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Special Topics
These are areas the IRB has questions about from time to time. Investigators whose protocols will involve research in these areas will find the information under each area useful.
Oral History Collaborative Research
Research with Children
Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally incompetent to give valid consent. Special procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children. Whenever feasible, appropriate studies should be conducted on animals, adults and older children before young children are involved as research participants. In reviewing protocols, the IRB will consider the degree of risk inherent in the proposed research and the methods for obtaining the assent of the children and the permission of parents or legal guardians.
Investigators, when developing protocols, must ensure the informed consent process is clear that there is no prospect of benefit to the individual participant, and that the assent and permission are voluntary and uncoerced with no implication of obligation.
Who is a child according to federal regulations?
"Children" are 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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd). In most cases, these are individuals under the age of 21 years. However, in the state of Maryland, individuals are adults and of legal age (released from parental authority), when one attains the age of 18 years. Minors are those individuals who have not attained the age of eighteen years (source: http://mlis.state.md.us/cgi-win/web_statutes.exe - section § 24).
Obtaining consent and assent for participation
In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18. In cases where child abuse is an issue, the requirement for parental consent can be waived.
Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either mentally or emotionally, of being reasonably consulted about participating. The assent form, submitted to the IRB for review, should include a simplified version of the elements of informed consent, such as an explanation, at a level appropriate to the child's age, maturity and condition, of the procedure(s) to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research.
(NOTE: Participants under the age of 18 will need to complete an Assent form; a separate parental consent form is required for these participants providing parental permission to participate)
Click to download the General instructions and a sample assent form
Exempt research with minor children (under age of 18)
Research with children is eligible for exemption from IRB review involving these situations: 1) normal educational practices in commonly accepted educational institutions, 2) educational testing, and 3) observation in public settings. These activities fall under exemption categories (1) and (2), with the following provisions:
46.101(b)(1): Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. All data collected must be compiled as “groups of students” with no possible way to identify individuals, or compromise privacy or confidentiality.
46.101(b)(2): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) also applies to children. Information must be obtained and recorded in such a way, that subjects cannot be identified.
Research and procedure involving surveys (such as longitudinal studies), interview procedures (of ethnographic nature) or observations of public behavior where the investigators participate in the activities being observed does NOT meet exemption classification. In these cases, investigators are involved in an intervention and/or interaction where privacy may be compromised.
Waiver of Parental/Guardian Permission
By regulatory definition, “children” are persons who have not attained the legal age for consent to treatments, procedures, or other activities involved in research. Since children are considered a vulnerable population, the IRB imposes additional protections on research involving children, in accordance with the 45 CFR Part 46, Subpart D. This includes the investigator obtaining the permission of parents or guardian through the consent process and of the assent of the child, and the IRB being able to make certain findings based on the level of risk and benefit of the research. Consent from a parent or guardian must always be an affirmative agreement to participate or to give permission for one's child to participate in research.
The IRB may waive parental or guardian permission if:
Click to download the sample waiver of parental permission
Research that does not pose greater the minimal risk
A waiver of the requirement for parental or guardian permission may be requested by the researcher in studies that do not pose greater than minimal risks to the subjects. In such research, prior parental notification could then be used as one mechanism for meeting the requirement in 46.408(c) that an "appropriate mechanism for protecting the children who participate as subjects in research is substituted." Researchers will be required to provide a detailed plan for fully informing parents/guardians about the potential study and document that the research meets the criteria found in 46.116(d). A letter or packet of information sent home to parents or guardians with information about the study (for example, with students as part of regular school mailings) would satisfy parental notification. The IRB may accept an alternative mechanism to protect the child participants (i.e., appoint a qualified child advocate). In accordance with the federal regulations, the IRB requires that the investigator obtain the assent of the children, if the children are capable of providing assent, and it is not waived. The IRB also needs to know how the affirmative assent of the child will be documented, e.g., signature on assent forms, documented by the investigator, or other.
In certain situations, studies that may have a risk/benefit ratio where the benefit is high and will make a positive impact on the life and welfare of the children population involved. In these cases, researchers may be interacting with subject groups where parents or guardians have a lower response rate and do not send in consent forms, even after repeated attempts. In other extreme cases, a parent or guardian may not have the capability or knowledge to decide what is in a child's best interests.
