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Attachment B: Return of Individual Research Results

Attachment B – Recommendation on Return of Individual Research Results

Sharing Study Data and Results: Return of Individual Results

Introduction

There is currently significant attention to the distribution of final study data and results, both to the subjects who participated in the research and to the public at large.  SACHRP has determined that there are four aspects of returning research results to subjects and releasing the results publicly, with overlap of the concepts along a spectrum: 

  • Return of incidental findings to subjects
  • Return of individual study results to subjects
  • Return of general study results to subjects
  • Public release of study data

SACHRP partially addressed the issue of public release of data in December of 2013 by providing commentary in response to the June 4, 2013, Food and Drug Administration (FDA) Request for Comment relating to the availability of masked and de-identified non-summary safety and efficacy data.  While this commentary was focused on the issues presented in the FDA request for comment, it also addressed some of the broader issues associated with the public release of study data.  SACHRP also released a recommendation on the return of general study results to research subjects on March 25, 2015.  SACHRP next released a recommendation on recent changes to HIPAA and CLIA regulations that potentially affect the return of individual research laboratory results on September 28, 2015.  In contrast, this recommendation addresses the return of individual results to research subjects.  SACHRP plans to address the remaining topic of return of incidental findings to subjects in a separate recommendation.  While there is overlap among the concepts, as shown above in the linear Venn diagram, SACHRP believes that each topic is best addressed individually for clarity.


In this recommendation, the return of individual results is considered to be a separate activity from the return of general results.  The return of individual results involves the return of information specific to the research subject.  The return of general results, in contrast, involves the return of information regarding the outcome of the research, without specific information regarding individual subjects.  As an example of this separation, Pfizer is currently running separate pilot programs for returning general and individual results.  Information regarding the Pfizer program for the return of general results can be found at the Center for Information & Study on Clinical Research Participation (CISCRP) website.[1]  Information regarding the Pfizer program for the return of individual results, known as the “Blue Button Initiative,” and can be accessed online as well.[2]  Theoretically, both activities could be combined in a single program, and in that case the recommendations of both of the SACHRP documents would be applicable.  However, the focus of this recommendation is solely on the return of individual results.

In what follows, SACHRP recommends a rebuttable presumption in favor of returning individual results.  SACHRP intends that this recommendation apply not only to clinical research, but also to other types of research such as genomics research and Social Behavioral research.  The relevant factors to consider in potentially rebutting this presumption are discussed below.  These factors are more likely to apply in other fields of research than in clinical research; the presumption to return individual results is strongest in clinical research when dealing with clinically relevant results.

Definition of Individual Results

When discussing the return of individual results to research subjects, it is important to define the term “individual results.” As used in this recommendation, the term encompasses information that is linked to the identity of a research subject, and pertains to that subject and the focus of the study.   Examples could include a reduction in hepatitis viral load, the individual’s ability to withstand a given gravitational force and still perform a physical task, psychological findings such as results of subliminal testing, an IQ test score, or disclosure of the study arm to which the subject was randomized.  Individual results can be obtained in clinical, social behavioral, and other types of research.  They are not limited to clinical research.

There are three categories of individual results, based chronologically on when the information is created.  The first category is “baseline findings.”  These are results that are collected at the beginning of a subject’s participation to determine if the subject meets the inclusion and exclusion criteria for the research.  Normally baseline findings can be shared with the subject at the time they are obtained, prior to participation, and the presumption is towards disclosure unless the return of the baseline findings could affect the validity of the research, for example by causing potential unblinding. For many types of research, including some biomedical research, there are no baseline findings.

The second category is “in-study findings.”  These are results that are generated during the progress of the research.  If in-study findings will be returned to research participants, then analysis of the timing must be made on a case-by-case basis.  While there is a presumption towards disclosure, there must be careful attention to avoid affecting the validity of the research through return of the in-study findings.  Usually the concern will be potential unblinding.  The decision will vary depending on the protocol at hand and the particular point of data under consideration.

The third category is “end-of-study findings.”  These are the results that are collected or collated or interpreted after the study has ended and analysis of all participant data is complete; end-of-study does not refer to the end of a particular participant’s involvement.  There are unlikely to be any reasons to withhold end-of-study findings, and the presumption is towards disclosure. 

