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. Show 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 (photos and videos documented). )

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.

As noted by Felicia Hodge in the article “No Meaningful Apology for American Indian Unethical Research Abuses”: Across Indian country there are cases where researchers stole indigenous medicinal knowledge of plants, cultural stories, songs, art… and even blood.

In 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.

Hodge goes on to list 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.

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 (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 already 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.

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).

But only 2 are Indian centered. Northwest Indian College (Bellingham) & Swinomish Indian Tribal Community (La Conner).
Resource to search for IRBs: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc

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 equity?

Sam Deloria stated in The Role of Tribal Government in Regulating Research: The federal government places conditions on the use of federal funds. But should Feds assume the full obligation of regulation or is there a necessary role for tribal governments?

Tribes can act to ensure that research functions as effectively as possible and reflect their needs and interests. But the fundamental responsibility to articulate the interest of Indian communities lies in these communities themselves, acting through their tribal governments, to articulate the conditions in which research will be permitted.

Questions: Can or should the Tribe obtain economic benefits from research? Must research show an immediate benefit (Wilson’s argument)? Do tribal members have an individual right to participate in research despite tribal opposition?

Starting a Tribal IRB:
https://drive.google.com/file/d/1L7vXn45jYFITrC2-mtfSHWUwd1fyMlPk/view?usp=...

Partnering with Tribes on research: https://drive.google.com/file/d/1jbOejJ4HuMMolRRDy-PQQK7Fg_dFlFGx/view?usp=...

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 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.

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

Discuss how to respond to the questions, cover letters, voluntary informed consent forms, letters of support.

When it comes to filling out the HSR application, it’s all about the form.

Use the samples provided on canvas! The language is extremely deliberate. Do not get fancy or try to reinvent the wheel here.

Use the TESC instructions for HSR application that you read. This is what you will use for faculty to review all of your instruments (survey/interview/focus group questions), cover letters, consent forms, letters of support.

See to do list here: https://docs.google.com/document/d/1C3dWn9mAWtH5z4Hco5jN7K0f-YjDJLkC/edit?u...

Review application packet:

Name, address, phone, e-mail: list only one person from your team.

Use is for: “Academic Program”

Quarter: check off “winter” and "spring" just in case you want to use this study for Capstone.

Year: 2024

Proposed project dates: The dates of your data collection should be January 1-June 15. (realistically you will collect your data during the first 3 weeks of winter quarter. But we have you write in a date until June so that you can have the option of going deeper into your research project for Capstone.)

Faculty sponsor: one of us assigned to you.

Funding agencies: None.

Indicate if the project involves any of the following: The only box that might get checked here is “a cooperating organization”. If this is the case, then you have to get a written letter of support from them, on letter head, that documents exactly what support they are promising you (ex. access to e-mail lists). A letter of support must be obtained from the appropriate authority within the org. A letter of support should include a description of the research, a description of any resources that will be provided by the org for the research project, and any promises made to the tribe by the study team. The letter of support must be obtained prior to submitting your HSR application to TESC.
Any resources that are required from the organization should be clearly outlined in the letter of support, i.e. meeting space, transportation, staff time, documents, e-mail lists, addresses, phone numbers, etc.

E-sign, E-date. (just the one person on the team listed at the top of the page)
No hard copy! We do not need a hard copy.

HSR questions:

1. Abstract= 150 words or less. Right here is where you state 3 very important points:
a) non-generalizable (case study),
b) your role as a researcher and your respondents role,
c) so what?--- the purpose of your research.

2. Procedures & Research Questions= when, where, and how will you do your research? Your plan. Attach your data collection instruments (survey/interview/focus group questions) to the HSR application. (add as an appendix to the document.)

3. Recruitment/Access= Who & How. Who are you going to ask questions, how are you going to contact them, and how are you going to get people to participate in your study? This is where you write about your sampling approach. For example, “using an in-person survey directed at a non-probability convenience sample of adults in downtown Olympia on xxx dates and yyy times,…” or “an online survey sent by the COO of Little Creek Casino will be distributed via employee e-mails using a non-probability (non-random) targeted sample of part-time employees only in xxx unit.”

4. Risks= This is where you are clear about what risks participants may be subjected to by participating in your study: embarrassment, awkwardness with questions, self-reflection, reflection upon society, frustration.

DO NOT write that a risk could be losing their job. If you seriously think this is a risk then we are going to need to modify your research project.

DO NOT write that there are no risks. There are always risks in any research project. Ex. Big picture risks: The leadership may not be ready for the results of your research. The org may have higher priorities for the limited staff.
Mitigate Risk: Write that respondents can skip any question they prefer not to answer. They can also stop or exit the survey/interview/focus group at any time.
Anonymity vs. Confidentiality: I doubt any of you will be able to guarantee anonymity (meaning that even you don’t know who the respondents are). Most of you will be able to guarantee confidentiality (no personal identifiers asked, or you will clean/code the data so any personal identifiers are not public).
Waiver: If identifying the people in your study is important to the findings (Ex. research on leadership among Mayors in WA and you are going to make a documentary with videotaped interviews that will show their name and title.), then you can write in that you will ask respondents to waive their confidentiality.

5) Benefits to justify the risks= provide participants with right to review initial findings plus give them a copy of the final full report, invite them to your final presentation, note social impacts. OCAP principles: "Ownership, Control, Access, Possession". Key is to not just take data and run. Always give back to the participants and community. This is also where you need to explain if there are org policies or plans already in motion about your topic and how your research will benefit them.

6) How will the info be used= academic and/or agency use only, not published. Explain how the raw data will be secured and how will destroy the raw data at the end of the project or given to Tribe. *Disclaimer: think this through in case you want to use it for other reasons in the future.