strict observance of relevant protocols including having all risk assessments and procedures conducted by capable personnel.

·   All lab techs should continue to wear appropriate PPE.

·   Processing should be conducted in a validated biosafety cabinet or a primary containment device.

·   The level of biosafety will depend on the nature of the work. BSL-2 for non-propagative work, and BSL-3 for propagative work.

·   All procedures in the bio lab should be done in such a way as to minimize the generation of aerosols.

·   Proper handling of biolaboratory waste.

·   Biospecimens should be placed in a secondary container if they are being transported.

·   Proper shipping of biospecimens based on their substance category.

All biospecimens should be handled as if they are infectious eliminates switching between protocols. Handling them as though they are infections also minimizes their exposure potential and the types of implications such exposure could have on the community and lab personnel.

There are exceptions when handling nucleic acid extracts, formalin-fixed, and paraffin-embedded (FFPE) tissue. When these processed biospecimens are handled using standard precautions and wearing appropriate PPE, no special considerations are necessary. Based on earlier studies of coronaviruses, the routine histologic fixation and processes should render SARS-CoV-2 inactive.

You can be assured that the products received from our repository are handled according to the ethical standards set forth by the World Health Organization. 100% of collected tissue samples are subjected to our strict quality control and all biospecimens are collected in accordance with our strict Standard Operating Procedure.

Resources:

https://academic.oup.com/ajcp/article/155/1/55/5911469

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543273/

https://www.biobanking.com/safety-for-biobanks-strategies-for-safe-covid-19-specimens-handling/

https://research.ucsf.edu/covid-19-biospecimen-guidelines

Interim Guidelines for Biosafety and COVID-19 | CDC

Human Biospecimens: Ethics and Regulations

Overview of Human Biospecimens

The human body and its collection of tissues have been studied since the ancient Greek times. After the Roman Empire fell, anatomical studies slowed down considerably as the use of cadavers became illegal in many places. Researchers were prosecuted for many years if they performed postmortem dissections. In the 15th century, medical schools in Europe allowed their researchers to study the human body and tissues without prosecution. Since then, the study of the human body has advanced significantly. Today, human biospecimens and tissue samples are vital for genetic research. Human biospecimens can be collected from several different sources:

• Prospective tissue collection

• Excess tissue obtained from clinical samples

• Specimens from cadavers

• Tissues with reproductive potential

With the increasing use of human biospecimens in research and clinical trials, issues regarding the ethics and regulations of these specimens needs to continuously be observed.

Governing Treaties, Laws, and Regulations

It is important to understand laws and regulations concerning human biospecimens as it helps researchers with issues of biospecimen ownership and ethical principles about human experimentation. One of the first important efforts of the medical community to regulate this kind of research is the Declaration of Helsinki. While it is not an international legally binding instrument, it has significantly influenced many regulations and national legislations.

Originally adopted in 1964, it has gone through six revisions. In the United States, the Code of Federal Regulations established by the government addresses the protection of the donors. In the Code of Federal regulations is the Common Rule that details the function and role of institutional review boards (IRBs) in the protection of human participants during the research activities. It also outlines the requirements in obtaining informed consent and additional protection for vulnerable groups such as pregnant mothers, neonates, fetuses, children, and prisoners. Some states also have their own laws that govern research using human participants.

Informed Consent

For informed consent, researchers must provide an explanation to potential participants regarding the purposes of the research and expected duration of the study. It should be noted that the descriptions provided should not be general and must be specific to the study. Without being adequately informed about the intended purpose of the research, participants cannot give “informed” consent the key element in the consent process is transparency. Participants should also know all the intended uses of the specimens. If their specimen is required in future research, additional informed consent should be obtained from the donors. However, the IRB can waive the need for informed consent for the use in a secondary project. IRB waiver is more likely if the donor has consented to future research at the time of tissue collection.

The participant also has to be informed regarding the potential risks, benefits, alternatives to participation, and what may be required of them during the study. Additional information required includes compensation and medical treatments that could be available should injury occur to the participants. Participation must be voluntary, and participants should be allowed to withdraw at any time without risk of penalty. Participants should also be provided a contact if they have any questions or concerns regarding the research.

The Common Rule is only applicable to human participants. In some circumstances, it permits research without participant consent. If the research is conducted using anonymous samples without access to the participant’s private information, by definition, informed consent would not be required. The Common Rule also does not apply if the IRB exempts it as the information used does not involve the identification of the donor. Finally, the IRB can waive or change the requirements of the informed consent if:

• The research poses no more than minimal risk to participants

• The welfare and rights of participants are not affected

• The research cannot be conducted without alteration or waiver of informed consent

• The participants are provided with relevant information

Biospecimen Ownership

The ownership of biospecimens has been analyzed in many cases. It has been a question of whether the donor retains ownership rights of their tissue. It has also been debated as an issue of “guardianship” versus “ownership”. In most cases involving excised tissue, courts have concluded that donors do not retain ownership of their excised tissue. However, different rulings have been reached in cases where there has been a previous understanding that the patient would retain their ownership rights. With leftover materials, many are considered to be “abandoned” with patients no longer having any property rights. In tissue obtained postmortem, the Common Rule does not apply as it only applies to living individuals. The Uniform Anatomical Gift Act (UAGA) allows individuals to give their bodies for the study of science. Without the individual’s consent, their spouse or family can also make the gift.

