Oversight of Fetal Tissue Research

The Deputy Director for Intramural Research is responsible for oversight of all research that uses fetal tissue conducted by intramural scientists at the NIH, whether they are working in NIH facilities or with collaborators outside of NIH. All intramural scientists are informed of the policies and legal requirements applying to fetal tissue research. Oversight of fetal tissue research conducted by intramural investigators is summarized below.

NIH Office of Human Subjects Research Protections (OHSRP)

The Office of Human Subjects Research Protections (OHSRP) provides first-line advice and guidance to intramural investigators who are using or contemplate using fetal tissue. The DDIR directs that all experiments using human fetal tissue must be reviewed and approved either by OHSRP or an NIH IRB. See the Reminder for Intramural Investigators of Legal Requirements Regarding Acquisition and Use of Human Fetal Tissue for Research Purposes for additional information or the FAQs on the Policy and Procedures for Research Using Human Fetal Tissue in the IRP. If still unsure contact OHSRP directly (301-402-3444).

Annual Reports

Intramural investigators with NIH supported projects must file annual reports on their research. The text of these reports are available electronically, fully searchable and publicly accessible (http://intramural.nih.gov/search/index.taf). The Office of Intramural Research and the Scientific Directors of each Institute/Center directs investigators to specifically identify when human fetal tissue is used during the reporting period.

Scientific Directors

The Scientific Directors (SD), who provide immediate oversight of intramural research in each institute, are aware of the legal requirements governing acquisition and use of fetal tissue. They are directed to ensure that all scientists who use human fetal tissue in their research assure fetal tissue is used and acquired in accordance with the legal requirements.

Management Controls

In the annual Management Controls review, each Scientific Director will be asked to verify that he or she has reviewed the legal requirements regarding fetal tissue acquisition and use for research in their intramural program, and to identify and correct any potential problem areas.

https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations/fetal-tissue-research/oversight-fetal-tissue-research

Reminder for Intramural Investigators of Legal Requirements Regarding Acquisition and Use of Human Fetal Tissue for Research Purposes

Purpose

This Notice is intended to remind NIH-intramural investigators and contractors that research involving human fetal tissue must be conducted in accordance with applicable Federal, State and local laws, regulations, and policies, including the NIH Sourcebook.

Selected Federal statutes, regulations, and policies are provided below:

42 U.S.C. 289g-1 and 289g-2 set forth specific requirements and prohibitions on research involving human fetal tissue. For example, among other prohibitions, 42 U.S.C. 289g-2 provides:

"Prohibitions regarding human fetal tissue

(a) Purchase of tissue

It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.”

The full text of 42 U.S.C. 289g-1 is available at: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-1.htm.

The full text of 42 U.S.C. 289g-2 is available at: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-2.htm.

Research involving human fetal tissue is also subject to the HHS Regulations for the Protection of Human Subjects (45 CFR 46 Subparts A and B). The following provisions may be specifically relevant:

§46.204 Research involving pregnant women or fetuses.

~ (a) – (g)

(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;

(i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and

(j) Individuals engaged in the research will have no part in determining the viability of a neonate.

§46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.

(a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.

(b) If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.

The full text of the HHS Regulations for the Protection of Human Subjects is available at: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf (PDF File).

https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations/fetal-tissue-research/reminder-intramural-investigators-legal-requirements-regarding

Dr. Michael Gottesman was appointed NIH deputy director for intramural research (DDIR) in November 1994. He had been acting DDIR for the previous year and was acting director of the National Center for Human Genome Research from 1992 to 1993. A well-known and respected basic cancer researcher who has focused on multidrug resistance in human cancer cells, Michael continues his role as chief of NCI’s Laboratory of Cell Biology.

As DDIR, Michael coordinates activities and facilitates cooperation among the 24 Institute- and Center-based Scientific Directors to achieve the scientific, training, and public health missions of the NIH Intramural Research Program. Michael provides guidance for the entire intramural program and reports to NIH Director Francis Collins. Michael oversees and ultimately approves the hiring of all NIH principal investigators, and he is the institutional official responsible for human subjects research protections, research integrity, technology transfer, and animal care and use at the NIH.

During his tenure as DDIR, Michael has created the post-baccalaureate training program, the Graduate Partnerships Program (which permits graduate students to conduct thesis research at NIH); implemented loan repayment programs; institutionalized an intramural tenure track and new career tracks for clinical investigators; created the NIH Intramural Database (providing online information about all researchers and research at NIH); and spearheaded multiple other programs in the realm of diversity, equity, research integrity, and leadership.

