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Oklahoma State University

Human Subjects Research (IRB) - Research Design Guidance

IRB Research Design Guidance

Recruitment Materials

Recruitment materials that are to be placed on the OSU-Stillwater campus must receive a stamp of approval from Meeting & Conference Services, 179 Student Union, after IRB approval has been obtained. The Campus Signage Form must be filled out to post recruitment flyers. If recruitment is to take place in or around the Student Union either the Student Union Indoor Request Form or Outdoor Event Request Form must be filled out. Please visit Meeting & Conference Services website, www.meetings.okstate.edu/guidelines, to find the appropriate form(s) needed for your study. Questions about this process should be directed to Meeting & Conference Services at 405-744-5232 or via email at meetings@okstate.edu.

 

Defining the Subject Population

The investigator will need to describe the population from which the subjects will be selected. This description should be as specific as possible. It must identify the source(s) of the potential subjects, data or derived materials (i.e., organizations, institutions, businesses, or the general public). Additionally it should describe the characteristics of the population as appropriate for the research such as age or age range, sex, ethnic background and state of health. The investigator must specify if the subjects will include members of a special population as defined by IRB policy.

As appropriate to the research, the description of the subject population should also include the following:

  • If there are gender-based or ethnic/race based restrictions to enrollment in the research please explain and justify.
  • Describe any inclusion criteria. These should be based on the scientific rationale and safety considerations and should define who will be eligible as a subject.
  • Describe any exclusion criteria. These should be scientifically valid and help to further define the subject population.

Recruitment

Recruiting participants for research projects actually begins the process of consent and is an important part of informing participants about your project. Investigators must describe how prospective subjects will be recruited in the IRB application. This should include who will be involved in the recruiting, the methods to be used for recruitment (i.e., flyers, letters, emails, etc.) and, if appropriate to the research, how the researcher will obtain the names of the perspective subjects.

When reviewing recruitment methods and materials, the IRB must determine that they are not coercive and that they accurately describe the likely risks and benefits to participants (i.e. that they do not state or imply a certainty of favorable outcome or other benefit beyond what is outlined in the consent document and the protocol).

Any form of advertising for recruiting of human subjects to participate in research projects must be submitted for review and approval by the IRB, either with the initial IRB application, or as a modification as it is developed.

Some of the more commonly used types of advertising include flyers, posters, brochures, media advertisements, recruitment letters and word-of-mouth recruiting.

When appropriate, the following items may be included (but are not required) in advertisements and recruiting materials:

  • Name and address of the investigator(s) and/or research facility;
  • Condition under study and/or the purpose of the research;
  • In summary form, the criteria that will be used to determine eligibility for the study;
  • A brief list of participation benefits, if any (e.g., a no-cost health examination);
  • The time or other commitment required of the subjects; and
  • The location of the research and the person or office to contact for further information.

Advertisements should:

  • Not emphasize monetary compensation;
  • Not use catchy words like “free” or “exciting”;
  • Not be misleading about the purposes of the research
  • Not use words that are insulting like “fat”; and
  • Be very clear that research participation is what is being solicited.

An example flyer can be found at http://irb.okstate.edu/sites/default/files/irb_docs/Exampleflyer.pdf.

*Remember, any flyer or poster to be displayed anywhere on the OSU-Stillwater campus must also be approved by OSU Office of Campus Life. Campus Life views any research flyer or poster that contains the IRB approval stamp as officially sanctioned and will allow it to be posted. Campus Life can be contacted at 211 Student Union, 405.744.5488.

Describing the Methods and Procedures

The description of the methods and procedures of the research should explain what information the PI will be gathering and exactly how it will be collected and recorded. When appropriate this should include a description of any existing data sets to be accessed for information.

The PI should state the location where they will work with the participants. The specific processes to be used to collect the data should be presented in sequence and include details of any equipment or interventions to be used, and descriptions of any testing instruments, surveys, questionnaires or interviews to be used or conducted.

The PI should clearly distinguish between any procedures that are part of the research and those procedures that would occur regardless of the research. Describe any procedures, situations or materials that may present risk and describe the precautions to be used to reduce risk.

The PI must indicate if any personnel, in addition to the PI, will be interacting with the subjects or will be present during the subject’s participation. The qualifications, role and training of the personnel must be presented

State whether the data are anonymous or will be kept confidential. If the data collected has no identifying information to link a subject to his/her data, the data are anonymous. If the investigator will not share subject’s data with anyone except in aggregate form, the data are confidential. Even if only the PI knows who the subjects are, the data are still considered confidential.

Study Recruitment and Consent Document Readability

Children

The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. Title 45 CFR Part 46, Subpart D provides for "Additional Protections for Children Involved as Subjects of Research." Research that is contrary to the rights and welfare of child-subjects is prohibited.

Definitions Used with Research with Children

The federal regulations and OSU policies require that the IRB classify research involving children into one of four categories and document their discussions of the risks and benefits of the research study.

