Special Topics

Children/Adolescents
Unanticipated Events
Risks/Benefits
Compensation
Classroom Research Projects
Confidentiality/Anonymity
Recruitment and Advertising
Continuing Reviews
Secondary Data

CHILDREN/ADOLESCENTS IN RESEARCH

• The vulnerability of children/minors as participants in proposed research warrants special ethical and regulatory considerations. It is essential that researchers understand that obtaining consent from minors/children is a two-fold process.
  • Step 1 - obtain signed consent from parent(s) or legal guardian
  • Step 2 - obtain assent/consent from the minor/child
• Risks, benefits, and associated discomforts for the child/minor may require the signature of both parents unless -
  • one parent is deceased
  • parent is unknown
  • parent is incompetent
  • parent is not reasonably available
  • one parent has legal responsibility of minor/child
• Federal law defines "children" as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. Under Pennsylvania law, persons under the age of eighteen (18) generally meet this definition of "children", with the exceptions noted below. As a result, permission of the child's parent(s) or guardian(s) must generally be obtained prior to the participation of that child in research. The following exceptions to the general rule apply, where a person under the age of 18 does not meet the federal definition of "child" and may provide legally effective consent to participate in research if either:
  1. The research involves the provision of medical care or treatment, (including care or treatment deemed to be experimental) AND the person:
     • (a) has graduated from high school, or
     • (b) is married, or
     • (c) is or has been pregnant.
  2. The person is an emancipated minor.
  If an emancipated minor provides consent for him or herself, the court order should be copied and included in the research records with the consent document.
  
  Federal regulation that govern research with children include 45 CFR 46, Subpart D and Subpart D of the FDA regulations.
• Assent/consent must also be obtained from the child.
• Dependent upon the age of the child, the appropriate methods for obtaining and documenting consent from the child will vary. The following guidelines are based on a panel discussion sponsored by the National Institutes of Health for obtaining assent/consent from children:
  • Ages 6 to 7 - A simple oral description (in terms the child can understand) of the child's involvement is to be given to the participant and oral assent is requested. This procedure is to be documented on the consent statement by the presence of the signature of a witness. Risks and complexity of the research need to be considered when determining the need for a witness signature documenting the assent/consent process.
  • Ages 8 to 13 - A more complete oral description (in terms the child can understand) of the research is to be given to the participant and verbal assent is requested. This procedure may be documented on the consent statement by the signature of a witness. Risks and complexity of the research need to be considered when determining the need for a witness signature documenting the assent/consent process.
  • Above age 13 - Signed written assent/consent is to be obtained from participants in an age-appropriate language consent document containing the basic elements of consent.
• Consent must be obtained before any research activity can be initiated.
• Literacy and mental development of child are factors that must also be considered when determining an appropriate means of obtaining assent/consent from children. A single method for obtaining assent/consent may not be appropriate for all children; therefore, the researcher may need to be prepared with alternate means of obtaining consent.
• Research involving children must follow the three basic ethical principles of research as defined in The Belmont Report. These principles are (1) respect for the persons; (2) beneficence; and (3) justice.
• Additional information concerning children in research may be found in the Code of Federal Regulations 45 CFR 46.408 and 21 CRF 50.55. Also, please refer to the IRB Parental Consent Guideline regarding parental consent and obtaining consent from children. You may also contact the Office for Research Protections at (814) 865-1775 for more information concerning children as potential research participants.

UNANTICIPATED EVENTS

It is the responsibility of the principal investigator to report unanticipated problems, adverse events, or issues of noncompliance to the Office of Research Protections (ORP) according to the Unanticipated Event policy. ORP will review the report and, if necessary, will notify the chair of either the Social Science or Biomedical (or both) Institutional Review Board (IRB) Committee to determine the course action that will be initiated. To report an adverse event, the Principal Investigator must submit a completed Unanticipated Event Report Form and any relevant medical records and consent forms. When attaching medical records and consent forms, do not include any of the participants' personal identifiers (e.g., name, social security number, etc.)

ORP and IRB Action

• Review submitted documentation;
• Determine if changes to the protocol will be required;
• Determine if revisions to the Informed Consent form will be required;
• Determine if current participants need to be informed of adverse event;
• Determine if study is to be monitored for a specified period of time;
• Request additional information, if necessary;
• Temporarily suspend research activity;
• Determine if actions taken by the investigator adequately addressed the adverse event or request further actions to be administered by the investigator;
• Determine if the study is to be permanently discontinued;
• Submit a report to the investigator regarding the findings of the IRB review.

