16. Special Topics

16 Special Topics

16.1 Certificate of Confidentiality

16.1.1 Statutory Basis for Protection

16.1.2 Limitations

16.2 Mandatory Reporting

16.3 Harvard University Students and Employees as Subjects

16.4 Psychology Department Study Pool

16.5 Student Research

16.5.1 Course projects

16.5.2 Independent Study, Theses, and Dissertations

16.6 Genetic Studies

16.7 Research Involving Coded Private Information or Biological Specimens

16.8 Investigator Self-Experimentation

16.9 International Or Off-Site Research, And Other Projects That Require External Verification

16 Special Topics 

16.1 Certificate of Confidentiality 

16.1.1 Statutory Basis for Protection 

Protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is provided by the Public Health Service Act §301(d), 42 U.S.C. §241(d): 

"The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so 

authorized to protect the privacy of such individuals may not be compelled in any Federal, State or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals." 

Certificates of Confidentiality constitute an important tool to protect the privacy of research study subjects. Certificates are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. 

Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to subjects. 

Certificates may be granted even if the study is funded from non-federal sources, or has no external funding. 

The Certificate goes beyond the consent form in ensuring confidentiality. Without the Certificate, researchers can be required by a court-ordered subpoena to turn over research documents (usually as part of a criminal investigation of the subjects or as part of a civil lawsuit where a subject is a party). 

Any investigator planning or conducting research in which identifiable sensitive information is gathered from human subjects may apply for a Certificate of Confidentiality. Research can be considered "sensitive" if it involves the collection of: 

• information about sexual attitudes, preferences, practices; 

• information about personal use of alcohol, drugs, or other addictive products; 

• information about illegal conduct; 

• information that could damage an individual's financial standing, employability, or reputation within the community; 

• information in a subject's medical record that could lead to social stigmatization or discrimination; or 

• information about a subject's psychological well-being or mental health. 

This list is not exhaustive. Researchers contemplating research on a topic that might qualify as sensitive should contact the CUHS Office for help in applying for a certificate. 

The CUHS may require investigators to apply for a Certificate of Confidentiality as a condition of approval. 

16.1.2 Limitations 

The protection offered by a Certificate of Confidentiality is not absolute. A Certificate protects research subjects only from legally compelled disclosure of their identity. It does not restrict voluntary disclosures. 

For example, a Certificate does not prevent researchers from making mandatory reports to appropriate authorities about matters such as child abuse, a subject's threatened violence to self or others, or from reporting certain communicable diseases. (However, the possibility of such disclosures should be clearly stated in the informed consent form that research subjects are asked to sign.) 

In addition, a Certificate of Confidentiality does not authorize the person to whom it is issued to refuse to reveal the name or other identifying characteristics of a research subject if 

the subject (or, if he or she is legally incompetent, his or her health care agent or legal guardian) consents, in writing, to the disclosure of such information; 

authorized personnel of the Department of Health and Human Services (DHHS) request such information for audit or program evaluation, or for investigation of DHHS grantees or contractors and their employees; or 

release of such information is required by the Federal Food, Drug, and Cosmetic Act or regulations implementing that Act. 

16.2 Mandatory Reporting 

While preparing a research protocol, investigators must keep in mind that the Commonwealth of Massachusetts mandates reporting by certain persons to designated officials and/or agencies, in cases of suspected child abuse and neglect; M.G.L. c. 119 sec. 51A; see Department of Social Services FAQ at 

http://www.doe.mass.edu/acls/abecert/update/041897upd.html

Investigators should consult the CUHS Office to determine if potential subjects should be advised of mandatory reporting requirements during the informed consent process. 

16.3 Harvard University Students and Employees as Subjects 

When Harvard University students and/or employees are being recruited as potential subjects, researchers must guard against coercion of these subjects. 

To minimize the risk of coercion, investigators should avoid, whenever possible, the use of their own students and employees in research studies. Participation in a research study must never be a condition of employment, insurance, grades, promotion, or any other benefits or bonuses. Investigators should solicit subjects via public forums, such as bulletin board notices, flyers, advertisements in newspapers, and announcements in classes other than their own. When entering a classroom to recruit students and conduct research, e.g., administer a survey, investigators should do so at the end of the class period to allow non-participating students the option of leaving the classroom, thereby alleviating pressure to participate. 