We wish to reiterate here that it is not the intent to discuss incidental findings in this recommendation, as that is the focus of a future SACHRP recommendation.  However, it is worth noting that in certain cases the findings that are discussed in this document could also qualify as incidental findings.

Definition of “Return”

It is also important to define what is meant by “return” of results.  There are several relevant issues.  First, there are many ways that results can be returned, such as discussion between the subject and their healthcare provider or investigator, postal mail, emailing, viewing on-line, downloading, or transferring.

Second, it is often appropriate to consider the action as offering to return results rather than returning the results.  Usually subjects should be provided with an ability to opt in to receiving the results, or to opt out of receiving the results, rather than automatically receiving them.

SACRHP considers “return of individual results” to subjects to include return of results to the subjects directly, or to the Legally Authorized Representative (LAR) of incapacitated adult subjects, or to the parents or guardians of pediatric subjects.  In such cases, the results might also be provided to the subject’s health care provider, but return of results solely to the provider is not a return of individual results to the subject. 

Finally, for certain types of research, such as genome sequencing, it may be appropriate to return “individual” results to family members of the proband as well as the proband.  However, this is a complicated ethical and legal area, and careful consideration should be given to such proposals.  These considerations will be heavily fact dependent.

Timing of “Return of Individual Results”

Another factor is the timing of the return of individual results to the subjects, in regards to when they are returned rather than when they are collected.  Above we classified individual results as being baseline, in-study, or end-of-study findings, depending on when they were collected.  In any of these categories, the findings might be returned to the subject immediately, or might be returned after a certain amount of time or a given milepost (such as the end of the study) has been reached.  Some results can be made available to subjects when or shortly after they are collected, during the course of the research.  For instance, if subjects have regular blood pressure and vital sign measurement, or lab tests, that information could be provided during the study.  However, consideration must be made of whether the return of the information could lead to unblinding of the study, or provide subjects with incentives to inappropriately drop out of the study early or stay in the study when they should not do so.  For instance, subjects in a placebo-controlled study of a drug with a known side effect of leukopenia might drop out of a study after seeing their white blood count, because they may speculate that they are on placebo.  As noted above, baseline findings and end-of-study findings can usually be returned promptly without concerns about causing bias, but there must be a case-by-case assessment.  The return of in-study findings will need more careful analysis to determine whether their return will affect the validity of the trial through introduction of bias.  It may be appropriate to withhold certain results until the subject’s participation is concluded, and perhaps after the results are analyzed.  This will be particularly true in blinded and masked studies, where some findings may not be available for months after the subjects’ participation ends.  On the other hand, research studies are sometimes very short in duration, and individual results can be returned soon after the research ends, even the same day in certain cases.

Ethical Foundation

SACHRP believes the provision of individual research results to research subjects is supported by the principles of Respect for Persons and Beneficence.  Subjects make an autonomous decision to participate in research, and in so doing help to create scientific knowledge that is valuable to society and to other individuals.  One means to provide recognition and appreciation for this contribution is to provide subjects with their individual information that results from the research.  This can help to build a sense of participation and partnership in the development, and makes their experience more fulfilling.  For these reasons, this policy has the potential to lead to greater public trust in research and greater willingness by individuals to participate in research, which will increase the development of new knowledge and interventions for the public good.  In addition, the information may (if sufficiently reliable and valid) prove valuable for the subjects or their families in making future decisions regarding their health or welfare, such as future choices about the use of certain classes of drugs or family planning decisions.   SACHRP would like to stress that the individual results do not have to be of clinical value to the subjects in order for return to be considered.  Even if the results are not clinically relevant, the pure intellectual curiosity of the subjects is sufficient reason to return the results absent other reasons not to return them.

However, SACHRP would like to stress that the return of individual results to subjects is a rebuttable presumption for several reasons.  Research can be conducted respectfully without returning individual results. In particular, when research subjects know that individual results will not be returned, and they nonetheless choose to participate in a study, then their autonomy has been respected. People may decide to participate absent the return of individual results because they have adopted the goals of the research as their own and because contributing to the advancement of science is meaningful for them.  There are many additional reasons for rebutting the presumption of returning individual results to subjects:

  • The potential to cause bias in the study (although this factor may call for changes to the timing of the return rather than not returning the results at all);
  • The meaning and significance of the research results  are not known;
  • The low import or insignificance of the results;
  • The lack of validity or actionability of results.
  • The administrative and financial burden to the investigator, institution and other parties involved in the research;

In some studies, it may be impossible to provide results because the subjects are de-identified or anonymous, for example certain tissue banking activities, research conducted under a waiver of consent, exempt studies, and cluster randomized studies. 