Conclusion

The laws regarding human biospecimens are still evolving. There will be much effort and discussion needed to improve the efficiency of informed consent. With increasing studies using human biospecimens, the frequency of lawsuits may be higher. It is therefore important for new legislatures and regulations as it can help to protect or help both participants and researchers. It is crucial for researchers to strive for transparency and avoid using specimens not outlined in the consent form. The awareness of existing rules is also essential to avoid lawsuits and the destruction of valuable human biospecimens.

Reference:

Allen MJ, Powers MLE, Gronowski KS, Gronowski AM. Human tissue ownership and use in research: what laboratorians and researchers should know. Clinical Chemistry. 2010; 56 (11): 1675-1682.

Ethics in Biobanking

Introduction

Biobanking ethics are important and one of the most debated issues in public health and bioethics. Biorepositories carry the potential to advance disease research in unprecedented ways. There are however concerns about donor privacy and not all biorepositories make sure that they follow ethical standards. People’s DNA and tissue sample has been used without respect for their rights. Regardless of peoples differing views and perspectives, one thing can be agreed upon among most experts, that biobanks are revolutionary. Biobanking ethics include issues such as, but not limited to:

• Controversies and key challenges faced in biobanking ethics

• Issues of informed consent

• Withdrawal from participants

• Broad consent

• Ethics of re-contact

• Confidentiality issues

• Ownership, property and commercialization problems

Issues in Brief

1)      Informed Consent

Informed consent is crucial in ensuring that ethical standards are followed in both research and therapy. It ensures that the participant understands “the nature, duration, and purpose of the experiment; the method and means it is to be conducted; all inconveniences and hazards reasonable is to be expected; and the effects upon the individual’s health may be due to the participation in the experiment." (Excerpt from Springer Article) One of the major issues of informed consent in biobanking is that it only applies to the donor and not those who are connected to the donor. Next, since biospecimens can be used in future studies, participants cannot be “informed” at the time their tissue is obtained as the nature of future researches are not yet known.

2)      Broad Consent

There are some experts who believe that broad consent can be a potential solution to the issues of informed consent in biobanking. However, there are some who disagree as it offers minimal protection and minimal guarantees. Broad consent is the permission given by the donor for the biobank, so the biorepository can do what they see fit with the genetic material. While some individuals argue that broad consent is a means of maximizing autonomy, some see it as the opposite where it is an abuse for autonomy. Ethicists worry that broad consent causes donors to relinquish their rights regarding how their genetic material is used in the future.

3)      Confidentiality

One of the main features of genetic information is that it can be used to identify the donor and those related to them. While ethicists argue that identification can be discouraged through various methods of anonymization, there is always the possibility that identification is possible. The risk of identification increases as databases grow.

4)      Property and Profit

There is also the issue that participants or donors do not own their tissue samples. This is based on the traditional understanding that body parts are res nullius which means that they do not belong to anyone once detached. Ethicists have argued that there are valid reasons for following the “no property” rule for biospecimens. Allowing property would restrain studies and research to the point where it would become untenable. Another issue is that commercial companies may look to make very large profits from donated samples.

5)      Feedback to Participants

Another ethical issue is whether or not to tell participants regarding incidental findings from their donated tissue samples. Incidental findings can be defined as “observations of potential clinical significance that have been discovered unexpectedly in a healthy subject unrelated to the purpose and variables of the study.”(Excerpt from Springer Article)

6)      Participation, Representation, Maintenance of Trust

Biorepositories are also worried about the mass withdrawal of participants as it will ultimately result in the loss of set-up costs. The maintaining of trust between the public and biobanks are crucial to prevent participant withdrawal and biobank failure. Currently, there is still no one way that is viewed as the best method of practice in this area.

7)      Re-contact

Re-contact is becoming an increasingly crucial issue as there is very little industry conformity on how re-contact should be managed. There needs to be a balance between what donors are informed and what's included without overburdening them. Biorepositories and research teams should view the ability to re-contact as a limited resource. Currently, there is no standard that biobanks can look to adopt for this issue.

Conclusion

The problems and challenges in biobanking ethics mean that there is a need for alternative models to address the issues. Biobanking presents important and significant ethical challenges. It is important for those involved to be aware of the advancements and developments in the debates surrounding these issues. By raising awareness of these issues, public interest of will increase and as a result biobanking can continue to change the medical research landscape.

References:

Widdows H, Cordell S. The ethics of biobanking: key issues and controversies. Health Care Anal. 2011; 19:207-219.