16.4 Psychology Department Study Pool 

The Faculty of Arts and Sciences Psychology Department administers a Study Pool. Students in participating Psychology courses may either sign up to participate in up to five study hours for course credit or complete alternate assignments determined by their course instructor. Members of the community may also participate for cash compensation. Graduate students, undergraduate thesis writers, and faculty may apply to use this Study Pool for their research. 

The Pool serves both to introduce students and members of the community to the process of psychological research and to provide members of the department with participants for their research studies. The Study Pool website is located at http://studypool.wjh.harvard.edu/. 

The Study Pool is guided by two principles: 1) Participation must be educational and 2) participation must be voluntary. 

The Department of Psychology conducts all Study Pool research and training in accordance with the ethical guidelines set forth by the American Psychological Association, as well as with CUHS policies and procedures. Any researcher using the Study Pool must have successfully completed the HETHR online training or equivalent as accepted by the CUHS. Department policies governing the use and operation of the Study Pool are regularly reviewed, and revisions pertaining to research activities are submitted to the CUHS for approval. 

16.5 Student Research 

All non-exempt research involving human subjects, including that conducted by students, is subject to review. Some student projects may not meet the regulatory definition of research since they are designed to instruct the students in research methods rather than being designed to develop or contribute to generalizable knowledge; the potential for risk to subjects who participate in 

student research will determine whether the protocol and consent information must be reviewed by the CUHS or by the course instructor(s). CUHS may require that students complete training in the ethics of human subjects research as a condition of approval of their application. 

The objective of the review, whether conducted by the CUHS or by the course instructor(s), is to ensure that the class assignment includes appropriate precautions for protecting human subjects—an important aspect of education in research methods. 

The CUHS has developed the following procedures to facilitate review. 

16.5.1 Course projects 

A faculty member who wants students in his or her course to conduct research involving human subjects as a class assignment should complete a CUHS application describing the nature of the research to be conducted by the students. Although exact details of each project will not be available, the application should describe the overall nature of the work to be done, the characteristics of subjects, how they will be recruited, the range of activities they may be asked to participate in, possible risks and benefits, procedures for obtaining informed consent, confidentiality protections, and any other relevant information as requested on the CUHS application form. 

If the proposed projects seem likely to involve no more than minimal risk to subjects, the course application will be reviewed by the CUHS Office and approval will be granted on the understanding that individual student projects will be reviewed, ordinarily using the CUHS application form, by the instructor or another experienced member of the course teaching staff, and any projects not falling within the boundaries of the approved course application will be referred to the CUHS to determine if further review is required. If the projects described in the course application seem likely to involve more than minimal risk, “blanket” approval will not be granted, and the students will be asked to submit individual applications to the CUHS. 

For student projects approved under these procedures, the instructor assumes responsibility for the conduct of the student research and is responsible for ensuring that projects are conducted in accordance with the requirements of CUHS approval. Instructors should educate students on the ethical conduct of research and help them prepare the CUHS application form. 

16.5.2 Independent Study, Theses, and Dissertations 

These research activities are considered to meet the federal definition of human subjects research and must be independently submitted to the CUHS by the student-researcher. Since students are not eligible to serve as Principal Investigators, they must have a faculty sponsor who meets their school’s Principal Investigator eligibility criteria; the faculty sponsor is ultimately 

responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. 

16.6 Genetic Studies 

Genetic research studies may create special risks to human subjects and their relatives, including medical, psychological, social, and economic risks, such as the possible loss of privacy, insurability, and employability; change in immigration status and limits on education options; and possible creation of social stigma. Knowledge of one's genetic make-up may also affect one's knowledge of personal disease risk status, or that of family members. 

In studies involving genetic testing, the following questions need to be addressed by completing an additional questionnaire, found at the CUHS website [link]: 

1. Will test results be given? 

2. Will disease risk be quantified, including the limits on certainty of the testing? 

3. Will a change in a family relationship be disclosed if discovered, such as mistaken paternity? 

4. Does the subject or family member have the option not to know the results? How will this decision be recorded? 

5. Could other clinically relevant information be uncovered by the study? How will disclosure of this added information occur? 

6. Do any practical limitations exist on the subject's right to withdraw from the research, withdraw data, and/or withdraw samples given for the research? 

7. Is the subject permitted to participate in the study while refusing to have genetic testing (such as in a treatment study with a genetic testing component)? 

