The Medical Research Guide

If you want to create your own database at your institution, you will need the Institutional Review Board (IRB) approval. This post will give you an overview of what the IRB is, HIPAA policies, and the ethics involved in institutional studies.

Why Ethics Matter in Medical Research

Medical research fundamentally aims to improve healthcare and patient outcomes, but it must do so within ethical boundaries that protect the rights, safety, and dignity of participants. Historically, unethical studies led to significant harm, prompting the establishment of strict ethical standards that we abide by today. The Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) policies are two central pillars of ethical research. Understanding these is crucial for medical students and residents to conduct research responsibly and ensure their studies comply with legal and ethical standards.

What is the Institutional Review Board (IRB)?

The Institutional Review Board (IRB) is a committee that reviews and approves research involving human participants. The IRB’s primary responsibility is to protect the rights and welfare of research participants. It ensures that studies meet ethical standards and comply with federal regulations. Every research project involving human subjects—whether a survey, clinical trial, or observational study—requires IRB approval before it begins.

Key Functions of the IRB

1. Risk-Benefit Analysis
   The IRB evaluates whether the potential benefits of the research outweigh the risks to participants. This is essential, as some studies involve procedures or interventions that may pose risks, from physical harm to emotional distress.
2. Informed Consent
   The IRB ensures that participants are fully informed about the study, including its purpose, procedures, risks, and benefits. Informed consent is a cornerstone of ethical research, as it guarantees that participation is voluntary and based on a thorough understanding of what the study entails.
3. Privacy and Confidentiality
   The IRB assesses how researchers plan to protect participants’ private information. This includes ensuring that data storage, access, and publication practices minimize the risk of identifying individual participants.
4. Vulnerable Populations
   Studies involving vulnerable groups, such as children, pregnant women, and individuals with cognitive impairments, undergo additional scrutiny to ensure their protection. These populations may have limited ability to provide consent or face higher risks, requiring extra safeguards.

Types of IRB Review

Depending on the level of risk involved, studies can undergo different types of IRB review:

• Exempt Review: Minimal-risk studies that meet specific criteria, such as anonymous surveys or educational research, may qualify for an exempt review, which requires minimal IRB oversight.
• Expedited Review: Studies involving no more than minimal risk, such as collecting blood samples or certain behavioral research, may be eligible for an expedited review by a smaller IRB committee.
• Full Review: Studies with greater than minimal risk or those involving vulnerable populations require a full IRB review, where the entire board evaluates the research proposal.

Applying for IRB Approval

For medical students and residents, applying for IRB approval may seem intimidating, but it’s a structured process designed to help researchers consider the ethical implications of their study. Here’s a basic outline of how to prepare an IRB proposal:

1. Develop a Research Plan
   Begin by defining your study’s purpose, methodology, and expected outcomes. Your proposal should clearly outline how the study will be conducted, including the procedures, data collection methods, and analysis plans.
2. Describe Participant Involvement
   Detail how participants will be recruited, how many will be involved, and what they will be asked to do. The IRB will assess whether the study places any undue burden on participants or exposes them to unnecessary risks.
3. Draft an Informed Consent Form
   The informed consent form should clearly describe the study’s purpose, procedures, risks, benefits, confidentiality measures, and the right to withdraw at any time. Use simple language, avoiding medical jargon, to ensure participants fully understand what they are agreeing to.
4. Outline Confidentiality Measures
   Describe how you will store, protect, and potentially anonymize participant data. The IRB wants to see that measures are in place to prevent unauthorized access or disclosure of sensitive information.
5. Submit the IRB Application
   Submit your application, including all necessary documents, to your institution’s IRB. Be prepared for potential revisions, as the IRB may ask you to clarify details or adjust aspects of the study to enhance participant safety.

Sample IRB Proposal

A sample IRB proposal typically includes:

• Study Title: A clear, descriptive title.
• Principal Investigator: The name and affiliation of the lead researcher(s).
• Purpose: A brief statement outlining the study’s objectives.
• Background: A summary of existing research relevant to the study.
• Study Design and Methods: A detailed description of how the study will be conducted.
• Participant Involvement: How participants will be recruited, what procedures they will undergo, and any risks they may face.
• Confidentiality: Details on data protection and storage.
• Informed Consent: A copy of the informed consent form.

Sample IRB document from one of my research projects.

SAMPLE IRB PROPOSAL DOCUMENT

Role of Cardiac CT in TAVR vs. SAVR in patients with prior Cardiac Surgery

Introduction  
The increased mortality and morbidity of reoperative cardiac surgery may be mediated by several factors including increased technical difficulty, and also by progression in the presence or severity in medical co-morbidities. From a technical perspective, a major factor includes the presence of cardiovascular structures immediately beneath the sternum that pose a threat for injury during surgical re-entry.  The potential for injury of arterial grafts (particularly the left internal mammary artery), which are often patent at the time of re-operation, poses a particularly high risk of arterial injury. Thus, reoperative cardiac surgery represents a challenging situation for the cardiac surgery team where methods to reduce the occurrence of serious but preventable complications achieves importance.

Contrast-enhanced multidetector computed tomographic (MDCT) angiography provides a potential method to mitigate the risk of surgical re-entry during reoperative cardiac surgery.  This technique comprehensively evaluates the structures of interest to the surgeon, including the chest wall, mediastinal structures, coronary bypass grafts, and their relationship. For the surgeon, a “roadmap” of substernal anatomy could theoretically minimize the risk of injury upon surgical re-entry. Studies on cardiac CT before reoperative cardiac surgery have suggested that perioperative outcomes may be improved.,Two recent studies performed at , the use of cardiac CT was associated with fewer peri-operative transfusions, post-operative MIs and shorter time in the ICU with decreased length of stay and cost.