Please contact the Office for Research Protections at (814) 865-1775 for additional information concerning unanticipated events.

RISKS AND BENEFITS

Potential participants are to be given a clear description of any foreseeable risks or discomforts they may experience by participating in a proposed research project. This description is not to be limited to "physical injury" alone, but needs to include information that addresses risks related to an individual's mental and emotional well being. The uniqueness of each participant will result in variations in the degree of risk they may or may not experience. Risks to participants are to be minimized and are to be reasonable in relation to potential benefits, if any, to participants and the importance of the knowledge that may reasonably be expected to result. Some risks, other than physical injury, to consider -

• Loss of employment;
• Admission of illegal drug use or under-age drinking could result in legal actions if data is subpoenaed;
• Loss of respect in community;
• Loss of family/friends;
• Emotional distress;
• Embarrassment;
• Negative social, psychological, and economic impact.

Investigators are encouraged to consider alternate ways to reduce risks (e.g., use fictitious names, code numbers only, etc.) when trying to evaluate and balance the risk/benefit factor.

Determining whether the risks are reasonable in relation to the benefits of the research is dependant upon a number of factors that are specific to the proposed study. Some benefits may be recognized immediately (e.g., learning new skills, an understanding of good nutrition, helping a community obtain a goal, etc.) However, some benefits are long term and are not as easily recognized when the intent is to contribute to society as a whole.

Please refer to the Code of Federal Regulations 45 CFR 46.111(a)(2), to The Belmont Report, or contact the Office for Research Protections at (814) 865-1775 for more information regarding this topic.

COMPENSATION

Federal regulations do not require researchers to give compensation to the participants participating in their research project. The Code of Federal Regulations 45 CFR 46.116 (a) (6) and (b) (3) clearly states that an explanation of compensation and an explanation of any additional costs the participant may incur are to be included in the Informed Consent Form.

If compensation is to be given to participants, it must be reasonable and non-coercive.

• Example - Paying $50 to disadvantaged individuals (e.g., unemployed participants) to participate in an interview could easily be considered coercive. A more reasonable compensation to consider would be $10.
• Example - A study occurring over a time period of several weeks with participants receiving payment of a $100 at the end of the study. In case participants need to terminate their participation (e.g., illness, family emergency, etc.) prior to their completing the study, prorating payment to the participant needs to be addressed in order to avoid coercion.
• Example - If participants are Penn State students and extra credit points are being offered as compensation, a comparable alternate means of earning the extra credit points needs to be offered in order to avoid coercion.

For information regarding payment to research participants, please read Penn State's document "CR2078 Payments to Research Participants" (PDF). This document may be found by doing a Penn State key word search for "payments to research participants" at Penn State's home web page.

Additional information regarding compensation for participants may be obtained from the Office for Research Protections at (814) 865-1775.

CLASSROOM RESEARCH PROJECTS

The following guidelines have been developed to assist instructors in differentiating pedagogical assignments/projects from research projects.

Research Projects

This differentiation is based on Title 45 Code of Federal Regulations (CFR) Part 46.102(d) where research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge (Federal Register, 56, p. 28013). Dissemination of findings to a scientific audience is a sufficient, but not a necessary, criterion for defining research. Dissemination includes, but is not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication, paper or electronic, in a scientific journal; and Internet postings. A human participant under the DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information (45 CFR §46.102[f]). If the project falls under this definition of research and human participant, review and approval of a human participants research protocol by the Institutional Review Board (IRB) may be required. Contact the Office for Research Protections (ORP) for guidance regarding the appropriate level of human participants review that must be conducted.

Please Note

Class-related instructional assignments/projects that do not fit the above criteria do not need to be submitted to the IRB/ORP for human participants protection review. If either knowledge contribution or dissemination is a possibility, and the project does not meet the exemption criteria, IRB review and approval must be obtained prior to the involvement of human participants. IRB approval of a research protocol cannot be granted retroactively under any circumstances. Research that falls under exemption criteria must be reviewed by the ORP prior to the involvement of human participants.

Advisory

• Instructors are advised to discuss these guidelines with students before the instructional assignment/project begins so informed decisions can be made about whether IRB review or ORP exemption determination is needed.
• If even the slimmest likelihood exists that an instructional assignment/project may fall under the definition of research and human participant outlined in this document, instructors are advised to submit the appropriate human participants research protocol to ORP for review and approval.
• Please remember that IRB approval of a research protocol cannot be granted retroactively under any circumstances.
• When overseeing instructional assignments/projects that do not fall under the definition of research and human participant outlined in this document, instructors are asked to advise students to identify the project as a class assignment. Labeling such projects as research is inaccurate and misleading for the students, as well as for others with whom the students may interact as a necessary component of completing the assignment.
• When overseeing instructional assignments/projects, instructors are asked to advise students that any data from human participants that are collected or analyzed should not contain personal identifying information when such information is not required for completion of the assignment/project.
• Instructors continue to be responsible for the ethical behavior of their students in conducting instructional assignments/projects.