In all cases, the IRB must determine that adequate provisions have been made for soliciting the assent of children and the permission of their parents or guardians [45 CFR 46.408].

The four categories of research involving children that may be approved by IRBs, based on degree of risk and benefit to individual subjects, are as follows:

  • Research not involving greater than minimal risk [45 CFR 46.404].
  • Research involving greater than minimal risk, but presenting the prospect of direct benefit to an individual subject. Research in this category can be approved, provided: (a) the risk is justified by the anticipated benefit to the subject; and (b) the relationship of risk to benefit is at least as favorable as any available alternative approach [45 CFR 46.405].
  • Research involving greater than minimal risk with no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. Research in this category is approvable provided: (a) the risk represents a minor increase over minimal risk; (b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational settings; and (c) the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition that is of vital importance for the understanding or amelioration of the subject's disorder or condition [45 CFR 46.406].
    Both parents must sign the parent form (for studies approved in this category) unless one parent is deceased, unknown, not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
  • Research that is not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Research that is not approvable under 45 CFR 46.404, 46.405, or 46.406 may be conducted or funded by DHHS provided that the IRB, and the Secretary of DHHS after consultation with a panel of experts, finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a significant problem affecting the health and welfare of children. The panel of experts must also find that the research will be conducted in accordance with sound ethical principles [45 CFR 46.407].
    Both parents must sign the parent form (for studies approved in this category) unless one parent is deceased, unknown, not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
  • Children who are wards of the state can participate in research involving greater than minimal risk and of no direct benefit to the child only if the research is: (a) Related to their status as wards; or (b) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. If such research is approved, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. [45 CFR 46.409]

Prisoners

Because the very fact of incarceration may make it difficult to ensure voluntary consent and confidentiality, special regulations are in place to provide protections pertaining to biomedical or behavioral research involving prisoners as subjects. [45 CFR 46, Subpart C]. These regulations apply whenever any human subject becomes a prisoner at any time during a study. OSU policy requires that all research involving prisoners be reviewed by the full board.

Definitions Used with Research Involving Prisoners:

For research that will involve prisoners to be approved, it must fall within the categories of research permissible by the regulations [45 CFR 46.306(a)(2)]. These categories are:

  • Minimal risk and no more than inconvenience to subjects and is a study of causes, effects and process of incarceration and of criminal behavior;
  • Minimal risk and no more than inconvenience to subjects and is a study of prisons as institutional structures or of prisoners as incarcerated persons;
  • Research on conditions affecting prisoners as a class (such as research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults). If the study is funded by DHHS, the DHHS Secretary must first consult with experts and publish in the Federal Register. The IRB will have to report to DHHS.
  • Research with intent and probability to improve health or well being of subject. If the project is funded by DHHS and includes control groups which may not provide an y benefit, the study may proceed only after the DHHS Secretary has consulted with experts and published notice in the Federal Register. The IRB will have to report to DHHS.

There are seven (7) conditions that must be met before the IRB can approve research using prisoners as subjects:

  • Advantages through participation, when compared to their current situation, are not so great that they impair the prisoners' ability to weigh risks;
  • The risks from participation in the study are the same as those that would be accepted by non-prisoners;
  • Procedures for selection is fair to all prisoners. There must be immunity from intervention by prison authorities, and the control subjects (if applicable) must be randomly selected;
  • Language for obtaining informed consent must be understandable to all prisoners;
  • Parole boards cannot take participation into consideration, and prisoners' informed participation will not impact parole;
  • When studies need follow up, the provision for follow up must include a consideration of the length of individual sentences, and prisoners must be informed about follow up;
  • IRB must find that the research falls in one of the permissible categories of research listed above.

Decisionally Impaired Persons

The predominant ethical concern in research involving individuals with psychiatric, cognitive, or developmental disorders is that their disorders may compromise their capacity to understand the information presented to them. Diminished capacity may be due to psychiatric, organic, developmental, or other disorders that affect cognitive or emotional functions.

Other individuals who may be considered decisionally impaired with limited decision-making ability are persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps. Investigators must take special care to consider issues such as the selection of subjects, privacy and confidentiality, coercion and undue influence, and the risks versus the benefits.

Pregnant Women and Fetuses

The federal regulations require the IRB to document specific findings for research in this category to minimize risk or harm to the fetus, and additional attention is required for obtaining informed consent. Research involving fetuses should be conducted when there is no reasonable alternative to obtaining the necessary scientific information.

Investigators are encouraged to consult 45 CFR Part 46, Subpart B for precise requirements regarding research with subjects in this category.

Confidentiality Protection

Confidentiality issues need to be considered at every stage of the research process:

  • Initial study design;
  • Identification, recruitment and consent of subjects;
  • Security, analysis and final disposition of the data;
  • Publication or dissemination of the data and results.

Protections should be developed consistent with the study design and potential risk of harm from breaches of confidentiality. Considerations to minimize confidentiality issues that may influence research design include:

  • Limiting the amount of personal information to the absolute minimum;
  • Collecting information without unique identifiers attached to the data, or known to the researcher. Note: Some studies will require consent forms which identify the subject, but these names do not necessarily need to be linked to the data;
  • Changing or aggregating other identifiers that may be used to identify the subject by deduction such as age, income and occupation.

