Policy, Guidelines, Regulations, and Ethical Principles
BYU Policies
Most BYU IRB policies are developed based on the interpretation of federal regulations (such as the Common Rule) and applicable Utah state laws. The primary source for these policies is BYU’s Human Research Protection Program (HRPP), with input from the University’s Office of General Counsel and relevant administrative offices. The Integrity and Compliance Office, under the direction of the Institutional Official, also contributes to policy development and oversight.
New or revised policies and guidelines are typically drafted by the HRPP, reviewed in consultation with legal counsel and university administration, and then shared with IRB members for comment and feedback. Final approval of policy changes rests with the Institutional Official.
Institutional policy may impose additional protections beyond those required by law; however, it must always meet or exceed federal and state regulatory standards.
Regulations and Ethical Principles
Below is a list of commonly referenced regulations:
- The Nuremberg Code
- The Belmont Report
- Office of Human Research Protections (OHRP): Protection of Human Subjects 45 CFR 46
- https://privacyruleandresearch.nih.gov/
Utah State Statutes
Recruitment and Informed Consent Considerations for Members
As discussed above, the first Belmont principle is that of respect for persons. This principle requires that subjects give their free and informed consent to participate in research. As such, during its review of a study, the Committee must examine the study’s recruitment and consent process – including recruitment materials and the consent form or information sheet to be used at the time of consent.
Below are some points to consider when reviewing the recruitment and consent process. Please also utilize the IRB Reviewers’ Checklist, which includes regulatory issues related to these processes.
Recruitment Considerations
Recruitment materials directed to potential subjects must be reviewed and approved by the IRB prior to use to ensure they are not unduly influential or misleading (301 FO). Recruitment materials must include information prospective subjects need to determine their eligibility and interest. Materials should be written in a language understandable to the subjects.
You will be asked to include a description of your recruitment methods in section 8 of the application.
Note: Some online platforms have limitations for the invitation being sent to potential subjects that prevent the inclusion of all the IRB-required elements. In that instance, document the limitation in writing for the IRB and, if the recruitment invitation links directly to an online consent that contains all the required information, the IRB may accept the briefer ad.
Required Elements:
- Study title and IRB study number
- The word “research.” Make it clear that this is a research study
- “Brigham Young University”
- The PI’s name
- A contact name with either a phone number or e-mail address
- Eligibility criteria, if applicable, should be noted briefly. Especially if payment depends on meeting these criteria. For example, “English speaking only,” “Women only,” etc.
- State whether subjects will be paid for their time and effort
If your study involves a drawing, include the odds of winning.
Acceptable:
- “You will be compensated for your participation.”
- “You will receive a gift card to X for [amt.] for your participation.”
- “Subjects will be compensated.”
- "Subjects will be entered into a drawing for [prize], with an estimated [1 in X] chance of winning."
- “You will be compensated for your participation.”
- The amount of payment may be included but should not be the most prominent element on the page. Compensation should not be excessive considering the nature of the project. Payment should be stated as a range of amounts or stated as “at least” or “up to” for payments dependent on the amount of participation.
Recommended Elements:
- Purpose of the study
- What is expected of the participant
- The time commitment
- The location where the research will take place
- Avoid phrases such as “help needed” or “subjects wanted.”
- The recommended wording is “You are invited” or “Subjects invited.”
Elements That Are Not Allowed*:
- Offers of compensation from the sponsor that would involve a coupon good for a discount on the purchase price of the product once it has been approved for marketing
- Claims that state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and protocol
- Claims that the drug, biologic or device is safe or effective for the purpose under investigation
- Claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling
- Use of the term “free” in reference to treatment or procedures
- Use of exculpatory language (language in the advertising whereby prospective subjects waive or appear to waive any of their legal rights)
- Use of bold or enlarged print or other means to emphasize payment or the amount to be paid
*Contact the IRB with any requests to include disallowed elements that may be appropriate within specific contexts of research.
