Informed Consent
Standard for
Human FetalTissue Donation
for Research

Version 1.0, April 2022
www.isscr.org

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1Informed Consent
Standard for
Human Fetal Tissue
Donation
2PREFACE

This preface provides background information
for anyone who meets with women to discuss thepossibility of donating tissue from fetal remains
following a pregnancy termination.
The International Society for Stem Cell Research(ISSCR) is an independent not-for-profit organizationthat fosters the exchange of information and ideas
related to stem cells, including professional andpublic education regarding research standards,ethics, and the responsible translation of stem cellresearch to the clinic. The ISSCR supports the useof human fetal tissue in research because it is animportant, non-replaceable resource for certain
aspects of stem cell work. It is also vital for theadvancement of other fields of biomedical research,
including the study of infectious diseases and early
human development. The ISSCR is providing thisdocument to outline a professional consent standard
for the donation of human fetal tissue for any field ofresearch. The information described in this standard
should be provided to any women who, after makinga final decision to have a planned pregnancy
termination, has expressed interest in donating
tissue from the fetal remains.
Human fetal tissue has unique properties that otherresearch materials cannot replicate. Human fetal
tissue enables research on the complex interactions
between different types of human cells over timeand in the genesis of complicated organ systems. It
is also helpful for studying infectious diseases that
especially target humans such as HIV and Zika. Itsavailability facilitates research on normal humandevelopment and the causes underlying congenitaland inherited disorders such as those of the heartand nervous system, which in turn may provide
unique insights into some adult disease states. While
there have been some advances in recent years
that have reduced the need for human fetal tissue
in certain research areas, the continued use of fetal
tissue is crucial for advancing scientific discovery andthe development of new therapies.
The use of human fetal tissue in research and theconsent process to donate tissue have come under
scrutiny in some countries, placing promisingbiomedical research in jeopardy. The ISSCR hopesthat by establishing an international standard for
informed consent, this will promote uniformity
and transparency for the entire process of tissue
donation, collection and use, thereby providing
confidence to everyone involved, as well as thepublic, that the entire process is being conducted inaccordance with internationally agreed principles.
Standardizing the consent process for human fetal
tissue donation will also foster international researchcollaborations around this scarce resource that are
helpful for the discovery of new treatments, as thetissue will be collected with the same ethicalprotections irrespective of where it is donated.
Some jurisdictions may require additional informationand consent procedures, for both the pregnancy
termination and any subsequent tissue donation
and use. Regardless of what is in this ISSCR informed
consent standard, any donation must also meet all
applicable local legal requirements. For example,
jurisdictions may require an ethics committee review ofthe donation process or the forms used to document
the consent. Most jurisdictions will require
documentation of the consent process; a sample
informed consent template adapted for the UnitedStates is included in Appendix I.
*This informed consent standard uses female pronouns to refer to the per-son
donating human fetal tissue. Transgender men and nonbinary persons arealso eligible donors. Informed consent materials and forms should be
updated according to the donor’s personal pronouns.

Informed Consent Standard for Human Fetal Tissue Donation

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INFORMED CONSENT STANDARD FOR THE DONATIONOF HUMAN FETAL TISSUE FOR RESEARCH

The information in this document outlines theessentials for an informed consent standard for fetaltissue donation. Consent for donation should besought only after confirming that the potential donor
is eligible under applicable local rules, policies,
and practices to give consent. The woman must be
provided with relevant information and time to readand understand it. The woman should also have an
opportunity to discuss donation and to ask questions
prior to giving consent.
1.	Discussionof Fetal Tissue Donation May
Not Occur Until After a Woman Has Madea Definitive Decision to Have a Planned
Termination of Pregnancya. 	The discussion of donation must be separate
from and occur after the decision to have aplanned termination. This separation ensuresthat the decision to terminate the pregnancy is
not influenced by the opportunity to donate.
b. 	Some jurisdictions may have additional
requirements for the consent process todonate fetal tissue.

2. Voluntary Informed Consenta. 	Explain to the potential donor that the donation of fetal tissue is voluntary; a choice notto donate will not incur any penalty or loss ofbenefits or care to which the potential donor
is otherwise entitled.
b. 	Explain that the donor may withdraw herconsent during the consent process, and that
this can be done without penalty or change
to medical care.
c. 	Explain whether and up to which point thedonor may withdraw her consent after thetissue has been donated.
d. 	Explain whether any member of the medical care team has a potential financial or
research interest in collection or use of thetissue that could be a conflict of interest.

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3. Information	Regarding Standard of Medical Carea. 	Explain that the medical care of the potential
donor will always take priority over the collection and subsequent use of the donated tissue.
b. 	Explain that the planned pregnancy termination
will meet the same standard of medical carethat would apply if she did not donate tissue.
c. 	Describe whether the tissue donation may
have additional medical implications for thedonor, such as screening for pathogens(see below).
4. Donor Screeninga. 	Explain the nature, purpose and risks (if any)of any additional screening (e.g., blood tests,donor survey) necessary for the donation ofthe fetal tissue.
b. 	Explain whether the results of tests will beshared with the donor, and if so, how and when.
c. 	If the tissue is donated for clinical transplantation research, explain why it may retain
identifiers to link it to the donor for adverse
event reporting.
5. Incidental Research Findingsa. 	Disclose whether and how any incidental andsecondary findings (e.g., genetic risks) will be
returned to the tissue donor.
6. Potential Uses of Donated Fetal Tissuea. 	If the specific purpose of the research is
known at the time of collection, provide thedonor with available information and an opportunity to learn more by providing contact
information for questions. If it is known, provide the potential donor with the following:i. Purpose of the research.
ii. 	Uses of the fetal tissue, including thedevelopment of new products or transplantation into humans or animals.
iii. Source of the funding.
iv. 	The benefits of using human fetal tissue
instead of alternative materials.

