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Community & Trust

Trust Must Be Earned

Caution about clinical research is a reasonable response to documented history. It is not something to be corrected out of people.

The history is real, and it is specific

The U.S. Public Health Service Untreated Syphilis Study at Tuskegee

From 1932 to 1972, the U.S. Public Health Service enrolled hundreds of Black men in Macon County, Alabama, in a study of untreated syphilis. The men were not told the true purpose of the study, and they were not given adequate information to make an informed choice.

Even after penicillin became the accepted treatment for syphilis, the men in the study were not offered it, and steps were taken that kept them from receiving treatment elsewhere. The study continued for forty years and ended in 1972 after it was reported publicly.

Men died. Wives and children were affected. The harm did not stay inside the study, and it did not end when the study ended. That history happened in Alabama, in communities close to where ACM is based.

Henrietta Lacks

In 1951, Henrietta Lacks, a Black woman from Virginia, was treated for cervical cancer at Johns Hopkins Hospital. Cells taken from her tumor were grown in a laboratory without her knowledge or consent, becoming the HeLa cell line.

HeLa cells have been used in research worldwide for more than seventy years and have contributed to major scientific and commercial advances. Her family was not asked, was not informed for decades, and did not share in the benefits that followed.

Her name matters here because it marks a specific failure: research that treated a person's body as material and her consent as unnecessary.

What exists now to protect participants

These safeguards were built in response to documented harm. They are real, and they are also not the whole answer.

Informed consent

Research involving people generally requires informed consent: a full explanation of purpose, procedures, risks, alternatives, and rights before anything begins — and a genuine option to refuse.

Independent ethical review

An Institutional Review Board (IRB) or equivalent independent body reviews a study, its consent documents, and its recruitment materials before participants can be approached, and continues to oversee it.

Participant rights

You may ask questions at any time, request information in language you understand, bring someone with you, decline to participate, and withdraw without penalty or loss of routine healthcare.

Oversight and monitoring

Studies are subject to sponsor monitoring and regulatory oversight, with requirements for documenting what happened and reporting safety concerns.

Limits of participation

Research cannot promise benefit. Some studies involve placebo. Some questions a participant has cannot be answered until the study is complete. Being honest about that is part of consent.

Where safeguards stop

Rules govern conduct; they do not create relationships. A board approval does not tell you whether the people in front of you will treat you with respect.

Our position

Legal and procedural safeguards alone do not establish trust. Trust is built by showing up before you need something, answering questions you were not required to answer, saying plainly when a study is not a good fit, and returning to the community with what was learned.

We also hold a firm line on how people are described. No one's race, income, diagnosis, neighborhood, or community membership is a recruitment asset to be counted. Community-based research means research designed around what people actually need in order to take part — not research that targets people because they are considered easier to enroll.

We will not claim community endorsement we do not have. ACM lists a practice, sponsor, investigator, or community partner only when that relationship is confirmed.

How community perspective reaches decisions

ACM is establishing a Community Advisory Board of 8–12 members with lived experience, community health knowledge, advocacy background, and accessibility perspective, to review participant-facing materials, app design, and outreach plans — with compensated review work.

A separate internal Community Research Review Committee assesses whether a proposed study is suitable for ACM and our community before we accept it.

Neither body replaces an IRB, an investigator's responsibilities, or required regulatory review.

How We Protect You