Classroom or school based research
Research is ordinarily NOT suitable for a waiver of permission if it involves any of the following issues: · parental political affiliations or beliefs · mental or psychological problems · sexual behavior or attitudes · illegal, antisocial, or self-incriminating behavior · appraisals of other individuals with whom the minor has a familial relationship · relationships legally recognized as privileged (lawyers, doctors, clergy), or · religious affiliations or beliefs.
More than minimal risk research
One cannot obtain a waiver of parental consent for research that involves more than minimal risk unless the research involves issues of child abuse or neglect or other situations where obtaining parental permission might increase the risks to the child participants. In such cases parental consent may be waived. However, the investigator must supply an appropriate mechanism and justification for obtaining consent from someone serving as an advocate for the child.
In situations where the protocol involves more than minimal risk, parental consent alone may NOT be sufficient. A recent ruling by the Maryland state appeals court (downloadable in .pdf format, Grimes v. Kennedy Krieger - 366 Md. 29) affects how researchers in Maryland may conduct research with children that involves more than minimal risk. Although this ruling pertained to medical research, UMBC investigators, who plan to involve children in more than minimal risk studies, must carefully design protocols that will sufficiently provide protections from potential research harms. That is, investigators cannot use a placebo control group if a more effective intervention is available. Protocol submissions will require full board review.
Online or Internet Research
The incidence of on-line or Internet research has increased exponentially over the years, rapidly advancing ahead of efforts to create effective compliance guidelines. Internet communities (such as mailing lists, chat rooms, newsgroups, or discussion boards on websites) are rich sources of qualitative data for researchers. The IRB believes that online and Internet-based research protocols must address potential risks (e.g., violation of privacy, legal risks, and psychosocial stress) and provide the same level of protection as any other types of research involving human participants.
All studies, including those using computer and Internet technologies, must ensure that the procedures fulfill the principles of voluntary participation and informed consent, maintain the confidentiality of information obtained from or about human participants, and adequately address possible risks to participants including psychosocial stress and related risks. Participation by minors must be addressed in the protocol application.
The following guidelines are offered to help researchers plan, propose, and implement on-line or Internet research:
Recruitment:
Online and internet-based procedures for advertising and recruiting study participants (e.g., internet advertising, e-mail solicitation) must follow the IRB guidelines for recruitment that apply to any traditional media, such as newspapers and bulletin boards.
Data Collection:
It is strongly recommended that data collected from human participants over computer networks be transmitted in encrypted format. This helps insure that any data intercepted during transmission cannot be decoded and that individual responses cannot be traced back to an individual respondent. The highest level of data encryption should be employed, within the limits of availability and feasibility. Participants may be required to use a specific type or version of browser software.
Data Storage:
All personal identifying information should be kept separate from the data, and data should be stored in encrypted format. Researchers are advised to use pseudonyms when reporting results.
Observation of Internet activity:
This usually involves such activities as gathering information about the use of the Internet, recording user information or users’ comments. Examples include: participant observation of an on-line discussion group, using "cookies" to track web sites visited, or asking visitors to a web site to provide demographic information. The human subjects issues involved in this type of research generally involve consent/disclosure issues. Investigators need to indicate to the IRB how they intend to obtain the subjects' consent to use this information for research. As with other types of participant observation, investigators generally must disclose their role as researchers to the group participants.
Informed Consent:
For anonymous web-based surveys, participants would still need to be presented with the consent information and level of potential risk as a result of participating in the research, but would be informed that their consent is implied by submitting the completed survey. Other web-based surveys must include "I agree" or "I do not agree" buttons on the website for participants to click their choice of whether or not they consent to participate. A cover letter/consent page should indicate that by clicking on a "I agree" link, subjects are consenting to participate. This page should also include an e-mail address in addition to a telephone number to withdraw consent and remove data, to the extent possible, upon request of the respondent.
Click to download a sample web-based survey cover page
E-mail solicitations requesting participation in a study should contain a version of the approved cover letter and consent forms. Participants must be informed that by replying to the e-mail and completing the requested task(s) constitutes consent. With all of the above cases, researchers must request a Waiver of Written Informed Consent from the IRB, documenting how and why written consent would not be appropriate, and what format will be used to provide consent information to participants.