3v.	Review
and approval process for theproject.
vi. 	If the tissue is being donated for unspecified research and therapeutic uses, discuss the types of research that use fetaltissue (e.g., research seeking to improveunderstanding of human development
and the development of treatments forhuman diseases).
c. 	Discuss whether the donated tissue and its
derivatives may be shared with other researchers, including not-for-profit research
institutions and for-profit companies, andused for the development of commercial
medical or biological products, and whether
it may be shared and used internationally.
d. 	If it is known, explain how the tissue will be
stored before use (if this is to be the case),
how long it may be stored, and how it will
be disposed of, including if it is not used forresearch purposes.

47.

Statement of Benefitsa. 	Discuss that the potential donor will notbenefit financially from the donation of human
fetal tissue for research or from any ensuingcommercial applications relating to that tissue.
b. 	Explain that there are potential benefits of
the research, including important knowledge
that may be gained.

Informed Consent Standard for Human Fetal Tissue Donation

8. Statement	of Risks to the Donor (includingConfidentiality)a. 	Provide the donor with information about any
risks from the donation, including the risk to
the donor’s confidentiality. Explain that thedonor might be identified in the future due togenetic analysis that could link deidentified
tissue to the donor and incidental findings ofrelevance to the donor.
b. 	Discuss whether the donated fetal tissue will
be deidentified and what deidentificationmeans in terms of privacy protections. If it
will not be deidentified, explain who will haveaccess to the identifiable information.
c. 	Explain that there are no additional medicalrisks from donating tissue outside thosewhich are related to pregnancy termination.
9. Contact Information for Questions	Provide contact information for the donor todiscuss questions related to the use of thedonated fetal tissue. Some jurisdictions may
require the disclosure of the researcher’s contact
information if the tissue is being provided to a
specific researcher or specific project.
10. If the Donation is for Transplantation Research	a. 	Explain that the donor will not be informed ofthe identity of the recipients.
b. 	Explain that the donation must be madewithout any restriction regarding the identity
or attributes of the recipient.

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Appendix I
DONATION OF HUMAN FETAL TISSUE INFORMED CONSENT TEMPLATE – U.S. ADAPTATIONStatements and Acknowledgments from the Donor
Please carefully read the statements and sign below if each of the following topics was explicitly discussed
before providing consent for the donation.

Statements and Acknowledgments from the Donor

5

I made a final decision to terminate my pregnancy before I was approached to discuss the possibility of donating
tissue from the fetal remains.
I have been provided information on fetal tissue donation in writing and have had an opportunity to consider thisinformation, ask questions, and discuss any concerns.
My decision to donate fetal tissue is completely voluntary, and I understand the limitations on when I can
withdraw my consent to use the tissue.
I understand I will not be paid for the donation of human fetal tissue, and I will not receive any other direct benefits
from the donation.
I understand that I will not receive any payment even if the tissue helps lead to a commercial product.
I have been informed of the risks of donating human fetal tissue, including the possibility that my identity may
be linked to the tissue.
I have been informed on how the tissue might be used, stored and what will happen to the tissue after use
or if it is not used.
I have been provided contact information to discuss any questions and report any concerns regarding the donation.

Signature of the Donor

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DateAppendix II
STATEMENTS FROM DONOR AND ATTENDING PHYSICIAN FOR HUMAN FETAL TISSUE DONATION FOR
TRANSPLANTATION RESEARCH

Statements from the Donor of Human Fetal Tissue for Transplantation ResearchIf the human fetal tissue is being donated for transplantation research, please read the statements and sign
below if each of the following topics was explicitly discussed before providing consent for the donation.

6Statements from the Donor of Human Fetal Tissue for Transplantation Research
The donated human fetal tissue may be used for therapeutic transplantation research without any restriction regarding
the identity of the individuals who receive the transplantation and without the disclosure of the identity of therecipient(s).
The identity of the recipient(s) of donated tissue used for therapeutic transplantation research will not be
disclosed to me.

Signature of the Donor

Date

Statement from the Attending Physician for Human Fetal Tissue
for Transplantation Research
The donated fetal tissue was obtained in accordance with the donor’s signed statement.
The consent process fully disclosed the possible uses of the tissue and the relationship of the person taking thatconsent to the possible research being done with that tissue.
The consent process disclosed any known risks to the donor, including risks to the donor’s privacy.
The pregnancy termination was performed in accordance with the normal medical standard of care. The standard ofcare was not altered solely for the purpose of obtaining tissue from the fetal remains.
The donor’s final decision to terminate the pregnancy was made before she was approached to discuss the possibilityof fetal tissue donation.
The pregnancy termination will be performed in accordance with applicable state and local laws.

Signature of the Attending Physician:Informed Consent Standard for Human Fetal Tissue Donation

Date

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Acknowledgments
TASKFORCE CO-CHAIRS

Roger Barker, University of Cambridge, UK
Olle Lindvall, Lund University, Sweden
TASKFORCE MEMBERS

Gerard J. Boer, Netherlands Institute of Neuroscience (Retired), Netherlands
Elena Cattaneo, University of Milan, Italy
Alta Charo, University of Wisconsin-Madison/Nuclear Threat Initiative, USA
Susana M. Chuva de Sousa Lopes, Leiden University Medical Center, Netherlands
Yali Cong, Peking University, China
Misao Fujita, Kyoto University, Japan
Steven Goldman, University of Rochester Medical Center, USA
Göran Hermerén, Lund University, Sweden
Insoo Hyun, IH: Harvard Medical School, USA
Steven Lisgo, Newcastle University, UK
Anne Rosser, Cardiff University, UK
ISSCR STAFF

Eric Anthony, Director of Policy (former)

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