Michael came to NIH in 1971 as a research associate in the National Institute of Arthritis, Metabolism, and Digestive Diseases (now NIDDK), where he worked for three years. He spent a year as an assistant professor at Harvard Medical School and joined the permanent staff of NCI in 1976. He became chief of the molecular cell genetics section in the NCI Laboratory of Molecular Biology in 1980 and chief of the NCI’s Laboratory of Cell Biology in 1990.

Michael’s research interests have ranged from how DNA is replicated in bacteria to how cancer cells elude chemotherapy. Collaborating with Dr. Ira Pastan, chief of NCI’s Laboratory of Molecular Biology, and others, Michael identified the human gene responsible for resistance of cancer cells to many of the most common anticancer drugs and showed that this gene encodes a protein that acts to pump anticancer drugs out of drug-resistant human cancers. This evidence supports the proposal, now widely accepted, that P-glycoprotein (P-gp), the product of the MDR1 gene, is an energy-dependent pump, ferrying toxins or drugs out of the cell. His recent work has defined the complexity of multidrug resistance in cancer.

Michael’s research has earned him many awards. He was elected a fellow in the American Association for the Advancement of Science in 1988, to the National Academy of Medicine (formerly called Institute of Medicine) in 2003, to the Association of American Physicians in 2006, and to the American Academy of Arts and Sciences in 2010. He received the Public Health Service Commendation, Outstanding Service and Distinguished Service awards, the NIH Director’s award in 2002, and the HHS Secretary’s Award for Distinguished Service in 2005.

https://oir.nih.gov/about/leadership-staff

https://oir.nih.gov/about/leadership-staff/michael-gottesman

https://www.ama-assn.org/delivering-care/ethics/research-using-human-fetal-tissue

Policy and Procedures for Obtaining Human Fetal Tissue for Research Purposes in the Intramural Research Program at NIH

Definition and Scope

This policy describes the requirements and procedures for obtaining human fetal tissue for research purposes within the Intramural Research Program (IRP) at the National Institutes of Health (NIH).

This policy defines “Human fetal tissue” as tissues or cells obtained from a dead human embryo or fetus after spontaneous or induced abortion, or after a stillbirth. This policy applies to research using human fetal tissue; however, this policy does not apply to secondary sources of tissues such as established cell lines or animal models containing human fetal tissue.

Requirements and Procedures

All NIH intramural investigators must be fully aware of and in compliance with all applicable legal requirements, including laws that govern research using human fetal tissue and research involving transplantation of fetal tissue. A summary of relevant laws and policies are described within the Fetal Tissue Research section of the NIH Sourcebook. All experiments using human fetal tissue must be reviewed and approved either by OHSRP or an NIH IRB.

For de-identified tissue (that will not be used as part of an IRB-approved protocol), review, sign, and submit both of the following documents to the NIH Office of Human Subjects Research Protection (OHSRP) indicating that you are aware of and in compliance with the relevant laws and policies pertaining to research with human fetal tissue, including the expectation of consent for use of materials for research purposes:

Request for Determination - Specimen Data Use Interview Survey or Other

Investigator Attestation I (PDF File): Review of Human Fetal Tissue at NIH by the Office of Human Subjects Research Protections (hereinafter referred to as “Attestation I")

If the samples include identifiable information, the NIH researcher is aware of the identity of the donor, or the samples will be used as part of an IRB-approved protocol which includes consent for use of fetal tissue for research purposed (see Subpart B of 45 CFR 46).

Institutional Review Board review of a new protocol or an amendment to an existing protocol will be required. Review, sign, and submit the following document, along with your protocol, to the IRB indicating that you are aware of and in compliance with the relevant laws and policies pertaining to research with human fetal tissue.

Investigator Attestation II (PDF File): Review of Human Fetal Tissue Research at NIH by the Institutional Review Board (IRB) ( “Attestation II”)

After obtaining OHSRP or IRB approval in order to obtain and use human fetal tissue, NIH Intramural Investigators must submit a request to their purchasing agents or completion of MTA or Collaborative agreement (See #5). A certified document, “Attestation I or II”, must accompany all such requests. (See Guidelines for Ordering Fetal Tissue). Intramural Investigators must maintain a copy of these forms as part of their NIH research records.

