# Presentation: 178682

## Providing Research Results to Participants

- David Shalowitz
- Department of Clinical Bioethics
- National Institutes of Health

- Pre-conference Program: *Advanced Research Ethics*
- October 28, 2004

## Definition

- _Results_:  Data collected about a given
- participant during the course of research—i.e. *individualized* 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 do not represent the official policies of 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 data

**X**

## 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 data

**X**

**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

- 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*:
- 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**
- Information has not been established to have clinical utility or validity at the time of review

**Notes:**
#4 has (1) sparked most debate and (2) is likely to be where most research data fall.

## 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.

## Case #1 Revisited

- Should investigators inform the siblings of the findings?
- Does it depend on the type of study?

**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.