Two senior women jogging in a park

What Should We Ask About Age-Based Criteria in Healthcare?

In the American health care system, age shapes patients’ options. Most people over age 65 are eligible for Medicare, which is inaccessible to almost everyone under 65.

But many providers limit older patients’ access to certain interventions—like in-vitro fertilization or organ transplants. Some clinical research studies also exclude older patients, while others stratify populations by age. And insurers in the Affordable Care Act’s individual marketplaces can legally charge older patients up to three times as much as younger patients, which has motivated calls to let people below 65 buy into the Medicare program (although these proposals use age 55 as an eligibility criterion). Many of these uses of age have generated debate in the past, and are likely to continue to generate debate in the future. Read More

Vulnerability, Coercion, and Undue Influence: From the Mud into the Muck?

According to the NPRM, “the only vulnerability that needs to be considered is vulnerability to coercion or undue influence, and not other types of vulnerability.” It therefore replaces all standalone uses of “vulnerable” with “vulnerable to coercion or undue influence.” This change is justified on the basis that it will “provide greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections,” where the vulnerable populations in question are “children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.”

Two provisions of the Common Rule (§107.a and §111.a.3) currently discuss vulnerability without further specification, whereas one (§111.b) discusses vulnerability to coercion and undue influence. Deleting §111.b’s reference to coercion and undue influence, however, would achieve consistency while making even fewer changes than the NPRM proposes. The proposed revisions, then, rest on improved clarity rather than improved consistency.

I doubt that narrowing vulnerability by adding the terms “coercion” and (in particular) “undue influence” adds much clarity. Rather, these changes may reduce protections against research flaws other than coercion and undue influence without offering counterbalancing advantages for the research enterprise. Read More