Obtaining patient consent for data collection

Obtaining patient consent for data collection involves a structured process to ensure ethical and legal compliance.

Understanding patient consent

Patient consent refers to when an individual agrees to share their medical or personal data for a specific purpose. There are several types of consent for different scenarios: 

• Informed consent: Patients explicitly agree to data collection after being fully informed of the purpose, risks, and how their data will be used. This is common in clinical trials and medical research.
• Implied consent: Consent is assumed through a patient’s actions, such as providing a sample for routine tests.
• Explicit consent: A higher standard of consent where patients must clearly agree, often in writing, before data is collected and used.
• Opt-in vs. Opt-out consent: Some regulations require patients to actively agree (opt-in), while others allow data collection unless the patient declines (opt-out).

Understanding these consent types helps to ensure ethical and legal compliance.

Go deeper: 

• Patient consent: What you need to know
• What to do when an individual revokes authorization

Legal and ethical considerations

According to a study titled Informed Consent by Parth Shah, “Ethical concerns arise when information is incompletely disclosed, either intentionally or unintentionally, such as downplaying certain risks or not presenting all available treatment options, including non-treatment. These occurrences can sometimes be driven by provider bias, where clinicians may assume what is best for the patient without fully engaging them in decision-making.”

Different regions have specific regulations governing patient data collection. Here are some key laws:

• General Data Protection Regulation (GDPR) – Europe: Requires explicit consent for processing personal health data. Patients must be informed about how their data will be used and stored.
• Health Insurance Portability and Accountability Act (HIPAA) – USA: Mandates that patient data be kept confidential and that written authorization is obtained for data sharing.
• Good Clinical Practice (GCP) Guidelines: Sets ethical standards for medical research worldwide, ensuring voluntary and informed participation.

HIPAA and patient consent

According to the U.S. Department of Health and Human Services (HHS), “A covered entity must obtain the individual's written authorization for any use or disclosure of protected health information that is not for treatment, payment or health care operations or otherwise permitted or required by the Privacy Rule. A covered entity may not condition treatment, payment, enrollment, or benefits eligibility on an individual granting authorization, except in limited circumstances.

An authorization must be written in specific terms. It may allow use and disclosure of protected health information by the covered entity seeking authorization or by a third party. Examples of disclosures requiring an individual's authorization include disclosures to a life insurer for coverage purposes, disclosures to an employer of the results of a pre-employment physical or lab test, or disclosures to a pharmaceutical firm for their own marketing purposes.

All authorizations must be in plain language, and contain specific information regarding the information to be disclosed or used, the person(s) disclosing and receiving the information, expiration, right to revoke in writing, and other data. The Privacy Rule contains transition provisions applicable to authorizations and other express legal permissions obtained prior to April 14, 2003.”

Step-by-step process for obtaining consent

Step 1: Identify the purpose of data collection

Clearly define why the data is being collected and how it will be used. For example:

• Clinical research
• Medical diagnosis and treatment
• Health policy planning
• Quality improvement initiatives

Step 2: Draft a comprehensive consent form

A well-structured consent form should include:

• Purpose of data collection: Explain why the data is needed and how it will be used.
• Types of data collected: List the specific data points, such as medical history, test results, or genetic data.
• Voluntary participation: Inform patients that they can refuse or withdraw consent at any time without repercussions.
• Confidentiality and data security: Describe how patient data will be protected and stored.
• Data retention and disposal: Indicate how long data will be kept and how it will be discarded after use.
• Contact information: Provide a way for patients to ask questions or withdraw consent later.

Step 3: Communicate clearly with patients

Use simple, non-technical language to explain the consent process.

• Provide consent forms in multiple languages if necessary.
• Allow patients to ask questions and ensure they fully understand their rights.

Step 4: Obtain and document consent

• Written consent: The patient signs a consent form (paper or digital).
• Verbal consent: If written consent is impractical, record verbal consent and document it in the patient’s file.
• E-consent: Digital platforms can facilitate consent through online forms, ensuring a secure and auditable process.

Step 5: Provide patients with a copy

After signing, patients should receive a copy of the consent form for their records. This reinforces transparency and allows them to review their agreement later.

Step 6: Regularly review and update consent

Consent should be revisited periodically, especially in long-term studies or when data usage changes. Patients should be informed and re-consented if necessary.

See also: A guide to obtaining explicit consent

Addressing special cases

There are circumstances where obtaining standard patient consent may not be straightforward. In such cases, additional considerations must be made to ensure ethical and legal compliance. This section explores special situations where alternative consent methods may be required and provides guidance on best practices for handling these challenges.

Patients who cannot provide consent

For minors, unconscious patients, or those with cognitive impairments, consent must be obtained from a legally authorized representative (guardian or legal proxy).

For the case of minors, the HHS states that “the procedures used in obtaining informed consent and parental permission should be designed to inform the subject population or the parents of the subject population about the research in terms that they can understand. Therefore, informed consent and parental permission language and its documentation in the accompanying forms (especially an explanation of the study’s purpose, duration, experimental procedures, alternatives, risks, and benefits) should be provided in language that is understandable and culturally sensitive to those being asked to participate or provide permission for their child’s participation.”

As for the sharing of information related to mental health, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) says that “Section 164.510(b)(3) of the HIPAA Privacy Rule permits a health care provider, when a patient is not present or is unable to agree or object to a disclosure due to incapacity or emergency circumstances, to determine whether disclosing a patient’s information to the patient’s family, friends, or other persons involved in the patient’s care or payment for care, is in the best interests of the patient.1 Where a provider determines that such a disclosure is in the patient’s best interests, the provider would be permitted to disclose only the PHI that is directly relevant to the person’s involvement in the patient’s care or payment for care.”

Learn more: 

• Obtaining consent from persons with mental illness
• Helping mental health patients choose a personal representative

Withdrawal of consent

“The Privacy Rule gives individuals the right to revoke, at any time, an Authorization they have given,” says the U.S. Department of Health and Human Services (HHS). Healthcare organizations must therefore establish a clear procedure for processing withdrawal requests and ensure that data is deleted or anonymized accordingly.

Emergency situations

“Informed consent may be waived in emergencies when there is no time to obtain consent or when the patient cannot communicate, and no surrogate decision-maker is available. If concerns or uncertainties exist about a patient's decision-making capacity, a psychiatrist may be consulted to evaluate their competency,” says Parth Shah.

Best practices for ensuring compliance

To ensure HIPAA compliance, 

• Maintain proper documentation: Keep signed consent forms and records of verbal consent securely stored.
• Educate staff: Train healthcare professionals and researchers on consent requirements and patient rights.
• Use secure systems: Store patient data in encrypted databases to protect against breaches.
• Ensure transparency: Clearly communicate data use policies and ensure patients understand how their information will be handled.

See also: HIPAA Compliant Email: The Definitive Guide (2025 Update)

FAQS

Why is patient consent necessary for data collection?

Patient consent ensures ethical and legal compliance, protects patient rights, and builds trust between patients and healthcare providers or researchers.

How should patient consent be documented?

Consent can be documented through signed forms, recorded verbal agreements, or secure digital platforms.

What should be included in a consent form?

A consent form should include the purpose of data collection, data types, voluntary participation, confidentiality measures, data retention details, and contact information.