Finally, the ethical principle of Beneficence also provides a directive to avoid harm to subjects, and to the extent that the return of individual results to subjects could lead to harm or discomfort, whether physical, psychological, financial, reputational or social, there must be consideration of whether it is appropriate to return individual results to subjects.  Subjects may misuse or misunderstand the individual results provided to them, and take inappropriate medical or personal action. For example, a subject with a medical contraindication such as a bleeding disorder might decide to take aspirin for the prevention of heart disease without physician involvement.  Investigators and sponsors should be aware of the potential for subject misunderstanding of the clinical importance of results, and make clear to subjects the limits of applicability of these individual results to the subject’s health or wellbeing.  In many cases it will be warranted to require that the individual results have a disclaimer that these are “research results” rather than “clinical results,” and should not be used to take individual action without proper guidance from healthcare providers.  In some cases, it may be appropriate to return results only with the involvement of providers in the return and discussion of the results.  Another risk is that the promise to return individual results to subjects will increase therapeutic misconception by potential research subjects.  Therapeutic misconception occurs when potential subjects fail to appropriately distinguish between clinical research and clinical care, and fail to understand that the primary purpose of research is to produce generalizable knowledge rather than to directly benefit the individual subjects.  Finally, if researchers retain contact information, or maintain records in an identifiable form so that they can return individual research results, this increases the risks to subjects of data breaches and unauthorized disclosures.

SACHRP believes that there should be due consideration of whether to return individual research results during the design, conduct, and oversight of research, with a general but rebuttable presumption towards disclosure.  As an ethical matter, returning research results to subjects is permissible, but not mandatory, and the ethical principles must be appropriately weighted depending on the facts of each individual research protocol. 

Validity and Actionability of the Results with Clinical Utility

When considering whether or not to return individual results that have potential implications for a subject’s physical or mental health, the more likely the results are to be validated and clinically actionable, the more justification there is for providing the results.  At the other end of the spectrum, those results that are not validated and not actionable carry the least justification for provision to subjects for reasons of direct clinical benefit.  One way to graph this approach is as follows:

 

Validated

Not Validated

Clinically Actionable

Box 1 – likely indicated

Box 2 - possibly indicated

Not Clinically Actionable

Box 3 - possibly indicated

Box 4 - likely not indicated

Box 1 – Individual results that are validated and actionable.  These would include many clinical tests done in the context of research like pregnancy tests, liver function tests, EKGs, MRIs, and chest X-rays.  There is a strong presumption of disclosure for these results.  From a regulatory perspective, particularly in the medical field, “validated” will usually mean that the test or diagnosis is conducted using devices or assays that have regulatory approval from the Food and Drug Administration (FDA) or certification under CLIA from the Centers for Medicare and Medicaid Services (CMS). 

Box 2 - Results that are not validated but could be clinically actionable.  An example is a genetic variant that is weakly associated with a heart condition, but the results have not been validated through a second study.  The decision to return results in this category will be fact dependent.  There is the possibility that the results in question become validated at a later date, either soon or long after the original study has concluded.  Consideration should be given to providing results at that later date.

Box 3 - Results that are validated but not clinically actionable.  An example here is a genetic diagnosis of Huntington’s Disease.  This is a category where the concept of personal utility has gained traction.  “Clinical utility” is usually from the physician’s perspective, but people might want and use information for their own purposes outside the clinical domain.  SACHRP encourages disclosure in these situations, even though it may be contrary to current practice but consistent with the emerging set of responsibilities.  Again, the decision to return results in this category will be fact dependent.  There is the possibility that the results in question become clinically actionable at a later date, either soon or long after the original study has concluded.  Consideration should be given to providing results at that later date.