CONFIDENTIALITY/ANONYMITY

Researchers must be aware that the differences between confidentiality and anonymity are distinct and unique from each other. The informed consent process must clearly describe the proposed means that a researcher will employ to ensure either confidentiality or anonymity.

DEFINITIONS

• Confidentiality means the researcher will have access to individually identifying information (e.g., the participant's name, social security number, driver's license number, etc.) for each participant. It is the researcher's responsibility to inform participants how their confidentiality will be protected. This may involve assigning a fictitious name to each participant. A researcher may consider employing a master list of code numbers that would replace the participants' name on specific questionnaires, surveys, interviews, etc.
• Researchers must inform participants, in the Informed Consent Form, how the collected data will be reported without individually identifying information and how the collected data will be protected from being individually identified.
• Anonymity means the researcher will collect NO identifying information from participants (e.g., no names, no social security numbers, no driver's license numbers, etc.) If participants can be assured anonymity, then this must be clearly explained in the Informed Consent Form. If the only link to identifying a participant is the consent document, the researcher may wish to use "implied consent". The only difference between implied consent and signed consent is the signature line. Signed informed consent may be waived if it is the only identifying link between collected data and the participants and the research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context. The only difference between a signed consent document and an implied consent document is the participant's signature line which may be replaced with a statement informing the participant that completion and return of the survey is considered implied consent.

Points to Consider

• Focus groups - Although participants will be aware of each other participating in the focus group (this is to be clearly explained in the Informed Consent Form), it is still the responsibility of the researcher to ensure that all data will be reported confidentially.
• One-on-one interviews - The proposed research may involve unique information (e.g., artists, musicians, historians, etc.) that may result in the need to identify the participants. If this is the case, this must be clearly explained in the consent document. Perhaps a specific "yes/no" statement can be used for the participant to complete that acknowledges their agreement to be identified or not to be identified.
• Reportable conditions - A proposed research project could result in the researcher finding circumstances of suspected child abuse. If this is the case, the researcher must inform the participants in the consent document that this information is considered reportable and to whom it will be reported.
• Tracking surveys - It may be necessary for the researcher to track the return of surveys (e.g., to mail follow-up surveys, payment to participants, etc.). One method of tracking to consider is to have a post-card returned by the researcher separate from the completed survey. A second method to consider is a code on the return envelope and have a third party (an individual not associated with the research) track, note, and destroy the code before giving the completed survey to the researcher.
• Certificate of Confidentiality - Researchers must be informed and they are to inform their participants that the courts can subpoena data. An avenue for researchers to explore to prevent data from being subpoenaed is to apply for a Certificate of Confidentiality. A research project does not have to be federally funded, but will only consider granting protection to research. For contact information (names, addresses, telephone numbers) regarding the Certificate of Confidentiality, please visit http://www.grants.nih.gov/grants/policy/coc/appl_extramural.htm?Display=Text.

You may contact the Office for Research Protections at (814) 865-1775 for additional information concerning this topic.

RECRUITMENT AND ADVERTISING

Researchers use many different methods for participant recruitment and advertising. Recruiting and advertising for participants is part of the research procedure and must be reviewed by the Institutional Review Board (IRB). Participant recruitment and advertising may not be initiated prior to review and approval by the IRB.

Recruitment

• Protect confidentiality of potential participants.
• Obtaining potential participants through a third party (e.g., a physician releasing the names of patients to a researcher), permission from the patients must be obtained.
• Researchers are responsible for ensuring that approved procedures are being followed by all (a third party) who may be assisting with recruitment.

Advertising

• Clearly state that recruitment is for research purposes.
• Identify study as a Penn State project, along with the name, address and/or telephone number of a contact person.
• Advertisements are to clearly represent the proposed research.
• Advertisements recruiting minors MUST clearly state that parental consent is required.
• Advertisements must not be misleading or coercive in anyway.
• Include eligibility criteria, if applicable.

For more information regarding this topic please refer to the guidelines for participant recruitment and advertising or contact the Office for Research Protections at 865-1775.