Confidentiality or Anonymity:
Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is in question. Investigators need to address how they intend to assure confidentiality, keeping in mind that the degree of concern over confidentiality is directly related to the sensitivity of the data. Data transmitted via e-mail cannot be anonymous without the use of additional steps. Because respondents' electronic addresses are typically provided when they return such surveys by e-mail, PIs should devise a plan for stripping such information to maintain the confidentiality and anonymity of respondents' names.
The researcher should also state how the confidentiality of the data will be maintained, for instance, when a survey will be posted online through a third party like Survey Monkey or Zoomerang, so that email addresses or web URLs will not be noted by the researcher.
Data submitted over the web can only be anonymous if software is used to store the information directly in a database without identifiers; otherwise identifiers are attached to the data. Web servers automatically store a great deal of personal information about visitors to a web site and that information can be accessed by others.
Further reading: Association for the Advancement of Science, Ethical and Legal Aspects of Human Subjects Research on the Internet (.pdf) Association of Internet Researchers, Ethical decision-making and Internet research American Psychological Association, Psychological Research Online: Report of Board of Scientific Affairs' Advisory Group on the Conduct of Research on the Internet
Oral History
All oral history interviews must conform to national standards of practice, such as those found in the guidelines at the Oral History Association web site. According to the Office of Human Research Protections (OHRP), oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and do not meet the definition of research offered by the Department of Health and Human Services. The Oral History Association and the American Historical Association have issued guidelines for their members about oral history projects. The guidelines take into account many concerns that an IRB would want to consider. The OHRP has concurred the OHA and AHA that most oral history projects are not research as defined by the HHS regulations governing human subjects research. However, some oral history interviewing projects may meet the definition of research.
To assist individuals in determining when oral history activities require human subjects review, the IRB is providing the following information from Michael Carome (OHRP). (This information represents a response to Northern Illinois University’s request for clarification regarding oral history projects.) In short, this guidance maintains that so long as oral history activities meet the federal definition of research according to 45 CFR 46.102(d), then they are still subject to IRB review. Therefore, investigators will be required to follow UMBC’s procedure for exempt review.
Investigators wishing to conduct oral histories may want to contact Dr. Joseph Tatarewicz, Department of History or Dr. Barry Lanman, Director of the Martha Ross Center for Oral History to discuss strategies in developing projects, interview and surveys.
Pilot Studies
The purpose of a pilot study is to evaluate the feasibility of a more exhaustive study and to serve as a model for the larger, more exhaustive scope of the research. In other words, pilot data is used to determine if a proposed study has the sufficient power to produce scientifically valid results. Some of the purposes for using a pilot study include the testing of a survey or questionnaire (to identify issues with wording or confusion with terms), identify potential issues with subject recruitment and participation, or to estimate statistical variations for the ultimate use and calculation of data.
IRB's need to review requests for such studies to determine if the risk/benefit ratio is acceptable. This will provide the Board an opportunity to comment on the ethical considerations of the design. Results from pilot studies may be used, and pooled, with the larger sample, provided the population remains the same and survey methods and instruments do not substantively change.
Pilot studies must be reviewed by the UMBC IRB before they are initiated. Such studies are generally approved for up to one (1) year. Following successful completion of pilot data collection, a closure report must submitted to the IRB prior to initiation of a larger scale study, for which the pilot data was collected.
Additional information about the design of pilot studies and the difference between pilot and exploratory studies may be found Steve Simon's web site, via Children's Mercy Hospital, Office of Medical Research, at http://www.childrens-mercy.org/stats/plan/pilot.asp.
Use of Existing and Archival Data
In many areas of the social sciences, one of the most commonly used methods of research is the secondary analysis of publicly available files of data. The federal government as well as large data consolidation bureaus and consortiums provide public access to many data sets. Additionally, many federal funding programs as well as social science professional organizations and journals now require that researchers make the data they collect publicly available to encourage scholarly replication of research. Data may also available from previously IRB approved protocols where the data sets do not contain information that could be used to identify individual research participants.