Box 4 - Results that are neither validated nor clinically actionable.  These can include experimental results in basic science studies, such as negative results when the subject might be found to have one biomarker or genetic variant or another that is not found to be associated with the disease of interest.  There is not a strong presumption to make disclosure the default position for these types of purely experimental results and this is where the rebuttable presumption factors will have the most weight when considering them against the reasons for return.  

Regulatory Status

HHS and FDA Human Subject Protection Regulations

The HHS and FDA regulations (45 CFR 46 and 21 CFR 50 and 56, respectively) are silent regarding the return of individual results to research subjects, and neither directly require nor disallow this activity.  However, FDA in ICH E6 Good Clinical Practice has stated that “The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.”[3]  Similarly, FDA in the guidance document “Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects,”[4] says that;

The investigator should also inform a subject when medical care is needed for conditions or illnesses unrelated to the study intervention or the disease or condition under study when such condition or illness is readily apparent or identified through the screening procedures and eligibility criteria for the study. For example, if the investigator determines that the subject has had an exacerbation of an existing condition unrelated to the investigational product or the disease or condition under study, the investigator should inform the subject. The subject should also be advised to seek appropriate care from the physician who was treating the illness prior to the study, if there is one, or assist the subject in obtaining needed medical care.

While these guidance documents do not recommend the return of individual research results for all clinical investigations, they do recommend that such information be provided to subjects when it will be useful for their clinical care. Note that these guidance documents apply to clinical investigations as defined by the FDA, a distinct type of research.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA)

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) (45 CFR 164) requires, among other things, that patients have access to their Protected Health Information (PHI) upon request.  There are certain exceptions, including some for research.  Subjects in research studies can obtain individual results from the research if they are part of the subjects’ “designated record set,” but those results may be withheld while the research is being conducted in order to protect the blinding and other research activities done to reduce bias in the conduct of the research, as long as subjects have been informed of the access restrictions in place during the trial. In responding to a request for access, a covered entity is not required to create new information, such as explanatory materials or analyses, that does not already exist in the designated record set.  However, individuals have a right under HIPAA to access PHI about themselves in human readable form.  Regardless of whether there are plans to return results, there may be an independent legal right under HIPAA for research participants upon request to have access to results in their designated record set. There are laws to consider in determining whether research information can or must be provided to subjects.

More information on this issue is available at http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA)

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 CFR 493) is intended to ensure that laboratory results used in patient care are accurate.  CLIA contains an exception for research laboratories to return of certain research results at 42 CFR 493.3(b)(2), by “Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients.”  However, if individually identifiable research results are reported from the laboratory to another entity and the results are available to be used for clinical care for individual patients, then this exception does not apply.

SACHRP has separately issued a recommendation regarding HIPAA and CLIA and the return of individual results from research laboratories, and the inconsistency in the content and application of those regulations.  See the SACHRP recommendation issued on September 28, 2015.

Administrative Considerations

Inclusion of Plans for Return of Results in the Protocol

When the return of individual results is planned while the research is being developed, this should be described in the protocol or otherwise prospectively described to government agencies, IRBs, institutions, or investigators.  Prospective disclosure will assist in preparation for the activities, such as maintenance by investigators of subject contact information.

The protocol should provide the basic information regarding the program for the release of the data, including what information will be released, who will do so, and when the disclosure is expected to take place.  However, investigators and institutions should be instructed, whether in the protocol or separately, if there are actions they need to take such as keeping subject contact information readily available after the study is closed.  The IRB should also understand if, how, and for how long such information is to be retained, and confidentiality assured during that retention period.

In addition, or alternatively, institutions and IRBs may wish to request plans from investigators or sponsors for return of individual results to subjects as part of the IRB submission.  However, it is important to stress that return of individual results is not required by regulation, and the costs and burden of the release need to be balanced with the benefit that will likely result.

Inclusion of Plans for Return of Results in the Consent Form and Consent Process

The intent to provide individual research results should be included in the consent form so that subjects are informed of the plan as they consider participation in the research.  The consent form should provide the basic information regarding the program for the return of the research results, including a basic description of the information that will be returned, who will provide the information, and when the disclosure is expected to take place.   A brief description will be sufficient.  SACHRP is currently working on recommendations regarding the informed consent process, and wants to ensure that this is not interpreted as an issue requiring lengthy disclosure. 

