Manual for Conducting Human Subject Research

Miscellaneous Policies

(Updated 3/14/08)

11.1 Tissue or Data Repositories (Databases) for Research

Under current regulations, the creation of a repository or database and the research use or disclosure of identifiable information from a database is considered “research”. In most cases, such research will be subject to either individual informed consent (and HIPAA Authorization when appropriate) or waiver of informed consent (and waiver of HIPAA authorization) by the HRRC. An individual may sign a consent form (and HIPAA authorization) allowing his or her information/tissue to be kept in a database for future research, however, any future use of information/tissue from that database for research purposes will require a new application to be submitted and approved by the HRRC and a new protocol-specific informed consent (and HIPAA authorization) or waiver of informed consent (and waiver of HIPAA authorization) by the HRRC. When subsequent research use of data/tissue from a repository is de-identified (absent the 18 specified identifiers according to the HIPAA Privacy Rule), such use is likely to be determined to be exempt by the HRRC. [45 CFR Parts 46, 160 and 164]

If a repository is created or has been created with the intent for future research use, including for recruitment purposes, HRRC approval and continued oversight of the database is required. For each repository, a Principal Investigator will be named "Repository Manager." In most cases, the repository will be required to prepare a “repository informed consent document" and accompanying HIPAA Authorization Addendum, which will clarify: the purpose of the repository (i.e. recruitment), who is responsible for it (repository manager), who will oversee it (HRRC), who will have access to the information (study recruiters, if the HRRC approves specific applications requesting access to the repository for recruitment), and the fact that any investigator who wants access to the repository will first have to submit an HRRC proposal for review and approval.

Repository Managers are expected to maintain a consent form and authorization corresponding to every new subject enrolled (unless waivers are granted by the HRRC). The Repository Manager must collect a copy of the HRRC approval for every investigator who wants access to the repository.

Tissue and Data Repositories

With regard to tissue and data repositories for research use, there are three components that need to be considered:

1. Tissue or Data Collectors
2. Repository Storage and Data Management Center
3. Recipient Investigators

Activity within each of these components must be under an HRRC approved protocol.

Tissue or Data Collectors

This process includes clinicians or researchers collecting and providing tissue and/or data to a repository. Such activities may be an ancillary part of an HRRC approved study conducted by the clinical investigator (i.e. clinical trial with an optional tissue banking component) or may involve a clinician, during the course of clinical care, helping to supply tissue/data to an HRRC approved repository managed by someone else. Likewise a researcher may be collecting tissue and/or data specifically for his or her own repository. All such activities must be conducted under an HRRC approved collection protocol (and an informed consent document when applicable).

Repository Storage and Data Management Center

The maintenance of a repository for current or future research purposes must have HRRC approval and ongoing oversight unless the HRRC has granted an exemption or determined the activity to not meet the definition of “human subject research”. The repository must have a protocol specifying the conditions under which data/specimens will be accepted, stored and shared, ensuring adequate provisions are in place to protect the privacy of subjects and maintain the confidentiality of data.

Recipient Investigators

Recipient investigators are those who receive tissue or data from an approved repository for intended research purposes. The recipient investigator must obtain HRRC approval unless the repository from which the tissue/data is being obtained has an approved HRRC protocol for releasing de-identified data/tissue or data/tissue including only a code or otherwise considered a limited data set under HIPAA. The recipient investigator may in such cases be required to sign a usage or data use agreement with the institution.

When individually identifiable information is to be released to a recipient investigator, HRRC approval is required. Such approval is project specific and is not covered by the approval of the repository.

The HRRC oversight process for each of the categories is as follows:

