Disclaimer: everything we do in social science is about real people with real lives going through real things.

As a result, all of our work in social science research will involve potential risks for activating our lived traumas.

Specifically, most of the topics covered in this slide deck are sensitive in nature and are not just "hot topics"; these are our lives and represent our collective, generational, and individual traumas.

Please engage in self-care and take a break if needed.

Some of the unethical research studies that led to the creation of ethics laws for research and IRBs:

(1932-1973) Tuskegee experiments. U.S. Public Health researchers intentionally withheld penicillin from 400 black males who were unaware of their positive diagnosis of syphilis. By the end of the study 28 men had died, their wives were now infected with syphilis, men were disabled from the disease, and their children had congenital disorders. In 1973 the study was stopped due to a federal investigation and the federal regulation of research was a direct result.

(1962) Thalidomide: Kefauver-Harris Bill was passed to ensure greater drug safety as a result of the 12,000 thalidomide babies born missing limbs. This drug was given to pregnant women to control nausea, however, the women were not informed this was an experimental drug nor about the risks involved.

(1963) Stanley Milgram: obedience study and electric shock. Investigate power dynamics due to the common response from soldiers in WWII, Korea, Vietnam that they did what they did because they were just “following orders”. Researchers set up a fake electric shock board. Participant A sat in one room and would read questions to Participant B in a separate room. If participant B got a question wrong, participant A would push a button to shock them. Participant A didn't know the shock board was fake nor that the person responding to the questions was an actor. The participant delivering the electric shock would keep going because the researcher was standing there telling them they had to do it. Video: https://www.simplypsychology.org/milgram.html
(related to the “following orders” defense in the 2003 Abu Ghraib prisoner abuse/torture/murder scandal in Iraq at the hands of U.S. soldiers.)

Stanford Prison experiments (1971) investigate the psychological effects of perceived power between prisoners and prison officers. It was conducted at Stanford University led by psychology professor Philip Zimbardo using college students. In the study, volunteers were randomly assigned to be either "guards" or "prisoners" in a mock prison.

(1989) Arizona State University and the University of Arizona collected 400 blood samples from Havasupai tribal members for diabetes research, but those samples were used for unauthorized research on schizophrenia, eugenics, and DNA mapping. The researchers did not inform the Tribe. There are countless unethical research practices against Native peoples: sterilization of Lakota women, U.S. Air Force- giving radioactive Iodine to Alaska Natives, and too many more.

In 1951, a young mother of five named Henrietta Lacks sought treatment for cervical cancer at Johns Hopkins Hospital in Baltimore Maryland. At the time, Johns Hopkins was one of only a few hospitals to treat African-Americans.

Without informing her and without her consent, a sample of her cancer cells retrieved during a biopsy were sent to a lab for research. Typically, tissue samples die quickly, but Mrs. Lacks’ cells were unlike any of the others researchers had ever seen: where other cells would die, Mrs. Lacks' cells doubled every 20 to 24 hours.

Today, these cells — nicknamed "HeLa" cells, from the first two letters of her first and last names — are used to study the effects of toxins, drugs, hormones and viruses on the growth of cancer cells. They have been used to test the effects of radiation and poisons, to study the human genome, to learn more about how viruses work, and played a role in the development of the polio and COVID-19 vaccines.

All done at the time without the patient's voluntary informed consent and still done today with risks to her family's medical and genetic data.

In 2013, the National Institute of Health (NIH) entered into an agreement with her descendants to allow biomedical researcher access to DNA or RNA HeLa cell whole genome sequence data (HeLa cell data), while also respecting the preferences and privacy of the Lacks family. In 2023, the family won the first of many legal battles they are fighting against corporations who have profited from the use of HeLa cells without consent.

https://grants.nih.gov/policy-and-compliance/policy-topics/sharing-policies...

https://stanfordbloodcenter.org/the-complicated-history-of-hela-cells-henri...

It was the combination of all these past unethical studies that led to the 1974 National Research Act (Public Law 93-348).

The legislation also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that, in 1979, issued the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Research.

The Institutional Review Board (IRB) process, formalized by the Commission, remains the present-day peer review method to ensure compliance with the basic ethical principles of the Belmont Report.

Current laws in place:
1974 National Research Act based on the Belmont Report,
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

1991 Common Rule (and then updated in 2018). https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/ind...

Major changes were:
non-generalizable research is no longer considered research,

streamlined processes for agency approvals of "minimal risk" research projects,

and long term consent for biospecimen research.

Major changes to the federal Common Rule as of 2018:
1) “harmonization”= one IRB for all federal agencies,
2) online review process,
3) more exemptions for ‘low risk’ studies,
4) clearer informed consent agreements that must include future uses of bio specimens---the changes are really as a result of the explosion of so many human genome/DNA projects and pharmaceutical drug testing in the U.S. over the past 25 years since the Common Rule was first adopted.

A concern is about “more” exemptions for “low risk” studies.

The Feds deem studies approved by a Department or Agency head for “public benefit” as exempt from having to go through IRB review.

