DISCLAIMER

The following is a staff memorandum or other working document 
prepared for the members of the Advisory Committee on Human
Radiation Experiments.  It should not be construed as representing
the final conclusions of fact or interpretation of the issues. 
All staff memoranda are subject to revision based on further 
information and analysis.  For conclusions and recommendations of
the Advisory Committee, readers are advised to consult the Final
Report to be published in 1995.



                    Ethics Data Collection

                         MEMORANDUM

TO:       Members of the Advisory Committee on Human Radiation
          Experiments

FROM:     Ethics Subcommittee and Staff

DATE:     July 22, 1994

RE: 	  Options for subject interviews

In response to the concerns and suggestions of the Advisory
Committee, we are posing three possible options for a subject
interview project. These options differ in their logistical
complexity and, correspondingly, in the amount and kinds of data
they would provide. What follows is a description of each option,
along with its methods and the research questions it could
answer. The subcommittee recommends either Option #2 or #3.

I. OPTION I: Short Survey.

A. Purpose: To gain answers to a few very specific questions
concerning (1) whether oncology patients seeking medical care at
major research institutions believe they are participants in
research: (2) the perceived voluntariness of this participation;
and (3) patients' reasons for agreeing to participate.

B. Overview: Two focus groups would be conducted to assist in
development of the interview instrument. Interviews then would 
be conducted with approximately 1000 patients drawn from 10
different institutions. Interviews would be administered in
waiting rooms and would last approximately five minutes.

C. Methods:

1. Development of the Interview instrument: Several focus groups
with five to ten patients in each would be conducted to assist in
questionnaire development. These focus groups would be drawn from
convenience samples (perhaps one at Johns Hopkins; one at Duke
University). The interview instrument then would be designed to
be administered by research staff in waiting rooms and would take
about five to ten minutes to complete.

2. Sample: The five academic and five governmental institutions
that receive the most federal research funding would be included
in this study. Approximately 100 patients would be interviewed at
each institution, for a total of 1000 patients. Patients would be
recruited from the waiting rooms of medical oncology and
radiation oncology departments. Staff conversations with
radiation and medical oncologists at leading medical research
institutions indicate that approximately 15-25% of patients in
such waiting rooms are participating in clinical research. By
picking particular days of the week ("research days"), it may be
possible to increase the proportion of patients who are engaged
in research.

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3. Recruitment Procedures: Local staff would inform all patients
that the facility is cooperating with an interview study of
patients' experiences, that the patient may be approached by
someone from the study, and that it is entirely up to the patient
whether s/he wants to participate. Project staff would describe
briefly the project to prospective participants and seek written
informed consent, both for the interview and for access to the
patients' medical records.

4. Data to be collected: The interview instrument will be
designed to capture the following domains. However, the specific
questions are provided as potential examples only. The actual
questions will be developed with focus group data to be refined
with pilot testing. Questions may be tightly structured and
close-ended or more open, but in either case they would require a
total of no more than five to ten minutes to answer.

a. Interview:

(1) Beliefs about being a research participant, e.g.:

(a) Are you currently receiving any treatments or drugs
considered to be experimental?

(b) Are you participating in any research studies or protocols
now?

(2) Voluntariness (to be asked of patients who believe they are
currently participants in research):

(a) Did you believe that you had a choice about whether to
participate in research or experimental therapies? Why or why
not?

(3) Reasons for participating:

(a) For which of the following reasons did you choose to
participate in this study? (e.g. to receive state-of-the-art
treatment; to help advance science; to receive compensation;
because someone else told you that you should)?

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(b) Was it recommended that you participate in this study? If so,
by whom (e.g., your doctor, another doctor, an outside
researcher)?

(4) Understanding of what it means to be in research:

(a) What does it mean for a drug or treatment to be experimental?
How is being a patient in a research project different from
getting regular medical care?

(b) Is everyone in your research project getting the same drug or
treatment?

b. Medical Record:

(1) Documentation as to whether they are receiving experimental
therapy/are participants in a research protocol.

(2) Existence of signed, informed consent form.

(3) Basic demographic information.

D. Logistics:

1. Identify sites for the focus groups.

2. Staff and/or consultant to conduct focus groups.

3. Along with agency assistance, identify participating
institutions for interviewing and establish working relationships
with these institutions.

4. Staff conducts pilot test (n=10-15) interviews; a consulting
firm or staff administers the final interviews (n=1000).

5. Staff and Dr. Faden to devise analytic plan. Consultant to
help with analysis.

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E. Strengths:

1. A small number of very specific and important questions can be
answered expeditiously.

2. A large number of subjects can be interviewed, thereby
enhancing the validity of findings.

3. If questions can be closed-ended, consistency of data
collection will be increased.

II. OPTION II: Short survey with follow-up focus groups.

A. Purpose: To gain the answers to specific questions, as in
Option I, but then to obtain more extensive data on certain areas
of interest.

