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❶In the exercise of ongoing enforcement discretion, however, with respect to the requirements of 21 CFR

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Clinical Research and the HIPAA Privacy Rule

In such cases, an Authorization that complies with section In some instances, express legal permissions, informed consents, or IRB-approved waivers of informed consents are not study specific. These permissions for research and waivers, if obtained before the compliance date, are grandfathered by the transition provisions even if provided for future unspecified research, subject to the conditions described above.

There are two main differences. These may include, but are not limited to, the risks associated with investigational products and the risks of experimental procedures or procedures performed for research purposes, and the confidentiality risks associated with the research.

The Privacy Rule is concerned with the risk to the subject's privacy associated with the use and disclosure of the subject's PHI. The FDA regulations apply only to research over which the FDA has jurisdiction, primarily research involving investigational products. By contrast, the Privacy Rule applies to a covered entity's use or disclosure of PHI, including for any research purposes, regardless of funding or whether the research is regulated by the FDA.

Under certain circumstances, the "preparatory to research" provision at section What kinds of activities are considered "preparatory to research"? Covered entities that obtain certain required representations from a researcher may use and disclose PHI for activities "preparatory to research" that include, but are not limited to, the following:. Under this provision, no PHI may be removed from the covered entity during the course of the review.

When do the requirements under HHS regulations at 45 CFR part 46 related to IRB review and informed consent apply to "preparatory to research" activities as permitted by the Privacy Rule at section Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public for example, a medical record.

Private information must be individually identifiable i. When a "preparatory to research" activity i involves human subjects research, as defined above; ii is conducted or supported by HHS or conducted under an applicable OHRP-approved assurance; and iii does not meet the criteria for exemption under HHS regulations at 45 CFR In addition, informed consent of the subjects must be sought and documented in accordance with, and to the extent required by, HHS regulations at 45 CFR The Privacy Rule permits, under section Such access is permitted provided that the covered entity receives certain required representations from the researcher and the researcher does not remove any PHI from the covered entity during the course of the review.

Activities in which an investigator obtains and records individually identifiable health information for purposes of identifying potential human subjects to aid in study recruitment, among other things, would involve human subjects research under the HHS regulations at 45 CFR part 46 and would not satisfy the criteria for any exemption under HHS regulations at 45 CFR In addition, informed consent of the subjects, about whom identifiable private information e.

For example, if an investigator who is covered by an applicable OHRP-approved assurance obtains and records identifiable private information from medical records for the purpose of contacting these individuals to determine if they would be interested in participating in a research study, this activity constitutes human subjects research and thus would require either 1 that subjects' informed consent be sought as required by the HHS regulations at 45 CFR Informed consent also must be documented in accordance with, and to the extent required by, the HHS regulations at 45 CFR Similarly, if such an investigator obtains and records identifiable private information to develop a database of potential research subjects for future research studies, this activity is also human subjects research as defined in 45 CFR part 46 and thus must meet the requirements of the HHS regulations as discussed above.

In situations where both 45 CFR part 46 and the Privacy Rule apply, institutions must adhere to both sets of regulations. If, under the "preparatory to research" provisions, a researcher identifies subjects that meet the study's eligibility criteria, how can the researcher contact the potential participant to obtain Authorization after identifying these individuals?

Under the "preparatory to research" provision, covered entities may use and disclose to researchers PHI to aid in study recruitment. In order to contact potential study participants, a researcher may do so, without Authorization from the individual, under the following circumstances:.

Is a covered entity required to account for disclosures made pursuant to an IRB or Privacy Board's alteration of the Authorization requirement? Covered entities are required to account for disclosures made pursuant to an altered Authorization.

Where an Authorization has been altered, pursuant to the process provided for by section However, where a covered entity discloses the records of 50 or more individuals for a particular research purpose during the period covered by the accounting, the Privacy Rule permits the covered entity to provide a more general accounting to the requestor.

The period covered by the accounting is no more than 6 years prior to the date on which the accounting is requested or less than 6 years if requested by the individual but does not include disclosures made prior to the compliance date-usually April 14, Therefore, if the Authorization language is part of the informed consent document, such as when the Authorization form is combined with an informed consent form, the IRB is required to review such language.

In the exercise of ongoing enforcement discretion, however, with respect to the requirements of 21 CFR The Privacy Rule does not require IRBs to review or approve Authorizations used for research or other disclosures; it only requires that the Authorization comply with the requirements of the Rule at section See 21 CFR Pursuant to this provision, IRBs that have written procedures requiring them to review all written materials provided to potential research subjects would have to review and approve stand-alone Authorizations, even though such review is not otherwise required under the Privacy Rule, HHS Protection of Human Subjects Regulations, or FDA regulations governing IRBs.