Activity	HRRC Application Required	HRRC Oversight Requirements
Collectors
Clinicians helping to supply an HRRC approved human tissue repository (collection only with no research intent)	none	Working under an approved collection protocol of an approved Human Tissue Repository (HTR) obtaining informed consent with an approved consent document.
1.) Investigators obtaining tissue for banking as an optional part of a clinical trial and: Are not planning to use the tissue for further research; and 2.)    Will not be managing the repository in which tissue will be stored	HRRC Expedited/Full Application	The HRRC will review the collection protocol and informed consent as part of the review of the clinical trial protocol.  No separate Repository Application is needed.
Investigators obtaining tissue/data for an identified research project, who will also maintain individually identifiable information for future unknown research purposes	HRRC Expedited/Full Application for current project & Repository Application if requesting to maintain for future use	At such time that individually identifiable information is being maintained for research purposes, a repository has been created.  Maintaining individually identifiable information for any future research purposes must receive approval as a research repository.
Repository Managers
Investigator maintaining a tissue and/or data repository for research use	Repository Application	HRRC approval and ongoing oversight is required for all repositories containing individually identifiable information.  Protocols for specimen/data collection and sharing must be specifically approved by the HRRC.
Recipient Investigators
Investigator receives only de-identified information from an HRRC approved repository	none	The repository must have an approved HRRC protocol for releasing de-identified data/tissue.  The Human Tissue Scientific Review Committee (SRC) must review and approve the removal of tissue from the repository.
Investigator receives only a limited data set from an HRRC approved repository	none	The repository must have an approved HRRC protocol for releasing coded data/tissue which is considered a limited data set under HIPAA.  A data use agreement between the recipient and repository manager/institution is required. The Human Tissue Scientific Review Committee (SRC) must review and approve the removal of tissue from the repository.

11.2 HRRC Subject Recruitment Guidelines

The HRRC will give consideration to the following basic principles and ethical considerations when determining whether or not recruitment strategies for a given research project are acceptable.

Ethical Considerations

• Respect for Privacy: Does the recruitment strategy respect an individual’s reasonable expectations for privacy? Will patients be upset when they learn researchers not involved in their care have read their medical records without permission?
• Lack of Pressure: Is the study introduced in a way that allows subjects ample time to consider participation, with no undue pressure because of timing of the request, who makes the request, or how the request is made? Will patients be put in a situation where they may hesitate to say “no” to their own physician? How will pressure be minimized?
• Unbiased Presentation: Is all information accurate, balanced and free of misleading emphases that make the study excessively attractive? Is the information as complete as is appropriate for each stage of recruitment?
• Conflicting Concerns:
  • Subjects may prefer that someone involved in their care contact them about research, but they may find it hard to say “no” to a care provider.
  • Clinicians may find their clinical judgment in conflict with a desire to enroll patients in their research.

Basic Principles

• Use of Medical Records: Access to medical records and identifiable health information by people not directly involved in a patient’s care should be avoided.
• Use of Protected Health Information: The amount of identifiable information gathered and the number of people who have access to it must be minimized.
• First Contact: Prospective research subjects should be contacted by people directly involved with their care, not by unknown researchers.
• Exceptions: Exceptions to these principles may be granted where necessary. The HRRC application must clearly explain why exceptions (waivers) are necessary and investigators must understand that approval is not automatic.

Acceptable Methods of Recruitment

The following methods of recruiting subjects are considered acceptable by the HRRC. Depending on the circumstances, any of these methods may be in compliance with both the federal Common Rule (45 CFR 46) and the federal HIPAA Privacy Rule (45 CFR 164), but there may be ethical and/or practical problems with any of the methods. All methods of recruitment should be clearly explained within the HRRC application.

1. Clinics maintain a separate HRRC-approved recruitment protocol/database that asks patients if they will agree ahead of time to be contacted for research. This requires a separate submission to the HRRC. See “Future Research Consent Form” used to obtain patient permission to contact them for future research. This allows investigators to contact patients about particular studies in accordance with their signed consent.  The HRRC has also determined that a separate HIPAA Authorization is not required from subjects who provide signed informed consent to allow their personal information to be stored for the purpose of future contact.
    
2. Advertisements, notices, emails, and/or media are used to recruit subjects. The HRRC must approve the text of recruitment materials prior to use. Subjects who respond to these methods of recruitment will contact the study investigators. Note: No HIPAA-regulated Protected Health Information is used in this recruitment strategy.
    
3. Study investigators provide their colleagues with a "Dear Patient” letter describing the study (see “Sample Physician Recruitment Letter” on HRRC website). This letter should be signed by the treating physicians and informs the patients how to contact the study investigators. The study investigators are prohibited from having access to patient names, addresses, or phone numbers; patients must initiate contact. See 7.b. below for additional options.
    
