Providing Research Results to Participants

David ShalowitzDepartment of Clinical Bioethics

National Institutes of Health

Pre-conference Program: Pre-conference Program: Advanced Research EthicsAdvanced Research EthicsOctober 28, 2004October 28, 2004

Definition

ResultsResults: Data collected about a given : Data collected about a given

participant during the course of participant during the course of research—i.e. research—i.e. individualizedindividualized results. results.

Case #1

Investigators discover that two siblings have a gene preliminarily associated with a disease that may cause loss of visual acuity or blindness. If pathology is identified early, vision loss can be prevented.

Should investigators inform the siblings of the findings?

Does it depend on the type of study?

Case #2

Investigators are conducting a large epidemiological study to determine whether various factors (social, economic, genetic) are associated with a greater risk for the development of heart disease.

Should the investigators notify participants of potential risk factors at the conclusion of the study?

What if a participant requests his or her results?

Disclaimer

The views expressed in this presentation The views expressed in this presentation do not represent the official policies of do not represent the official policies of the NIH, DHHS or the USPHS.the NIH, DHHS or the USPHS.

What are researchers’ responsibilities to participants?

Pure Clinical Model

Act to maximize the health of the participant

Pure Research Model

Act solely to collect generalizable data

Why the pure clinical model fails:

Researchers seek to create generalizable knowledge, not to maximize the health of participants

Research interventions are determined by protocol, not by characteristics of individual participants

Example: Randomized Controlled Trials

What are researchers’ responsibilities to participants?

Pure Clinical Model

Act to maximize the health of the participant

Pure Research Model

Act solely to collect generalizable dataX

Why the pure research model fails:

The “pure research” model would imply that investigators are free to collect information from participants without any regard for their needs and interests.

Implication for information of imminent heart attack?

This is implausible.

What are researchers’ responsibilities to participants?

Pure Clinical Model

Act to maximize the health of the participant

Pure Research Model

Act solely to collect generalizable dataX X

What are researchers’ responsibilities to participants?

The “pure clinical” model fails, as does the “pure research” model.

Where do we go from here?

Collaborative partnership Social value Scientific validity Fair subject selection Favorable risk/benefit ratio Independent review Informed consent Respect for participants

8 principles of ethical clinical research

What does “respect” require of investigators?

Investigators should communicate individualized results to participants that are meaningful.

What constitutes meaningful information?

Is the information likely to be clinically relevant? Are there implications for further screening, treatment or

prevention?

…relevant to reproductive decisions? E.g. Gene carrier status

…relevant to life-planning? E.g. Early- or late-onset conditions without possible

intervention

…desired by participants for other cultural or social reasons? E.g. Information about ancestry

Respect and requests

Respect for participants also confers a responsibility on investigators to respond to requests for results.

NIH Human Subjects Research Advisory Committee (1998)

Participants may access research information unless:

1. Information would compromise a promise of confidentiality

2. Information may endanger the life or physical safety of an individual

3. Access would compromise the scientific validity of the study (e.g. blinding) OR

4. Information has not been established to have clinical utility or validity at the time of review

Participant access to information of uncertain significance Potential Concerns:

Risk of misinformation Misinterpretation of information Cost of disclosure

These concerns can and should be addressed, but they do not appear to be overriding reasons to withhold results.

Exceptions to disclosure

Information would compromise a promise of confidentiality

Information may endanger the life or physical safety of an individual

Access would compromise the scientific validity of the study (e.g. blinding) OR

Expected costs of access would make the study prohibitively expensive to conduct.

If requested, study results should be disclosed to participants unless:

*

Method of Disclosure

Meaningful information should be disclosed in a manner that has meaning for participants. “Plain Language” requirements, etc. Disclosure to third-parties when necessary. Results should be offered.

Similarly, when results are requested by participants, investigators should try to address the participants’ underlying concerns.

Investigators discover that two siblings have a gene preliminarily associated with a disease that may cause loss of visual acuity or blindness. If pathology is identified early, vision loss can be prevented.

Should investigators inform the siblings of the findings?

Does it depend on the type of study?

Case #1 Revisited

Yes—this result appears to be clinically meaningful

Probably not—the information itself is enough to warrant disclosure

Case #2 Revisited

Investigators are conducting a large epidemiological study to determine whether various factors (social, economic, genetic) are associated with a greater risk for the development of heart disease.

Should the investigators notify participants of potential risk factors at the conclusion of the study?

What if a participant requests his or her results?

Investigators should disclose the results, but should ensure that the request is not based on a misunderstanding

Probably not—these data are unlikely to be meaningful

Application

What text should be included in protocols and consent forms?

Possible boilerplate text for informed consent

The researchers will offer you the results of tests that they judge to be meaningful to you, including results that may be useful for your health care.

If there is some information that you do NOT want to know about yourself, please tell us, or call Dr. _______ at ______.

Also, if you would like the results of a specific test conducted during this study, please tell us, or call Dr. _______ at _______.

(Grade level 9.3)

Conclusions

Investigators have a responsibility to offer meaningful results to participants. I.e., information relevant to health, reproduction, life plans,

culture or information specifically requested by participant

Information should be communicated in a manner that is responsive to participants’ needs and interests Information is made understandable or disclosed to a third

party Information is offered, not automatically disclosed

Investigators should develop plans for dealing with results during study design, with the help of the IRB.