However, in the exercise of ongoing enforcement discretion with respect to the requirements of 21 CFR For OCR guidance on this topic, see http: See ICH E6 4. This language recommends, but does not require, such review. As such, they are not subject to enforcement by U. May a covered health care provider discuss with a patient his or her enrollment in clinical research without the patient's Authorization?

What if the individual is not a patient of the covered provider? These types of conversations may arise under a variety of circumstances. For example, a physician may for treatment purposes discuss treatment alternatives with the individual, which may include the option of enrolling in a clinical trial.

In addition, a physician may speak to the individual about a clinical trial as part of asking the individual to sign an Authorization to permit the covered provider to use or disclose the individual's PHI for the research study.

Also, the Privacy Rule generally permits a covered entity to communicate with individuals and to disclose their PHI to them. Therefore, covered health care providers and patients may continue to discuss the option of enrolling in a clinical trial without patient Authorization, regardless of whether the individual is a patient of the covered provider, and without an IRB or Privacy Board waiver of the Authorization.

However, the covered health care provider must obtain the individual's Authorization or an IRB or Privacy Board waiver of Authorization, or meet certain other conditions, before using or disclosing the individual's PHI as part of the research study. Similarly, if a physician knows of a study in which his or her patient might enroll that is being conducted by others, the physician may discuss such a trial with the patient and give the patient the researcher's contact information so the patient may contact the researcher directly.

However, the physician may only contact the researchers about the patient so long as de-identified information is disclosed, the individual's Authorization or IRB or Privacy Board waiver of Authorization is obtained, or other conditions that satisfy the Privacy Rule are met.

For example, it is acceptable to give a clinical summary of a patient to a researcher to determine if the patient might meet enrollment criteria, if such discussions omit the patient's name, address, medical record number, and any other identifying information set forth in section May a covered entity obtain an individual's Authorization to include his or her PHI in a clinical research recruitment database of possible research participants, such as a pre-screening log?

The Privacy Rule permits a covered entity to include an individual's PHI in a clinical research recruitment database and permit researchers access to the recruitment database, provided the individual has given permission through a written Authorization. The Authorization must inform the individual of the purpose for which e. Alternatively, a covered entity may provide a researcher access to the PHI for reviews preparatory to research, provided the required representations are obtained.

Unless otherwise permitted by the Privacy Rule, a subsequent Authorization must be obtained from the individual before a covered entity may use or disclose the individual's PHI for the clinical trial itself.

One common method for recruiting research participants involves organizing a call center for potential research participants to contact in response to advertisements about the research. Would a call center be required to obtain the individual's Authorization before speaking to the individual about the trial?

Call centers in many cases will not be part of a covered entity health plan, health care clearinghouse, certain health care providers , and thus, are not required to comply with the Privacy Rule.

A call center for research is an entity established to receive and answer calls from interested individuals about a research project. Commonly, a call center will collect identifiable information about a caller who may be interested in the research study and then transmit such information to researchers involved in the study or send information about a study directly to callers.

If a call center is part of a covered entity, e. However, any use or disclosure of the individual's PHI for the research study itself or other purposes is subject to the conditions set forth in the Privacy Rule.

Is a covered health care provider that conducts clinical research required to provide the Notice of Privacy Practices to participants of that trial? The Privacy Rule requires covered health care providers that have a direct treatment relationship with the individuals to provide to individuals the Notice of Privacy Practices in accordance with section A direct treatment relationship means a treatment relationship between an individual and a health care provider that is not an indirect treatment relationship.

An indirect treatment relationship between an individual and a health care provider is one in which:. Where a covered health care provider does not have a direct treatment relationship with the individual, the Privacy Rule does not require that provider to give to the individual the Notice of Privacy Practices. However, the covered provider is still responsible for making its Notice of Privacy Practices available to any person that requests it, and prominently posting and making available its Notice of Privacy Practices on any Web site it maintains that provides information about its customer services or benefits.

Under the Privacy Rule, a patient's Authorization is for the use and disclosure of PHI, which can include use or disclosure for research purposes. In contrast, an individual's informed consent, as required by the HHS or FDA Protection of Human Subjects Regulations, is a consent to participate in the research study as a whole, not simply a consent for the research use or disclosure of PHI.

Thus, both sets of requirements can be met by use of a single, combined form, which is permitted by the Privacy Rule. For example, the Privacy Rule allows the Authorization for research to state that the Authorization will be valid until the conclusion of the research study, or to state that the Authorization will not have an expiration date or event. This is compatible with HHS' Protection of Human Subjects Regulations requirement for an explanation of the expected duration of the research subject's participation in the study.