4. Study investigators send a HRRC-approved letter to colleagues asking for referrals of eligible patients interested in the study. The study investigators may provide the referring physicians a HRRC-approved information sheet about the study to give to the patients. If interested, the patient will contact the PI. Or, with documented permission from the patient (e.g., note in medical record indicates primary care provider spoke with patient who agreed to be contacted), the PI may be allowed to contact patients about enrollment.
    
5. Study investigators who are also clinicians providing direct care recruit their own patients directly. Nurses or staff working with the investigators may also approach the patients. This respects privacy but also raises ethical concerns because of the subject’s potential difficulty of saying no).
    
6. Study investigators recruit potential subjects who are unknown to them. Examples include “snowball sampling,” use of social networks, direct approach to unknown people in public situations, and random dialing.
    
7. Study investigators request a Waiver of Consent/HIPAA Authorization for recruitment purposes. Because patient medical information is private, any access by persons other than the patient’s caregiver raises confidentiality and privacy concerns. Therefore, where at all possible, other means of recruitment should be considered and used. If access to patient medical information for recruitment is being sought, in all cases the waiver must be justified in the HRRC application and “Attachment 8 Request for Waiver of Informed Consent/HIPAA Authorization” must be completed. Waivers are granted in three primary situations:
   1. In minimal risk studies in which subjects will be not be contacted (e.g., many chart review studies) researchers request a complete waiver of consent/HIPAA authorization. The application must explain why the study cannot be done without the waiver.
   2. If the study requires researchers to review charts to identify prospective subjects who will then be contacted and asked to be in the study, the justification for the waiver to review charts must show why the study cannot be done without the waiver. Among the factors the HRRC may consider in determining whether this review may be permitted are the sensitivity of the information, who will be accessing the records, importance of the research and whether other recruitment mechanisms may be reasonable alternatives. The waiver covers collecting only the minimum amount of information needed to make contact; consent/HIPAA Authorization is obtained before additional information is gathered.

Acceptable Methods of Approach

The HRRC’s usual policy is that patients identified through chart review should be approached by someone already involved in their care. “Already involved in their care” includes healthcare professionals directly involved in their clinical care. The research opportunity is presented to the healthcare professional and he/she is asked to notify the prospective participant of the opportunity. In such cases where the investigator is already involved in an individual’s care or where participants have explicitly agreed to be contacted about future research studies, a third party is not necessary. The patient’s health care provider is often in the best position to assess whether the research project might be in the best interests of the patient. Further, contact from others not directly involved in the patient’s care may in some cases be upsetting to the patient. Thus, contact with the potential research participant is usually not allowed by the researcher and generally must be made by a person or on the behalf of a group (i.e. clinic) that is directly involved in the patient’s care. The initial contact is generally by a letter that notifies the patient of the availability of the study and allows the patient to indicate whether he/she is interested in having the researcher or research staff contact him/her to provide further information (see #3 above). The precise method of contact must be pre-approved by the HRRC. Primary caregivers, due to their position as authority figures and medical caregivers, must take care when contacting patients about research participation to avoid being coercive when discussing the opportunity. All recruitment strategies are reviewed and approved by the HRRC on a case-by-case basis.

Recruitment Documents that Require HRRC Review

The following types of recruitment documents must be submitted as part of the initial application for HRRC review. Any additions or changes to these documents must be submitted as formal modifications of the study:

• Letters to Subjects: All letters to subjects or their representatives, regardless of who signs the letters, including the PI, a primary care provider, or an organization the subject has joined.
• Advertisements: All advertisements in all media, including flyers, posters, newspaper ads, emails*, brochures, radio or television announcements, and informational videos. TV or video materials should be submitted as tapes or DVDs. An advertisement will most likely be approved which states: "Participants will be compensated up to $____ for their time and inconvenience" if the amount is not felt to be coercive and the statement is not in bold or larger letters so as to attract someone's attention.  Also, if overnight stays, multiple procedures or visits or extensive time commitments are going to be needed, such information should be included in the advertisement to justify larger compensation amounts.
• Scripts: All scripts or guides that will be used for in-person or telephone recruitment interviews.
• Web Postings or Pages: With one exception, all advertisements for human research studies must have specific HRRC approval. This exception is for internet advertising. For internet listings of human research studies, limited basic information may be posted without specific HRRC approval. This information is limited to: title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information.

*NOTE: If using the UNMHSC public affairs email system as a method of recruitment, this must be approved by HRRC first.  UNMHSC Public Affairs will refer the investigator to the HRRC if documentation of prior approval has not been provided.