Teaser Advertisements:
For online recruitment, projects may use teaser ads placed on social media sites where character length permits the following information:
- the teaser mentions that it is a research project;
- the teaser does not use inflammatory language or misleading statements; and
- the teaser refers the potential participant to a full flyer with all the required elements
Social media can be defined as any online and mobile resource that provides a forum for generating, sharing, or discussing ideas and content; variably grouped as online communities (e.g., patient support groups, population-specific dating services); social networking (e.g.,
Facebook; Twitter); professional networking (e.g. LinkedIn); content production and sharing (e.g., YouTube, Tumblr, blogs); location-based services (e.g. Tinder, Grindr); and others.
Ensure that proposed social media recruitment strategies respect all relevant ethical norms, including:
- Proposed recruitment does not involve deception or fabrication of online identities
- Research studies are accurately represented in recruitment overtures
- Proposed recruitment does not involve members of research team ‘lurking’ or ‘creeping’ social media sites in ways members are unaware of
- Recruitment will not involve advancements or contact that could embarrass or stigmatize potential subjects
Facebook:
- Allowable for recruitment and secondary data analysis only
What is the difference between Groups and Pages in Facebook?
Open forums are known as Pages and are created by companies, celebrities, and brands. These are public and although only administrators of Pages can post to the account, people with personal Facebook profiles can comment on any posts or pictures. The comment feature cannot be disabled, but comments can be removed/hidden by the administrator.
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Groups can be more private than Pages because the administrator has an option to choose the privacy setting. The comment feature can be managed in each group, as determined by the administrator.
- In “Closed Groups,” only those who are invited to join the group can see content shared within it. Other people on Facebook can see that the Group exists and who are members, but unable to see any information.
- “Secret Groups” are more private and no one else on Facebook can see that the Group exists except its members. The Group will not appear on the personal Facebook profile.
- “Public Groups” allow anyone on Facebook to see that the group exists and view the information that is posted, but only members of the Group have the ability to post.
General Considerations of Informed Consent (summarized from the federal regulations):
Consent must obtained from subjects or representatives before enrollment (there are very rare exceptions).
Consent must be obtained under circumstances that provide the subject or the representative sufficient opportunity to consider whether or not to participate. The possibility of coercion or undue influence must be minimized.
Prospective subjects must be able to understand the information provided to them. Subjects or representatives who do not speak English must receive information in their own language.
No language may be used that makes subjects waive or appear to waive any rights.
We will soon post a checklist of criteria required by federal regulation to approve informed consent.
Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers.
This requirement is founded on the principle of respect for persons, one of the 3 ethical principles governing human subject research described in the Belmont Report. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. The requirement for informed consent is one of these central protections defined by the Department of Health & Human Services (HHS) regulations at 45 CFR part 46.
Potential subjects must be provided with information about the research that is understandable and that permits them to make an informed and voluntary decision about whether or not to participate. The amount of information and the manner of presentation will vary depending on the complexity and risk involved in the research study. Informed consent is an ongoing educational interaction between the investigator and the research participant that continues throughout the study.
You must describe your process for obtaining informed consent for participation in human research. The process you employ for obtaining informed consent will depend on the research setting and your participant population. An in-depth description of the Process to Obtain Informed Consent has been provided for reference as you write the study protocol.
Types Of Consent
To assist you in choosing the right type of consent process for your study, read the descriptions of the types of consent, parental permission and child assent on the Protocol Templates & Forms page. Upload the proposed consent document(s) in section 4.1 of Initial Review Submission Packet.
We need to change Stephanie’s Role. She is now the HRPP Administrator and we will use her email address as sstone@byu.edu. I have ordered her own RC line and will see what her new number will be.
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- Questions about the transition from the iRIS system to OneAegis.
- Online submission system troubleshooting.
- Scheduling training sessions for individuals or for groups.
- Questions about research compliance
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