Publicly available, de-identified sources
Under the federal regulations for human subjects (45 CFR Part 46), research involving publicly available data sets are exempt from IRB review:
Investigators who plan to use these publicly available, de-identified sources do not require prior IRB review - no application is required.
The IRB has created a list of pre-approved data holders whose archives include publicly available, de-identified data. Review this list and follow the respective links below to learn more about the access and download procedures each data source.
Caution: If you are designing a research project that merges more than one public data set and you recognize that this may increase the risk of identification of individual research participants, please contact the Human and Animal Research Protections Office.
To obtain pre-approval of other eligible data sets and archives, investigators must submit the following information to the IRB:
If the IRB endorses the submission, the data set will be added to the list.
Data holders whose archives are available on a restricted basis will require the submission of an application for Expedited or full board review. Examples of such data involve:
Investigators may wish to use the below list as a reference for sources of data sets available on a restricted basis:
Human Tissues and Samples
A ‘human subject’ is a living individual about whom an investigator obtains either data through intervention or interaction with the individual or identifiable private information. Exemption category # 4 (§46.101(b)4 may be used for research projects 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 subjects cannot be identified, directly or through identifiers linked to the subjects.
Legal obligations to protect human subjects apply, for example, to research that use–
a) Bodily materials, such as cell lines, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials
What is meant by "existing" data or specimens?
Exemption #4 applies to retrospective studies of specimens and/or data that have already been collected. The materials must be "on the shelf" (or in the freezer) at the time the protocol is submitted to the IRB. Research that involves the ongoing collection of specimens and/or data does not meet the criteria for Exemption #4.
What is meant by "publicly available sources"?
This language in the regulation was intended to apply to public sources of data, such as census data. Its meaning with respect to human tissue specimens is widely debated. Although there are organizations that make human cells and tissues broadly accessible to the research community, these materials are not usually available to the public at large and are not generally considered to be publicly available.
What is meant by "identifiers linked to the subjects"?
Identifiers, such as names, social security numbers, medical record numbers, or pathology accession numbers, or other codes that permit specimens to be linked to living individuals and perhaps also to associated medical information.
Biological or pathological specimens qualify for exempt review (under Exemption category # 4 §46.101(b)4 only if: · Investigators do not receive or have access to existing individually identifiable private information or identifiable specimens from living individuals (e.g., pathology or medical records). If one retains or can access any identifiers, the research project is not exempt under Exemption 4 and must be submitted for expedited or full board review.
See the “Does this Require IRB Review” page for examples of research with biological or pathological specimens that do not require IRB oversight. Researcher’s are advised to review the following guidance from The Office for Human Research Protections coded private information or specimens “ Guidance on Research Involving Coded Private Information or Biological Specimens at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.”
Additional information and regulatory guidance and proper biohazardous materials waste disposal procedures may be found on the UMBC Biosafety Program web site, http://www.umbc.edu/ibc/
Collaborative Research
Collaborating Individual Investigators
Investigators from institutions with a Federalwide Assurance
If a study is being conducted at multiple sites, and IRB approval is needed from all of the institutions “engaged” in research, one institution may act as the “IRB of record”. This institution would assume the responsibility of the studies conducted at these multiple sites.
If the cooperative site(s) has its own IRB, the UMBC’s IRB preference is that each site be responsible for reviewing the research activities to be conducted at the respective site. The UMBC investigator should obtain a copy of the other institution’s IRB approval letter and submit that with the IRB application (or make arrangements to do so when the documents become available).
An IRB Authorization Agreement typically describes the role and authority of the IRB(s) involved in the study, the responsibilities of the investigator’s regarding human subjects protection education, training, policies, and reporting, the term of the agreement and the number of protocols to be reviewed.
Investigators from institutions that do not have a Federalwide Assurance
Investigators, who are not faculty, staff, students, or employees of the University of Maryland, Baltimore County may be covered under the UMBC’s Federalwide Assurance (FWA) only in accordance with the submission of a formal, written agreement of commitment to relevant human subject protection policies and IRB oversight. (source: Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement)
Applying for Ceritifcates of Confidentiality
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. Please continue to this page to learn more from the Department of Health and Human Services.
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