For DNA banking studies, several questions need to be addressed, including: 

1. Will DNA be stored or shared? If shared, will the subject's identity be known by the new recipient investigator? 

2. Will the subject be contacted in the future by the investigator to obtain updated clinical information? 

3. How can the subject opt out of any distribution or subsequent use of his/her genetic material? 

16.7 Research Involving Coded Private Information or Biological Specimens 

Harvard University policy is based on the OHRP guidance document entitled, “Guidance on Research Involving Coded Private Information or Biological 

Specimens” (August 10, 2004 http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf). This document: 

• Provides guidance as to when research involving coded private information or specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46). 

• Reaffirms OHRP policy that, under certain limited conditions, research involving only coded private information or specimens is not human subjects research. 

• Provides guidance on who should determine whether human subjects are involved in research. 

For purposes of this policy, coded means that: (1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. 

Under the definition of human subject in Section 2 of this policy, obtaining identifiable private information or identifiable specimens for research purposes constitutes human subjects research. Obtaining means receiving or accessing identifiable private information or identifiable specimens for research purposes. This includes an investigator’s use, study, or analysis for research purposes of identifiable private information or identifiable specimens already in the possession of the investigator. 

In general, private information or specimens are considered to be individually identifiable when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Private information or specimens are not considered to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. 

Research involving only coded private information or specimens do not involve human subjects if the following conditions are both met: 

1. the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; 

and 

2. the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example: 

(a) the key to decipher the code is destroyed before the research begins; 

(b) the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement); 

(c) there are CUHS-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or 

(d) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased. 

In some cases an investigator who obtains coded private information or specimens about living individuals under one of the conditions cited in 2(a)-(d) above may (1) unexpectedly learn the identity of one or more living individuals, or (2) for previously unforeseen reasons now believe that it is important to identify the individual(s). If, as a result, the investigator knows, or may be able to readily ascertain, the identity of the individuals to whom the previously obtained private information or specimens pertain, then the research activity now would involve human subjects. Unless this human subjects research is determined to be exempt (See Section 7.2), CUHS review of the research would be required. Informed consent of the subjects also would be required unless the CUHS approved a waiver of informed consent (See Section 9.3). 

Who Should Determine Whether Coded Private Information or Specimens Constitutes Human Subjects Research 

The investigator in consultation with the CUHS Chair or Officer will determine if the research involving coded information or specimens requires CUHS review. If the request is oral (by phone or in person) or by email, it is the investigator’s responsibility to maintain documentation of such a decision. If the request is submitted in writing, it must include sufficient documentation of the activity to enable a determination by the CUHS Officer. Written submissions will be responded to in writing and a copy of the submitted materials and determination letter/email will be kept on file. 

16.8 Investigator Self-Experimentation 

The University-Area schools do not prohibit investigator self-experimentation. However, as it would with any proposed research, the CUHS will review each protocol and determine the appropriateness of the research. The CUHS will consider as part of its review the level of self-experimentation and the potential risks and benefits to the investigator as research subject. 

A main concern for the CUHS when reviewing a protocol that involves self-experimentation, is that the ideation of a novel concept may outweigh the investigator’s concern for his/her own welfare. For this reason, the CUHS may require that a CUHS member obtain informed consent from the investigator. The CUHS also may institute additional safeguards for the research project, such as shorter review periods and monthly progress reports. 

16.9 International Or Off-Site Research, And Other Projects That Require External Verification 

For international research, the CUHS seeks sufficient knowledge of the local research context by requesting approval for the project from local IRBs or ethics committees (which may or may not be NIH-registered) and/or local letters of support. The source of this information will depend on the nature of the study, on the country and on the resources available to the PI. At its discretion, the CUHS also may request that someone with special knowledge of the local research context either review a particular protocol, or attend an IRB meeting to provide the CUHS with recommendations based on his or her expertise. 

In some circumstances where research may be performed internationally and/or in settings where there are no IRBs, the CUHS may, prior to approval of the research, require additional verification and information from people outside the particular research project who are familiar with the customs, practices, or standards of care where the research will be taking place, such as local IRBs or ethics committees, other Harvard researchers with knowledge of the region, or other experts on the region. 

At its discretion, the CUHS may require verification from someone other than a researcher (for example, a Department Chair or CUHS member) that changes to documents or procedures, agreed upon by the researcher and the CUHS, have been made. Although uncommon, this external verification may be required by the CUHS if it has made more than one unsuccessful attempt to receive documentation of changes from the researcher, or if it has received a report from study personnel, study participants, or others, that changes it recommended were not implemented.