Guidelines for Developing Recruitment Materials

When developing recruitment materials, keep the following considerations/guidelines in mind:

1. Advertisements may not be misleading by making promises of safety or efficacy
2. Benefits or financial compensation must not “stand out” in outsized or bolded fonts
3. “Payments” must not appear to be an incentive for participation. However, you may use the phrase “You will be compensated for your time and inconvenience”
4. Advertisement should clearly state that this is research or an investigation.
5. Advertisement should include the name of a primary contact and a method of making contact
6. Advertisement may give some brief eligibility criteria such as disease, condition, age limits, etc.
7. Printed materials should contain the HRRC study number clearly posted in the lower left corner; Radio advertisements, Movie Theaters, Bill Boards, Buses, etc. - Researchers can be creative when they add the HRRC study number to non-printed recruiting materials.
8. May also provide some brief procedural information such as the location of the research, duration of participation, type of intervention, or mode of administration.

11.3 Finder’s Fees and Bonus Payments for Recruitment

Faculty, staff, residents, medical students, nurses, and all others conducting human research under the purview of the HRRC are strictly prohibited from offering or receiving any "finder’s fee" or other inducement, in cash or in kind, for the purpose of referring patients as candidates for participation in clinical research. Paying or receiving such fees is forbidden under New Mexico law and, depending upon the circumstances, may be in violation of the federal anti-kickback statute. Likewise, no individual or organization conducting human research under the purview of the HRRC may receive “bonus payments” from sponsors that are tied to the rate or timing of subject enrollment.

11.4 State Laws and Human Research

In addition to the federal laws, human research conducted in New Mexico must adhere to applicable state law. Investigators and subjects should be informed with regard to how state laws affect a particular research study.

UNM researchers may conduct research in states other than New Mexico.  As each state has different laws, UNM researchers are expected to adhere to the laws of the state in which research is being conducted as well as those of New Mexico.  For example, states often differ in laws pertaining to "legally authorized representatives" as discussed in section 7.4.  Researchers are encouraged to contact legal counsel for guidance on other state's laws regarding the "legally authorized representatives."

State law requires reporting to the Public Health Division of the Department of Health certain communicable and infectious diseases including HIV/AIDS, sexually transmitted diseases and tuberculosis and nontuberculous mycobacterial infections. Reportable events also include certain wounds (i.e. firearms and gunshot injuries; stab wounds; projectile wounds), health conditions related to environmental exposures, certain occupational injuries, adverse vaccine reactions, cancer, and birth defects. Visit the State Health Department For a complete list of Notifiable Conditions in New Mexico (pdf.) If research involves the potential detection of these diseases, investigators should be aware that the discovery of a reportable event does not affect the legal requirement to report these events. In addition, during the discussion of steps to maintain confidentiality the informed consent should disclose that should the research staff uncover a reportable disease, the participant’s personal information will be reported to the Public Health Division of the Department of Health in accordance with state law.

Any competent adult including a researcher, who knows or has a reasonable suspicion that a child is an abused or neglected child, is required by state law to report the matter immediately to:

1. a local law enforcement agency;
2. the department office in the county where the child resides; or
3. tribal law enforcement or social services agency for any Indian child residing in Indian country.

Resident abuse (i.e., abuse of an inpatient of a UNM HSC facility) is also a reportable event. If the research involves the potential detection of child abuse or neglect or resident abuse and neglect by mandatory reporters, investigators should be aware that the discovery of a reportable event does not affect the legal requirement to report these events. In addition, during the discussion of steps to maintain confidentiality the informed consent should disclose that should the research staff detect child abuse or neglect or resident abuse and neglect suspect, the participant’s personal information will be reported to Child Protective Services in accordance with state law. See the following “WHERE TO REPORT INCIDENTS, INJURIES AND DISEASES INVOLVING PATIENTS” for more information.

When HIV testing is done as part of a research study, the standard HIV testing consent must be signed in addition to the research consent form. Investigators should use this form, and IRB members should ensure this form will be used in research studies that involve HIV testing.

