Miriam Macias

ID 7748193

Ethical and Practical Considerations

in Community-Engaged Research
(CEnR)
Seattle University - Human Subjects Research for IRB (Faculty, Staff, and
Student)

Quiz Results
You correctly answered 5 of 5 quiz questions.

Question 1
Question How has the evolution of CEnR affected communities?

Your Communities inform research processes through participation in study

Answer design and assist in the dissemination of research results.

Result Correct

Comment CEnR has affected communities in a variety of ways. Communities can

inform research processes through participation in study design, subject

recruitment, data collection, analysis and interpretation of data, and/or
dissemination of research results. Communities are now viewed as active
 participants and not just passive bystanders. Communities are interested in
the immediate and long-term group and community risks and impacts of
the proposed research, so the literature may be of interest but not the
primary focus. CEnR has increased in frequency and expanded in scope,
and community members are increasingly collaborating with community-
engaged researchers.

Question 2
Question The NIH indicates that individuals who are involved in the design or
conduct of a research study must fulfill the education requirements set out
by their organization. In CEnR, the question of training becomes more
complicated. Which of the following terms describes effective training for
the purposes of CEnR:

Your Culturally appropriate

Answer

Result Correct

Comment Effective training for the purposes of CEnR is culturally appropriate,

supports the development of useful skills but should not require advanced
technologies for completion, and is developed in consultation with
community partners. Training that requires prior knowledge of scientific
research methods is not effective for community partners. Effective
trainings should be developed by both academic researchers and
community partners together.

Question 3
Question Select the statement that is true:

Your One FWA holding organization may rely on another FWA holding

Answer organization for review and continuing oversight of a human subjects

research project.
Result Correct

Comment Organizations that hold FWAs are responsible for ensuring that their
researchers, who are conducting HHS supported research, understand and
act in accordance with the regulations for human subjects protection. The
extension of these obligations to community members participating on the
research team is a unique aspect of CEnR, which may raise concerns for
IRBs regarding how to satisfy reviewers and meet organizational and
federal policies. The extension of FWA obligation is generally done in
contract with the community-based organization or via an agreement,
commonly referred to as a reliance agreement or Institutional
Authorization Agreement (IAA). This agreement documents that one
organization (the community-based organization) may rely on another
designated IRB (that of the researchers’ organization) for review and
continuing oversight of a human subjects research project. If a community-
based organization does not have an FWA, the reviewing organization may
issue IIAs to any of the organization’s staff who will be members of the
research team so that they may conduct research. This is a strategy if an
organization does not have an FWA or an individual is working
independently from an organization.

Question 4
Question What is the main obstacle or challenge to applying federal regulations to
CEnR?

Your Federal regulations were written to protect the rights and welfare of
Answer individuals and not communities.

Result Correct

Comment There are many challenges when applying federal regulations to CEnR, but
the primary challenge is that federal regulations governing IRBs were
written to protect the rights and welfare of individuals, and as such are not
explicitly designed to protect the rights and welfare of communities

involved in research.
 Question 5
Question How should researchers and IRBs assess and address risk of harm during
the planning, conduct, and review of CEnR?

Your Consider both short-term and long-term risks of harm to both individual
Answer research subjects and the community

Result Correct

Comment In CEnR, IRBs may want to consider both short- and long-term risks of harm
to individual research subjects AND the community; community members
can be instrumental in identifying long-term risks to the community as a
whole.

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