NIH Institute and Center purchasing agents must be provided a copy of the appropriate Attestation prior to ordering material and must maintain the Form with related transaction records. Purchasing agents must be aware of applicable legal requirements associated with acquiring and obtaining human fetal tissue (U.S.C. §§289g-2).

NIH Intramural Investigators must obtain human fetal tissue, as determined by the needs of their specific research projects, in a manner consistent with all applicable legal requirements.

A Materials Transfer Agreement (MTA) or collaborative agreement (CA) must be executed for human fetal tissue obtained from an academic institution, clinic, or hospital, and must provide documentation that they are in compliance with the applicable Federal laws and policies or provided information on comparable restrictions in force in their country. This includes a statement, that NIH expects informed consent to have been obtained from the donor for any NIH-supported research using human fetal tissue. IRP Investigators must keep a record of this documentation.

All commercial suppliers of research material must provide documentation that they are in compliance with the applicable Federal laws and policies. IRP Investigators must keep a record of this documentation.

NIH Intramural Investigators are required to submit all documentation regarding their use of human fetal tissue to their SD and to the NIH Intramural Compliance Officer including:

A copy of the appropriate Attestation Form (I and/or II);

A copy of the OHSRP Determination or IRB protocol approval letter with précis;

A copy of all documentation from the supplier of the research material

…

https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations/fetal-tissue-research/policy-procedures-obtaining-human-fetal-tissue-research-purposes

https://breaking911.com/man-shot-after-trying-to-run-over-border-patrol-officer-at-arizona-port-of-entry-new-details/

What Happens to Unborn Babies After Abortion? Pathologists Share the Horrors

Some, we know, are cremated. Others are tossed in the trash, and discovered by pro-lifers like Dr. Monica Miller, who dutifully record their fate and give them the funeral and respect their humanity demands. But what about the other babies—the ones shipped off in containers and sealed buckets to pathology labs? When searching for the answer to that question, I found a series of horrifying testimonies on a Student Doctor Network Forum hosted by St. George’s University. On the discussion board, those who worked with the bodies of aborted babies shared their horror at what they saw.

“Anyone get tripped on these?” one wrote (spelling and grammar errors his), “I’m talking especially the big ones, where you can actually make out facial expressions like they knew they were being hacked the hell up (im serious). I almost went bonkers once over one, that is some scary crap. Am I the only pathologist who freaks when a 0.5 cm eye ball comes rolling out of bag and stares right at you…I know we are thinking this, just no one in pathology is talking about it.”

Another pathologist, identifying himself as “Andy Milonakis,” responded by saying, “Totally trippy man. We get a fair number of fragmented fetuses from abortion procedures and they come in a container with formalin. The fact that they’re all hacked up is disturbing to begin with. Of course, there is the whole eyeball issue which freaks me out as well. Echoing in my mind is the sound effects from the movie Psycho…Reee Reee Reee Reee Reee Reee Reee!”

The original poster continued, describing an absolutely nightmarish scene:

“One incident really freaked me, it was a boy fetus, at least 3+ pounds, around 24+ weeks. It sat decomposing because the rest of the staff was AFRAID of it, Im not joking. Then the chief of staff told me to deal with it because I was the FNG (f-kcin new guy) so I went to work. Pulled out 2 well formed arms and then the torso, headless. The head was at the bottom of the container, when I pulled it, he had this expression of such utter horror it flipped me wayyyy out, my PA saw it and ran, literally left work and went on disability (Im serious here). It was like a headless screaming baby, like it had been born at least for a split second to realize it was screwed and let out one agonal yelp. The story of this reverberated around the department, someone actually accused me of doing what should have been a ME case and threatened to call the medical board! Im not joking, I woke up once shortly after that in a cold sweat with piss running down my leg….not pretty.”

It is the eyes, it seems, that disturbs those dealing with the corpses of butchered pre-born children the most. Another pathologist wrote:

“Most of my abortion-path anecdotes come from my PSF. Here one of the residents grosses most of them in as part of some project he is doing, and we are more than happy to let him.

https://www.lifenews.com/2013/10/23/what-happens-to-unborn-babies-after-abortion-pathologists-share-the-horrors/

UK guidance to disposal

https://www.hta.gov.uk/sites/default/files/Guidance_on_the_disposal_of_pregnancy_remains.pdf

Medical waste disposal company stops doing business with ‘many Planned Parenthood’ clinics

https://www.lifesitenews.com/news/medical-waste-disposal-company-stops-doing-business-with-many-planned-paren