CONTINUING REVIEWS

Federal regulations require that all research activities involving the use of human participants and that do not meet the exemption criteria be submitted to either the Social Science Institutional Review Board (IRB) or the Biomedical IRB for review and approval prior to initiating the proposed project. The IRBs are also required by Federal regulation to conduct continuing reviews to ensure that measures are being followed to protect the rights and welfare of human participants participating in research.

Continuing reviews must be conducted within a twelve-month time frame of the projects original approval date. The degree of risk to the participant may warrant a more frequent continuing review process by the IRB (e.g., every three months, every six months, etc.).

PLEASE NOTE: Approval is only granted for one year. ORP attempts to reach all investigators prior to their expiration, however, principal investigator's are responsible for ensuring their approval does not lapse.

Research protocols that have been initially reviewed and approved by the full IRB require continued review by the full review process. Requests for continued review (Continuing Progress Report and Review Form) and approval for protocols requiring full review are forwarded to the principal investigator approximately two months prior to the expiration date.

The request for continued review should contain the most current Informed Consent Form, recruitment material and a completed Continuing Progress Report form. If continued approval is not obtained, termination of the project is immediate.

You may contact the Office for Research Protections at (814) 865-1775 or access the Office for Human Research Protection | En Español online for additional information concerning this topic.

USE OF SECONDARY DATA (PREVIOUSLY COLLECTED DATA - NOT PRIMARY DATA COLLECTION)

Use of previously collected data and/or human biological samples (e.g., DNA, blood, tissue, etc.) still warrants research investigators to respect the rights and welfare of the participants who have provided the data and/or samples. Participants who have previously provided data or human biological samples deserve the same respect and protection of their rights that potential participants are given when participating in primary data collection for research. Awareness of the participants' rights is especially critical when the secondary data and/or previously collected human biological samples contain identifiers or codes.

Review by the Institutional Review Board (IRB) may not be warranted if the data or previously collected does not contain identifiers or codes. However, proposed research for use of secondary data and/or previously collected human biological samples must be reviewed by The Office for Research Protections. This is specifically stated in The Code of Federal Regulations 45 CRF 46.101 (4), "Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants". Additional information may found at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm or http://www.cdp.ims.nci.nih.gov/policy.html.

The research investigator must consider the following information when proposing to use previously collected data and/or human biological samples for their research.

• Previously collected data and/or human biological samples that do not contain identifiers or codes that link information to the primary source may be exempt from IRB or may not even be defined as human participant research; however this determination cannot be made by the investigator, rather it must be determined by The Office for Research Protections.
• If secondary data and/or previously collected human biological samples can be identified by the investigator, or anyone associated with the research project, then review by the ORP/IRB is warranted.
• Secondary data and/or human biological samples that are coded, which means an avenue for identification is available, then review by the ORP/IRB is warranted.
• The principal investigator must identify the source of the data and/or human biological samples for the proposed research project -
  • Public data source - Census Bureau, public court records, opinion polls, etc.
  • Private data source - Organizations, corporations, colleague, another researcher, advisor, etc.
• A letter, or a form of acknowledgment, from the owner of the private data source acknowledging their permission for the research investigator's proposed use of the data must accompany the submission application.
• If applicable, a copy of the IRB approval for the original data and/or human biological samples collection is to be supplied.
• Use of previously collected human biological samples (blood, other body fluids and tissues, DNA) also warrant review by the Institutional Biosafety Committee (IBC). The application and information regarding submission to the IBC may be obtained at Biohazardous Materials page. For additional information, please see Penn State's Policy SY-24, "Use of Biohazardous Materials in Research and Instruction".

Definitions - as defined by the National Bioethics Advisory Commission (NBAC) in August 1999.

• Human biological samples include blood and other body fluids, tissues, DNA.
• Human data include responses to questionnaires or surveys, medical histories, and diagnoses.
• Source means the individual who provided the sample or from whom data was collected.
• Identified means samples or data that are still attached to a readily available participant identifier such as a name, social security number, address, telephone number, medical record number, etc.
• Coded means that collected samples or data are unidentified for research purposes by use of a random or arbitrary alphanumeric code but the samples may still be linked to their sources through use of a key to the code available to an investigator or collaborator.
• Unlinked means human data or samples that were initially collected with identifiers but, prior to research use, have been irreversibly stripped of all identifiers by use of an arbitrary or random alphanumeric code and the key to the code is destroyed, thus making it impossible for anyone to link the samples to the sources. This process does not preclude linkage with existing clinical, pathological, and demographic information before participant identifiers are removed.
• Unidentified means that the samples or data were collected without identifiers of any kind. Samples or data may retain demographic or diagnostic information and still be considered unidentified if such information cannot be used to reveal the identity of the source.

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