If there are no plans to return results, or a stated objective to not return results, then subjects should be apprised of this.

In research studies involving incapacitated adults, Legally Authorized Representatives (LARs) provide consent for the subjects, and in studies involving children, parents or guardians provide consent for the child.  The fact that these populations are included in research should not be a prima facie factor in a decision not to provide individual research results. The return of results will provide the same benefits for these populations and their LARs and parents or guardians. 

IRB Review

One issue that arises in consideration of return of individual research results is the role of the IRB.  The return of individual results may be a planned activity at the time of initial IRB review, or the decision to share such results may be made after initial IRB approval but while the study is still open with the IRB, or the decision to share results may be made after the research is closed with the IRB. 

  1. Consideration of Return of Individual Results Proposed at Time of Initial IRB Review
    If there is a plan in place for the return of individual research results to subjects at the time the research is provided to the IRB for initial review, the plan should be disclosed in the protocol or other study documents, and described in the consent form.  The reviewing IRB must consider whether the plan to provide individual results to subjects will affect the applicable criteria for IRB approval at 21 CFR 56.111 and 45 CFR 46.111, similar to any other component of research.  
  1. Consideration of Return of Individual Results Proposed After Initial IRB Review, But While Study is Still Open
    If return of individual results is proposed after initial IRB review has occurred, the IRB should review it as a change in research.  The IRB should consider whether the change in research changes the acceptability of the criteria for IRB approval of research.  The change can be expedited if it is considered not to increase risk or change the risk-benefit relationship.  Re-consent is necessary if the new information might affect the willingness of subjects to continue participation.  This is most likely to occur in studies with long term follow up, or important interim data.
  2. Consideration of Return of Individual Results Proposed after IRB Review Has Ended and Study is Closed with the IRB
    There are two arguments for the position that the activity of returning individual research results do not need IRB review if the decision to return results is made after the study has been closed with the IRB.  The first is that the activity is no longer research and there are no human subjects in the activity.  The HHS definition of human subject is an individual about whom an investigator intervenes or interacts to collect data, or about whom an investigator obtains private identifiable information.  A research result communication after a study has ended involves none of these conditions.  Similarly, the definition of a human subject under the FDA regulations is an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  In this case, the study has ended and has been closed with the IRB, so there is no longer open research and the individuals are no longer subjects in the research.  Rather, they are former subjects.
    The second argument for the IRB not reviewing the return of research results after the study is closed is that they are unlikely to affect the criteria for IRB approval.  They don’t affect subject recruitment, in that they are not coercive or unduly influential as to the subject’s decision to join or stay in the study.  They don’t affect equitable selection of subjects, as both the designed and the actual selection of subjects is a finished issue by this point.  The communications don’t affect subject safety monitoring, as the subject has already been exposed to the physical risks.  They won’t adversely affect vulnerable subjects.  Finally, they enhance the consent process to the extent they extend the consent process with more information after the study has ended. The issues are reduced to consideration of whether the return of results represent a risk to the former subjects, as discussed below.
    There are several arguments for requiring IRB review even after the study is closed.  The first is the possibility of information risks to subjects in the form of a breach of confidentiality, such as revealing that the subject was a participant in the research.  A second risk is that subjects will misinterpret or misunderstand the information they receive, and take an inappropriate action.  It is also worth questioning whether an IRB’s duties to subjects completely end once the study is closed with the IRB.  For instance, if there were a breach of confidentiality or new risk information important to the subjects, it is likely that the IRB would feel that it had the authority and the duty to take appropriate actions to protect and inform subjects.  Additional considerations include the desire for consistency in IRB review of results return plans, and the need to avoid “gaming” the system by waiting till after a study is complete to determine results return plans in order to avoid IRB oversight/interference.
    In SACHRP’s opinion, these arguments are not sufficient to make IRB review of return of results a requirement in all cases if the decision to return results is made after the study is closed with the IRB.  However, institutions and sponsors can require IRB review based on internal policies if desired.  Furthermore, IRBs can serve as a resource when there are questions about returning results, and in this circumstance can provide consultation or an opinion without having to reopen the study.
  3. An Alternative Approach:  IRB Review of  Standard Processes for Return of Individual Results rather than Protocol-by-Protocol Review
    One approach currently used for the regulatory oversight of tissue banks that gather, store and distribute human tissue for research activities is to have IRBs review the processes for gathering, storing, and protecting the privacy confidentiality, as opposed to looking at the collection and storage as part of each individual research protocol utilizing the tissue.  If an institution, IRB or sponsor does wish to have oversight of the return of individual results, then a similar system of oversight could be applied to return of results activities, particularly those that occur after a research project is “closed” with the IRB.  Under such a system, industry and government sponsors could establish standard procedures for data sharing, and obtain IRB approval and continued oversight of those standard procedures, and then any data sharing and the subsequent analyses done in compliance with the policies would not need individual IRB review.  If there were reason to vary from the standard procedures, this could be presented to the IRB as a formal amendment or one-time deviation for prior review and approval.

