Informed consent in clinical research, clinical investigation, and clinical trials

Secondary purposes of the patient medical record do not relate directly to patient care and includes providing data for use in clinical research, epidemiology studies, education, public policy making, facilities planning, and health care statistics.

Some examples of  patient medical record that do not relate directly to patient care but providing data for use in clinical research include the following:

1. Alzheimer Registry to collect data to evaluate prevalence of Alzheimer’s disease and related disorders by providing non-identifying information and data for policy planning purposes and to support research
2. Birth Defects Registry which maintains national surveillance for collecting information on birth defect incidence, to monitor annual trends in birth defect occurrence and mortality, to conduct research studies to identify genetic and environmental risk factors for birth defects, and  promote educational activities for the prevention of birth defects
3. Cardiac Registry that captures cardiac surgery information as a research tool for assessing cardiac patient outcomes and pinpointing how patient care can improve
4. Cancer Registry for the management of cancer data collection, recording data elements for each entry that become part of a national registry which is used for education, prevention, quality improvement, and research activities
5. Trauma Registry of all trauma admissions, deaths in the emergency department due to trauma, recording data elements for each entry that become part of a national registry which is used for education, prevention, quality improvement, and research activities

In this post I shall focus on informed consent that must be obtained when a patient decides to participate in clinical research, clinical investigations, or clinical trials, and skip the discussion on privacy issues and requirements when health care providers routinely allow medical professionals engaged in clinical or epidemiological research to access patient records, abstract individually identifiable information (e.g., date of birth, birthplace, and so on), and exchange that information with other researchers.

Image credit :http://www.cancer.gov/

Informed consent is an ongoing process during which information is presented to an individual patient and families to enable them to voluntarily decide whether or not to participate in or continue participation in clinical research, clinical investigations, or clinical trials. The information provided at the time the decision to participate was made serves as the basis for the informed consent. Informed consent for research involves presenting the research information orally and  obtaining written consent on an approved consent form prior to entering a subject into a study and documenting the consent process in the subjects’ medical record or research file.

Health Information Management (HIM) / Medical Records (MR) practitioners need to be aware that medical records of patients in an ongoing process when such patients participate in clinical research, clinical investigations, or clinical trials will contain the following:

1. the informed consent form must be dated
2. the identity of the individual providing the information to the patient and family and obtaining the consent must noted in the patient’s medical record
3. consent is documented in the patient’s medical record by signature or record of verbal consent

If you are wondering why the patient’s family is involed in obtaining the consent, then the reader should be aware that a family member or person involved in the care of the patient as the participant  are usually encouraged to participate in the consenting process because (i) of the potential subject’s physical and mental state at the time of obtaining the consent, and (ii) to allow time for the patient to consider whether to participate and to discuss the research with his/her family over a period of time (which may include days or weeks). This is especially when particularly complex issues about the research are discussed, an investigator might consider testing the subject’s understanding of the information by asking questions about the presentation and when a family member or person involved in the care of the participant should be encouraged to participate in the consenting process.

At this jucture, I like to advice HIM / MR practitioners who wish to know more about the process of obtaining  informed consent from potential research subjects to explore the ‘Informed Consent  and Authorization Toolkit for Minimal Risk Research’ developed by the Agency for Healthcare Research and Quality (AHRQ). Although this toolkit is applicable in the United States and subject to the Health Insurance Portability and Accountability Act (HIPAA) requirements, it is a good read for understanding  the process to facilitate the process of obtaining informed consent and authorisation from potential research subjects if any such HIM / MR practitioner(s) is/are working at a hospital where clinical research, clinical investigations, or clinical trials is a common activity.

HIM / MR practitioners must also be aware that the Joint Commission International (JCI) Standard PFR.8 which states that “Informed consent is obtained before a patient participates in clinical research, clinical investigation, and clinical trials” and its four (4) Measurable Elements (ME) which must be met fully at hospitals that are JCI accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status.

HIM / MR practitioners must also check on the process of obtaining signed informed consent when patients voluntarily decide whether or not to participate in or continue participation in a research study which must comply with the requirements of any existing hospital guidelines or hospital policy.  HIM / MR practitioners can be proactive to suggest or initiate proper documentation in medical records for patients who participate in in a research study at the hospital they work at.

Lastly, HIM / MR practitioners do take note that the JCI Standard PFR.8  is checked for compliance in the Medical Record Review Tool form used in the Medical Record Review process if your hospital is already JCI accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status.

References:
The Agency for Healthcare Research and Quality (AHRQ), Informed Consent and Authorization Toolkit for Minimal Risk Research,  viewed 20 October 2012,< http://www.ahrq.gov/funding/grants/policies/informedconsent/index.html >

Joint Commission International 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA

Michelle, AG & Mary, JB 2011, Essentials of Health Information Management: Principles and Practices, 2nd edn, Delmar, Cengage Learning, NY, USA