If an Authorization to use or disclose PHI for research is combined with an informed consent form, does a covered entity need to obtain a signature authorizing the use or disclosure of PHI separately from a signature that may be required for informed consent under 45 CFR part 46 or 21 CFR parts 50 and 56? Where an individual's signature is sought for a single form that combines Authorization with informed consent [also known as a compound Authorization at Yes, when Authorizations for use or disclosure of PHI will be incorporated into previously approved informed consent documents for a series of protocols, and the Authorizations are composed entirely of identical template language, the IRB may approve the insertion of the Authorization language as a single modification that applies to the entire series of protocols.

However, when Authorizations for use or disclosure of PHI will be incorporated into previously approved informed consent documents for a series of protocols and the Authorization statements include protocol-specific information unique to each of the protocols, the IRB should review and approve the insertion of the Authorization language separately for each protocol.

Do the core elements of an Authorization differ from a medical records release form? A Privacy Rule Authorization may be a more detailed document than what physicians and hospitals are accustomed to using as a release of medical records.

Medical records release forms usually are phrased very generally, but Authorizations are much more specific with regard to what information is being released, to whom, for what purpose, and for how long. An Authorization must also inform patients of certain rights they have in relation to their PHI. An Authorization may contain more information than required by the Privacy Rule, as long as the additional information is not inconsistent with the information required for the Authorization.

An Authorization for research uses and disclosures need not have a fixed expiration date or state a specific expiration event; the form can list "none" or "the end of the research project. Must a separate Authorization be obtained for each research use or disclosure of PHI?

As long as each use or disclosure is part of a specific research activity and the Authorization describes the types of uses or disclosures that will occur as part of that research activity, only one Authorization is required from each subject.

That Authorization will generally be obtained at the time of enrollment in the trial itself, as part of the informed consent process. It is important, therefore, that researchers, research nurses, or others involved in informed consent discussions with subjects also understand the Authorization and its meaning so that subjects' questions and concerns can be answered accurately. The Privacy Rule does not specify who may draft the Authorization, so a researcher could draft it.

However, in order to comply with the Privacy Rule, an Authorization must be written in plain language and contain the core elements and required statements specified at section A covered entity may disclose PHI as specified in a valid Authorization that has been created by another covered entity or a third party, such as a researcher.

When a covered entity chooses to combine the Authorization with the informed consent document for a research study, can the compound document cross-reference required elements for both permissions i. The Privacy Rule permits the compound Authorization to cross-reference relevant sections of an informed consent document, provided the compound document includes the core elements and statements required by section How may a covered entity use or disclose PHI for the creation of a research repository or database when it is unknown at the time of collection what specific protocols will make use of the repository or database in the future?

There are two separate activities to consider: A covered entity's use or disclosure of PHI to create a research database or repository, and use or disclosure of PHI from the database or repository for a future research purpose, are each considered a separate research activity under the Privacy Rule.

Documentation of a waiver or an alteration of Authorization to use or disclose PHI to create a research database requires, among other things, a statement that an IRB or Privacy Board has determined that the researcher has provided adequate written assurances that PHI in the database will not be further used or disclosed except as permitted by the Privacy Rule e.

A covered entity also could use or disclose a limited data set to create a research repository or database under conditions set forth in a data use agreement. For subsequent use or disclosure of PHI for research purposes from a repository or database maintained by the covered entity, the covered entity may:.

A covered entity may also use or disclose PHI from databases and repositories for other purposes without Authorization as permitted by the Privacy Rule, such as if required by law or to a public health authority for a public health activity e.

Covered entities may also de-identify PHI according to standards set forth in the Privacy Rule so that its use and disclosure is not protected by the Privacy Rule. What documentation of an IRB or Privacy Board waiver or alteration of the requirement for an Authorization must a covered entity receive in order to permit a use or disclosure of PHI for research without Authorization? Patients, therefore, have the rights to their health information, as well as the right to obtain a copy of their health records.

This also gives them the right to request corrections in case of any errors. Privacy, therefore, facilitates personal autonomy, individuality, respect as well as dignity and worth as a human being.

Disclosure of patient information ruins the physician-patient relationship as well as trust between them. The patient is unable to trust the physician with any information pertaining to health.

They would be less likely to share sensitive information or refuse to seek care and be honest during healthcare visits. When sensitive information regarding a patient is disclosed, it may result to stigma, embarrassment, and discrimination. Violations of patient information also carry significant civil and criminal penalties which are under the law of the state.

These fines are not only imposed on individuals, but also on various health institutions. In some cases, the violations could also lead to criminal sentencing. Individuals will only accept to participate in health research if the protection of their information is guaranteed.


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