SACHRP General Policy Recommendation

SACHRP believes that the return of individual research results in many cases is a beneficial activity that has the possibility to enhance public trust in research, enhance willingness for subjects to participate, and thus increase the development of new knowledge.  It also has the potential to provide information to subjects that is medically or otherwise important to them.  The benefit of returning individual results will not be equal across all studies, and in some studies will not be possible or appropriate.  

SACHRP recommends a rebuttable presumption in favor of returning individual results.  SACHRP intends that this recommendation apply not only to clinical research, but also to other types of research such as genomics research and Social Behavioral research.  The relevant factors to consider in potentially rebutting this presumption are discussed above. 

SACHRP Specific Recommendations to Federal Agencies on Best Practices to Promote the Return of Individual Results to Subjects

As noted previously, the HHS and FDA human subject protection regulations are silent regarding the return of individual results to research subjects, and neither require nor disallow this activity.

  1. SACHRP believes that the agencies should take steps to promote the return of individual results to subjects, due to the overall benefit of the activity.  To this end, the agencies should issue guidance or other forms of communication that describe how regulated parties can return individual research results without violating any regulations or guidance. 
  2. IRB Approval Time Line Considerations: Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA)

    The return of individual results may be a planned activity at the time of initial IRB review, or the decision to share results may be made after initial IRB approval but while the study is still open with the IRB, or the decision to share results may be made after the research is closed with the IRB.  SACHRP believes it is preferable to plan for the return of individual results during the development of the protocol and to provide the plan for IRB initial review.  In addition, if there is no intent to share research results, this should be addressed in the protocol as well.

Consideration of Return of Individual Results Proposed at Time of Initial IRB Review

If there is a plan in place for the return of individual research results to subjects at the time the research is provided to the IRB for initial review, the sponsor should describe the plan in the protocol or other study documents, and describe the plan in the consent form.  The reviewing IRB must consider whether the plan to provide individual results to subjects will affect the applicable criteria for IRB approval at 21 CFR 56.111 and 45 CFR 46.111, similar to any other component of research. 

Consideration of Return of Individual Results Proposed After Initial IRB Review, But While Study is Still Open

If return of individual results is proposed after initial IRB review has occurred, the IRB should review it as a change in research.  The IRB should consider whether the change in research changes the acceptability of the criteria for IRB approval of research.  The change can be expedited if it is considered not to increase risk or change the risk-benefit relationship.  Re-consent is necessary if the new information might affect the willingness of subjects to continue participation.  This is most likely to occur in studies with long term follow up, or important interim data.

Consideration of Return of Individual Results Proposed after IRB Review Has Ended and Study is Closed with the IRB

SACHRP believes that in general IRBs do not have to open the study or otherwise review either the plan for the return of individual results to subjects, nor the return of results documents that will be provided to the subjects, if the activity is designed and implemented after the study has been closed by the IRB.  If, on the other hand, an investigator proposes to return individual results to subjects following the study conclusion, but does not formalize the format or content of those documents until after the study is complete, IRBs may—as a matter of institutional policy—choose to reopen the study to review the proposed documents prior to their being shared with subjects.

Conclusion

There is incredible variety in the design and scope of research conducted with human subjects, encompassing medical, social behavioral, and other fields.  SACHRP believes it is often appropriate as an ethical issue to return individual results to research subjects, with a stronger presumption as the validity and actionabililty increase.

 


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Content created by Office for Human Research Protections (OHRP)
Content last reviewed on July 21, 2016