Where to Report Incidents, Injuries and Diseases Involving Patients (Please Post)

Incident, Injury, Disease	Legal Duty	No Legal Duty	Report To:
Abandoned Newborn/ Infant (Safe Haven for Infants)	X		UNMH Risk Management Pager # 951-3777
Adult (abuse, neglect, or exploitation of an incapacitated adult)	X		Children, Youth and Families Dept. Hotline #  841-6100
Adverse reactions to vaccinations	X		Physician who gave vaccine reports to: http://vaers.hhs.gov/
Animal bites – if whereabouts of animal are known	X		Animal Control Officer #  768-1975
Child (abuse, neglect, or exploitation of a minor)	X		(1) Law enforcement if the child needs to be detained at a UNM HSC Clinical Facility; (2)  Children, Youth and Families Dept. Hotline #  841-6100
Communicable diseases including sexually transmitted diseases	X		(1) Infection Control # 951-3000 (2)  Tricore labs reports cases from positive lab results
Domestic abuse		X	No legal duty to report unless victim is also a “vulnerable adult”  (lacks capacity/ unable to care for self, then report adult abuse)
EMTALA (inappropriate transfers)	X		UNMH Risk Management Pager # 951-3777
Firearms and gunshot injuries; stab wounds; projectile wounds	X		1) Appropriate jurisdiction of Law Enforcement 2) NM Department of Health # 1-800-432-4404
All Abortions are reportable within 5 days of the event, irregardless of weeks gestation, procedure, or self-induced.	X		UNMH Pathology reports to State Registrar at Department of Health  # (505) 827-2536 Report abortions on the “Report of Induced Termination of Pregnancy” available from N.M. Vital Records and Health Statistics in the Dept. of Health
Medical device contribution to serious injury or death	X		UNMH Safety Pager # 951-2994 during business hours; after hours, report the following business day (save device)
Medical equipment contribution to serious injury or death			Clinical Engineering Dept.
Motor vehicle accidents/ DWI		X
Resident abuse (i.e., abuse of an inpatient of a UNM HSC facility)	X		New Mexico Dept of Health Incident Management Bureau 1-800-752-8649 or fax form found at this web page
Restraint-related deaths	X		UNMH Risk Management Pager  # 951-3777
Seizure or other conditions that affect driving ability			HSC Legal Counsel # 272-2377
Reporting of fetal death (for fetuses weighing > 500 grams) within 10 days of the event.	X		State Registrar at Department of Health # (505) 827-2536. Report on the “Report of Fetal Death” available from N.M. Vital Records and Health Statistics in the Dept. of Health
Suddenly, violent, untimely death, or cause of death is unknown	X		Office of the Medical Investigator (OMI)  # 272-3053

UNM HSC Legal Office: # 272-2377 or 272-6638/ UNMH Risk Management: # 272-8639 or 951-3777.

11.5 Research Involving Partners of Family Members of Study Participants

If your research involves partners or family members of study participants then the following guidelines apply to you:

• Identifiable information on the partner/family members may not be collected until they have signed an HRRC approved consent document and HIPAA form that allows health information to be collected (i.e. You cannot collect - Name, address, phone number, etc.)
   

• Investigators/staff cannot directly contact the partner/family member. 
  One acceptable method of contact is to provide the study participant with a letter that can be given to the partner/family member.  The letter should contain information about the reason for the contact and how to get in touch with investigator or staff should the partner/family member choose to participate in the data collection or wish to obtain further information.  The investigator should not initiate further contact with the partner/family member if there is no response to the letter.
   

• Investigators must supply the HRRC with information relating to the inclusion of partner/family member data:

1.     Specific information to be collected

2.     Proposed method of consent

3.     HIPAA documents

4.     Proposed letters to the partner/family member (requires final review and approval by the HRRC)

• Federal regulations require that IRBs address specific protections for protected populations including pregnant women, children, and newborns.

 

 

 

• Manual for Conducting Human Subject Research

• ---

• Table of Contents
•  1. Introduction
•  2. Oversight
•  3. HRRC Membership
•  4. HRRC Meetings
•  5. HRRC Review & Investigator Applications
•  6. Criteria for HRRC Review and Approval of Research
•  7. Informed Consent Requirements
•  8. Monitoring of and Investigator Requirements Regarding Research in Progress
•  9. Use of Drugs & Devices Beyond the context of Research
• 10. Research Records
• 11. Miscellaneous Policies
• 12. Available Regulations, Policies & educational Material
•  
• Human Research Review Committee Home