In many studies, however, the use of unique identifiers is unavoidable. In these cases there are data collection procedures that can reduce the risk to confidentiality. Some of these are:

  • Temporarily identifying responses and removing the subject names as soon as data are analyzed;
  • Assigning codes to names and storing the identifying list in a safe or separate area from the study data. Some studies use aliases to protect identity.

Certificate of Confidentiality

A Certificate of Confidentiality protects participants by protecting research records from subpoena. Without the certificate, researchers can be required by a court-ordered subpoena to disclose research results, usually as part of a criminal investigation of the participants.

Certificates of Confidentiality help to minimize risks to subjects by adding an additional level of protection for maintaining confidentiality of private information.

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies under two conditions: the research is on a sensitive topic; and the protection is necessary to achieve the research objectives. These certificates are granted sparingly but are not limited to federally funded research.

Research can be considered ‘sensitive' if it involves the collection of:

  • Information about sexual attitudes, preferences, practices;
  • Information about the 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 participant's medical record that could lead to social stigmatization or discrimination; or
  • Information about a participant's psychological well-being or mental health.

This list is not exhaustive. Researchers contemplating research on a topic that might qualify as sensitive should investigate the use of a Certificate of Confidentiality.

It must be understood that Certificates of Confidentiality protect participants from compelled disclosure of identifying information, but do not prevent the voluntary disclosure of identifying characteristics of participants. Researchers are not prevented from voluntarily disclosing certain information about research participants, such as evidence of child abuse or a participant's threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, it should be clearly indicated in the consent form. See an Example Voluntary Disclosure Statement.

Additional information can be obtained at the web site of the Office for Human Research Protections (OHRP) and at the NIH web site. Visit the NIH Confidentiality Kiosk. The OSU IRB office is available to assist with questions about, or application for, a certificate.

Data Storage

Data storage and disposition are also important considerations. Data should be stored in files accessible only to the investigator and their assistants. If computers are used to store data, the investigator must be certain that access to sensitive files is limited, and if possible, the computer is isolated from any networks. Audio and video tapes may be particularly revealing and may require special precautions to maintain confidentiality when airing or viewing and for storage.

Payment of Participants

A researcher may pay research participants. The payment for participation is not considered a benefit but rather a recruitment incentive or compensation for time and effort. All payments to participants in research must be fair and equitable.

Establishing the Level of Compensation

The IRB will review and determine that the amount is reasonable and not so large as to interfere with the ability of the participant to give informed consent without the possibility of undue influence. While the Federal Regulations do not specifically state how much researchers should pay participants or what that payment should look like, the IRB will apply a principle of reasonable compensation as it reviews participant payment for their time, effort and inconvenience. The IRB will also take into account information from the make-up of the sampling population, and the community environment and culture as it evaluates the appropriateness of participant payment.

Method of Disbursement

The method of disbursing payment should be included in the IRB application and should include discussion of the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive nor present undue influence. For research involving multiple interactions, payment for participation in research should not be contingent upon the participant completing the entire study but rather be prorated as the study progresses to insure voluntary participation. While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable providing that such an incentive does not present undue influence.

Processing Payments and Recordkeeping

Forms for and information on the procedures established for processing payments to participants to be used by OSU faculty and staff is available on the Grants and Contracts Financial Administration website at http://gcfa.okstate.edu/human-subject-compensation. These payment procedures have been developed to ensure that participant confidentiality is maintained while meeting Internal Revenue Service (IRS) reporting requirements and also conforming to the University's standard accounting and payment practices.

PhotoVoice

Some researchers use a method of qualitative data collection in which participants take photographs of some aspect(s) of their lives, environment, community, etc. The photographs are then used as a basis for group discussions and to elicit important qualitative information about the photographers' attitudes, beliefs, etc. The degree of risk to subjects in such research depends, in part, on what is photographed. For example, this process may pose the risk of self-incrimination to subjects who photograph themselves taking part in certain activities.

From the perspective of the IRB, the "human subjects" in the research are the research participants who are taking the photographs and then presenting their interpretations in group or other data gathering sessions. If the photographers are minors, then written parental consent for their participation in the research is required, along with assent of the minor participant.

Although the individuals whose photos are taken are not the subjects of the research, there may be legal requirements for obtaining permission for using their photographs. If the photographers take photos of other people, then permission to use the photo should be obtained. If the person being photographed is a minor, then permission to take the photo must be obtained from the child's parent or guardian. Those being photographed must be informed about how their photo will be used, and whether they will have the opportunity to view the photo before making a final decision about its use. If the photographs will be publicly displayed, such as at a professional meeting or community gathering, or used in manuals or brochures or other publications, then written consent to take and display the photograph publicly is required. Researchers must have a method to link pictures with the signed permission forms.