Feds also deem anything not “generalizable” as “not research”, low risk, and therefore exempt. So, case studies are automatically exempt.

Indeed, your case studies for this class are “exempt” (why? because we are federally funded).

But, we know case studies in public service can cause harm. That’s why your faculty require you to still go through the HSR application and we review your HSR application to make sure you are following ethical protocols. Just because a case study isn’t “generalizable” doesn’t mean it can’t do harm.

You can act to ensure that your research functions as effectively as possible and reflects your participants needs and interests.

Articulate the conditions in which research will be permitted.

For example, how much risk will you tolerate in your research in order to better describe, explain, explore, or understand your topic?

Is a little frustration an ok risk?

Is the possibility of a participant being denied program benefits an ok risk?

What are IRBs?
Institutional Review Boards oversee research conducted by federally funded organizations.

What do they do? Review research designs before data is collected to ensure human subjects are protected.

WHY DO WE HAVE IRBs?
prevent unethical research practices

There are 112 Federally approved IRBs in WA (behavioral, health, psych, medical, FDA: most are colleges, universities, and hospitals).

2 are Indian centered. Northwest Indian College (Bellingham) & Swinomish Indian Tribal Community (La Conner).

1 for WA state https://www.dshs.wa.gov/administrations-and-offices/reports-publications-an...

Resource to search for IRBs: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc

There are 5 main rules of ethics in social science research agreed upon through Federal law and enforced by IRBs that use the Human Subjects Review (HSR) process.

The 5 rules are:

Ethical Responsibilities of the Researcher to Subjects:

1) Informed Voluntary Participation : subjects must voluntarily & informed consent to participate in research. The subjects must base their voluntary informed participation in research projects on a full understanding of the possible risks and benefits involved.

2) No Harm to Subjects : researchers must not inflict physical, psychological, or emotional harm.

However, subjects may consent to some harm when you inform them about the risks of the study.

3) Guarantee either Anonymity or Confidentiality : (not both!) Big difference between confidentiality and anonymity. Most common mistake is students try to guarantee "both". It is one or the other or nothing.

Anonymity : when nobody, including the researcher, can identify a particular response with a particular respondent.

Confidentiality : when the researcher can identify the respondents, but others cannot.

However, either anonymity or confidentiality can be waived by the subject in the consent form reviewed in HSR, but it must be formally waived.

4) Deception : the researcher cannot deceive the subjects about who the researcher is or why they are there. If you are there to conduct research, you must make it known.

However, deception may be justified through HSR. If you must conceal your identity for the sake of the research (studying prison life or gang life for example) then the HSR may waive this rule.

Ethical Obligations of Researcher to Scientific Community:
5) Analysis and Reporting- make technical limitations of your research known. This includes reporting negative findings.

Data ownership during and after the research study should be clearly considered in advance in collaboration with the organization involved. Who stores raw data, who owns it, for how long? https://fnigc.ca/ocap-training/

Intellectual Property Rights (IPRs). Be very clear about this. Follow the OCAP principles of ownership, control, access, and possession.

Even if you aren't collaborating with an organization, you need to be clear about OCAP. As students, your work is your work. TESC doesn't own it. However, ethically, you may want to gift your work to the participants in your study. You may want to write in a process on your consent forms that they will have an opportunity to review your initial results before you finalize your report at the end of winter quarter and then explain how you will give them a final copy of the report.

A plan for review of the findings by a cooperating organization should be outlined in the letter of support along with how the organization will retain the raw data: ownership, control, access, possession.

There are no specific federal regulations for artificial intelligence (AI) under the Common Rule human subjects protection laws. Instead, Institutional Review Boards (IRBs) rely on existing federal frameworks (45 CFR 46 and 21 CFR 50/56) alongside evolving institutional guidance.

Key Areas of IRB Scrutiny

• Data Privacy & De-identification: Using human data—even de-identified data or training models—requires careful evaluation because AI can infer re-identifiable patterns or capture sensitive metadata (timestamps, geolocation).

• Bias and Hallucination Mitigation: Researchers must outline how they will independently verify algorithmic outputs, manage systemic or demographic bias, and ensure scientific reproducibility.

• Informed Consent: Protocols must explicitly disclose to participants if and how AI tools are used to process their data or to analyze results.

As researchers, it's on us to
use disclosure language in our informed consent forms and outline data de-identification and privacy safeguards in our research protocols.

The Human Subjects Review (HSR) process is overseen by the Institutional Review Board (IRB). All institutions that receive federal funding and conduct any research involving human subjects, must have an IRB. The fundamental responsibility of the IRB review is to assure that the rights and welfare of the human subject are protected. https://www.evergreen.edu/humansubjectsreview/who-must-apply-human-subjects...
Review TESC HSR application:
https://www.evergreen.edu/humansubjectsreview/irb-application

See Handout. https://docs.google.com/document/d/1EqCr7RcGDSYVNLR6HQoJWwsgV2zC9Fun/edit?u...
Discuss how to respond to the questions, cover letters, voluntary informed consent forms, letters of support.