B. Overview: All procedures of Option I would be followed, after
which focus groups consisting of a sample of patients
(n<unreadable text>15) who had been interviewed would be
conducted at each of the ten institutions.

C. Methods:

1. All methods of Option I would be repeated.

2. Follow-up Focus Groups:

a. Recruitment Procedures: Every patient interviewed would be
asked if s/he was willing to be contacted subsequently to be a
member of a focus group discussing in further detail the issues
raised in the interview. From the pool of patients who have
expressed a willingness to participate in a focus group, a
purposive sample would be contacted to assure that the focus
groups includes participants who actually are research subjects.
Patients would be paid $25 for their participation in a focus
group to compensate them for their time and to offset travel and
expenses related to participation in it.

b. Focus Group Guide:

(1) The same domains covered in the closed-ended survey would be
included in the guide, with questions being posed to the group in
the broadest possible fashion.

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(2) Also, as is usual for a focus group, topics of interest that
arise during the course of the group's discussion deliberately
will be pursued.

D. Logistics:

1. Staff would conduct focus groups or would be present for at
least one focus group session if they are conducted by an outside
consultant.

2. Focus groups will be tape recorded and subsequently
transcribed.

3. Transcripts will be coded and analyzed using available
software (e.g., TALLY or Ethnograph).

E. Strengths:

1. All strengths of Option I remain.

2. There is greater ability than when limited to only a few
probably closed-ended questions to understand the reasons why
persons chose to participate in research and the personal
situations or factors associated with this decision. Focus groups
also facilitate the pursuit of any topic of interest that arises
during discussion. This format thus allows us to learn more about
what is important to patients/subjects and therefore to develop a
better understanding of the experiences of being a research
subject.

III. OPTION III: Short survey with follow-up in-depth interviews.

A. Purpose: To gain the answers to specific questions, as in
Option I, but then to obtain more extensive data on certain areas
of interest.

B. Overview: All procedures of Option I would be followed, after
which semi-structured in-depth personal interviews would be
conducted with 10-15 patients at each of the ten institutions.

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C. Methods:

1. All methods of Option I would be repeated.

2. Follow-up in-depth structured interviews:

a. Recruitment procedures: Every patient interviewed would be
asked if s/he was willing to be interviewed more extensively at a
later date, with the expectation that each interview would last
approximately 30-45 minutes. From the pool of patients who have
expressed a willingness to participate in a personal interviews,
a purposive sample would be contacted to assure that the
interviews include participants who actually are research
subjects. Interviews would be scheduled in advance. Patients
would be paid $25 for their participation in a personal interview
to compensate them for their time and to offset travel and
expenses related to being interviewed.

b. Development of the interview guide:

(1) The same domains covered in the closed-ended survey would be
included in the guide, with questions posed to individuals in an
open-ended fashion and follow-up questions asked based on the
patient's response to previous questions. Through this process,
considerably more attention can be given to topics such as the
meaning of research participation for subjects. For example,
participants can be asked why they chose to participate, what
they think are the advantages and disadvantages of participating,
and more specifically what "experimental treatment" means to
them. Similarly, the voluntariness of their participation can be
explored more deeply and in a more nuanced fashion than can occur
in a five to ten minute interview.

(2) In addition, this format would allow us to explore the
personal and medical context behind the respondents'
participation in research as well as their concerns and
priorities with respect to research participation.

D. Logistics:

1. Staff would conduct ten to twenty of the semi-structured
interviews. Outside consultants would conduct the remainder of
the interviews.

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2. Interviews will be tape recorded and subsequently transcribed.

3. Transcripts will be coded and analyzed using available
software (e.g., TALLY or Ethnograph).

E. Strengths:

1. All strengths of Option I remain.

2. Option III, to an even greater extent than Option II, can
provide insight into the reasons why persons choose to
participate in research trials and which factors are associated
with this decision, the degree to which they perceived their
decision to be voluntary, etc..

3. Persons being interviewed individually are not subject to
influence of others' responses, as may occur in focus group
discussions.

IV. Limitations to all options.

A. Limited to cancer patients.

1. Because cancer may be life-threatening, data from this sample
may not be generalizable to other patients whose illnesses are
less severe who are also participating as research subjects.
These findings also are not generalizable to "healthy
volunteers."

2. Because they have a condition that may carry more "labeling"
than other conditions, they may have different motivations for
participating in research than patients with other diagnoses.

B. Limited to radiation oncology (with chemotherapy included as a
comparison).

C. Limited to adults.

D. Limited to select research institutions (i.e., those that
conduct a large amount of research). Subjects at smaller
institutions, including industry sites, may be quite different.

E. Limited to therapeutic research.

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V. Advantages to all options.

A. Findings would enrich the deliberations of the Committee with
direct information about the contemporary experiences of some
research subjects. Although some level of self-selection bias is
unavoidable, these options would provide less biased information
than any other (non-research) approach that has been suggested
for "hearing from current subjects."

B. To date, no national committee or commission charged with
addressing research ethics has obtained systematic information
from persons most affected by governmental policies concerning
research subjects.


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