Research Involving Human Subjects Policies and Procedures

Research conducted within the School of Dental Medicine must adhere to the policies of both the School and CWRU. Any research involving external collaborations, such as University Hospitals or international sites, must account for the policies of those institutions as well. 

ClinicalTrials.gov Registration

Studies involving clinical interventions MUST be registered on ClinicalTrials.gov per federal regulations. Although other studies (e.g. observational research or biospecimen collection) are not required to be registered, it is highly recommended.

In order to register a study, the Principal Investigator must work with the CWRU IRB Office which administers the University's ClinicalTrials.gov registrations (cwru-irb@case.edu).

Informed Consent

Consent is an ongoing process that must occur throughout the duration of a research study to ensure subjects understand the procedures, risks, and benefits of the study in which they are participating. The process allows for exchange of information before, during, and after enrollment between investigators, study staff, subjects, and subject affiliates. Consent is ALWAYS a voluntary decision by subjects. 

Certain types of research may not require signed informed consent, or a consent process at all. Waivers of consent MUST be approved by an IRB before implementation.

Elements of Consent

1. Research Statement
2. Risks
3. Benefits
4. Alternatives to Participation
5. Confidentiality
6. Compensation/Reimbursement
7. Contact Information
8. Voluntary Participation
9. Additional Elements (if applicable)

Consent Process

The consent process for each subject must be documented within study records using the SODM ICF Documentation Checklist. The consent process should include:

• Obtaining consent in a location that ensures subject privacy
• Ensuring subject comprehension
• Obtaining signature and date of both subject and study staff performing consent process
• Providing copy of consent document to subject
• Placement of consent document copy in subject medical/dental records
• Secure storage of consent document in locked office

Consent of Special Populations

Special considerations are required when consenting individuals within special populations. 

1. Children/Minors
   Parental consent MUST be obtained before speaking with minors (individuals under the age of 18) about research participation. Consent documents and/or scripts must be approved by an IRB before use, and one or more parental signatures may be required on the document. IRBs may also require the assent or consent of minors in addition to the parental consent.
2. Employees and Students
   Employees and students must be informed that participation will not affect employment and/or academic status.
3. Impaired Subjects
   Subjects with impairments, including illiteracy, blindness, or mental impairment, require the presence of a third party witness during the consent process. Additional mental impairment may require the presence of a legally appointed representative or guardian. 

Data Collection + Management

Collection of data must adhere to strict federal and institutional HIPAA, privacy, and confidentiality regulations. The importance of following proper guidelines when handling patient information is crucial, and failure to do so may result in serious consequences. Read an example of recent HIPAA violations at universities. 

Protected Health Information (PHI)

PHI is any individually identifiable health information transmitted or maintained in a medical record (paper or electronic), or a designated data set that was created, disclosed, or used in the course of providing health care services, such as diagnosis, treatment, and/or payment. 

There are 18 identifiers considered to be PHI under HIPAA:

1. Name
2. All geographic information smaller than a State (e.g. street address, city, county, full zip code, geocodes)
3. All elements of date (except year) that are directly related to an individual, including:
   • date of birth
   • admission/discharge dates
   • treatment dates
   • date of death
   • all ages over 89
4. Phone numbers
5. Fax numbers
6. E-mail addresses
7. Social Security numbers
8. Medical Record Numbers
9. Health plan beneficiary numbers
10. Account numbers
11. Certificate/license numbers
12. Vehicle identifiers and serial numbers, including license plate numbers
13. Device identifiers and serial numbers
14. Web URLs
15. Internet Protocol (IP) address numbers
16. Biometric identifiers, including finger and voice prints
17. Full face photographic images and any comparable images
18. Any other unique identifying number, characteristic, or code