In particular, in patients with severe aortic stenosis, patients often have several risk factors for morbidity including advanced age, severe lung disease and renal insufficiency.  Recently, the use of transcatheter aortic valve implantation has offered patients an alternative to median sternotomy.  Clinical risk stratification for either procedure.  has typically involved the use of risk scoring systems such as the Society of Thoracic Surgery Risk score.  However, these methods of risk stratification may not capture technical elements of risk stratification afforded by cardiac CT.  

Based upon this therapeutic potential of cardiac CT to improve the safety of reoperative cardiac surgery, our center began performing cardiac CT in 2004 for the indication of defining the substernal anatomic structures.   Given recent treatment advances in severe aortic stenosis with the advent of transcatheter aortic valve implantation (TAVI), findings on cardiac CT may improve appropriate patient selection for surgical versus transcatheter based approaches.  There is no data on the impact of cardiac CT on risk stratification in patients with severe aortic stenosis.
Methodology

Design
Retrospective review of patients in the Cardiac CT registry, Aortic Stenosis, Echocardiography and Cardiac Surgery registry, including those patients who were referred for evaluation for novel Aortic Stenosis therapies at the  with a history of prior cardiac surgery or having been previously considered for surgery.  The time period to be analyzed is 2007 to 2013.  We expect a sample size of about 500 patients.

 Cardiac CT features to be studied include, but not limited to:

Proximity of the major cardiovascular structures including the right ventricle (RV), aorta, innominate vein, or bypass graft to the sternum

Adherence of a major cardiovascular structure to the sternum

Coronary bypass grafts which cross the sternal midline

Porcelain Aorta

Annulus, coronary height and other measurements related to valve sizing

Clinical Features to be studied include:

Age

Gender

Race

HTN, DM, HL, Family Hx of CAD, h/o smoking, h/o prior MI, prior PCI, prior CABG, CKD, ACS, PCI, CABG

Intraoperative Findings

Echocardiographic Findings

Prior surgical factors

Treatment assignment

Other pertinent clinical features

The primary endpoint of the study will be type of treatment utilized: Sternotomy versus TAVI versus medical therapy.  Secondary endpoints will be estimated blood loss during surgery, surgical time, mortality.  Descriptive statistics such as frequencies, means and standard deviations (SD) will be used to describe the study population.  Student’s t-test will be used to compare mean values of normally distributed data.  Cox-regression methods will be used to evaluate risk factors for the primary and secondary outcomes.  Statistical significance will be set at a P value of <0.05 for the primary endpoint.

Identity of patients will be known to investigators, but investigators will deidentify personal information as per HIPAA privacy rule.  As this is a retrospective study, the patients are placed at no risk and this study involves no direct involvement of the patient.  

Budget

There are no additional costs incurred by this study, and no budget is proposed.

Personnel:

XXXX

References

.XXXXX.

HIPAA and Its Role in Medical Research

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that safeguards patients’ protected health information (PHI) to ensure privacy and security. HIPAA applies to any study that involves PHI, which includes medical records, lab results, and any data that can identify an individual. Medical students and residents must understand HIPAA’s requirements to handle patient data responsibly.

Key HIPAA Terms

1. Protected Health Information (PHI)
   PHI includes any health-related information that can identify an individual, such as names, addresses, dates of birth, Social Security numbers, and medical history.
2. De-Identification
   HIPAA-compliant studies often involve de-identified data, meaning all personal identifiers are removed. De-identified data is not subject to HIPAA regulations, making it easier to use in research.
3. Limited Data Set
   A limited data set contains some indirect identifiers but no direct identifiers, like names or addresses. Researchers can use a limited data set if they sign a data use agreement with the institution.
4. Authorization
   For studies that involve PHI, researchers must obtain authorization from participants to use their health information. The authorization form must clearly explain what information will be used, who will access it, and how long it will be retained.

HIPAA Compliance in Research

HIPAA compliance is essential when conducting research that involves PHI. Here are a few strategies to ensure your study follows HIPAA guidelines:

1. Use De-Identified Data When Possible
   De-identified data is not subject to HIPAA, so whenever possible, remove personal identifiers before analyzing data. This can often be done for retrospective chart reviews or large datasets.
2. Secure PHI
   If you need to use identifiable information, ensure that it’s securely stored. Use password-protected files, encrypted databases, and limit access to only those directly involved in the study.
3. Sign Data Use Agreements
   When working with a limited data set or collaborating with other institutions, sign a data use agreement that specifies the terms for handling PHI.
4. Obtain Participant Authorization
   If your study requires PHI, obtain authorization from each participant. Be transparent about what information you’ll collect, how it will be used, and how it will be stored.

Conclusion

Understanding IRB and HIPAA policies is essential for conducting ethical medical research. By adhering to these guidelines, medical students and residents not only protect participants’ rights but also build a foundation of trust and responsibility in their careers. Compliance with IRB and HIPAA ensures that research contributes positively to both science and society, paving the way for innovations in healthcare while respecting the individuals who make such advancements possible.

References

1. Belmont Report. (1979). Ethical Principles and Guidelines for the Protection of Human Subjects of Research. U.S. Department of Health, Education, and Welfare.
2. Health Insurance Portability and Accountability Act of 1996. (1996). Public Law 104-191. U.S. Government Publishing Office.